(104 days)
The UltraShape 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 System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
The purpose of this submission is to increase acoustic intensity and to add an additional smaller ultrasound transducer.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Syneron UltraShape System
Intended Use: The UltraShape 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.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" with numerical thresholds in a table format. However, it describes the effectiveness (circumference reduction) and safety outcomes that demonstrate the device's performance met the requirements for substantial equivalence.
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance (Effectiveness) | Reported Device Performance (Safety) |
|---|---|---|
| Effectiveness: | ||
| Non-invasive reduction in abdominal circumference | Average -2.37 cm circumference reduction at the midline (at final follow-up, 12 weeks after last treatment). | Not applicable for effectiveness. |
| Maintain effectiveness in weight-stable subjects | Midline circumference reduction results in weight-stable subjects (-2.18 cm) were very similar to the overall population. | Not applicable for effectiveness. |
| Patient satisfaction | The majority of subjects in the UltraShape studies reported overall satisfaction with treatment. | Not applicable for effectiveness. |
| Safety: | Not applicable for safety. | Maintained safety profile through long-term follow-up. |
| Only events were mild to moderate in severity and resolved within a few hours or days. | ||
| No device-related serious adverse events. | ||
| In a separate safety study, only one minor event occurred, from which the patient completely recovered without intervention. | ||
| Subjects reported minimal discomfort. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Effectiveness & Safety Studies): 102 enrolled subjects (across "two, separate, prospective, single arm studies").
- Sample Size (Additional Safety Study): 21 patients.
- Data Provenance: The document does not explicitly state the country of origin of the data. The submitter, Syneron Medical Ltd., is located in Yokneam Illit, Israel. The studies were prospective clinical evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not specify the number of experts used to establish a "ground truth" for the test set or their qualifications. The study primarily evaluated objective measurements (circumference reduction, weight) and patient-reported outcomes (satisfaction, adverse events) rather than expert interpretation of images or other data requiring "ground truth" consensus in the typical sense.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given the primary endpoints were objective measurements (circumference reduction) and patient-reported outcomes (satisfaction, adverse events), an adjudication process like "2+1" or "3+1" (common for expert interpretation of medical images) would not be directly applicable. Adverse events were likely reported and categorized by the clinical investigators.
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 conducted. The studies were "single arm studies" and focused on the performance of the UltraShape device itself, not on comparing it to human reader performance or assessing human reader improvement with AI assistance. The device is a direct treatment modality, not an AI diagnostic aid for human interpretation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the clinical studies described evaluate the standalone performance of the UltraShape System as a treatment device. This device is not an algorithm for diagnosis or interpretation that would typically involve a "human-in-the-loop" for performance evaluation. Its efficacy is measured directly by its effect on abdominal circumference and its safety profile.
7. The Type of Ground Truth Used
The "ground truth" for effectiveness was based on objective anatomical measurements (abdominal circumference reduction) and patient-reported outcomes data (satisfaction, discomfort). For safety, it was based on adverse event reporting and assessment.
It was not based on expert consensus, pathology, or direct "ground truth" in the diagnostic sense.
8. The Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This is because the UltraShape System is a physical medical device that delivers focused ultrasound energy, not an AI/ML algorithm that requires a training dataset in the conventional sense. The "training" for such devices involves rigorous engineering, design, and internal testing before clinical studies.
9. How the Ground Truth for the Training Set Was Established
As stated above, this device is not an AI/ML algorithm that relies on a "training set" with ground truth in the typical fashion of machine learning. Therefore, the concept of establishing ground truth for a training set is not applicable to this device. Any "ground truth" for its development would be engineering specifications, physical principles, and non-clinical testing results (e.g., beam profile, acoustic power, in vitro and in vivo animal studies).
§ 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.