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The Cardioblate® Monopolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® generator or for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker.

The Medtronic Cardioblate® Monopolar Pen is a hand-held, electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy when connected to the Cardioblate 68000 generator along with a return electrode when the operator presses the footswitch. In addition, the Cardioblate Pen can be used with the Medtronic Model 2090/2290 Programmer/Analyzer, and the Medtronic Model 5348/5388 External Temporary Pacemaker. When connected to a ground source, the monopolar pen can sense depolarization's of the ventricle and stimulate (pace) either the atrium or ventricle. The Cardioblate Pen is intended for intermittent operation, is sterile, non-pvrogenic, disposable, and single use only.

The provided text is a 510(k) summary for the Medtronic Cardioblate Monopolar Pen. It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, it is not possible to fully populate the table and answer all questions directly from the provided document. The document primarily states that the devices were "tested and compared to the performance specification of the Detect Surgical Pacing and Mapping Tool" and "are considered safe and effective per the following standards for Medical Electrical Equipment: Part 1:General Requirements, IEC 60601-1 and, IEC 60601-2-27." However, it does not provide the specifics of these performance specifications or test results.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document states "The performance characteristics of the Cardioblate Monopolar Pen and XL Pen were tested," but does not provide any details about the number of units tested, the types of tests (e.g., bench, animal, clinical), or the sample size of any data collected from these tests.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not specified. This type of information is typically found in human factors or clinical studies, which are not described here. The study described focuses on device performance against standards and predicate specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. Adjudication methods are usually relevant for human-read interpretations or clinical endpoints, which are not detailed in this document.

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

• Not applicable. This is not an AI-assisted device. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical electrosurgery pen, not an algorithm. The performance described is "standalone" in the sense that the device itself was tested, but "human-in-the-loop" is fundamental to its operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" or reference for performance was based on performance specifications of the predicate device (Medtronic Detect™ Surgical Pacing and Mapping Tool) and adherence to international standards (IEC 60601-1 and IEC 60601-2-27). There is no mention of clinical outcomes, pathology, or expert consensus as ground truth for this type of device performance evaluation.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. (See #8)

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