(46 days)
A surgeon glove is a disposable device intended for medical purposes that is worn on the surgeon's hand to prevent contamination between patient and surgeon.
The device in this 510(k) submission is the SensiCare -C Synthetic Polyisoprene Powder-free Surgical Glove (Classification number 79KGO). The SensiCare C Synthetic Polyisoprene Powder-free Surgical Glove is a sterile, synthetic rubber latex surgical glove. These gloves are intended to be used as a barrier by providing protection for surgical personnel and patients against microbial migration and to protect a surgical wound from contamination.
The provided text describes the SensiCare-C Synthetic Polyisoprene Powder-Free Surgical Gloves and their regulatory clearance, but it does not contain information about a study involving an AI/Machine Learning device or its performance criteria, ground truth, or expert review process.
The document is a 510(k) summary for a medical glove, focusing on its substantial equivalence to a predicate device and its compliance with relevant ASTM standards for physical properties, sterility, and freedom from holes.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input does not contain any of the following:
- A table of acceptance criteria and reported device performance for an AI/ML system.
- Sample sizes for test sets, data provenance, or details about training sets for an AI/ML system.
- Information on experts used to establish ground truth or adjudication methods for an AI/ML system.
- Details about Multi-Reader Multi-Case (MRMC) studies or standalone performance of an AI/ML system.
- The type of ground truth used for an AI/ML system.
§ 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).