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A surgeon's glove is a sterile and for single use device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Motex Powder-free Nitrile Surgical Gloves are made of synthetic rubber. Thev are sterilized by radiation, and intended for be used in surgery for patient and user.

The provided document describes the acceptance criteria and a study to demonstrate the substantial equivalence of the "Motex Powder-free Nitrile Surgical Gloves" to a predicate device, focusing on safety and effectiveness.

Here's a breakdown of the requested information:

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 sample sizes for each specific test mentioned (e.g., number of gloves tested for dimensions, holes, powder). The studies are primarily laboratory-based performance tests against established standards. The provenance of the data is from Shanghai, China, where the manufacturer (Shanghai Motex Healthcare Co., Ltd.) is located. These are likely retrospective tests conducted on manufactured batches to ensure compliance with the 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 in the context of this device. The "ground truth" for these types of medical devices is established by adherence to internationally recognized consensus standards (ASTM, ISO). These standards define the acceptable range or threshold for each characteristic, and laboratories perform tests to measure these characteristics against those predefined limits. There isn't a team of experts adjudicating individual glove results in the same way a medical image might be reviewed.

4. Adjudication method for the test set:

This is not applicable. As mentioned above, the assessment is against established objective technical standards, not subjective expert judgment that would require adjudication.

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. This document describes a surgical glove, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance assessment was conducted.

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

This is not applicable. This device is a physical medical device (surgical glove), not a software algorithm.

7. The type of ground truth used:

The ground truth used is based on established industrial and medical device standards (ASTM, ISO). These standards define the limits and methodologies for testing physical properties, safety (biocompatibility), and sterility of surgical gloves.

8. The sample size for the training set:

This information is not applicable. This product is a physical device, not an AI or machine learning model that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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