(134 days)
The Primaeva Medical Finesse System is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
The Primaeva Medical Finesse System is comprised of four primary components; an RF Generator with User Interface Software, a Cooling System Hand Piece, a Cooler Controller, and a disposable Electrode Insertion Device with an integrated cable. RF energy is delivered from the RF Generator, through the electrodes, and into the target tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs. The RF Generator, Cooler Controller, and Cooling System Hand Piece are not disposable. Each Electrode Insertion Device is supplied sterile and is for single patient use only and cannot be re-sterilized. The insertion device is a hand-held mechanical device that is used to insert the electrodes, at an acute angle, into the target tissue. The device has ten (10) electrodes arranged in a single row array. The device has a mechanism to deploy and retract the electrodes when actuated by the user. There is a cable with a connector that connects to the RF Generator. The Cooler system comprises a solid state cooling device with a feedback loop to monitor and control temperature. The cooling device is placed on the tissue surface during the treatment cycle. The RF Generator is the energy source for the system. Accessory cables and power cords are also supplied with the system.
There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Primaeva Medical Finesse System, which outlines the device's description, intended use, and comparison to predicate devices for substantial equivalence. It also includes the FDA's clearance letter.
Therefore, I cannot provide the requested table or information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for acceptance criteria.
§ 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.