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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

SENSIFLEX meet the requirement for surgeon's glove described by the American Standard for Testing and Material ASTM D3577 as Type 1, white in color and non-powdered. Sizes available is from 6 - 9.

The provided text describes the 510(k) summary for the SENSIFLEX Powderfree Surgeon's Glove. Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not explicitly stated. The document mentions "Tests conducted per ASTM D3577, ASTM D512," implying that the testing was done on a sample, but the specific number of gloves tested is not provided.
• Data provenance: Not explicitly stated, though the tests were conducted by a Malaysian company (Terang Nusa Sdn Bhd) for a device manufactured in Malaysia. It is prospective testing as it was done to demonstrate substantial equivalence for a new device.

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 as the described tests are non-clinical, performance, and biocompatibility tests, not studies requiring expert interpretation of results to establish ground truth (e.g., medical image analysis). The ground truth for these tests is established by the specifications defined in the ASTM standards.

4. Adjudication method for the test set:

This information is not applicable for the type of non-clinical and biocompatibility tests described. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters.

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:

No, an MRMC comparative effectiveness study was not done. This device is a surgeon's glove, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

No, a standalone algorithm performance study was not done. This device is a physical product (surgeon's glove), not an algorithm.

7. The type of ground truth used:

The ground truth used for the non-clinical tests is based on established industry standards and specifications (ASTM D3577, ASTM D512, ASTM F 719-81, ASTM F 720 - 81 (86)) and the requirement for starch-free status. For biocompatibility, the ground truth is the absence of irritation and sensitization.

8. The sample size for the training set:

Not applicable. This device is a physical product (surgeon's glove), not an AI model, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for it.

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