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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Grape Scented, Blue

This document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves, Grape Scented, Blue." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the information requested in the prompt. It is a regulatory clearance, not a study report detailing acceptance criteria or device performance data. The letter explicitly states that the FDA's determination of substantial equivalence "does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria or reported performance data. For examination gloves, acceptance criteria typically involve physical properties (e.g., tensile strength, elongation), barrier integrity (e.g., freedom from holes), and biocompatibility.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for this type of device and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (gloves), not an AI algorithm.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable, as this is a physical medical device.
9. How the ground truth for the training set was established: Not applicable, as this is a physical medical device.

The FDA's 510(k) clearance process for devices like examination gloves typically relies on demonstrating substantial equivalence to a predicate device, often by showing that the new device meets recognized consensus standards (e.g., ASTM standards for medical gloves) and performs similarly to the predicate. The details of these tests and their results would be in the 510(k) submission itself, not in the clearance letter.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Grape Scented, Blue and White color

The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves, Grape Scented, Blue And White Color". It primarily focuses on the regulatory approval and substantial equivalence determination for this medical device.

This document does NOT contain information about acceptance criteria, device performance studies, ground truth establishment, sample sizes for training or testing, or expert qualifications for AI/ML device evaluation.

Therefore, I cannot provide the requested information from the given text. The request is based on the assumption that the document describes an AI/ML medical device, which is not the case here. This document pertains to a physical medical device (gloves) and its regulatory clearance process, not a software algorithm that would have the study components listed in your request.

Ask a specific question about this device