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For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The FIRMap Catheter may also be used for delivery of externally generated pacing stimuli.

The FIRMap Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. The FIRMap Multiple Electrode Recording and Pacing Catheter may also be used for delivery of externally generated pacing stimuli. The FIRMap catheter is delivered to the heart chamber via an intravascular sheath. After the catheter is positioned the sheath is withdrawn enough to allow the basket to expand and the electrodes to contact the heart wall.

The furnished document is a 510(k) summary for the FIRMap Catheter, which is an electrode recording catheter used in cardiac electrophysiology procedures. It states that "No animal or clinical testing was conducted." Therefore, there is no study described that proves the device meets specific acceptance criteria based on performance with human or animal subjects.

However, the document lists several performance data tests and concludes that these tests demonstrate substantial equivalence to the predicate device and assure conformity to appropriate requirements. This represents the "study" that was performed and its findings regarding acceptance.

Here is an attempt to structure the requested information based on the provided text, while noting the absence of clinical performance data in the traditional sense:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific acceptance criteria values were explicitly stated for the listed tests, and the "reported device performance" is a general statement of success rather than quantitative results, I will infer the acceptance criterion as "conforms to requirements" and the performance as "met this standard."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for the listed tests (Radial Strength, Lateral Strength, etc.). These appear to be bench or engineering tests where "sample size" might refer to the number of catheters tested, which is not provided.
• Data Provenance: The tests are likely retrospective bench/engineering tests conducted in a lab setting by the manufacturer (Abbott Electrophysiology) to demonstrate the physical properties and functional aspects of the device, rather than involving patient data. Country of origin not specified, but likely where Abbott Electrophysiology's R&D is located.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. For bench/engineering tests like Radial Strength or Torque, "ground truth" is typically established by engineering specifications, material properties, and relevant industry standards, not by human expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As these were non-clinical bench tests, adjudication methods like 2+1 or 3+1 (common in image interpretation or clinical trials) are not relevant. Test results would be compared against predefined engineering specifications or performance limits.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No animal or clinical testing was conducted." Therefore, no MRMC study involving human readers or AI assistance was performed or described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The FIRMap Catheter is a physical medical device, not a software algorithm or AI. Performance is related to its physical and functional characteristics, not algorithm capability.

7. Type of Ground Truth Used

The ground truth for the performance data (Radial Strength, Lateral Strength, etc.) would be established by engineering specifications and recognized industry standards (e.g., ISO and IEC standards listed in the document), rather than expert consensus, pathology, or outcomes data, as no clinical testing was performed.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would involve engineering and material testing, but not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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