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This Sugeon's Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

NUZONE SYNGARD, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTMID 3577 - 01a-2.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NUZONE SYNGARD Surgical Glove:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set for any of the described tests (ASTM D 3577-01a-2, ASTM F 719-81, ASTM F 720-81).

The data provenance is not explicitly stated in terms of country of origin for the testing itself, but the submission is from Malaysia. The tests are based on American Society for Testing and Materials (ASTM) standards. The nature of the tests (physical properties and biocompatibility) suggests they were conducted on samples of the manufactured device.

The study is retrospective in the sense that the tests were performed on finished products before submission, rather than as part of an ongoing clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the data presented. The tests described are laboratory-based physical and biocompatibility assessments against established industry standards (ASTM). They do not involve expert interpretation or ground truth establishment in the way clinical studies with human participants or imaging data would. The "ground truth" for these tests is defined by the parameters and methodologies outlined in the respective ASTM standards themselves.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective, laboratory-based measurements against pre-defined ASTM standards. There is no mention of subjective interpretation requiring 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 information is not applicable. The device is a surgical glove, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a surgical glove, not an algorithm or software. Standalone performance for an algorithm is not relevant.

7. The Type of Ground Truth Used

The ground truth used for the device's performance assessment is based on regulatory and industry standards (ASTM) for physical properties and biocompatibility (skin irritation and sensitization). These standards define acceptable ranges and methodologies for determining whether a surgical glove performs as intended and is safe for use.

8. The Sample Size for the Training Set

This information is not applicable. As a physical medical device (surgical glove), there is no "training set" in the context of machine learning or AI. The product is manufactured and then tested to ensure it meets pre-defined quality and safety standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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