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The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.

The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.

The EPi-Sense Guided Coagulation System with VisiTrax consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm 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). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The Cannula accessory changes are the subject of this submission.

This document describes a 510(k) premarket notification for the nContact Surgical, Inc. EPi-Sense Guided Coagulation System with VisiTrax. The submission focuses on minor changes to the Cannula accessory, not the core coagulation device or an AI component. Therefore, the request for information related to AI/algorithm performance (acceptance criteria, sample sizes for test/training sets, experts, MRMC studies, standalone performance, ground truth establishment) is not applicable to this submission.

The "device" in this context refers to the EPi-Sense Guided Coagulation System with VisiTrax, specifically the Cannula accessory.

Here's the information based on the provided document, addressing the non-AI aspects:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of precise acceptance criteria with numerical targets. Instead, it states that "Performance bench tests were executed to ensure that the Cannula accessory performed as intended and met design specifications." The reported device performance is that the tests were "successfully completed to evaluate equivalence."

The successful completion of the following tests implies they met pre-defined acceptance criteria, although the specific criteria are not detailed in this summary:

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each of the nonclinical tests. It only states that "Performance bench tests were executed." There is no mention of data provenance (e.g., country of origin, retrospective/prospective) which is typically relevant for clinical studies, not bench testing of a device accessory.

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

This question is not applicable. The testing described is bench testing of physical properties and regulatory compliance (biocompatibility, sterilization), not a diagnostic or AI performance study requiring expert ground truth.

4. Adjudication method for the test set

This question is not applicable for the reasons stated above.

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

This question is not applicable as there is no AI component mentioned in this 510(k) submission.

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

This question is not applicable as there is no AI component mentioned in this 510(k) submission.

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

This question is not applicable. The "ground truth" for these tests would be established by validated test methods and industry standards (e.g., ISO for biocompatibility and sterilization, IEC for electrical safety), not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This question is not applicable as there is no AI component mentioned in this 510(k) submission.

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

This question is not applicable as there is no AI component mentioned in this 510(k) submission.

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The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.

The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.

The EPi-Sense Guided Coagulation System with VisiTrax - generation 4 product) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm 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). An optional temporary sensing electrode feature may be used with . an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile).

The provided text describes a 510(k) premarket notification for the nContact Surgical, Inc. EPi-Sense Guided Coagulation System with VisiTrax. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and performance against them.

Therefore, the study described is primarily focused on demonstrating equivalence to existing predicate devices, not on proving that the device meets novel, independently established acceptance criteria through a clinical trial with a defined ground truth and expert consensus. The acceptance criteria in this context are implicitly met by demonstrating this equivalence through non-clinical testing.

Here's an analysis based on the information provided, highlighting why it doesn't fit the typical "acceptance criteria and study proving performance" structure you're looking for, but rather focuses on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria (e.g., sensitivity, specificity thresholds) for device performance in a clinical context, nor does it report specific performance metrics for such criteria. Instead, the "acceptance criteria" are implied by demonstrating equivalence to a predicate device, and the "performance" is judged by successful completion of non-clinical tests.

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

The document describes non-clinical testing (bench and in-vivo pre-clinical testing). There is no mention of human clinical trial data, and therefore no "test set" in the sense of patient data.

• Sample Size for Test Set: Not applicable, as no human clinical test set data is described.
• Data Provenance: Not applicable, as no human clinical test set data is described.

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

Not applicable, as no human clinical test set data or ground truth established by experts for such data is described. The "ground truth" for the non-clinical tests would be the established performance of the predicate device and the design specifications.

4. Adjudication Method for the Test Set:

Not applicable, as no human clinical test set data is described.

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

No MRMC study was performed or described. The submission is for a medical device (surgical system) used for coagulation and sensing, not for an imaging or diagnostic AI device that would typically involve an MRMC study.

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

Not applicable. This device is a surgical instrument where human interaction is integral to its function. Its "performance" is inherently tied to its use by a human surgeon or clinician. There is no isolated algorithm being evaluated for standalone performance.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by:

• Predicate Device Performance: The primary ground truth is the established safety and effectiveness profile of the legally marketed predicate devices.
• Design Specifications: The device's design specifications serve as a benchmark for bench testing.
• ISO and IEC Standards: Compliance with relevant international standards (e.g., ISO 10993, ISO 11137-2, IEC 60601-1-2) defines successful performance in those areas.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware system, not an AI/ML model that requires a "training set" of data in the typical sense.

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

Not applicable for the same reason as above.

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