(103 days)
The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen 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 abdomen 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 study information for the Cynosure SculpSure device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance |
|---|---|
| Primary Endpoint: Photographic Evaluations (Correct identification of pre-treatment vs. post-treatment images) | In 95% of total individual evaluations, blinded evaluators correctly identified before and after images. |
| Secondary Endpoint: Change from baseline in adipose layer thickness (ultrasound measurements) | An average of 11.5% fat reduction based on ultrasound measurements at 12 weeks. |
| Third Endpoint: Subject satisfaction survey | 91% of patients rated the treatment "satisfied" on the Likert Satisfaction scale. |
| Safety: Absence of serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) | No deaths, SAEs, or UADEs reported. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: 35 subjects initially enrolled. 34 subjects returned for the 12-week post-treatment photographic evaluation.
- Data Provenance: The study was a prospective clinical study conducted at two centers. The racial demographics included Caucasian, African American, and Hispanic subjects. The country of origin for the data is not explicitly stated, but given the FDA submission, it is highly likely to be the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Three blinded evaluators.
- Qualifications of Experts: Board-certified dermatologists.
4. Adjudication Method for the Test Set
- The photographic evaluations were performed individually by three blinded evaluators. The text states, "In 95% of the total individual evaluations the evaluators correctly identified the before and after images." This suggests that the performance was aggregated from individual assessments, but it does not specify a formal adjudication method like a 2+1 or 3+1 consensus. It seems each individual expert's correct identification contributed to the overall 95% figure.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This study focused on the effectiveness of the device itself, with experts evaluating photographic outcomes as a primary endpoint.
6. Standalone (Algorithm Only) Performance
- No, a standalone (algorithm only) performance study was not explicitly mentioned or performed as described. The primary endpoint involved human evaluators (dermatologists) assessing photographs. The device itself is a laser system, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
- Expert Consensus/Opinion: For the primary endpoint (photographic evaluation), the ground truth was established by the agreement of board-certified dermatologists on the correct identification of before and after images, implying visual assessment of aesthetic improvement.
- Quantitative Measurement: For the secondary and tertiary endpoints, objective measurements were used:
- Ultrasound Measurements: To determine the change in adipose layer thickness.
- Subject Satisfaction Survey: To gauge patient perception of outcome.
8. Sample Size for the Training Set
- The document does not explicitly state a sample size for a "training set." The clinical study described involved 35 subjects and appears to be the primary study for demonstrating effectiveness, not a separate training set for an AI algorithm. The device is a laser, not an AI-driven diagnostic.
9. How the Ground Truth for the Training Set Was Established
- As there's no mention of an AI-specific "training set" in the context of this device and study, the method for establishing ground truth for such a set is not applicable based on the provided text. The clinical study's results are presented as evidence of the device's performance.
§ 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.