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The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Disposable Nitrile Powder-Free Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

Based on the provided text, the device in question is "Disposable Nitrile Powder-Free Examination Gloves," which are Class I medical devices used to prevent contamination between patients and examiners. The document describes non-clinical performance testing rather than a study involving human subjects or AI, as would be typical for software or imaging devices.

Therefore, many of the requested categories for AI-based device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this premarket notification for examination gloves.

Here's the relevant information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for examination gloves.

Table of Acceptance Criteria and Reported Device Performance for Disposable Nitrile Powder-Free Examination Gloves:

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The Disposable Nitrile Examination Gloves 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 Nitrile Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

This document is a 510(k) Premarket Notification for "Disposable Nitrile Examination Gloves" (K203436) by Shandong Zhushi Pharmaceutical Group Co., Ltd. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (K171422).

The 510(k) submission primarily relies on non-clinical performance testing to demonstrate safety and effectiveness.

Here's an analysis based on your request, focusing on acceptance criteria and study proving device meets criteria:

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

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The Disposable Nitrile Gloves are intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification summary for Disposable Nitrile Gloves (K210276). It is not for an AI/ML medical device, but rather for a physical medical device (gloves). Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) is not applicable to this document.

The document discusses the substantial equivalence of the Disposable Nitrile Gloves to a predicate device (K171422) based on performance testing and adherence to recognized standards.

Here's an attempt to interpret the provided content in the context of your request, while acknowledging that it doesn't fit the typical AI/ML device evaluation structure:

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

The document outlines comparisons between the subject device (K210276) and the predicate device (K171422), effectively serving as the acceptance criteria for substantial equivalence. The reported device performance is demonstrated by its compliance with the listed standards.

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

• Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., number of gloves tested for tensile strength, holes, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The standards themselves (e.g., ASTM D6319, ASTM D5151) would define the required sample sizes for their respective tests, but these details are not present in this summary.
• Data Provenance: The tests were non-clinical performance tests, usually performed in a lab setting by the manufacturer or a contracted lab. The manufacturer is Fujian Ercon Medical Management Co., Ltd. in China. The provenance is internal testing, not patient data.

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 a study requiring expert readers or ground truth establishment in the context of interpreting medical images or data. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., a hole is present or absent according to ASTM D5151 criteria).

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

• Not Applicable. As this is not an interpretive/diagnostic study, no adjudication method for human readers is relevant. The tests are laboratory measurements.

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 a physical medical device (gloves), not an AI/ML diagnostic aid. There were no human readers or AI assistance involved.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device's performance is objective measurements and compliance with industry standards (e.g., ASTM D6319-19 for glove specifications, ASTM D5151-19 for holes, ISO 10993 for biocompatibility). It is based on pre-defined engineering specifications and test protocols.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; there is no training set.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

In summary, the provided document details the regulatory submission for a physical medical device, not an AI/ML diagnostic tool. Therefore, many of the questions related to AI/ML study design are not applicable. The device's acceptance is based on non-clinical performance testing confirming its compliance with recognized standards and substantial equivalence to a legally marketed predicate device.

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