Search Results

The MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical procedures and in laparoscopic and percutaneous ablation procedures, using image guidance, including partial or complete ablation of non-resectable liver tumors. An optional Temperature sensor may be used to monitor tissue temperatures.

The MicroThermX® Microwave Ablation System (MTX) delivers 915 MHz microwave energy for coagulation (ablation) of soft tissue. The procedure time and power parameters are operator selected via a touchscreen monitor. The system consists of a generator and pump attached to a mobile cart or tabletop stand, sterile disposable SynchroWave antennas with cooling circuit, and optional disposable TempSure temperature sensors. The closed cooling circuit consists of a bag of sterile isotonic saline (not supplied by Perseon), disposable, single-use cooling circuit tubing and connectors; and fluid pathway channels within each single-use antenna. A reusable pump circulates isotonic saline through the cooling circuit.

The provided text from the 510(k) submission for the MicroThermX Microwave Ablation System mainly focuses on regulatory compliance and substantial equivalence to a predicate device. It describes general performance testing against various IEC and ISO standards and internal requirements, but does not detail specific acceptance criteria for a clinical study comparing device performance to a predefined benchmark. The "Performance Testing" section primarily lists standards and does not offer explicit performance metrics or acceptance thresholds in the way a clinical study would for a specific diagnostic outcome (e.g., sensitivity, specificity).

However, it does mention a retrospective clinical study and animal study that supports the device's ability to treat non-resectable liver tumors.

Based on the provided document, here's what can be extracted and what information is missing regarding acceptance criteria and a study to prove they are met:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., target ablation size, success rate, sensitivity/specificity) from a clinical performance perspective in a measurable table format with clear thresholds.

It lists internal safety and performance requirements that were tested, but these are general categories rather than specific, quantifiable acceptance criteria.

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

• Test Set (Clinical Study):
  • Sample Size: 51 lesions in 31 patients.
  • Data Provenance: Retrospective clinical study. The country of origin is not specified.
• Test Set (Animal Study):
  • Sample Size: 18 ablations in liver and 22 ablations in lung.
  • Data Provenance: Porcine study. No country of origin is specified.

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

This information is not provided in the document. The document refers to a "retrospective clinical study" but does not detail how the success or outcome of the ablations in this study was adjudicated or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance

This document is for a microwave ablation system, which is a therapeutic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not performed.

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

This is not applicable as the device is a medical instrument for direct therapeutic intervention, not an algorithm.

7. The Type of Ground Truth Used

For the clinical study on non-resectable liver tumors, the ground truth regarding the "ability to treat" these tumors is implied by the clinical outcome observations. The specific method for establishing this ground truth (e.g., biopsy for complete necrosis, follow-up imaging showing absence of viable tumor, etc.) is not explicitly stated.

For the animal study, the ground truth for "ablation zone sizes" and "performing ablations in liver and lung" likely referred to direct pathological examination of the ablated tissue ex-vivo, but this is also not explicitly stated.

8. The Sample Size for the Training Set

The document describes performance testing for a physical device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The device has undergone various engineering and pre-clinical tests but not "training" in the AI sense.

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

As the concept of a "training set" for an AI/ML algorithm is not applicable here, this point is also not relevant.

Ask a specific question about this device