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The Coolrail linear pen is a sterile, single use electrosurgery device intended to ablate cardiac surgery using radiofrequency (RF) energy.

The AtriCure Coolrail Linear Pen (MCR1) is a hand held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by the AtriCure Ablation and Sensing Unit (ASU) and is used with the AtriCure Switch Matrix (ASB3), a passive source switch, and footswitch. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar radiofrequency (RF) energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.

The provided text describes a 510(k) premarket notification for a medical device, the Coolrail Linear Pen (MCR1). However, the document is an FDA clearance letter for a modified version of an existing device, emphasizing its substantial equivalence to a previously cleared predicate device.

Crucially, this document is a regulatory clearance letter and does not contain the details of a study that proves the device meets specific performance acceptance criteria in the manner requested (e.g., using a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance).

The document states:

• "The Coolrail linear pen device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K183065 MCR1 device."
• "The results of the verification and validation testing: o Demonstrated the subject device met the predetermined performance specifications o Did not raise any new risks or issues of safety."

This indicates that internal verification and validation testing was performed, but the specifics of that testing (e.g., the criteria themselves, the methodology, sample sizes, ground truth establishment, or expert involvement) are not detailed in this FDA letter. The focus of this 510(k) is on the safety and effectiveness of a modified circuit board in a device already cleared by the FDA, primarily by demonstrating that the modifications did not introduce new risks and maintained the performance of the predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, because those specific details are not present in the provided text. The text does not describe a clinical study of the type that would involve a test set, expert readers, MRMC studies, or specific performance metrics like sensitivity/specificity for diagnostic AI, for example. It is a regulatory submission for a physical electrosurgical device with a minor internal modification.

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The Coolrail linear pen is a sterile, single use electrosurgery device intended to ablate cardiac surgery using radiofrequency (RF) energy.

The AtriCure Coolrail Linear Pen (MCR1) is a hand held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by the AtriCure Ablation and Sensing Unit (ASU) and is used with the AtriCure Switch Matrix (ASB3), a passive source switch, and footswitch. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar radiofrequency (RF) energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.

The provided text is a 510(k) summary for the AtriCure Coolrail Linear Pen (MCR1). It describes a submission for a modified version of an existing device, emphasizing its substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria and reported device performance. Instead, it makes a general statement about meeting predetermined criteria.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It describes non-clinical bench testing. The data provenance is internal to AtriCure, Inc., as the testing was completed "per AtriCure's Quality System." The testing is described as "Non-clinical Bench Testing," which by nature would be prospective for the purpose of this submission.

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

This information is not provided. The study involves bench testing of a medical device, which typically relies on established engineering and performance specifications rather than expert ground truth in a clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study involves engineering and performance characteristics of a physical device, not subjective interpretations requiring adjudication.

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 information is not applicable and not provided. The device described is an electrosurgical tool, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The device is a physical electrosurgical pen; there is no "algorithm only" component.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on engineering specifications and established performance standards for electrosurgical devices. The testing (Reliability, Thermistor, Mechanical) verifies that the device performs according to these pre-defined, objective criteria. This is not clinical 'ground truth' like pathology or outcomes data, but rather a demonstration of physical device performance.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a hardware product, not a software algorithm or AI model that requires a training set.

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

This information is not applicable and not provided since there is no training set for this type of device.

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The Coolrail™ linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

The Coolrail Linear Pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.

The provided text is a 510(k) summary for the Coolrail Linear Pen, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria, sample sizes, or ground truth establishment typically associated with a new AI/software-as-a-medical-device (SaMD) submission.

Therefore, the document does not contain the information required to answer the specific questions about acceptance criteria for device performance, study details, sample sizes, ground truth, or multi-reader multi-case studies.

The submission clearly states:

• "Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Coolrail Linear Pen conformance to design controls and specification. Testing determined that the modified Coolrail Linear Pen conformed to design controls and product specifications."
• "The modified Coolrail Linear Pen proposed in this submission is considered substantially equivalent to the Coolrail Linear Pen cleared via K073605. The indications for use, basic overall function, and materials used are substantially equivalent."

This indicates that the device met its internal design controls and product specifications, and its performance was deemed equivalent to the predicate device. However, the specific metrics, statistical methods, and data provenance requested in your prompt are not part of this 510(k) summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, or MRMC studies based on the provided text.

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The Coolrail™ Linear Pen (Coolrail Pen) is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

The Coolrail Linear Pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.

The provided text is a 510(k) summary for the Coolrail Linear Pen, which is an electrosurgery device. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific performance acceptance criteria for a new clinical indication or diagnostic accuracy.

Therefore, many of the requested sections about acceptance criteria, studies, sample sizes, and expert adjudication are not applicable or cannot be extracted from this document. The document describes the device, its indications for use, and confirms it meets general manufacturing, safety, and substantial equivalence requirements to existing devices.

Here's a breakdown of what information is available and what is not:

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

This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on indications for use, basic overall function, and materials, rather than setting specific performance acceptance criteria for a new device type and reporting performance against them.

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

This information is not available. The document mentions "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices," but it does not detail specific acceptance criteria or the results of such testing in a quantitative manner suitable for a "test set" as would be used in a diagnostic device study. The focus is on demonstrating equivalence, implying that the established safety and efficacy of the predicate devices apply.

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):

This information is not applicable/available. The device is an electrosurgery tool, not a diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable/available. As above, there's no diagnostic test set requiring adjudication in this context.

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 information is not applicable/available. The Coolrail Linear Pen is an electrosurgery device, not an AI-assisted diagnostic tool.

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

This information is not applicable/available. The device is a surgical instrument, not an algorithm.

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

This information is not applicable/available in the context of a "ground truth" for a diagnostic study. For this device, the "ground truth" for its safety and effectiveness would be established through:

• Biocompatibility testing against ISO 10993-1.
• Performance testing to ensure it meets its intended function (e.g., ability to ablate tissue, proper energy delivery).
• Demonstration of substantial equivalence to predicate devices which have already established safety and effectiveness.

8. The sample size for the training set:

This information is not applicable/available. This is not a machine learning or AI device that would have a "training set."

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

This information is not applicable/available. As above, no training set for an AI/ML algorithm is involved.

Summary of available information related to "acceptance criteria" (understood as criteria for substantial equivalence):

The primary "acceptance criteria" for the Coolrail Linear Pen in this 510(k) process were:

• Indications for Use: The device must have substantially equivalent indications for use as the predicate devices.
• Basic Overall Function: The device must have a basic overall function substantially equivalent to predicate devices.
• Materials: The materials used must be suitable for the intended use and demonstrate appropriate biocompatibility (conforming to ISO 10993-1).
• Performance: Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence (though specific quantitative criteria are not listed).

Table of Acceptance Criteria and Reported "Performance" (in the context of 510(k) equivalence):

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