(116 days)
The BeShape One™ device delivers High Intensity, Non-Focused Ultrasound energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The BeShape One™ device is specifically indicated for non-invasive waist circumference reduction.
The BeShape One™ device is a non-invasive, high intensity, non-focused US device intended for disruption of the subcutaneous adipose tissue and indicated for noninvasive waist circumference reduction. The BeShape One™ device utilizes continuous wave (CW) ultrasonic energy applied to the adipose tissue at a temperature of 47-49ºC. A cooling system maintains the skin temperature at below 35℃. The device consists of hardware and software. These elements are integrated in the BeShape One™ console and applicator/hand piece. BeShape One™ is supplied as a console and two identical applicators. The device is portable and was specifically designed to be utilized in clinic environments.
The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems:
- Power Source
- Controller unit (CPU) .
- Water cooling system (Chiller) ●
- Vacuum System
- . Block Amplifier
- Touchscreen display monitor ●
- Personal computer and proprietary software .
- Two designated applicator cradles .
- Two designated applicator connector ports .
The BeShape One™ device applicator is a mechanical handpiece with an internal rectangular bathtub-shaped chamber and consists of the following elements:
- Two parallel facing US transducers Each transducer includes four piezoelectric . (PZT) ceramic elements which convert electrical energy into acoustic energy in the ultrasound frequency range. Each transducer can transmit up to 1.5W/cm2 of acoustic energy at a frequency of 2MHz.
- . Vacuum - The vacuum provides effective fixation of the adipose tissue under the skin in the cup-shaped chamber of the Applicator.
- The cooling system which includes thermoelectric coolers (TEC) for ultrasound ● (US) transducers (TD) and a water-cooling system for the hot side of the thermoelectric coolers (TEC). The cooling system is intended to cool the applicator and skin to below 35°C.
The Applicator uses vacuum during the procedure, which draws adipose tissue under the skin into the inner cup-shaped chamber, thereby heating the subcutaneous adipose tissue.
The provided text is a 510(k) summary for the BeShape One™ Device, which is a medical device for non-invasive waist circumference reduction. It describes the device, its intended use, performance testing, and comparison with a predicate device (LIPOcel).
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a formal "acceptance criteria table" with specific numerical targets. However, it implicitly defines success by demonstrating statistical significance, clinical meaningfulness, and positive user/investigator ratings compared to baseline.
| Performance Metric | Acceptance Criteria (Implicit from Study Design/Goals) | Reported Device Performance at 12 Weeks Post-Treatment |
|---|---|---|
| Waist Circumference Reduction | Statistically significant decrease from baseline and clinically meaningful. | Statistically significant decrease of -1.87 cm (STD=2.62). This met the performance goal. |
| Subject Self-Reported GAIS | Significant percentage of subjects rating improvement in waist circumference reduction. | 55% of subjects rated an improvement. |
| Investigator Rated CGAIS | Significant percentage of subjects rating improvement in waist circumference reduction. | 72.3% of subjects rated an improvement. |
| Subject Satisfaction Self-Rating | High level of satisfaction. (Though a decline was noted from 6 to 12 weeks, the 6-week satisfaction may be an implicit target met) | 53.7% satisfaction at 6 weeks (declined at 12 weeks). |
| Abdominal Fat Thickness Reduction | Reduction indicated. (No specific threshold mentioned as an "acceptance criteria") | -0.20 cm (STD=0.43). |
| Safety (Adverse Events/LSR) | No significant or unmanageable adverse effects; acceptable Local Skin Reactions (LSRs). | Most frequent LSRs: erythema and application site bruise. No abnormal vital signs. No adverse effect mentioned. |
The "performance goal" for waist circumference reduction having been met indicates an implicit acceptance criterion was defined for this key efficacy endpoint.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The "Clinical Performance Data" section states, "The SAS comprised 72 participants." (SAS likely stands for Safety Analysis Set or Statistical Analysis Set, representing the main study cohort).
- Data Provenance: The study was a "prospective, multi-center, single-arm study." The country of origin is not explicitly stated, but the applicant company is based in Israel, which suggests the study was likely conducted there or in regions accessible to them. It was a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
-
For the Clinical Global Aesthetic Improvement Scale (CGAIS), an "investigator" rated subject improvement. The number of investigators/experts is not specified. Their qualifications are also not explicitly detailed, but as it's a clinical study, they would typically be trained medical professionals (e.g., physicians, dermatologists, or clinical research staff with experience in aesthetic assessments).
-
For other objective measures like waist circumference and abdominal fat thickness, these are quantitative measurements, not typically requiring "expert consensus ground truth" in the same way as image interpretation or subjective aesthetic scales. The ground truth for these would be the direct measurement itself.
4. Adjudication method for the test set:
- The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical study's assessments. For subjective scales like CGAIS, if multiple investigators were involved, it's common practice to have methods for ensuring consistency or resolving discrepancies, but this is not detailed in the summary.
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 conducted. This device is a treatment device, not an AI-assisted diagnostic device. The study described is a clinical trial assessing the direct efficacy and safety of the device on patients, not comparing human reader performance with and without AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The BeShape One™ Device is a physical medical device that delivers ultrasound energy for treatment, not a standalone AI algorithm for diagnosis or image analysis. Its "performance" is measured by its clinical effect on patients, not by an algorithm's output.
7. The type of ground truth used:
- Clinical Efficacy Ground Truth:
- Objective Measurements: Waist circumference reduction (direct measurement).
- Objective Measurements: Abdominal fat thickness reduction (direct measurement).
- Subjective Clinical Assessment: Investigator-rated Clinical Global Aesthetic Improvement Scale (CGAIS). The "ground truth" here is the clinical judgment of the investigator(s).
- Subjective Patient Assessment: Subject self-reported GAIS and a 5-point Satisfaction Likert scale. The "ground truth" here is the patient's direct perception and experience.
- Safety Ground Truth:
- Observation of Local Skin Reactions (LSRs) and vital signs.
- Pre-clinical (animal) study: Thermal safety, lipid profile, micro and macro-histopathology requirements.
8. The sample size for the training set:
- The document describes a single-arm clinical study used for demonstrating safety and efficacy for the 510(k) submission. It does not mention a separate training set or any machine learning model training. The clinical study described served as the primary performance evaluation.
9. How the ground truth for the training set was established:
- As no training set (in the context of machine learning) is mentioned or implied for this device's performance evaluation, this question is not applicable. The clinical trial data was primarily used for validation of the device's efficacy and safety.
§ 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.