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The Skinsense Polyisoprene Underglove is a disposable device made of non-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 Skinsense Polyisoprene Underglove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.

This document is a 510(k) summary for a medical device called the "Skinsense Polyisoprene Underglove." It describes characteristics and performance data related to physical properties and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For the LAL Test, the acceptance criterion specifically states "<0.25 EU/ml" which is also presented as the reported performance, implying this is the established threshold.

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

The document does not specify the exact sample sizes used for testing each characteristic. It lists the tests performed (e.g., Cytotoxicity Study, ISO Skin Irritation Study, LAL Test, and conformance to ASTM D3577 for Dimensions, Physical Properties, and Freedom from Holes). The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. It is implied that these are lab-based tests conducted to demonstrate compliance with standards.

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

This document describes performance testing against established standards (ASTM D3577) and biocompatibility tests, not the interpretation of complex data requiring expert consensus for a "ground truth" in the way it might for AI diagnostic tools. Therefore, the concept of "number of experts used to establish the ground truth" with specific qualifications is not applicable in this context. The "ground truth" is defined by the objective criteria within the ASTM standard and the pass/fail thresholds for the biocompatibility tests.

4. Adjudication method for the test set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The performance is determined by objective measurements against predefined standards and thresholds.

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 a study of an AI-assisted diagnostic device, but rather a
summary for a surgical glove.

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

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

7. The type of ground truth used

The "ground truth" for the performance data in this document is defined by:

• Established Industry Standards: ASTM D3577-01-ae2, which specifies requirements for various characteristics of surgical gloves.
• Biocompatibility Test Pass/Fail Criteria: Standardized protocols for Cytotoxicity, ISO Skin Irritation, and LAL (Endotoxin) tests with defined pass/fail thresholds.

8. The sample size for the training set

Not applicable. This document is for a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set involved for this device.

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