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The nContact Guided Coagulation System (VisiTrax™) is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.

The nContact Guided Coagulation System (VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). The functionality of this System is the same as the cleared predicate system.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria":

It's important to note that this document is a Special 510(k) summary for a device modification. The concept of "acceptance criteria" here is implicitly tied to demonstrating substantial equivalence to the predicate device. Unlike a de novo submission where new performance metrics might be established, for a 510(k), the primary "acceptance criterion" is that the modified device is as safe and effective as the predicate, and that the modifications do not raise new questions of safety or effectiveness. The performance data presented is focused on demonstrating this substantial equivalence.

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

The document does not specify a sample size for a "test set" in the traditional sense of a clinical trial or algorithm validation. The "Performance Data" section states:

• "Performance bench tests were executed to ensure that the nContact Guided Coagulation System (VisiTrax) performed as intended and met design specifications."

This indicates bench testing, which typically involves laboratory experiments, not patient data. Therefore, there's no information on data provenance (country of origin) or whether it was retrospective/prospective in a clinical context.

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

This information is not applicable and not provided in the document. The study described relies on bench tests and design verification/validation directly against specifications and the predicate device's performance, not on expert-adjudicated ground truth from a test set.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as there is no mention of a test set requiring adjudication in a clinical or image-based context.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or is not reported. The document describes bench testing and design verification, not studies involving human readers or clinical comparative effectiveness against an AI system.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not done or is not reported. This device is a physical electrosurgical system, not an AI or software algorithm. The "Performance Data" refers to the physical device's operation.

7. Type of Ground Truth Used

The "ground truth" for this special 510(k) is implicitly derived from design specifications and the performance characteristics of the legally marketed predicate device. The modified device's performance was compared to these established benchmarks through "performance bench tests" and "design verification and validation." There is no mention of pathology, outcomes data, or expert consensus in this context.

8. Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is not an AI or machine learning model, so there is no concept of a "training set."

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

This information is not applicable and not provided in the document, as there is no training set for this type of device.

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