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The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

The provided text details the 510(k) summary for the "Vinyl Patient Examination Glove (Yellow)" (K173580) and compares it to a predicate device (K163168). The information specifically relates to the technical specifications and performance of the examination gloves, rather than an AI/ML device or a medical imaging system. Therefore, many of the requested categories in the prompt regarding AI/ML device evaluation are not applicable.

Here's an analysis based on the available information:

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

The acceptance criteria for the Vinyl Patient Examination Glove (Yellow) are primarily based on established industry standards and specific physical and biological properties. The reported device performance is presented in comparison to a predicate device and adherence to these standards.

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

The document does not specify general "test set" sample sizes or data provenance in the context of clinical studies (as it states "No clinical study is included in this submission"). For non-clinical tests like physical properties and freedom from holes, the standards (e.g., ISO 2859-1 for sampling) outline the sampling procedures, but specific sample sizes used in this submission are not explicitly stated. The manufacturer is "NATURE MEDICAL PRODUCTS CO., LTD." in Hebei, China, which suggests the tests were likely conducted in China. These non-clinical tests would be considered prospective for the device being evaluated.

3. 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)

This is not applicable as the device is a Vinyl Patient Examination Glove, not an AI/ML device requiring expert medical interpretation for ground truth. The "ground truth" for these types of devices is based on established laboratory testing and adherence to recognized performance standards (e.g., ASTM, ISO standards) for physical and biological properties.

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

This is not applicable since this document relates to a physical medical device (examination gloves) and not a diagnostic system requiring human interpretation or adjudication for ground truth.

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

This is not applicable. The device is an examination glove, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an examination glove.

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

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

• Industry Standards: Compliance with established physical and chemical property requirements outlined in standards such as ASTM D5250, ASTM D5151, ASTM D6124.
• Biocompatibility Testing: Results from in vitro and in vivo tests (ISO 10993-5, ISO 10993-10) determining irritation, sensitization, and cytotoxicity.
• Manufacturing Specifications: Adherence to the manufacturer's own design and material specifications.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/ML model for this type of physical medical device.

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

This is not applicable as there is no training set for an AI/ML model.

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The Vinyl Patient Examination Glove (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.

The acceptance criteria and study proving the device meets these criteria are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device