(69 days)
The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis.
The modified Cryocare Cardiac Surgical system consists of a control unit that operates one single use, disposable cryoprobe. The control unit is software controlled and operates off standard 120/230 VAC wall power. System control is accomplished directly through keys on the console itself. The Cryoprobes operate on the Joule-Thompson principle and the refrigerative capacity is limited to the freeze zone of the probe. The cryoprobe incorporates a thermocouple to measure temperature at the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor some operations of the system. The temperature probe is a standard T-type needle thermocouple.
The provided text describes a submission for a Modified Cryocare Cardiac Surgical System, which is a Class II device. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, expert qualifications, MRMC studies, and detailed ground truth methods for clinical performance) is not present in the provided documentation, as these are typically features of more rigorous clinical trials (e.g., for PMA applications) or detailed performance studies that go beyond demonstrating substantial equivalence based on in-vitro testing and intended use.
However, I can extract the available information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Inspection | Yielded acceptable results |
| Flex Tests | Yielded acceptable results |
| Endurance Tests | Yielded acceptable results |
| Burst Pressure Tests | Yielded acceptable results |
| Performance under Simulated Use Conditions | Yielded acceptable results |
Note: The document states "All testing of the product yielded acceptable results" without providing specific quantitative targets or results for each test. This is typical for a 510(k) summary focusing on substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "In-vitro performance testing."
- Data Provenance: The testing appears to be internal "in-vitro performance testing" conducted by Endocare, Inc. The country of origin is not specified but presumed to be where Endocare, Inc. is located (Irvine, CA, USA). The testing is not described as retrospective or prospective clinical data but rather as laboratory/bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The testing described is "in-vitro performance testing" rather than a clinical study requiring expert-established ground truth for diagnostic accuracy or similar clinical outcomes.
4. Adjudication Method for the Test Set
- Not applicable. As described above, this was "in-vitro performance testing," not a clinical study involving human judgment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a cryosurgical system, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study. There is no mention of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a medical instrument (Cryocare Cardiac Surgical System) and not an AI algorithm.
7. The Type of Ground Truth Used
- For the in-vitro performance tests, the "ground truth" would be engineering specifications, physical measurements, and pass/fail criteria for the various mechanical and functional tests (dimensional, flex, endurance, burst pressure, simulated use). The document does not detail these specific criteria.
8. The Sample Size for the Training Set
- Not applicable in the context of the described testing. This is a physical medical device, and the testing outlined is in-vitro performance testing, not a machine learning model's training. While the device is "software controlled," the document refers to "in-vitro performance testing" of the physical system, not the software's learning phase.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, for the same reasons as #8.
§ 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.