(51 days)
The AtriCure Ablation System is intended to ablate soft tissues during general surgery using radiofrequency energy.
The AtriCure Ablation System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (Isolator® Transpolar Clamps or Isolator Synergy™ Clamps) intended for the ablation of soft tissues and an accessory instrument guide (Glidepath™ Tape). The clamp handpieces are connected via an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU2) or an Isolator Switch Matrix (ASB3) console.
This document, K063630, is a 510(k) summary for the AtriCure Ablation System. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria for performance, nor does it describe a study to prove the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing de novo performance metrics or studies against them. The review process for a 510(k) typically involves showing that the new device is as safe and effective as a predicate device, often through technological comparisons and performance data that demonstrate the new device does not raise new questions of safety or effectiveness.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because these elements are not present. The document focuses on regulatory approval based on equivalence, not on a detailed clinical or performance study demonstrating specific acceptance criteria.
The "Testing" section merely states: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." This is a high-level statement and does not provide the specifics of any such tests or their results against defined 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.