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The Biogel® Sensor™ Surgeon's Glove is a sterile 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® Sensor™ Surgeon's 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 for the Biogel® Sensor™ Surgeon's Glove. This device is a Class I surgical glove, which is a low-risk device. As such, the "study" demonstrating its performance is primarily based on meeting established industry standards for surgical gloves, rather than complex clinical trials or AI-specific validation studies.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The Biogel® Sensor™ Surgeon's Glove meets the technological characteristics of ASTM D3577 and is substantially equivalent to the predicate devices cited in this 510(k) summary." For protein content, the device name explicitly includes "Protein Content Labeling Claim (50 micrograms or less)," indicating it meets this claim.

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

The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective). For surgical gloves, compliance with ASTM and ISO standards typically involves standardized testing of batches of gloves, but the specific sample sizes for these tests are not provided in this summary.

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 surgical gloves, the "ground truth" is adherence to established engineering and material science standards (ASTM D3577, ISO 10993-1) and specific chemical limits (LAL test, protein content) rather than expert interpretation of a clinical dataset. These standards define objective pass/fail criteria.

4. Adjudication method for the test set

Not applicable. As noted above, the evaluation is based on objective measurements against established standards, not on expert adjudication of subjective assessments.

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 a medical device (surgical glove), not an AI algorithm or an imaging/diagnostic tool requiring human reader studies.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on objective measurements against established national and international standards for surgical gloves (ASTM D3577 and ISO 10993-1) and specific chemical assays (LAL test for endotoxins, protein content for extractable proteins). It's a materials science and manufacturing quality ground truth, not a clinical diagnostic or pathology ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As there's no AI model or training set, this question is not relevant.

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