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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.

1. Acceptance Criteria and Device Performance:

2. Sample Size and Data Provenance (Test Set):

The document does not explicitly state a specific sample size used for the test set. Instead, it refers to the device meeting the requirements of ASTM D 6319 – 00aEI, ASTM D 6319 – 00dEI, FDA 21 CFR 800.20, and ASTM D 6124 – 01. These standards inherently specify their own sampling plans and methods for evaluating product characteristics.

The data provenance is implied to be from testing conducted by the manufacturer, WRP Specialty Products Sdn Bhd, in MALAYSIA, as part of their submission to the FDA. The data is retrospective in the sense that it represents results from prior testing to demonstrate compliance with established standards.

3. Number and Qualifications of Experts for Ground Truth (Test Set):

The study relies on established industry and regulatory standards (ASTM and FDA regulations) for acceptance criteria rather than individual expert establishment of ground truth for each test case. Therefore, there is no mention of a specific number of experts or their qualifications for establishing the ground truth for an independent test set in the traditional sense of a clinical study. The "ground truth" is defined by the parameters and thresholds set forth in the referenced standards.

4. Adjudication Method (Test Set):

There is no adjudication method described in the document as it pertains to an independent test set. The evaluation is based on meeting predefined performance criteria outlined in industry standards and FDA regulations, which typically involve laboratory testing and quantitative measurements against these criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The device is a patient examination glove, and the evaluation is based on material and performance characteristics against established standards, not on human interpretation or diagnostic accuracy where an MRMC study would be relevant.

6. Standalone Performance:

Yes, a standalone performance evaluation was done. The "Device Performance" column in the table directly reports the device's ability to meet the specified standards independently. The evaluation of glove characteristics like dimensions, physical properties, freedom from pinholes, powder-free status, and biocompatibility are intrinsic to the device itself and do not involve human-in-the-loop performance for their assessment.

7. Type of Ground Truth Used:

The ground truth used is based on established industry standards and regulatory requirements. Specifically, ASTM standards (D 6319 – 00aEI, D 6319 – 00dEI, D 6124 – 01) and FDA regulations (21 CFR 800.20) define the acceptable limits and performance characteristics for patient examination gloves. Biocompatibility testing results (Primary Skin Irritation in Rabbits, Dermal Sensitization) also serve as a form of ground truth based on established biological testing protocols.

8. Sample Size for the Training Set:

The document does not describe a "training set" in the context of machine learning or AI. This submission is for a medical device (patient examination gloves) where compliance is demonstrated through laboratory and material testing against established standards, not through iterative model training.

9. How Ground Truth for the Training Set Was Established:

As there is no training set in the context of AI/machine learning, the concept of establishing ground truth for a training set is not applicable to this device submission. The underlying principles for manufacturing and quality control of such gloves are guided by the same industry and regulatory standards that define the acceptance criteria for the final product.

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