(102 days)
The Medtronic® Cardioblate™ Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Medtronic Cardioblate System is comprised of a radiofrequency ablation pen, radiofrequency generator, and accessories for the application of radiofrequency energy to tissue. The Cardioblate Pen is a hand-held, unipolar, radiofrequency surgical ablation pen for use during open-heart surgery. The Cardioblate Generator is capable of delivering the controlled radiofrequency energy that is required for the creation of linear lesions during open-heart surgery. The Cardioblate Generator delivers up to 50 Watts to the delivery device with a 20 - 500 Ohm range.
The Medtronic Cardioblate Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The device met acceptance criteria by demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Substantial equivalence to predicate devices regarding performance characteristics for intended use. | Performance characteristics tested and compared to predicate device specifications. Differences deemed minor and not raising concerns for safety and effectiveness. | Bench testing and non-bench analyses |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not specify a "test set" in the context of patient data. The device's performance was evaluated through "bench testing and non-bench analyses" against specifications of predicate devices. This suggests engineering or laboratory testing rather than a clinical study with a patient test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The study involved non-clinical performance testing against predicate device specifications, not expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable. The study involved non-clinical performance testing, not a clinical trial requiring adjudication of outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on non-clinical performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The performance evaluation was of the device itself (radiofrequency ablation system) in a non-clinical setting, without a human operator performing interpretations or making decisions that would be part of a "human-in-the-loop" clinical scenario for an AI device. However, this is not an AI device, so the concept of "standalone" algorithm performance as typically applied to AI is not directly relevant. The "standalone" performance here refers to the device's ability to meet its technical specifications.
7. The Type of Ground Truth Used
The "ground truth" for the performance study was the performance specifications of the legally marketed predicate devices. The Cardioblate System's performance was compared to these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning device that requires a "training set." Its performance was evaluated through engineering and laboratory testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no "training set" for this device.
§ 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.