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Powder free 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.

Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)

The provided document describes the safety and effectiveness information for Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) submitted by SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD., under K092415.

Here's an analysis of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of typical AI/ML studies focusing on diagnostic accuracy. The performance data presented are based on adherence to established material and safety standards for medical gloves.

• Sample Size: Not explicitly stated for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). The claim is that the device "Meets" the specified standards, implying an adequate sample size was used to demonstrate compliance according to those standards.
• Data Provenance: The studies were conducted by the manufacturer, SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD., likely in China, as that is the submitter's country of origin. The studies are retrospective in the sense that they are engineering and biocompatibility tests conducted on manufactured product batches to ensure compliance with pre-defined standards.

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

This information is not applicable to this type of device and submission. This is a 510(k) submission for a Class I patient examination glove, which relies on demonstrating conformance to recognized consensus standards and biocompatibility tests, not on expert interpretations of medical images or clinical outcomes. The "ground truth" for these tests is defined by the objective metrics and methodologies outlined in the ASTM standards and FDA regulations (e.g., 21 CFR 800.20, ISO10993-10).

4. Adjudication method for the test set

This is not applicable. The "adjudication method" concept typically applies to studies where human experts are making subjective assessments that need to be reconciled (e.g., reading medical images). Here, the tests are objective measurements and evaluations against predefined criteria in standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers. This device is a medical glove, for which AI assistance for human readers is not applicable.

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

No, a standalone algorithm performance study was not done. This device is a physical product (a glove), not an algorithm or software. Therefore, this question is not relevant.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Standard Specifications: Adherence to the defined dimensional, physical, and powder residual limits set forth in ASTM standard D 5250-06 and D6124-06.
• Regulatory Requirements: Compliance with 21 CFR 800.20 for freedom from pinholes.
• Biocompatibility Test Results: Objective results from standardized animal tests (Primary Skin Irritation in rabbits, Dermal sensitization in guinea pig) showing "Passes" and "Not a Primary Skin Irritation" / "Not a Dermal Sensitization," as per ISO10993-10.

8. The sample size for the training set

The concept of a "training set" is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

This is not applicable, as there is no "training set" for this device.

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