Search Results

The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.

The Polaris RF Ablation System includes the following components:

1. Polaris Radiofrequency Generator and Desk Stand
2. Polaris Pump, Pump Cable and Desk Stand
3. Polaris Standard Connector Hub / Polaris Cooled Connector Hub
4. Polaris Footswitch
5. Polaris Cooled RF Probe Kit:
   i. Polaris Cooled RF Ablation Probe
   ii. Polaris Tube Kit
   iii. Polaris Introducer
6. Polaris Single-Use RF Probe
7. Polaris Reusable RF Probe
8. Polaris RF Cannula
   The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue. The system is designed to deliver controlled RF energy from the Polaris RF Generator to target tissues via the Polaris RF Probes for standard RF procedures or Polaris Cooled RF Probes for cooled RF procedures. RF energy is applied based on the configured RF generator settings to create the desired lesions in the target tissue. The generator also delivers low frequency stimulation pulses during procedures.
   During standard RF procedures, the Polaris RF Probe is used with a compatible Polaris RF Cannula to enable RF energy delivery via the active electrode to the target tissues. During cooled RF procedures with Polaris Cooled RF Probes, the system integrates a cooling mechanism by internally circulating water through the probes using the Polaris Pump Unit. This cooling results in minimal charring of the surrounding tissue and also prevents tissue from adhering to the electrodes. This allows for larger and more consistent ablation volumes to be achieved.

The document you provided is a 510(k) summary for a medical device, the Polaris RF Ablation System. It details the device's substantial equivalence to predicate devices, rather than establishing primary effectiveness through clinical trials with defined acceptance criteria for diagnostic output.

Therefore, the information requested for AI/ML device studies such as sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document, as it focuses on demonstrating product safety and performance against established standards and predicate devices.

However, I can extract the information relevant to performance testing based on the provided tables.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted on different components of the Polaris RF Ablation System. The general acceptance criterion for all tests is "All samples passed the acceptance criteria," with the reported performance consistently stating that the device or its components met all relevant requirements and confirmed compliance with applicable standards.

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

The document does not specify exact sample sizes (e.g., number of units tested) for most of the performance tests. It mentions "All samples passed" for many tests, indicating that multiple units were likely tested for each category. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are technical performance tests on the device itself, not clinical data.

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

Not applicable. This is a technical performance and substantial equivalence submission for a medical device, not an AI/ML diagnostic or prognostic device that requires expert-established ground truth for a test set. The "ground truth" here is compliance with engineering standards and predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/ML diagnostic output, there is no adjudication method in the context of expert review. Test results are compared against predefined technical standards and requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not pertain to an AI/ML device that assists human readers, so an MRMC study is not relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No. The Polaris RF Ablation System is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering and medical device standards (e.g., IEC 60601 series, ISO 10993 series, ANSI/AAMI ISO 11607) and the performance characteristics of the legally marketed predicate devices. For mechanical and electrical tests, it's compliance with these standards. For lesion validation, it's the demonstration of "substantially equivalent ablation performance" compared to the predicate in a soft tissue model.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

Ask a specific question about this device