Search Results

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.

Ask a specific question about this device