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The Biogel Orthopedic Surgeon's Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Biogel Orthodepic Surgical Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Biogel Orthopedic Surgical Glove. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel clinical effectiveness with extensive studies. As such, many of the requested elements (like sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or training set details) are not relevant or typically included in such filings for this class of device.

Here's a breakdown 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 specified. For this type of device and regulatory pathway, testing typically involves validating against specified ASTM and ISO standards. These standards define the sampling plans and testing methodologies.
• Data Provenance: Not specified, but generally refers to in-house laboratory testing following established international standards (ASTM, ISO).

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

• Not applicable. The ground truth for performance characteristics of surgical gloves is established by objective, standardized laboratory tests according to ASTM and ISO specifications, not by expert consensus on individual cases.

4. Adjudication method for the test set:

• Not applicable. Performance is measured objectively through lab tests against predefined specifications, not through adjudication of expert opinions.

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 device is a surgical glove, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

• Not applicable. This device is a physical product (surgical glove), not an algorithm.

7. The type of ground truth used:

• The "ground truth" is defined by the objective thresholds and methodologies specified in the ASTM D3577 standard for surgical gloves, ISO 10993-1 for biocompatibility, and LAL test standards for endotoxin levels, along with the specified protein content limit. These are laboratory-derived, validated standards.

8. The sample size for the training set:

• Not applicable. This device is manufactured to meet specifications, not "trained" like a machine learning model.

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

• Not applicable. See point 8.

Summary of Study (Performance Data):

The performance data presented in the 510(k) summary are derived from testing the Biogel Orthopedic Surgical Glove against established industry standards. The manufacturer states that the device was tested to meet the requirements of:

• ASTM D3577: This standard specifies the requirements for rubber surgical gloves, covering aspects like dimensions, physical properties (e.g., tensile strength, elongation), and freedom from holes.
• ISO 10993-1: This standard covers biological evaluation of medical devices, ensuring biocompatibility.
• LAL Test: This test measures endotoxin levels. The device met the requirement of <0.25 EU/ml (non-pyrogenic claim).
• Protein Content Claim: The glove contains 50 micrograms or less of total water extractable protein per gram, meeting its specific labeling claim.

The submission concludes that "No clinical data was required" because the device demonstrated substantial equivalence to predicate devices (K980516 and K060030) based on these technological characteristics and performance data against recognized standards.

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