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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)that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" based on the provided text, structured according to your requested points:

Acceptance Criteria and Device Performance Study

The submission details the non-clinical testing performed to demonstrate that the Powder Free Vinyl Patient Examination Gloves meet predefined acceptance criteria and are safe and effective.

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 explicitly state the specific sample sizes used for each individual test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). The tests are described as conforming to established standards (ASTM D 5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO10993-10), which would typically specify sample sizes.

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It refers to standard tests.

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

This information is not provided in the document. For these types of device performance tests (physical and biocompatibility), "ground truth" is typically established by the results of the standardized tests themselves, performed by qualified laboratory personnel, rather than expert consensus on interpretive data.

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

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., radiology image readings) where multiple experts initially assess a case, and discrepancies are resolved by an additional expert or group. The reported tests are objective measurements and standardized assessments.

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 MRMC comparative effectiveness study was done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret images or data. These gloves are a Class I medical device and do not involve AI or human interpretation in their intended use.

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

No standalone algorithm performance study was done. This device is a physical medical glove and does not involve any algorithm or AI component.

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

The "ground truth" for the tests is defined by the objective criteria and methodologies outlined in the referenced ASTM standards, 21 CFR regulations, and ISO standard. For example:

• Dimension and Physical Properties: Direct measurements and physical testing according to the ASTM D 5250-06 standard.
• Freedom from pinholes: Water leak test as per 21 CFR 800.20, with results compared against AQL (Acceptable Quality Limit) levels.
• Powder Residual: Measurement of powder content according to ASTM D 5250-06 and D6124-06.
• Biocompatibility: Results from standardized animal model tests (rabbits for skin irritation, guinea pigs for dermal sensitization) according to ISO10993-10 protocols.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore no "training set" is used.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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