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Powdered vinyl 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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard I) 525()-00'd

The provided text is for a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)." It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. The information focuses on regulatory compliance based on established standards rather than a study proving the device meets acceptance criteria through clinical or comparative effectiveness trials.

Here's a breakdown based on your request, highlighting the information that is not present in the provided document, as it's not typically required for this type of device and submission:

Acceptance Criteria and Reported Device Performance

Study-Related Information (Not Applicable or Not Provided for this type of device)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not provided. For examination gloves, performance is assessed against established technical standards (ASTM, CFR) through laboratory testing, not human clinical trials with "test sets" in the conventional sense of AI/diagnostic device studies. The document refers to meeting these standards rather than conducting a separate study on a specific "test set" of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. "Ground truth" established by experts is a concept typically relevant to diagnostic devices, especially those using AI. For examination gloves, the "ground truth" is defined by the technical specifications in the ASTM standards and regulatory requirements (e.g., 21 CFR 800.20 for pinholes).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are relevant for expert review in clinical studies or AI ground truth establishment, not for laboratory testing of a physical medical device like a glove against predefined technical standards.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, not done, and not applicable. This type of study relates to diagnostic imaging or AI-assisted interpretation, which is entirely outside the scope of an examination glove.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, not done, and not applicable. This applies to AI algorithms.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Standardized laboratory test results against predefined technical specifications. For example, "Freedom from pinholes" is verified by testing against 21 CFR 800.20, and "Biocompatibility" is assessed via standard animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) whose results are compared to established criteria for what constitutes irritation/sensitization.

7. The sample size for the training set:

   • Not applicable / Not provided. This device does not involve a "training set" in the context of AI or machine learning. Its manufacturing and testing processes are governed by quality systems and adherence to standards.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for this device type, there is no ground truth to be established for it.

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