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The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.

The PadTac Electrophysiology catheters are between 5 and 8 french (fr), 4, 10, 12 and 14 pole, fixed, monitoring and recording.
The multi-electrode electrophysiology catheters are used for electrophysiology electrocardiograph recording and cardiac stimulation during diagnostic procedures. The cables and box serve as an extension between the catheter and the pin block.

The provided text outlines the 510(k) summary for the TZ Medical PadTac Electrophysiology Recording Catheters, Junction Box Cable Connector, and Electrophysiology Connector Cables. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, a complete answer as requested is not possible from the provided text. However, I can extract what is available regarding the "acceptance criteria" and "study" as presented:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria or specific performance metrics in terms of accuracy, sensitivity, specificity, or other numerical results for the device's function. Instead, it references adherence to existing guidance documents and standards for safety and effectiveness.

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

The document does not describe a clinical study with a test set of data. The assessment appears to be based on engineering tests and adherence to recognized standards for substantial equivalence, not on performance data from patient cases. Therefore, information on sample size and data provenance is not available.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document does not describe a study involving expert-established ground truth for performance evaluation.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a test set requiring adjudication.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence through adherence to existing guidelines and standards, not through comparative clinical performance against human readers.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical medical catheter and associated cables, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

Not applicable. The document does not describe a study that uses ground truth data from patients (e.g., pathology, outcomes data, or expert consensus) to evaluate performance. The "ground truth" implicitly refers to the established safety and effectiveness parameters outlined in the referenced preliminary guidance and standards.

8. Sample Size for the Training Set:

Not applicable. The document does not describe a machine learning algorithm or a training set.

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

Not applicable. The document does not describe a machine learning algorithm or a training set.

Summary of the "Study" (as described in the 510(k) summary):

The "study" referenced in the 510(k) summary is not a clinical performance study with human or simulated data. Instead, it refers to the testing and evaluation conducted to demonstrate that the PadTac EP Catheters and cables meet the safety and effectiveness requirements outlined in existing FDA guidance and international standards.

• For the PadTac Electrophysiology Catheters: The device was tested and determined to be safe and effective per the "Electrode Recording Catheter Preliminary Guidance" from 1995. This guidance likely outlines specific engineering and performance tests (e.g., electrical parameters, biocompatibility, mechanical integrity) that the device must pass to be considered equivalent to existing devices.
• For the PadTac Cables: The cables were tested and determined to be safe and effective per "Standard for Medical Equipment; Part 1: General Requirements, UL 2601 (IEC 60601-1)." This refers to electrical safety and general requirements for medical equipment.

In essence, the "study" is an engineering and regulatory compliance assessment, not a clinical trial or a performance study involving patient data or human readers. The acceptance criteria are implicitly the requirements set forth in the referenced guidance and standards, and the "reported performance" is the conclusion that the device meets those criteria and is therefore considered safe and effective and substantially equivalent to predicate devices.

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