(50 days)
Brightway TM Brand Nitrile Examination Gloves, Powder Free, Non - Sterile (Grey Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
Brightway ™ Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Grey Color)
This looks like a 510(k) clearance letter from the FDA for medical gloves, and as such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device isn't directly applicable here.
This document pertains to a Class I medical device (patient examination gloves), which are largely regulated based on established standards for manufacturing, materials, and basic performance rather than clinical efficacy studies and "acceptance criteria" of an AI algorithm.
Therefore, many of the specific questions you've asked regarding AI/ML studies (like effect size of AI assistance, sample size for training/test sets, ground truth methodology, and expert qualifications for adjudication) do not apply to this type of device.
If you are looking for an example of a device with such details, this document is not the right source.
§ 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.