(52 days)
AtriCure's cryolCE cryoSPHERE cryoablation probes are sterile, single use devices intended for use in blocking pain by temporarily ablating peripheral nerves.
The cryolCE cryoSPHERE cryoablation (CRYOS) probe is a single use device that achieves cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable, and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe.
The provided text describes a 510(k) premarket notification for a medical device, the AtriCure cryoICE cryoSPHERE cryoablation probe. It states that the device is substantially equivalent to a previously cleared predicate device based on bench testing. However, the document does not contain information about the device's performance in a study involving human or animal subjects, nor does it detail acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML-based medical device.
The provided document focuses on demonstrating substantial equivalence for a physical medical device (a cryoablation probe) through non-clinical bench testing. Therefore, it does not provide the information requested in the prompt regarding acceptance criteria and study data for an AI/ML device's diagnostic performance.
Specifically, the document states:
- Performance Data: "The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared CRYO2 device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared CRYO2 device. No new safety or performance issues were raising during testing."
- Non-clinical Bench Testing:
- Reliability Testing
- Transit
- Shelf-life
- Cryogen Performance/Thermal Insulation
- Mechanical testing
- Biocompatibility
Given this, I cannot construct a table of acceptance criteria and reported device performance for an AI/ML diagnostic device, nor can I provide details about sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information provided in this 510(k) summary for a physical cryoablation probe.
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).