(29 days)
The Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® 68000 Generator or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary cardiac pacemaker.
The Medtronic Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a hand-held, monopolar, radiofrequency ablation device powered by the Cardioblate® 68000 Generator. It has a saline irrigation system that delivers fluid at the contact point between tissue and electrode tip to cool tissue during radiofrequency energy delivery. The device can also be used with the Medtronic Model 2090/2290Programmer/Analyzer and the Medtronic Model 5388/5348 External Temporary Pacemaker for bipolar sensing of the ventricle or the atrium and bipolar stimulation (pacing) of the atrium. The device is intended for intermittent operation. The device is provided sterile, nonpyrogenic, disposable, and for single use only.
This looks like a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel technology.
Here's an analysis based on the provided text:
Summary of Acceptance Criteria and Device Performance:
The document states that the current device is "substantially equivalent" to its predicate device (Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device, Model 49205 (K090721)). Substantial equivalence inherently means that the device meets the same performance standards and has the same safety and effectiveness as the predicate. However, specific numerical acceptance criteria and reported device performance are not explicitly stated in this 510(k) summary.
The document highlights: "The historical changes in this submission did not involve changes to control mechanism, operating principles, energy type, indication process. None required clinical evidence to evaluate Impact to safety and effectiveness. The changes were considered to be routine changes to maintain or Improve device performance based on internal or external feedback and the information generated as oart of design verification and validation activities or technical assessments confirmed these changes did not adversely the device's safety or effectiveness."
This suggests that the "acceptance criteria" were met by demonstrating that the modifications did not alter the fundamental scientific or indication of the device, and that design verification and validation activities confirmed no adverse impact on safety or effectiveness.
Since no specific quantitative performance metrics or acceptance criteria are detailed in the provided text, a table cannot be populated as requested. The "reported device performance" is implicitly that it performs as safely and effectively as the predicate device.
Missing Information & Why It's Not Present:
This document is a 510(k) summary for a modified device, not a report of a de novo study for a new device type. Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, specific ground truth methods for new studies) are typically not included because the submission focuses on demonstrating that the modifications do not introduce new questions of safety or effectiveness compared to an already approved device.
Here's a breakdown of the requested information and why it's not present based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical or specific qualitative criteria in the provided text. The overall criteria are implied to be "no adverse impact on safety or effectiveness" and "substantial equivalence" to the predicate device after modifications. | "The current device is substantially equivalent to the previously submitted and approved predicate Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device, Model 49205 (K090721)." |
| "design verification and validation activities or technical assessments confirmed these changes did not adversely the device's safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The submission focuses on device modifications and their impact rather than new clinical trials that would generate test set data in this manner. The "design verification and validation activities or technical assessments" likely involved internal testing rather than patient-derived test sets described in clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. Since this is a submission for device modifications and substantial equivalence, there is no mention of a test set requiring expert ground truth establishment in the context of diagnostic or prognostic performance. The "ground truth" here would relate to engineering verifications and validations against established specifications for the physical and functional aspects of the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. As above, this type of adjudication method is used in clinical studies or studies evaluating diagnostic algorithm performance, which is not the focus of this 510(k) summary.
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
- No. This is a medical device (electrosurgical ablation/pacing device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study with AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an electrosurgical tool and always involves a human operator (surgeon). "Standalone" performance is usually relevant for AI algorithms or automated diagnostic systems. The performance of this device would be evaluated through its functional capabilities (e.g., ablation power, pacing accuracy, sensing fidelity) in a simulated or real surgical environment, but always with human interaction.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated in the provided text. For a device like this, the "ground truth" for design verification and validation would likely involve:
- Engineering specifications: Ensuring the device meets predefined technical requirements for power output, temperature control, irrigation flow, electrical safety, biocompatibility, sterility, etc.
- Bench testing: Performance against established materials or models.
- Animal studies (possibly): To confirm tissue effects if any significant change were made (though the text suggests changes were minor and didn't require clinical evidence).
- Predicate device comparison: Directly comparing functional performance to the predicate under controlled conditions.
8. The sample size for the training set
- Not applicable/Not provided. There is no "training set" in the context of an AI/machine learning model for this type of electrosurgical device.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an AI model, this question is not relevant.
§ 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.