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A patient examination latex Powdered Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

LATEX POWDERED EXAMINATION GLOVES

This document is a 510(k) premarket notification letter from the FDA regarding "Latex Powdered Examination Gloves." It does not contain information about acceptance criteria or a study proving that a device meets those criteria. This type of document is for a medical device that does not require clinical studies for market clearance.

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A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

NITRILE BLUE POWDER FREE EXAMINATION GLOVE

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Nitrile Blue Powder Free Examination Glove. It is a regulatory document and does not contain information about the acceptance criteria, study details, or performance of a device in the context of AI/ML or medical imaging analysis as implied by your detailed request.

The document discusses:

• The FDA's review of a premarket notification for a medical glove.
• The determination of substantial equivalence to a legally marketed predicate device.
• General controls and regulations applicable to the device.
• The intended use of the glove as a disposable device to prevent contamination between patient and examiner.

Therefore, I cannot extract the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

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A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powdered Examination Glove

The provided document is a 510(k) premarket notification letter from the FDA for a Nitrile Blue Powdered Examination Glove. It is a regulatory document affirming equivalence to a predicate device and does not contain information about acceptance criteria or performance studies as typically described for a medical device that relies on algorithmic or diagnostic performance.

Therefore, I cannot answer your request regarding acceptance criteria and device performance studies because the information is not present in the provided text. The document is about a physical medical device (examination glove) that falls under general controls and does not involve AI or complex performance metrics as implied by your questions.

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A patient examination Latex Powder Free Glove is a 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 Glove

This document is a 510(k) clearance letter for a "Latex Powder Free Examination Glove." It does NOT contain information about acceptance criteria or a study proving device performance in the context of an AI/software as a medical device (SaMD).

The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for this type of medical device (a physical glove) to be marketed, but there are no performance metrics or clinical study details as would be expected for a SaMD.

Therefore, I cannot provide the requested information for an AI/SaMD according to the provided text. The document pertains to a physical medical device (examination glove) and its regulatory clearance based on substantial equivalence, not a software device with performance criteria.

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