(540 days)
The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.
Sonatherm 600 Ultrasonic Lesion Generating System is comprised of a generator, which feeds a 3 to 5 MHz electrical signal to one or more piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. A Coupling Fluid Recirculation System is provided to provide a temperature stabilized coupling/coolant fluid surrounding the Transducer crystal(s). The fluid is contained by a flexible membrane surrounding the transducer head. A user interface provides Input Controls and Output Readouts for Operator.
In operation, the Transducer Membrane is placed against the organ to be treated. When the unit is engaged, the transducer will vibrate, create acoustic waves in the coupling fluid that then couples to the organ tissue and propagates into it. The waves converge to a focal point that concentrates the energy within a finite tissue volume. As the temperature of the tissue rises above the ablation point, the tissue necroses. The treatment head is moved under Operator control to treat a preselected volume of tissue from the focal point back to the surface of the organ.
The Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is an ultrasonic surgical system designed for the laparoscopic or intraoperative ablation of soft tissue. The provided document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study report in the way a clinical trial might. Therefore, the information typically found in acceptance criteria and study design for AI/CADe devices, such as sensitivity, specificity, or reader performance, is not directly applicable or available in this document.
However, based on the provided text, we can infer the "acceptance criteria" were related to safety and engineering performance, and the "study" involved non-clinical tests to demonstrate that the device met these engineering and safety standards and was substantially equivalent to existing devices.
Here's an interpretation of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Voluntary Standards" and "Non-Clinical Tests for Determination of Substantial Equivalence." These effectively serve as the acceptance criteria and the methods used to demonstrate performance for pre-market notification (510k) of this type of medical device.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Summary from document) |
|---|---|---|
| Safety Standards | UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety | "designed to and will be tested to pass" |
| EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety | "designed to and will be tested to pass" | |
| FCC Part 18 EMC Requirements | "designed to and will be tested to pass" | |
| EN 60601-1-2:2001 Electromagnetic Compatibility | "designed to and will be tested to pass" | |
| Non-Clinical Engineering Performance | Output Frequency Measurements | Performed, results led to conclusion of substantial equivalence. |
| Output Power Measurements | Performed, results led to conclusion of substantial equivalence. | |
| Focal Length Accuracy Measurements (Schlieren Photos) | Performed, results led to conclusion of substantial equivalence. | |
| Life Tests | Performed, results led to conclusion of substantial equivalence. | |
| Input Power Measurements | Performed, results led to conclusion of substantial equivalence. | |
| EMI Tests | Performed, results led to conclusion of substantial equivalence. | |
| Dielectric Tests on Mains Circuits | Performed, results led to conclusion of substantial equivalence. | |
| Patient Current Leakage and Patient Sink Current Measurements | Performed, results led to conclusion of substantial equivalence. | |
| Power Line Ground Leakage Measurements | Performed, results led to conclusion of substantial equivalence. | |
| Dielectric Tests on Patient Circuits | Performed, results led to conclusion of substantial equivalence. | |
| Sterilization/Disinfection | Sterilization or Disinfection Protocol Validation for all Reusable Components | Performed. "Validation statements are contained in Exhibit J." |
| Performance Modeling/Accuracy | In Vitro Targeting Accuracy Measurements | Performed, results led to conclusion of substantial equivalence. |
| Computer Modeling of Lesion Creation vs Time and Focal Depth | Performed, results led to conclusion of substantial equivalence. |
The document concludes that "Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, FMEA Analysis and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is substantially equivalent" to the predicate devices. This implies that the device successfully met the criteria in all the listed tests and analyses.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this device and report. The tests conducted were non-clinical engineering and performance characterization tests, not studies on a "test set" of patient data.
- Data Provenance: Not applicable. The tests were conducted internally by the manufacturer (Misonix, Inc.) through "Output of Engineering Tests," "FMEA Analysis," and investigations into "Voluntary Consensus Standard."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the sense of expert consensus on patient data, is not mentioned as part of the 510(k) submission for this device, which relies heavily on engineering and performance testing against established standards and comparison to predicate devices. The "ground truth" here would be the physical properties and performance parameters measured in a lab setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" of patient cases requiring expert adjudication.
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. This device is an ultrasonic lesion generating system, not an AI/CADe diagnostic tool that would involve human readers or image interpretation. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for diagnostic interpretation in this device. The device itself performs the therapeutic function, with operator control. The document explicitly states: "There is no software associated with this product."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests would have been engineering specifications, physical measurements, and compliance with recognized voluntary standards. For example, for "Focal Length Accuracy Measurements," the ground truth would be the accurately measured focal length of the device compared to its design specification. For "In Vitro Targeting Accuracy Measurements," the ground truth would be the actual ablated tissue volume/shape in an in vitro model compared to the intended or predicted ablation.
8. The sample size for the training set
Not applicable. As noted, there is no software or AI component that would require a training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.