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The G-Derm™ Surgical Glove is a disposable sterile powder-free medical device made of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styreneethylene/propylene (SEPSEP) synthetic copolymers that is intended to be worn by operating room personnel to protect a surgical wound from contamination.

The G-Derm™ Powder Free Surgical Glove is made of a blend of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers. It is coated with a polyurethane based coating on the inner side to facilitate donning.

The provided text describes a 510(k) submission for the Hutchinson Santé G-Derm™ Surgical Glove, a Class I medical device. The submission focuses on demonstrating substantial equivalence to predicate devices through performance data and adherence to recognized standards, rather than an AI-driven diagnostic or prescriptive device requiring complex clinical studies. As such, many of the requested categories (like MRMC studies, number of experts for ground truth, adjudication methods, training set information) are not applicable to this type of device submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

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 specify the precise sample sizes for each test conducted (e.g., how many gloves were tested for thickness, holes, etc.) or the data provenance beyond stating that the tests meet the listed ASTM and ISO standards. For device performance testing of physical characteristics and biocompatibility, these would typically be conducted by the manufacturer or accredited labs on representative samples as part of their quality control and R&D processes. The data would be prospective, generated specifically for the device under evaluation.

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

This is not applicable for this device and submission type. The "ground truth" for surgical gloves is established by objective measurements based on the specified ASTM and ISO standards, not expert consensus or interpretation of complex data.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation of data (e.g., radiology reads). For physical and chemical tests of a surgical glove, the results are quantitative and directly compared against the standard's limits.

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. The G-Derm™ Surgical Glove is a physical medical device, not an AI-driven one. No such study would be performed for this product.

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

This is not applicable. The device is a surgical glove, not an algorithm.

7. The type of ground truth used

The ground truth is established by the specified ASTM International (ASTM) and International Organization for Standardization (ISO) standards. These standards define the acceptable physical, chemical, and biological properties for surgical gloves. The device performance is measured objectively against the quantitative and qualitative requirements outlined in these standards.

8. The sample size for the training set

This is not applicable. As a physical medical device (surgical glove), there is no 'training set' in the context of machine learning or AI.

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

This is not applicable. There is no training set for this device.

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