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The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during 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, 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.

This document is a 510(k) premarket notification for a medical device called the "Isolator Multifunctional Linear Pen." It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the acceptance criteria or a study demonstrating the device meets specific performance criteria in the way that would typically be presented for an AI/ML medical device.

The document focuses on demonstrating substantial equivalence to an existing predicate device (K130521) for regulatory clearance. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, not necessarily that it meets novel, quantifiable performance metrics against a specific clinical condition using AI/ML.

Here's what can be extracted from the document, and what is missing based on your request:

What can be found in the document:

• Device Name: Isolator Multifunctional Linear Pen
• Intended Use:
  • To ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode.
  • 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.
• Regulatory Status: Class II medical device, Product Code OCL (Electrosurgical Cutting and Coagulation Device and Accessories).
• Predicate Device: Isolator Multifunctional Linear Pen (cleared via 510(k) K130521 on April 05, 2013).
• Comparison to Predicate Device:
  • Same intended use
  • Same operating principle
  • No changes in operating principle or performance specifications
  • Same sterilization parameters
• Performance Data (Non-clinical Bench Testing and Biocompatibility):
  • Reliability Testing (details not provided)
  • Biocompatibility Testing (in accordance with ISO 10993-1, included Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogen). This testing was done to assess risks of a modification to the PET material.

What is MISSING based on your request (and why):

This document is a 510(k) summary for a hardware electrosurgical device, not an AI/ML algorithm. Therefore, many of the requested elements for AI/ML device evaluation are not applicable or detailed:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of specific, quantifiable clinical or AI performance metrics. The "performance data" section states "Testing determined that the Isolator Multifunctional Linear Pen conformed to design controls and product specifications," which is a general statement of compliance, not specific performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable as there's no "test set" in the context of an AI/ML algorithm evaluating data. The performance claims rely on the substantial equivalence to the predicate device and general non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document demonstrates regulatory clearance for a traditional medical device based on substantial equivalence and general safety/performance testing, not the type of detailed AI/ML performance evaluation you've described.

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The Multifunctional linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the AtriCure Ablation and Sensing Unit or to the ASU Source Switch in Ablation mode and the Multifunctional 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 Multifunctional linear pen is a hand-held, sterile, single patient use electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. When the pen is connected to the AtriCure Ablation and Sensing Unit (ASU) directly or via the AtriCure ASU Source Switch in ablation mode, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the pen is connected to a commercially available temporary pacemaker or recorder the pen is used for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery.

The information provided describes a 510(k) submission for the AtriCure Multifunctional Linear Pen. A 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria in the way a clinical trial would for a novel device.

The document states: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. In-vitro and in-vivo testing demonstrated that the Multifunction linear pen is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the AtriCure Isolator Transpolar pen and the AtriCure Coolrail linear pen."

This indicates that the acceptance criteria are implicitly defined by the performance of the predicate devices: the AtriCure Isolator Transpolar pen (K050459, K061593) and the AtriCure Coolrail linear pen (K073605). The study's goal was to show similar performance. However, specific quantitative acceptance criteria and detailed performance metrics are not explicitly provided in this 510(k) summary.

Based on the provided text, a table of explicit acceptance criteria and reported performance cannot be fully constructed as it would be for a direct performance study against pre-defined thresholds. The submission focuses on substantial equivalence, meaning the new device's safety and effectiveness are similar to legally marketed predicate devices.

Here's an attempt to extract and present the information as requested, acknowledging the limitations of data from a 510(k) summary:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) premarket notification, the "acceptance criteria" are implicitly set by the performance and safety profiles of the legally marketed predicate devices. The study's objective was to demonstrate substantial equivalence rather than meeting specific numerical performance targets.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document mentions "in-vitro and in-vivo testing," but does not provide details on the number of samples, animals, or human subjects used.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

   • Not applicable to this 510(k) summary. The testing described is technical or preclinical (in-vitro/in-vivo) to demonstrate functional equivalence, not a clinical study requiring expert ground truth or consensus.

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

   • Not applicable. Adjudication methods are typically relevant for clinical studies involving human subject data and interpretive assessments, which are not detailed in this submission.

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:

   • No. An MRMC study is not mentioned. This device is a surgical tool, not an AI diagnostic or interpretive device.

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

   • N/A. This is a medical device, not an algorithm. The testing described involves the device's physical functions (ablation, pacing, sensing, stimulation).

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

   • For the "in-vitro" and "in-vivo" testing, the ground truth would likely be based on established physiological measurements, histological analysis (for ablation efficacy), and direct observation of electrical signals (for pacing/sensing/stimulation).
   • However, specific details on how this "ground truth" was established are not provided in the 510(k) summary. The primary "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.

7. The sample size for the training set:

   • Not applicable. This is a hardware medical device, not a machine learning model, so there is no "training set."

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

   • Not applicable, as there is no training set.

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