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The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.

Here's a breakdown of the acceptance criteria and study information for the WRP Asia Pacific Sdn Bhd surgical gloves, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each test. However, it indicates that the device performance "Meets" the specified ASTM and FDA standards. These standards typically define the sampling plans and acceptable quality limits (AQLs) for testing. For example, for "Freedom from pinholes," FDA 21 CFR 800.20 specifies water leak test requirements and AQLs.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are performed in accordance with international and US standards (ASTM, FDA), implying established testing methodologies.

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

This information is not applicable and not provided in the document. The "ground truth" for this medical device (surgical gloves) is established by meeting predefined scientific and engineering performance standards (e.g., tensile strength, elongation, freedom from pinholes, powder content, biocompatibility) as outlined in ASTM and FDA regulations, not by expert consensus on clinical interpretation or outcomes in the same way an AI diagnostic tool would.

4. Adjudication Method for the Test Set

This is not applicable and not provided. The performance assessment relies on standardized laboratory testing protocols, not on human adjudication of results in the way a diagnostic study would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. Surgical gloves are a manufacturing product, and their performance is assessed through laboratory testing against established specifications.

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

Yes, in a conceptual sense, the performance described is "standalone" in that it refers to the intrinsic physical and chemical properties of the glove itself, as measured by standard tests, independent of human interaction during operational use. There is no AI algorithm involved in this device.

7. The Type of Ground Truth Used

The "ground truth" for this device is the predefined specifications and acceptable limits established by recognized standards such as ASTM D 3577, FDA 21 CFR 800.20, and ASTM D 6124. For biocompatibility, it's the biological response criteria (e.g., "not a primary skin irritant," "not a contact sensitizer") determined through in-vivo testing (rabbits).

8. The Sample Size for the Training Set

This information is not applicable. Surgical gloves are not an AI/machine learning device; therefore, there is no "training set."

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

This information is not applicable, as there is no "training set" for this device.

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