Can products used in vehicle environments be registered in the same unit as products used in hospitals?
In principle, products used in vehicle environments (when the vehicle is stationary) and products used in hospitals can be classified into the same registration unit. If there are other differences between the products besides the usage environment, they should be classified according to the principles of registration unit division.
Is it sufficient to provide in vitro burst testing and animal trials as supporting evidence for ultrasonic soft tissue cutting and hemostasis surgical equipment capable of sealing vessels up to 7mm?
According to the "Guidelines for Technical Review of Clinical Evaluation of Ultrasonic Soft Tissue Cutting and Hemostasis Systems," given the relatively high clinical use risks and technical challenges associated with devices capable of sealing up to 7mm vessels, it is recommended to further demonstrate their safety and effectiveness through clinical data of the product itself, in addition to in vitro burst testing and animal trials. Clinical trials conducted domestically should comply with the "Quality Management Regulations for Medical Device Clinical Trials."
For the various measurement functions of ophthalmic optical biometers, if measurement accuracy has already been specified, is it still necessary to consider repeatability?
Measurement repeatability and measurement accuracy reflect different meanings. Measurement accuracy refers to the consistency of the measurement values with the true values; measurement repeatability refers to the consistency among measurement values obtained at different times, considering systematic errors. If the test method for measurement accuracy already takes into account systematic errors over different periods, it is not necessary to consider repeatability separately.
What factors should be considered for the stability study of in vitro diagnostic reagent samples?
The selection of sample concentrations should be a key consideration, including at least negative, weakly positive, and moderate/strongly positive samples, to investigate the stability of samples at different concentrations and their impact on detection.
What are the raw material requirements for Vaseline gauze products?
Vaseline must comply with the standards of the "Pharmacopoeia of the People's Republic of China." For imported products, reference can be made to the United States Pharmacopeia or the European Pharmacopoeia. For degreased cotton gauze or degreased cotton viscose blended gauze, it is recommended to refer to YY0331 "Performance Requirements and Test Methods for Degreased Cotton Gauze and Degreased Cotton Viscose Blended Gauze."
How should we consider the design types for clinical trials of computer-assisted decision-making products based on deep learning?
For products that provide decision support in triaging and referring patients based on whether they have a target disease, without specifying the exact lesion conditions, and where a professional physician must review the patient's images regardless of the triage outcome (whether negative or positive), a single-group target value design can be considered. The main evaluation metrics should focus on the diagnostic accuracy of the product's assistance in triaging, such as sensitivity and specificity, typically at the patient level. For products that assist in detecting specific lesions of a target disease, such as lung nodule detection aids or bone fracture CT image detection aids, a controlled trial design is recommended. In this setup, the experimental group consists of physicians using the product in conjunction with traditional diagnostic methods (like clinical review or comprehensive diagnosis). The main evaluation metrics should consider diagnostic accuracy indicators such as sensitivity, specificity, AFROC curves, and detection rates, with sensitivity generally assessed at the lesion level and specificity at the patient level. The type of clinical trial comparison should reflect the acceptable risk-benefit ratio of the product, and an effectiveness design is suggested. For example, for software assisting in detecting lung nodules larger than 4mm on CT images, consider superiority in specificity at the patient level and non-inferiority in sensitivity at the lesion level.
For high-frequency ultrasound integrated surgical equipment that can output either high-frequency or ultrasound energy separately, as well as simultaneously, how should the testing modes be considered during electromagnetic compatibility testing?
For high-frequency ultrasound integrated surgical equipment that can output high-frequency or ultrasound energy separately or simultaneously, the testing modes for electromagnetic compatibility should be considered as follows: According to the requirements in Chapter 36 of the GB 9706.4-2009 standard, "When the power is on but the high-frequency output is not excited, it should meet the limit requirements of Group 1." Therefore, for the emission test, the most unfavorable mode (which should at least include the maximum ultrasound output mode) should be selected for testing, and the test should be conducted according to Group 1 Class A. For the immunity test, the standby mode, ultrasound output mode, high-frequency output mode, and dual output mode should be selected separately, and the tests should be conducted under the most unfavorable conditions.
How to classify facial injectable filler products into registration units
According to Article 3 of the "Guidance Principles for the Division of Medical Device Registration Units," products should be classified into different registration units if differences in their structural composition or processing methods lead to different performance indicators. For facial injectable fillers, they should be classified into different registration units if there are differences in chemical composition, ratio (concentration), cross-linking method, degree of cross-linking, gel particle size distribution, designed average molecular weight, and its distribution. However, for the same product intended for different parts of the face, such as for altering the contours of the mid-face or for rhinoplasty, it can be classified into the same registration unit.
How to understand "different sources" in the requirement of using samples from different sources for analytical performance evaluation of in vitro diagnostic reagents
In order to evaluate the analytical performance of in vitro diagnostic reagents, it is usually required to select samples from the applicable population at different times, different locations, and with different representativeness (such as age, gender, ethnicity, and other situations) to assess the detection capability, that is, to select samples from "different sources" for evaluation. The selection of representative samples should be determined based on factors such as the characteristics of the product itself and its intended clinical use.
How should dental handpiece registration units be classified?
According to the requirements for dividing registration units, products with significant differences in technical principles, structural composition, performance indicators, and scope of application should be classified into different registration units. Following these principles: 1. High-speed air turbines and dental contra-angle handpieces/dental straight handpieces should be classified into different registration units. 2. Within dental contra-angle handpieces/dental straight handpieces, devices that hold root canal files for enlarging tooth root canals, devices used for oral implant treatments, and devices used for drilling and grinding teeth should each be classified into different registration units. 3. Handpieces with lighting devices and those without should be classified into different registration units; however, those with light guides and those without lighting can be placed in the same registration unit.