(102 days)
The Cynosure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.
Here's a breakdown of the acceptance criteria and the study that proves the device (Cynosure SculpSure) meets these criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Correct identification of pre-treatment vs. post-treatment images by blinded evaluators. | In 88% of total individual evaluations, blinded board-certified dermatologists correctly identified the before and after images. The study states "all endpoints were met." |
| Secondary Endpoint: Change from baseline in adipose layer thickness between device and control based on ultrasound measurements. | An average of 13% normalized fat reduction was observed based on ultrasound measurements at 12 weeks. The study states "all endpoints were met." |
| Tertiary Endpoint: Subject satisfaction survey. | 98% of patients rated the treatment as "satisfied" on the Likert Satisfaction scale. The study states "all endpoints were met." |
| Safety: No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs). | No deaths, SAEs, or UADEs were reported. Events logged (edema, bruising, pain, blistering, erythema, nodule, hardness) were typical, transient, and resolved without medical intervention. |
| Pre-clinical: Device elevates tissue temperature to 42-47°C. (Implicitly a criterion for the hyperthermic treatment's mechanism of action to cause adipocyte injury comparable to hypothermic.) | Pre-clinical testing demonstrated that the device would elevate the temperature of the tissue to 42-47 °C. This was concluded to result in comparable adipocyte injury and fat reduction to hypothermic treatment. |
Study Details
- Sample Size used for the test set and the data provenance:
- Sample Size: 49 subjects initially, with 43 subjects returning for the 12-week post-treatment photographic evaluations.
- Data Provenance: The study was a prospective clinical study conducted at two centers. The countries of origin are not specified, but the governing body (FDA) is US-based, suggesting it was likely conducted in the US.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three blinded evaluators.
- Qualifications: Board-certified dermatologists.
- Adjudication method for the test set:
- The text states that photographs "were evaluated individually by three blinded evaluators." It doesn't explicitly mention an adjudication method like 2+1 or 3+1 for discrepancies. However, the reported 88% correct identification is presented as a singular consensus or aggregate result across all individual evaluations.
- 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 involving human readers improving with AI vs. without AI assistance was not done. This study focuses on the effectiveness of the SculpSure device for lipolysis, not on software/AI interpretation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this device is a laser system for medical treatment. The "performance" being evaluated is the physical effect of the laser on target tissue, and the subsequent aesthetic and physiological changes, not the performance of an algorithm.
- The type of ground truth used:
- For Primary Endpoint (Photographic Evaluation): Expert consensus (specifically, correct identification by blinded evaluators) implicitly serves as the ground truth for aesthetic improvement.
- For Secondary Endpoint (Adipose Layer Thickness): Objective quantitative measurement via ultrasound scans serves as the ground truth for fat reduction.
- For Tertiary Endpoint (Satisfaction): Subjective patient satisfaction surveys.
- For Pre-Clinical (Mechanism of Action): Histologic examination and quantitative measurements comparing hyperthermic and hypothermic (predicate) treatments, suggesting a pathology-based ground truth for cellular injury and fat reduction comparability.
- The sample size for the training set:
- The document describes a single clinical study that serves as the basis for performance evaluation. It does not explicitly mention a separate "training set" in the context of machine learning or AI algorithm development. The study described is a clinical validation study for the device's efficacy and safety.
- How the ground truth for the training set was established:
- As there's no explicitly mentioned training set for an AI algorithm, this question is not directly applicable. The "ground truth" for the overall device effectiveness and safety was established through a clinical trial with the methodologies described above (photographic evaluation by experts, ultrasound measurements, patient surveys, and pre-clinical histologic analysis).
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.