(90 days)
The Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is intended to ablate soft tissue during general surgery using radiofrequency energy.
The Medtronic® Cardioblate® Bipolar Radiofrequecy Ablation System is made of bipolar Surgical Ablation Device (Model 60821 & 60822) and a Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator & accessories (Model 60890) for the application of radiofrequency energy to tissue.
The Medtronic® Cardioblate® BP (Bipolar) Surgical Ablation Device, (Model 60821 & 60822) is a hand-held, bipolar, radiofrequency surgical ablation device.
The Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, (Model 60890) is capable of delivering the controlled radiofrequency energy for Bipolar or Monopolar surgical ablation. The Generator delivers in Bipolar mode up to 40 Watts, with a 20 - 350 Ohm range, and a Monopolar mode up to 50 Watts to the delivery device with a 20-500 Ohm range.
The provided text describes a 510(k) premarket submission for the Medtronic Cardioblate Bipolar Radiofrequency Ablation System. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report with specific performance metrics.
Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided document.
However, based on the available information, here's what can be inferred and what remains unknown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in safety and effectiveness for soft tissue ablation. | Performance characteristics were tested and compared to the performance specifications of listed predicate devices through bench testing and non-bench analyses. The differences were "minor and not raise any concern regarding the overall safety and effectiveness." |
| Effective ablation of soft tissue during general surgery using radiofrequency energy. | The device is intended to ablate soft tissue during general surgery using radiofrequency energy. (No specific ablation effectiveness metrics or success rates are reported in this summary.) |
| Safe operation with no undue risks. | The device is considered "substantially equivalent" in terms of safety and effectiveness to predicate devices. (No specific safety event rates or adverse effect data are reported.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "bench testing and non-bench analyses" for performance characteristic comparisons. These would typically involve test articles of the device but the number is not provided.
- Data Provenance: Not specified. The types of tests mentioned (bench testing) suggest laboratory-based data, but the country of origin or whether it's retrospective/prospective is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified. It is unlikely that an adjudication method in the context of human reader performance would be applicable to the "bench testing and non-bench analyses" described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is an electrosurgical ablation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: The document describes "bench testing and non-bench analyses" which would represent standalone performance of the device itself (not an algorithm). However, detailed results or specific metrics for this standalone performance are not provided beyond the general statement of comparison to predicate devices.
7. The type of ground truth used
- Type of Ground Truth: For the "bench testing and non-bench analyses," the ground truth would likely be established through engineering specifications, physical measurements, and comparison to the documented performance of the predicate devices. For instance, if testing ablation depth, the ground truth would be the measured depth in a controlled environment. The document is not specific on the methodology.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is an electrosurgical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for this type of device.
Summary of what the document does indicate:
- The device is intended to ablate soft tissue during general surgery using radiofrequency energy.
- The primary method for demonstrating its suitability for approval was non-clinical testing (bench testing and non-bench analyses) to show substantial equivalence to existing predicate devices (Medtronic Cardioblate Radiofrequency Ablation System K013392 and AtriCure Bipolar System K020919).
- The conclusion was that differences were "minor and not raise any concern regarding the overall safety and effectiveness."
- No human clinical trial data, AI performance metrics, or reader studies are mentioned in this 510(k) summary.
§ 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.