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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

Device: Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color

1. Table of Acceptance Criteria and Reported Device Performance

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.(21 CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Examination Vinyl Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

The provided 510(k) summary is for the Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue. As such, the "device" in this context refers to these gloves. This document describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study of an AI algorithm. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to this type of medical device submission.

Here's the information extracted from the document, focusing on the acceptance criteria and the study (non-clinical testing) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on the ASTM-D-5250-06 standard for examination vinyl gloves, and FDA requirements for pinholes and biocompatibility. The reported device performance is compared to the predicate device, which implicitly meets these standards.

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

• Sample Size: Not explicitly stated as a single "test set" sample size. For physical and dimensions testing, the inspection levels are S-2, AQL 2.5. For the FDA 1000 ml. Water Fill Test (pinhole), the inspection level is I, AQL 2.5. These are industry standard sampling plans, but the specific number of gloves sampled is not provided in this summary.
• Data Provenance: The tests were conducted by Zibo Intco Medical Products, Co. Ltd. (the manufacturer) in China. The data is prospective, generated specifically for this submission.

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

Not applicable. This is not an AI/diagnostic device that requires expert ground truth establishment in the traditional sense. The "ground truth" for glove performance is determined by established engineering and material science standards (ASTM, FDA water fill test).

4. Adjudication method for the test set

Not applicable. This is not an AI/diagnostic device. Performance is measured against objective 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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on:

• Industry Standards: ASTM D5250-06 for physical properties and dimensions.
• Regulatory Requirements: FDA 1000 ml. Water Fill Test for pinhole integrity.
• Biocompatibility Testing: Primary Skin Irritation and Skin Sensitization tests (in vivo tests on biological systems, typically animals or human volunteers for patches, but the document doesn't specify for this case, only "with results showing no primary skin irritant or sensitization reactions").
• Chemical Analysis: Measurement of powder content (no more than 2 mg/glove).

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

The provided document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information.

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