(367 days)
Patton Surgical PolarCoat is a single patient use device which is intended for use on electrodes to reduce sticking.
The Candidate Device is a yellow-brown substance, Lecithin with soy protein removed. The Candidate Device is a single patient device, available on sponge or in bottle, to be used on electrodes to reduce sticking. The Candidate Device is sterilized by the Irradiation method and packaged individually within a shipper container of 20 units per container.
The provided text is a 510(k) summary for the Patton Surgical PolarCoat, a device intended to reduce sticking on electrosurgical electrodes. It is a submission for substantial equivalence to a predicate device, not a study evaluating acceptance criteria for a new AI/Software as a Medical Device (SaMD).
Therefore, the information requested in the prompt, such as acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth definitions, are not present in the provided document.
This document describes a medical device (a coating for electrosurgical electrodes) seeking 510(k) clearance based on substantial equivalence to an existing device (Mectra Labs, Inc.'s Electro-Lube). The 510(k) process for this type of device does not typically involve the kind of performance studies, particularly those related to AI/SaMD, that would generate the information you've requested.
In summary, the provided document does not contain the information necessary to complete the table and answer the questions regarding acceptance criteria and study details for an AI/SaMD.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.