Search Results

AtriCure's cryolCE cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.

The cryosurgical handpiece, or cryo-ablation probe, utilized in the AtriCure Cryosurgical System is a hand held, single use, cryosurgical instrument intended for the cryosurgical treatment of cardiac arrhythmias during cardiac surgery; it is also intended for use in blocking pain by temporarily ablating peripheral nerves. The cryosurgical handpiece utilizes a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpiece provides probe temperatures below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitrous oxide is supplied to the cryoprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probe is malleable to allow access to varying and anatomical sites. The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler and three internal inlet orifices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be used to bend the desired form. The cryotip is attached to an insulated rigid shaft that allows the surgeon to adjust the length of the exposed cryotip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the shaft to display real time temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).

This document is a 510(k) premarket notification for a medical device called the AtriCure cryoICE cryo-ablation probe (CRYO2). It is a submission to the FDA for a modified version of an already cleared device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the performance of a new device against clinical acceptance criteria in the way AI/ML devices often require.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or available in this document for the following reasons:

• This is a 510(k) for a modified device, not a novel AI/ML device. The focus is on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, not on proving new clinical performance metrics against defined acceptance criteria.
• The device is a cryo-ablation probe, not AI/ML software. The performance data described is non-clinical bench testing (mechanical reliability, transit, shelf-life, cryogen performance/thermal insulation), which is standard for hardware modifications to medical devices. It does not involve algorithms, human readers, or clinical ground truth in the context of diagnostic or prognostic AI.
• "Acceptance criteria" here refer to regulatory requirements for demonstrating substantial equivalence, not performance metrics. The conclusion states that the modified device is "equivalent to the previously cleared AtriCure cryoICE cryoablation probe (CRYO2) as there is no change to intended use, operating principals, or function of the device." This "equivalency" is the primary acceptance criterion for a 510(k) of this nature.

Based on the provided document, I cannot generate the table or specific details requested because the information simply isn't present, as it pertains to a different type of device and regulatory submission.

Ask a specific question about this device