(136 days)
The SlimShape System is indicated for non-invasive lipolysis (breakdown of fat) of the abdomen. The device is indicated for reduction in circumference of the abdomen.
The SlimShape System is comprised of a console and an applicator that delivers radiofrequency energy to the fat tissue and also applies mechanical vacuum to the treatment area. The SlimShape System is designed to enable hands-free abdominal treatment that is based on a predefined user protocol. The system also incorporates a skin temperature control mechanism as a safety feature during treatment. Users interface with and control the SlimShape System via the touch-screen panel.
Here's a breakdown of the acceptance criteria and study details for the SlimShape System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance |
|---|---|
| Primary: Statistically significant abdominal circumference and fat reduction post SlimShape treatment at the final follow-up compared to baseline, based on tape measurements and ultrasound imaging. | Primary: Met endpoint; Both the midline reduction in abdominal circumference and the reduction in abdominal fat layer were statistically significant at the final follow-up compared to baseline. Specifically: |
- Average of 1.98 ± 2.53 cm reduction in abdominal circumference
- Average of 6.03 ± 3.09 mm reduction (-24.5% ± 11.3%) in fat thickness measured by ultrasound at 12 weeks follow-up compared to baseline. |
| Secondary: - Correct identification of the pre- and post-treatment photos as demonstrated in at least 70% or greater of treated subjects.
- Abdominal circumference reduction at each visit, based on tape measurements.
- Abdominal fat reduction at each visit, measured by Ultrasound.
- Subject's self-assessment for satisfaction and recommendation.
- Subject satisfaction self-assessment.
- Subject's discomfort (pain) level after each treatment. | Secondary:
- The blinded reviewers assessed correctly 86% of the photographs.
- The amount of circumference reduction was statistically significant compared to baseline at each visit, as well as at the upper and lower abdomen.
- The majority of the subjects were satisfied (53% at treatment 3, 62% at 4 week follow up, 59% at 8 week follow up and 59% at 12 week follow up).
- Most of the subjects reported they will recommend this procedure (75%, 76%, 76% and 77% reported they recommended at treatment 3, 4, 8 and 12 weeks follow up, respectively).
- Most subjects (91%) reported none to moderate pain for each treatment. |
| Safety: No serious or unanticipated adverse events. | Safety: There were no reports of serious or unanticipated adverse events, with 8 mild adverse events after 144 treatments. No subjects discontinued from the study due to adverse events. The immediate responses included erythema and edema, which resolved completely within several hours without any intervention.
Histology data from a separate study of 11 healthy subjects also confirmed safety, showing discrete areas of fat necrosis solely within subcutaneous tissue, with intact dermal and epidermal layers and no adverse skin events. |
2. Sample size used for the test set and the data provenance
- Sample Size: 52 subjects were enrolled and treated in the primary clinical study.
- Data Provenance: The study was a prospective, single-arm, self-controlled, single-site clinical study. The country of origin for the data is not explicitly stated, but the submission is from Syneron Medical Ltd. in Israel, suggesting the study might have been conducted there or internationally under their purview.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 2 blinded reviewers.
- Qualifications of Experts: Not specified in the provided text. They are only described as "blinded reviewers" for visual assessment of photographs.
4. Adjudication method for the test set
- Adjudication Method: Not explicitly stated as a formal adjudication method like "2+1" or "3+1." For the visual assessment of pre- and post-treatment photographs, it mentions "visual assessment of the before and after photographs by 2 blinded reviewers." It doesn't detail how discrepancies between the two reviewers were handled, if any.
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
- No, an MRMC comparative effectiveness study was not explicitly done. The study's focus was on the performance of the SlimShape device itself, not comparing human reader performance with and without AI assistance. The "blinded reviewers" assessed photographs, but it was to validate the device's effect, not to evaluate human reader improvement with an AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this device is not an AI/algorithm-only device. The SlimShape System is a physical device that delivers radiofrequency energy and vacuum. Its performance is measured directly by its effects on subjects, not as a standalone algorithm. The "software verification and validation" mentioned is for the device's control software, not a diagnostic algorithm.
7. The type of ground truth used
- Ground Truth: A combination of objective measurements and expert assessment:
- Objective Measurements: Tape measurements for abdominal circumference and ultrasound imaging for fat thickness reduction are primary objective ground truths.
- Expert Assessment: Blinded reviewers' assessment of pre- and post-treatment photographs contributed to a secondary effectiveness endpoint.
- Patient Reported Outcomes: Subject satisfaction, recommendation, and pain levels served as additional self-reported ground truth.
- Histology data: From a separate study, histology confirmed the safety profile by demonstrating fat necrosis without epidermal/dermal damage.
8. The sample size for the training set
- The document describes a single clinical study involving 52 subjects, which appears to be the primary study for performance evaluation. It does not explicitly mention a separate "training set" for an AI algorithm. If this refers to the data used to develop the device's operational parameters (e.g., specific RF settings, vacuum levels), that information is not detailed here. The focus is on the clinical validation of the final device.
9. How the ground truth for the training set was established
- Given that this document describes the validation of a physical medical device (SlimShape System) rather than an AI/ML algorithm, the concept of a "training set" for ground truth as typically understood in AI is not directly applicable. The device's operating parameters would have been developed through engineering, bench testing, and potentially earlier pilot studies or design validation, rather than explicitly "training" an algorithm against a ground truth dataset in the same way an AI model is trained. The document focuses on the validation of the device against clinical outcomes.
§ 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.