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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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This document is a 510(k) Premarket Notification summary for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the provided information, framed by your questions:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is for a medical device (patient examination gloves) that is subject to performance standards rather than requiring complex algorithmic analysis or human reader studies. Therefore, most of your requested points regarding AI/algorithm performance, ground truth establishment, and expert involvement are not applicable to this type of device and submission.

The "acceptance criteria" here refer to the performance requirements outlined in recognized standards (like ASTM and FDA regulations) for patient examination gloves. The "study" proving the device meets these criteria refers to non-clinical testing performed by the manufacturer.

1. A table of acceptance criteria and the reported device performance

Note: The powder amount in the "Device performance" column for "Biocompatibility" appears to be misplaced from "Powder Amount." I've corrected this in the table above based on the text. The Powder Amount test would yield a specific level, and the <10mg/dm² is under the biocompatibility section which is unusual. However, the document states "Powder Amount Meets" and then lists "<10mg/dm2" under the device performance for biocompatibility. I've attempted to align it to what seems most logical based on common glove testing.

2. Sample size used for the test set and the data provenance

The document explicitly states that "Clinical data is not needed for gloves or for most devices cleared by the 510(k) process."

Therefore, there is no "test set" in the context of clinical data or patient data. The tests performed are non-clinical, laboratory tests on the gloves themselves. The sample sizes for these specific non-clinical tests (e.g., number of gloves tested for pinholes, physical properties, or for biocompatibility testing on animals) are not provided in this summary.

Data provenance: Not applicable in the sense of country of origin for patient data or retrospective/prospective studies, as no human or patient data was used. The data comes from internal laboratory testing conducted by the manufacturer (Hebei Handform Plastic Products Co.,Ltd. in China) or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "test set" requiring ground truth established by experts in the context of this device and submission type. The ground truth is established by objective measurements against recognized industry standards (ASTM) and regulatory requirements (21 CFR).

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

Not applicable. No expert adjudication was required or performed for this type of non-clinical testing.

5. 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

Not applicable. This device is a physical product (gloves) and does not involve AI or human readers.

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

Not applicable. This device is a physical product and does not involve an algorithm.

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

The "ground truth" for the performance claims relies on objective measurements against established, recognized industry standards (ASTM D 5250-06, ASTM D6124-01) and FDA regulations (21 CFR 800.20) for glove characteristics, as well as biocompatibility testing according to standards like ISO10993-10.

8. The sample size for the training set

Not applicable. There is no algorithm or model that requires a training set for this device.

9. How the ground truth for the training set was established

Not applicable. There is no algorithm or model that requires a training set for this device.

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