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The Isolator Transpolar Pen is a sterile, single use electro surgery device intended to ablate cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU Source Switch in Ablation mode. When the Pen is connected to the ASU Source Switch in Auxiliary mode, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode. The Isolator linear pen may be used for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Isolator Multifunctional Linear Pen (MLP1) utilizes radiofrequency (RF) energy from the RF generator (ASU) to create lines of ablation on cardiac tissue. The MLP1 device is comprised of an end effector, shaft, handle, and cable. This end effector consists of one pair of ablation electrodes separated with insulating material, with the electrodes used for the pacing and sensing functions. When the Isolator Multifunctional Linear Pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Isolator Transpolar Pens (MAX1, MAX5; hereafter MAX devices) are a hand-held, single use bipolar surgical instrument intended for the ablation of cardiac tissue and for use by trained surgeons only. It is composed of a handpiece with a bipolar electrode configuration at its distal end with integral cable and a re-usable ablation and sensing unit (ASU). When a Transpolar pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The provided text is a 510(k) Premarket Notification from the FDA regarding two electrosurgical devices, the Isolator Transpolar Pen (MAX) and the Isolator Multifunctional Linear Pen (MLP1). This document primarily focuses on a proposed material change (an alternate resin for electrode separation) for these devices and demonstrates their substantial equivalence to previously cleared versions.

However, the provided document does not contain the information requested regarding acceptance criteria and the study that proves the device meets specific performance criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details of multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) beyond general statements of "verification and validation testing."
• How ground truth was established for training or test sets.

The document states: "The Isolator Linear and Transpolar Pen devices met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K163408 MLP1 device, and K061593 MAX device. No new safety or performance issues were raising during testing." This indicates that some performance testing was done against predetermined criteria, but the specifics of those criteria and the study results are not detailed in this publicly available 510(k) summary.

In summary, based on the provided text alone, it is not possible to answer the detailed questions about acceptance criteria and the specific study proving the device meets those criteria, as these details are not present in this document. The document focuses on demonstrating substantial equivalence primarily due to a material change, rather than providing a comprehensive performance study that would typically be required for a novel AI/software-based device.

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• The Isolator® linear pen is intended to ablate cardiac tissue during cardiac surgery using . radiofrequency (RF) energy when connected directly to the ASU or to the ASU Source Switch (ASB) in Ablation mode.
• The Isolator® linear pen may be used for temporary cardiac pacing, sensing, recording, . and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Isolator™ linear pen System is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator™ linear pen (Pen), Footswitch, ASU Source Switch(ASB). The Pen is a single patient use electrosurgical instrument designed for use only with the ASU and ASB. The Pen is used to ablate cardiac tissues and as a surgical pacing and mapping tool. When the Pen is connected to the ASU, the ASU provides the bipolar radiofrequency (RF) energy flowing between both electrodes of the Pen. The Operator controls the application of this RF energy by pressing the Footswitch. When the Pen is connected to an auxiliary pace, sense, or stimulation device, the Pen is designed to provide temporary pacing or monitoring.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Isolator® Linear Pen:

Disclaimer: The provided document is a 510(k) summary for a medical device. These summaries often focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria in the same way a PMA (Pre-Market Approval) or clinical trial report might. As such, direct "acceptance criteria" for performance metrics and a "study that proves the device meets the acceptance criteria" in the format typically seen for a new drug or novel medical device effectiveness claim are not explicitly detailed. Instead, the document discusses conformity to design controls and specifications.

Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Isolator® Linear Pen does not provide a table of quantitative acceptance criteria and reported device performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it states that the device was tested to conform to "design controls and specification."

Study Information (Based on Available Text)

The document describes pre-market testing to ensure conformity, rather than a clinical study comparing performance against a specific metric.

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

   • Sample Size: Not specified. The document states "Testing was conducted on all patient contacting materials" and "Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Isolator linear pen conformance to design controls and specification." This implies engineering and laboratory testing rather than human subject clinical trials with a defined sample size for performance evaluation.
   • Data Provenance: Not specified. Likely internal laboratory and engineering test data, given the nature of a 510(k) for a modification to a previously cleared device.

2. 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 specified. The testing described is verification of design controls and biocompatibility, not expert-adjudicated performance relative to a clinical ground truth.

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

   • Not applicable/None specified.

4. 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. This device is an electrosurgical device, not an AI-driven diagnostic tool necessitating MRMC studies.

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

   • Not applicable. This is a physical surgical device, not an algorithm.

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

   • For biocompatibility: Adherence to ISO 10993-1 standards (a regulatory/scientific standard).
   • For design conformance: Adherence to internal product specifications and quality system regulations (21 CFR 820.30).
   • For substantial equivalence: Comparison to the predicate device (K100501) based on intended use, function, and materials.

7. The sample size for the training set:

   • Not applicable. This is a medical device subject to design verification and validation, not an AI model requiring a training set.

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

   • Not applicable.

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