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The APT Map-It™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The Map-iTTM Diagnostic Mapping Catheters are biocompatible, flexible, radiopaque fixed and steerable catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, including a guidewire tip configuration to aid the physician in accessing and mapping a patient's heart. They are available in fixed curve and steerable configurations. The fixed curve catheters are available in 4/3.3F (4F tapering to 3.3F), 4F, 5F and 6F sizes with a 0.026'' floppy guidewire tip configuration in the 4/3.3F and 4F sizes for access into smaller anatomies. The steerable catheters are available in 4F, 5F, 6F and 7F sizes. There is a tip electrode on all models except the guidewire tip and PV loop configuration: the band electrodes are set at predetermined distances along the catheter shaft. The catheters can be used for recording intracardiac signals in the atrial and ventricular regions of the heart and for cardiac stimulation during electrophysiology studies. The Map-iT™ Diagnostic Mapping Catheters are comprised of a Pebax catheter shaft, platinum-iridium electrodes and electrical connectors that are either shrouded pin for the bipolar configurations or industry standard Redel connectors. The distal end of the fixed catheters is preformed into industry standard shapes with a variety of electrodes spacing to reach specific areas in the targeted chamber of the heart. The steerable catheters are available in a variety of curves that are controlled to the precise location in the heart by pulling or pushing the plunger on the handle.

The provided document is an FDA 510(k) premarket notification for the Map-it™ Diagnostic Mapping Catheters. The document states that the device is "substantially equivalent" to a legally marketed predicate device (St. Jude Medical Livewire™ Diagnostic Mapping Catheter). This means the FDA determined that the new device is as safe and effective as the predicate device, and thus does not require a new premarket approval (PMA).

Crucially, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way one might expect for a new, de novo device or a clinical AI/ML device. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.

Here's an breakdown based on your request, highlighting what is and isn't present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document as specific performance metrics and acceptance thresholds. Instead, the performance is implicitly demonstrated by meeting existing standards and test methods as discussed in the "TESTING PERFORMED" section.

The document states:
"The Map-iT™ Diagnostic Mapping Catheters were thoroughly tested based on existing standards and test methods. These tests included visual, dimensional, electrical performance - continuity, leakage impedance, dielectric; mechanical performance - tensile, torque, deflection, shaft buckling, radio-detectability, corrosion; biocompatibility (short term <24 hours, blood contacting) and packaging. Testing demonstrates that the Map-iT™ Diagnostic Mapping Catheters met the specifications and are substantially equivalent to the predicate."

Therefore, the "acceptance criteria" here are implied to be adherence to the specifications of these standards and methods, and the "reported device performance" is that it "met the specifications."

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

This information is not provided in the document. The testing described is pre-clinical (e.g., electrical, mechanical, biocompatibility) rather than a clinical study with a "test set" in the context of AI/ML or a new clinical performance claim.

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

This information is not applicable as there is no mention of a "test set" requiring expert ground truth in the context of clinical performance evaluation for this device. The testing conducted is primarily engineering and materials-based.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

An MRMC study was not done and is not applicable for this type of device submission. This is a diagnostic mapping catheter, not an AI/ML-assisted diagnostic software requiring human reader performance improvement assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

A standalone performance study of an algorithm was not done and is not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

For the engineering and materials performance, the "ground truth" implicitly used would be "specifications" derived from recognized standards and predicate device performance. For biocompatibility, it would be based on laboratory test results showing compliance with established biological safety standards. There is no mention of pathology, outcomes data, or expert consensus in relation to a diagnostic accuracy study for this device.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

This information is not applicable for the same reasons as point 8.

Summary of Device Acceptance and Study:

The acceptance of the Map-iT™ Diagnostic Mapping Catheters by the FDA is based on demonstrating substantial equivalence to an existing predicate device (St. Jude Medical Livewire™ Diagnostic Mapping Catheters). The company performed a series of pre-clinical tests (visual, dimensional, electrical, mechanical, radio-detectability, corrosion, and biocompatibility) that confirmed the device "met the specifications" derived from existing standards and the characteristics of the predicate device. The document explicitly states: "There are no new questions raised regarding safety or efficacy of the Map-iT™ Diagnostic Mapping Catheters." This approach is common for 510(k) submissions where a new device is very similar in design, materials, and intended use to a legally marketed device.

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