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A patient examination glove is a disposable device intended for medical purposes worn A patient examiner's hand or finger to prevent contamination between patient and examiner.

Silk Touch Powdered Latex Examination Glove with Protein Content Labeling Claim ( 200 Micrograms or Less )

The provided text is a 510(k) premarket notification letter from the FDA to a manufacturer of "Silk Touch Powdered Latex Examination Glove with Protein Content Labeling Claim (200 Micrograms or Less)". It confirms that the device is substantially equivalent to legally marketed predicate devices for its indicated use as a disposable medical device worn on an examiner's hand or finger to prevent contamination.

This document is a regulatory approval letter for a medical device (examination gloves). It does not contain information about the performance criteria, study design, or results of a study as would be relevant for an AI/ML powered medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or expert involvement. The concept of "acceptance criteria," "test set," "training set," "ground truth," or "multi-reader multi-case (MRMC) comparative effectiveness study" is not applicable to an examination glove in the same way it would be for a diagnostic AI algorithm.

The letter simply states that the device is substantially equivalent to existing devices for its stated indications for use: "A patient examination glove is a disposable device intended for medical purposes worn A patient examiner's hand or finger to prevent contamination between patient and examiner."

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The Top Quality Skingard Polycoat Powdered Latex Examination Glove with Aloe Vera is intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Latex Examination Glove with Aloe Vera

The provided text describes a 510(k) summary for a medical device, specifically a "Powdered Latex Examination Glove with Aloe Vera." The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material properties and intended use. There is no information regarding AI/ML device performance, human reader studies, or ground truth establishment relevant to AI/ML.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance (for an AI/ML device).
• Sample size used for the test set and data provenance (for an AI/ML device).
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
• If a standalone (algorithm only without human-in-the-loop performance) study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• The sample size for the training set (for an AI/ML device).
• How the ground truth for the training set was established (for an AI/ML device).

The document is a 510(k) submission for a physical medical product (gloves), not an AI/ML powered device, and thus does not contain the type of information requested regarding AI/ML device performance and validation studies.

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Ask a specific question about this device

Ask a specific question about this device