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

The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex and is brown in color. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature an independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only. This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery.

The provided document describes the predicate device and the performance data that supports substantial equivalence for the "Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating." This is a medical device approval summary, and as such, it focuses on non-clinical tests to demonstrate performance in line with existing standards for gloves, rather than a study for an AI-powered diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, ground truth for training set) are not applicable to this type of device and submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. For medical gloves, testing is typically done on a representative sample from production lots according to the specified ASTM standards. The standards themselves define the sampling plans.
• Data Provenance: The tests are non-clinical (laboratory/material tests). As such, there is no "country of origin of the data" in the sense of patient data. The tests were performed by the manufacturer (Cardinal Health 200, LLC) in a laboratory setting to demonstrate compliance with international and national standards. These are retrospective analyses of material properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. These are objective physical and chemical property tests, not expert-adjudicated diagnostic interpretations. The "ground truth" is defined by the technical specifications and methodologies of the referenced ASTM, ISO, and FDA standards.

4. Adjudication method for the test set

• Not applicable. The tests involve objective measurements against defined criteria, not subjective interpretations 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

• Not applicable. This is not an AI-powered diagnostic device.

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

• Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used

• Ground Truth: The "ground truth" is defined by the Pass/Fail criteria and quantitative limits specified in the referenced international standards (ASTM D3577, ISO 10993-10, AS/NZ 4179) and FDA guidance for medical gloves (e.g., 21 CFR 800.20, FDA Medical Glove Guidance Manual, ASTM D5712). These standards establish the acceptable physical, chemical, and biological properties for safe and effective surgical gloves.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not a machine learning or AI algorithm.

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

• Not applicable. This device does not involve a training set.

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