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The Numeris™ Tethered Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery.

The modified nContact system, "Numeris Tethered Coagulation System with VisiTrax", consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, 3cm, & 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, however two addition RF coil electrode lengths have been added to the product offering (1cm and 3cm).

The provided documentation is a K082203 510(k) Special Notice for the nContact Surgical, Inc. Coagulation System Device Modification, specifically the Gen 3 tethered version. This submission focuses on demonstrating substantial equivalence to a predicate device for minor material and design changes, and the addition of new electrode lengths. As such, the information you're requesting regarding clinical studies, acceptance criteria for performance metrics, and detailed ground truth establishment is not present in this type of submission.

Special 510(k)s typically rely on bench testing and comparisons to the predicate device to establish that the modified device's performance is not adversely affected and remains substantially equivalent. They do not usually involve extensive clinical trials or human-in-the-loop studies unless the changes are considered significant enough to warrant them, which is not the case here.

Here's a breakdown of why many of your requested points cannot be answered based on the input:

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

• Not present. The document states: "Performance bench tests were executed to ensure that the Numeris Tethered Coagulation System with VisiTrax performed as intended and met design specifications." However, no specific acceptance criteria (e.g., minimum RF energy delivered, maximum temperature, coagulation depth) or the actual results of these tests (e.g., "device achieved X coagulation depth, meeting the criterion of Y") are shared in the summary. This information would typically be in the detailed testing protocols and results submitted to the FDA, but not in the public summary provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not present. No clinical "test set" in the context of human subjects or complex data analysis is described. The "performance data" refers to bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not present. No ground truth established by experts is mentioned, as there are no clinical trials or image analysis involved.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not present. No clinical test set to adjudicate.

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

• Not applicable/Not present. This device is an electrosurgical tool, not an AI-powered diagnostic system. No MRMC study was conducted.

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

• Not applicable/Not present. This device is not an algorithm; it's a medical instrument.

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

• Not applicable/Not present. The "ground truth" for this type of device modification would be its ability to perform its stated function (coagulating tissue) reliably and safely, as demonstrated through engineering and bench testing against design specifications, and its equivalence to the predicate device. These are established through physical measurements and comparisons, not expert clinical consensus or pathology from human trials in this context.

8. The sample size for the training set

• Not applicable/Not present. This device does not use machine learning or AI, so there is no "training set."

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

• Not applicable/Not present. As there's no training set, this is not relevant.

Summary of what IS stated regarding performance:

• Device Performance Claim: "Performance bench tests were executed to ensure that the Numeris Tethered Coaqulation System with VisiTrax performed as intended and met design specifications."
• Basis for Substantial Equivalence: The submission claims substantial equivalence based on "the results of design verification and validation." The key characteristics that are maintained are the "indications for use, principle of operation, technology, performance specifications (as reverified through design controls), labeling and sterilization parameters."
• Comparison to Predicate Device: The functionality of the system is stated to be the same as the cleared predicate system. The technological characteristics (transmitting RF energy from an electrosurgical generator to an electrode) remain "identical to the predicate device."

In conclusion, based solely on the provided text, a detailed table of acceptance criteria and proven device performance as requested cannot be constructed. The document emphasizes that the modifications are minor and that bench testing confirmed the device performed as intended and met design specifications, implying successful adherence to internal criteria, but these criteria themselves are not disclosed in this public summary.

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