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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Blue Nitrile Examination Gloves (Polymer Coated)

This document is a 510(k) clearance letter from the FDA for "Powderfree Blue Nitrile Examination Gloves (Polymer Coated)". It does not describe a study that proves the device meets acceptance criteria in the manner requested (e.g., performance metrics like accuracy, sensitivity, specificity, etc., with associated ground truth, expert review, or sample sizes) for an AI/software as a medical device.

The FDA's 510(k) clearance process for this type of device (medical gloves) focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety and effectiveness.

Therefore, I cannot provide the specific information requested in the format of acceptance criteria and study details for an AI/software device. The document does not contain:

1. A table of acceptance criteria and reported device performance: This document does not present performance data like accuracy, sensitivity, or specificity. For gloves, acceptance criteria would typically relate to physical properties (e.g., tensile strength, elongation, puncture resistance) and barrier integrity (e.g., AQL for pinholes), which are not detailed here. The "reported device performance" section is thus not applicable in the context of this document.
2. Sample sizes, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or ground truth types for a test set: These are all concepts relevant to performance studies for AI/software devices. This document only states that the device is "substantially equivalent" to predicate devices, implying that its safety and effectiveness are comparable, not that a specific performance study in the AI/software context was conducted.
3. Sample size for the training set and how ground truth was established for the training set: These are also concepts for AI/software development and are not part of a 510(k) for medical gloves.

In summary, the provided document is a regulatory clearance for a physical medical device (examination gloves) based on substantial equivalence, not a technical report detailing a performance study for an AI or software device. As such, the specific information requested about acceptance criteria and study details (especially those related to AI/software performance) cannot be extracted from this document.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Blue Nitrile Examination Gloves

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powderfree Blue Nitrile Examination Gloves." This document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

Instead, it is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices. The letter primarily addresses:

• The FDA's review and determination of substantial equivalence.
• Regulatory classification (Class I).
• Applicability of general controls provisions of the Federal Food, Drug, and Cosmetic Act.
• Contact information for various FDA offices.
• The "Indications For Use" for the gloves.

Therefore, I cannot provide the information requested in the prompt based on the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device