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510(k) Data Aggregation
(476 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 ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue.
The Sonatherm 600i is a modification of the previously cleared Sonatherm 600 (K 042096). The Sonatherm 600i uses the same HIFU transducer, with the same ultrasonic lesion generating power output as the Sonatherm 600.
The Sonatherm 600i operates in the same manner as the Sonatherm 600. The Sonatherm 600i operates by utilizing a focused ultrasound transducer positioned at the surface of the targeted ablation area to create a thermal lesion from the focal point of the transducer back to the surface of the targeted area in an open field or laparoscopic scenario.
The Sonatherm 600i incorporates three changes to the Sonatherm 600: a microprocessor controlled LCD user interface; a visually aided focal point targeting system; an integrated transducer positioning device
The microprocessor controlled LCD user interface incorporates a graphical interface that makes the operation of the device easier. The integrated positioning device allows the user to verify the positioning of the Sonatherm 600i probe over the intended target volume. This reduces the chance for operator error.
The Sonatherm 600i Ultrasonic Lesion Generating System, a modification of the previously cleared Sonatherm 600, was reviewed. This device generates thermal lesions for the laparoscopic or intraoperative ablation of soft tissue. The 510(k) summary provides details about its non-clinical testing.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria or a specific table with "reported device performance" in the typical sense of a diagnostic device. However, it lists nonclinical tests performed to demonstrate substantial equivalence, which implicitly serve as the studies to meet underlying performance expectations for safety and effectiveness.
| Acceptance Criteria Category (Implied) | Reported Device Performance/Study Conclusion |
|---|---|
| Targeting Accuracy | "Sonatherm 600i Targeting Accuracy Test Report": This report would demonstrate the device's ability to precisely direct the ultrasonic energy to the intended ablation area. While specific performance metrics (e.g., deviation from target in mm) are not provided in the summary, the existence of the report implies successful demonstration of adequate targeting for its intended use. |
| Thermal Lesion Generation | "Thermal Mapping of Ablation Region": This study would characterize the size, shape, and temperature distribution of the lesions created by the device. The goal is to confirm that the device generates consistent and effective thermal lesions within the soft tissue as intended, similar to the predicate device. Specific performance values are not given. |
| Imaging Operation Validation | "Validation of Imaging Operation": This test validates the functionality and accuracy of the visually aided focal point targeting system, ensuring it provides reliable guidance to the user. This would confirm that the integrated positioning device helps reduce operator error. Specific performance values are not given. |
| Acoustic Power Output | "Total Acoustic Power Tests of Transducers": This testing confirms that the transducer's power output is consistent with the predicate device (Sonatherm 600) and within safe and effective limits. The summary explicitly states: "The Sonatherm 600i uses the same HIFU transducer, with the same ultrasonic lesion generating power output as the Sonatherm 600," implying successful verification of this. |
| Overall Safety and Efficacy | Conclusion from Nonclinical Tests: "Based upon an analysis of the operating characteristic specifications, Risk Analysis, and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Sonatherm 600i is substantially equivalent to the predicate devices and introduces no new safety or efficacy concerns." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a "test set" in the context of human data or a machine learning model. The studies described are non-clinical engineering and performance tests (e.g., targeting accuracy, thermal mapping). Therefore, information on sample size for a "test set" or data provenance (country of origin, retrospective/prospective) for patient data is not applicable as no clinical studies were performed, and the non-clinical tests would involve physical measurements and simulations, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Since the studies involved non-clinical performance evaluations of a medical device (e.g., measuring power output, thermal profiles), the "ground truth" was established by engineering specifications, physical measurements, and comparison to the predicate device's known performance. No human experts were involved in establishing "ground truth" for patient data in this context.
4. Adjudication Method for the Test Set
This information is not applicable. As there was no test set of patient data requiring expert review, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The 510(k) summary explicitly states: "No clinical testing is required because product did not change HIFU power output or type. Note: clinical data was also not required to clear the original device." Therefore, there is no effect size of human readers improving with or without AI assistance, as AI is not mentioned and clinical studies were not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The Sonatherm 600i is a physical medical device (ultrasonic lesion generating system), not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was established through:
- Engineering specifications and design parameters: For acoustic power output.
- Physical measurements and objective testing: For targeting accuracy and thermal mapping.
- Validation against established performance standards: To demonstrate equivalent performance to the predicate device.
8. The Sample Size for the Training Set
This information is not applicable. As the device is a physical medical instrument and not an AI/machine learning model, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There was no training set for an AI/machine learning model.
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