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The Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.

The device in this 510(k) submission is intended for the Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove (Classification number 79KGO). The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made from Non-Latex synthetic rubber material, polvisoprene. Glove size is available from size 5.5 through 9.0 in a half size increment.

Here's a breakdown of the acceptance criteria and the study information for the Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

Due to the nature of this submission (a 510(k) for a medical glove, which is a Class I device), the study design is centered on bench testing and material property evaluation rather than clinical efficacy studies involving human subjects in the same way an AI diagnostic device would.

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

   • Sample Size: Not explicitly stated for each specific test (e.g., how many gloves were tested for sterility, holes, etc.). However, industry standards like ASTM D3577-00 and ASTM D6124 would dictate specific sampling plans for these tests.
   • Data Provenance: Implied to be from internal testing conducted by the manufacturer, SSL Americas, Inc., as part of their 510(k) submission. No information on country of origin of data (beyond the company location being in the US) or whether it was retrospective or prospective is provided, as it's not relevant for this type of device testing.

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

   • Not applicable in the context of this device. Ground truth for physical properties and biocompatibility of a surgical glove is established through standardized laboratory testing protocols (e.g., ASTM standards) and validated analytical methods, not by expert consensus on clinical images or outcomes.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human readers or expert panels when establishing ground truth for subjective or complex diagnostic tasks. For objective physical and material property testing, results are determined by the test method itself.

4. 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 device is a surgical glove, not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

   • Not applicable. This is not an AI algorithm.

6. The type of ground truth used:

   • Standardized Test Specifications: The ground truth is defined by the specific requirements and methodologies outlined in the referenced ASTM standards (ASTM D3577-00 for sterility, freedom from holes, physical properties, physical dimensions, and ASTM D6124 for powder-free claims) and internationally recognized test methods for biocompatibility (non-irritating, non-sensitizing). These standards provide quantifiable criteria that the glove must meet.

7. The sample size for the training set:

   • Not applicable. As this is not an AI device, there is no "training set." The development of the glove involved formulating and manufacturing it to meet the aforementioned physical and material specifications.

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

   • Not applicable. There is no training set for this type of device. The "ground truth" for the device's design and manufacturing revolves around adherence to established material science, engineering principles, and regulatory standards for medical devices.

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