(74 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves, Powder Free
The provided document refers to a 510(k) premarket notification for Blue Nitrile Examination Gloves, Powder Free, and does not contain information about acceptance criteria or a study proving that a device (in the context of AI/software) meets acceptance criteria. The document is an FDA letter granting substantial equivalence for medical gloves, and the "Indication for Use" section simply states the intended purpose of the gloves.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document. The questions you've posed (sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training) are all relevant to the evaluation of AI/software medical devices, but not to the type of device discussed in this document.
§ 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.