(99 days)
The UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
The UltraShape Power System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape Power System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducers are electro-mechanical devices that convert an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
The primary purpose of this submission is to add an increased acoustic intensity level to the device. Additional minor changes since the prior clearances were also included as part of this submission.
The UltraShape Power System is a medical device designed for non-invasive reduction of abdominal circumference by disrupting subcutaneous adipose tissue (SAT) using focused ultrasound energy.
1. Acceptance Criteria and Reported Device Performance:
The primary efficacy endpoint for the UltraShape Power System was the reduction in abdominal circumference and fat thickness. While specific acceptance criteria for "statistically significant" were not explicitly detailed in terms of a numerical threshold, the study's results demonstrated strong positive outcomes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Statistically significant reduction in abdominal circumference | Achieved: 2.55 cm reduction at 12 weeks post-treatment (statistically significant). Consistent reduction at midline, 2 cm above, and 2 cm below midline. |
| Statistically significant reduction in fat thickness | Achieved: 3.63 mm reduction at 12 weeks post-treatment (mean change adjusted for baseline: 3.77 ± 1.11 mm), which was statistically significant. |
| Positive safety profile (no adverse events/minimal discomfort) | Achieved: No adverse events reported in the main 43-subject study. An additional 21-patient study reported only one minor event from which the patient fully recovered. Subjects reported minimal discomfort and high comfort levels (100% or 96%). |
| High patient satisfaction/willingness to recommend | Achieved: By 2 weeks, approximately two-thirds of subjects were satisfied and 81% would recommend the procedure. While satisfaction slightly decreased over time, overall results were positive. |
| Device functions as intended | Achieved: Nonclinical performance testing (beam profile, acoustic power, thermal evaluation, software V&V, electrical safety, EMC, biocompatibility, in vivo animal testing) demonstrated the device functioned as intended. |
2. Sample Sizes and Data Provenance:
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Test Set (Clinical Evaluation):
- Main Study: 43 enrolled subjects.
- Additional Safety Study: 21 patients.
- Data Provenance: Not explicitly stated, but the submission is from Syneron Medical Ltd. (Israel), and the study likely took place in a clinical setting related to their operations. It can be inferred to be prospective as it describes recruitment, treatment, and follow-up over specified time periods.
- Demographics (Main Study): Mean age 48 years, 95% female, all Caucasian.
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Training Set: Not applicable for this type of device and study. The studies described are clinical trials for safety and effectiveness, not for training a machine learning algorithm.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable in the context of this device. The "ground truth" for efficacy was objective measurements (abdominal circumference, fat thickness) and patient-reported outcomes (satisfaction, comfort). These do not require expert consensus in the same way an imaging diagnostic device might.
4. Adjudication Method:
Not applicable. The study utilized objective physical measurements and patient self-assessment questionnaires, not the adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This was a standalone clinical evaluation of a physical device for aesthetic purposes, not a diagnostic imaging device requiring expert interpretation.
6. Standalone Performance (Algorithm Only):
Yes, in a sense. The described clinical studies (43 subjects, 21 patients) evaluate the device only without human-in-the-loop performance influencing the primary efficacy outcomes. The device is operated by a healthcare professional, but the effectiveness measurements (circumference, fat thickness reduction) are direct outcomes of the device's action on the body, not a human interpretation of an algorithm's output.
7. Type of Ground Truth Used:
- Efficacy:
- Objective Measurements: Abdominal circumference reduction (measured physically).
- Objective Measurements: Fat thickness reduction (presumably measured by imaging, though the method isn't specified, it's an objective physical change).
- Safety: Observational data for adverse events and patient-reported comfort/discomfort.
- Patient Satisfaction: Self-reported patient satisfaction and willingness to recommend.
8. Sample Size for the Training Set:
Not applicable. This is not a device driven by a machine learning algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.