(59 days)
The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Cardima Ablation System consists of the disposable Cardima Ablation Probe with Stabilization Sheath, the reusable INTELLITEMP® energy management device, and associated cables.
This document describes the Cardima Ablation System, a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. Based on the provided information, the following details about its acceptance criteria and study are available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safe and effective for its intended function (general statement) | Results of in-vitro testing demonstrate that the Cardima Ablation System is safe and effective for its intended function. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Results of in-vitro testing," indicating that the testing was conducted in a laboratory setting. However, it does not specify the sample size (e.g., number of tests, number of devices) used for this in-vitro testing. It also doesn't provide information about the data provenance; specifically, it doesn't mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the in-vitro testing. Therefore, there is no information about the number or qualifications of such experts.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned in relation to the reported in-vitro testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned. The document only refers to in-vitro testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This device is an electrosurgical system, not an AI algorithm. Therefore, the concept of a "standalone algorithm-only performance" study does not apply. The device's performance is inherently tied to its physical operation and interaction.
7. The Type of Ground Truth Used:
For the in-vitro testing, the ground truth would inherently be based on measurable physical and electrical parameters related to the ablation process (e.g., lesion depth, tissue temperature, energy delivery). However, the document does not explicitly specify the "type of ground truth" using terms like "expert consensus," "pathology," or "outcomes data."
8. The Sample Size for the Training Set:
This device is not an AI algorithm that would require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This device is not an AI algorithm; therefore, there is no "training set" or ground truth establishment relevant in this context.
§ 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.