(187 days)
The Latex Powder Free Examination Glove with Colloidal USP Skin Protectant is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant.
The provided text describes a 510(k) premarket notification for "Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant." This document is a regulatory approval letter from the FDA, and it does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device.
The product is a physical medical device (gloves), not a software or AI device. Therefore, the requested information about device performance, ground truth, study design, and AI-specific metrics is not applicable to this document.
To answer your specific points based on the provided text:
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A table of acceptance criteria and the reported device performance: Not available. This document is an FDA approval letter for a physical product (gloves), not a performance report for an AI/software device. Acceptance criteria for gloves would typically involve physical properties like tensile strength, freedom from holes, and biocompatibility, which are not detailed here.
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Sample sized used for the test set and the data provenance: Not applicable. There is no test set for an AI model.
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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. There is no ground truth establishment for a physical glove in the context of an AI model.
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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.
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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.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
The document primarily states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs as intended and is as safe and effective as existing products. It mentions the "Indications for Use" (prevent contamination between patient and examiner) but does not provide performance metrics or study details.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.