(103 days)
A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (21 CFR 878.4460)
FINESSIS VIOLET Element Polyisoprene Powderfree Sterile Surgical Gloves
The provided text is a U.S. FDA 510(k) clearance letter for a medical device: "FINESSIS VIOLET Element Polyisoprene Powderfree Sterile Surgical Gloves."
This document does not contain information about acceptance criteria, device performance, study design, or ground truth establishment for a medical imaging or AI-based device. Instead, it's a regulatory clearance for a physical medical product (surgical gloves) based on substantial equivalence to a legally marketed predicate device.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, training set details) from the provided text.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).