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

The nContact Coagulation System 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 provided text is a 510(k) summary for the nContact Coagulation System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics that would typically be found in a clinical or non-clinical validation report.

Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC study, ground truth details, training set size) cannot be answered from the provided document.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with corresponding performance results. Instead, it states:

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

• The document states that "Performance testing was completed," but it does not specify the sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective nature). This document is a 510(k) summary, which often summarizes testing without full detail.

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

• This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparison and non-clinical performance, rather than an expert-adjudicated test set typically used for AI algorithms.

4. Adjudication method for the test set

• This information is not provided in the document, as no specific test set requiring expert adjudication is described.

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

• An MRMC comparative effectiveness study is not mentioned in the document. This submission pertains to a medical device for coagulation, not an AI-assisted diagnostic or interpretative tool for human readers.

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

• The nContact Coagulation System is a physical medical device (electrode device and electrosurgical generator), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" as typically applied to AI does not apply in this context. The non-clinical performance testing implicitly refers to the device's functional integrity.

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

• The document implies that "performance testing" was conducted to validate its intended use (coagulation of cardiac tissue). However, the specific type of "ground truth" (e.g., histological assessment of coagulation, functional cardiac outcomes) used to evaluate this performance is not described. For a device that performs coagulation, "ground truth" would likely involve objective measures of tissue effect.

8. The sample size for the training set

• The concept of a "training set" is not applicable to this device. The nContact Coagulation System is a traditional medical device (electrosurgical) and does not involve AI or machine learning that would require a training set.

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

• As the device is not an AI/ML system, there is no training set, and therefore no ground truth established for it in that context.

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The nContact Coagulation System is intended for the coagulation of soft tissue using Radiofrequency (RF) energy.

The nContact Coagulation System consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate soft 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 provided text describes a 510(k) summary for the nContact Coagulation System, an electrosurgical device intended for the coagulation of soft tissue using radiofrequency (RF) energy. However, the document does not contain specific acceptance criteria or a detailed study description with performance metrics.

The summary states that "Performance testing was completed to validate its intended use" and that "The nContact Coagulation System may be considered substantially equivalent to the predicate devices based on performance and comparative data, and does not raise new questions of safety and efficacy." This implies that the device likely met acceptance criteria, but the criteria themselves and the detailed results are not provided in this document.

Therefore, I cannot populate the requested table or answer most of the questions as the necessary information is not present in the provided text.

Based on the provided information, I can only state the following:

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

• Information Not Available: The document only generally states that "Performance testing was completed to validate its intended use" and that the device is "substantially equivalent to the predicate devices based on performance and comparative data." It does not provide specific acceptance criteria (e.g., minimum coagulation depth, maximum thermal spread) or quantitative performance metrics (e.g., specific coagulation results, efficacy rates).

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

• Information Not Available: The document mentions "Performance testing" but does not specify sample sizes, whether the data was from animal or human subjects, its country of origin, or if it was retrospective or prospective.

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)

• Information Not Available: The document does not describe any study involving experts for ground truth establishment.

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

• Information Not Available: The document does not describe any study that would require an adjudication method.

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

• Information Not Applicable/Not Available: This involves a medical imaging device with AI assistance, which is not what the nContact Coagulation System is. No such study is mentioned or relevant to this device's description.

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

• Information Not Applicable/Not Available: This involves an algorithm, which is not part of the nContact Coagulation System's description.

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

• Information Not Available: The document does not describe the specific type of ground truth used for performance testing beyond "to validate its intended use."

8. The sample size for the training set

• Information Not Applicable/Not Available: There is no mention of a training set, as this is not an AI/machine learning device.

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

• Information Not Applicable/Not Available: As there's no training set, this question is not applicable.

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