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

The provided documents describe a Special 510(k) submission for the Numeris™ Guided Coagulation System with VisiTrax®, which introduces modifications to a previously cleared device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing to assure that the modifications do not significantly affect safety or efficacy.

Therefore, the study supporting this submission is a performance bench test study, rather than a clinical trial with acceptance criteria for a specific device performance metric in human subjects.

Here's a breakdown of the requested information based on the provided text, with explanations where information is not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "Performance bench tests were executed to ensure that the Numeris Guided Coagulation System with VisiTrax performed as intended and met design specifications."
However, the specific acceptance criteria (e.g., maximum temperature, impedance range, coagulation depth) and the detailed reported device performance against these criteria are not provided in this summary. Instead, it makes a general statement that the device "met design specifications."

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

• Sample Size: Not explicitly stated. The document mentions "Performance bench tests," implying a series of tests performed on the modified devices. These tests would involve a certain number of units or test conditions, but the exact sample size is not detailed.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by the manufacturer, nContact Surgical, Inc., in the USA. The study is retrospective in the sense that it's performed on manufactured devices to verify design specifications.

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

• Number of Experts: Not applicable/not stated. Bench tests generally rely on established engineering standards and design specifications, not expert interpretation of results in the way clinical studies do. The "ground truth" is defined by the device's design specifications and performance standards.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would be performed by qualified engineers or technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench testing for substantial equivalence evaluates physical and electrical performance against predefined specifications, which does not typically involve adjudication by experts in the same way clinical image interpretation or diagnosis would.

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

• Was it done? No. This submission is for a medical device which transmits RF energy, not an AI-assisted diagnostic tool. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the nature of this device.
• Effect size: Not applicable.

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

• Was it done? Not applicable in the context of an AI algorithm. This device is an electrosurgical device; its performance is inherent to its physical and electrical characteristics, rather than an algorithm performing a task. The "standalone performance" is the device's ability to coagulate tissue as designed, which was assessed via bench testing.

7. Type of Ground Truth Used

• Type of Ground Truth: Design specifications and engineering standards. The "ground truth" for these performance bench tests would be the established acceptable ranges and values for various physical and electrical parameters as defined by the device's design and applicable medical device standards.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI/machine learning device, so there is no "training set." The device is built and tested against design specifications.

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

• How Established: Not applicable, as there is no training set for this type of device.

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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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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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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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