(381 days)
Our surgeon's gloves are a device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Gantex Model NSG-75PF Powder Free Surgeon Glove
The provided text is a 510(k) clearance letter from the FDA for a surgeon's glove, not a document describing an AI/ML medical device study. Therefore, most of the requested information about acceptance criteria, study design, ground truth, and expert involvement for an AI medical device cannot be extracted from this document.
However, I can extract the following relevant and limited information:
Device: Gantex Model NSG-75PF Powder Free Surgeon Glove
Regulatory Class: I
Product Code: KGO
Indications For Use: Our surgeon's gloves are a device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Regarding the requested information, here's what can be inferred or stated as "not applicable":
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics typical for AI devices. The clearance is based on "substantial equivalence" to a predicate device. For gloves, this typically involves material properties (dimensions, tensile strength, elongation), barrier integrity (water leak test), and biocompatibility.
- Reported Device Performance: Not detailed in this letter. The letter affirms "substantial equivalence," implying the device met the performance characteristics expected of general surgeon gloves.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document is not about an AI/ML study. Performance data for physical devices like gloves would be generated from laboratory testing and quality control, not "test sets" in the AI sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the AI sense is not relevant for this device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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 an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for a surgeon's glove would be its physical and chemical properties meeting established standards (e.g., ASTM standards for medical gloves) and maintaining barrier integrity, which are verifiable through standard laboratory tests, not expert consensus in the diagnostic sense.
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The sample size for the training set:
- Not applicable. This pertains to an AI model, not a physical device like a glove.
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How the ground truth for the training set was established:
- Not applicable.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).