(224 days)
The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy
Cardima® Ablation System
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Cardima Ablation System, which primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and detailed device performance metrics are NOT available. The document only states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "Results of in-vitro testing demonstrate that the Cardima Ablation System is safe and effective for its intended use." |
| Biocompatibility | "The materials used in the Cardima Ablation System meets the requirements of ISO 10993-1." |
| Functional Equivalence | Demonstrated substantial equivalence to predicate devices (Boston Scientific Electrosurgical Probe, AtriCure Bipolar Coagulator, Medtronic Cardioblate Surgical Ablation Pen). |
| Intended Use | "The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy." |
Missing Information:
The summary does not provide quantitative acceptance criteria (e.g., specific thresholds for ablation depth, temperature, lesion size, or success rates) or detailed performance data (e.g., actual measured ablation parameters, complication rates, success rates in a clinical context). The statement "safe and effective" is a high-level conclusion, not a detailed performance metric.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "in-vitro testing" but does not provide details on the number of samples, devices, or tests performed.
- Data Provenance: The testing appears to be in-vitro, meaning conducted in a controlled laboratory environment rather than on live subjects. The country of origin of the data is not specified, but the applicant (Cardima, Inc.) is based in Fremont, CA, USA, suggesting the testing was likely conducted in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable / Not Specified. For in-vitro testing of an ablation system, "ground truth" would typically be established by physical measurements (e.g., using calipers, thermometers, oscilloscopes, or histological analysis of tissue models) rather than expert interpretation of images or clinical data. There is no mention of human experts establishing ground truth for the in-vitro performance tests described.
4. Adjudication Method for the Test Set
- Not Applicable / Not Specified. Since the ground truth for in-vitro tests is typically objective measurement, an adjudication method for human expert disagreements would not be relevant or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is an ablation system, and the reported testing is primarily in-vitro performance, not related to image interpretation by humans. No mention of such a study is made.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Specified. This device is a manual-use surgical tool, not an AI algorithm. "Standalone performance" in this context refers to the device operating as intended without human intervention for automated tasks. While the device itself operates "standalone" in delivering energy, the concept of "algorithm only" or "human-in-the-loop" performance doesn't apply as it's not an AI-driven diagnostic or automated system. The reported in-vitro testing can be considered an evaluation of the device's standalone physical performance parameters.
7. The Type of Ground Truth Used
- Physical/Objective Measurements: For "in-vitro testing," the ground truth would have been established through objective measurements of physical parameters such as temperature, energy delivery, lesion size, depth, or electrical characteristics in tissue models or non-biological materials. The specific type of measurements or the gold standard used for these measurements is not detailed in the summary.
8. The Sample Size for the Training Set
- Not Applicable / Not Specified. This device is an electrosurgical ablation system, not an AI/machine learning device that requires a "training set." Therefore, there is no training set in the context of AI.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Specified. As there's no training set for an AI algorithm, this question is not relevant to the provided document.
§ 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.