(85 days)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.
The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
The provided document is a 510(k) premarket notification for the Cynosure SculpSure device, specifically seeking clearance for the treatment of the submental area. It contains information about the device's
description, indications for use, and a summary of clinical and non-clinical tests conducted to demonstrate safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal table of pre-defined acceptance criteria with corresponding performance metrics. Instead, it describes performance outcomes that were achieved. However, based on the narrative, we can infer the implied acceptance criteria from the reported results.
| Metric/Criteria (Inferred) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Efficacy: Blind Evaluation of Photos | High percentage of post-treatment photos identifiable by blind evaluators (indicating visible change). | 93% (51/55) of post-treatment photographs were identifiable by blind evaluators. |
| Efficacy: Fat Reduction (Ultrasound) | Demonstrable and statistically significant reduction in adipose tissue thickness via ultrasound. | 15.2% (1.785mm) normalized fat reduction at 12 weeks post-final treatment was shown by ultrasound imaging. |
| Efficacy: Patient Satisfaction | High patient satisfaction rate with the treatment. | 100% (55/55 subjects) satisfaction rate reported at 12 weeks post-final treatment follow-up visit using a 6-point Likert scale. |
| Safety: Adverse Events | Side effects should be transient, and the majority should be mild or moderate in nature, with no significant difference across BMI groups. | All reported adverse events (swelling, pain, nodules, redness, hardness, numbness, hair loss, itching, bruising, and blisters), except for one, were transient, and the majority were mild or moderate in nature. No significant difference in safety (or efficacy) between BMI = 30 groups. |
| Software Verification & Validation | Software performs as intended. | Software verification and validation was performed, and it was demonstrated that the software performs as intended. |
| Power Output Consistency | Power output meets specification. | Testing confirmed that the power output meets specification. |
| Electromagnetic Compatibility (EMC) & Electrical Safety | Device meets relevant standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1). | Results confirmed the device meets the standards. |
| Biocompatibility | Patient-contacting materials are biocompatible per ISO 10993-1. | All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible. |
| Submental Mask Beam Uniformity | Submental mask provides beam uniformity within +/- 15% specification. | Additional bench testing was performed to demonstrate that the submental mask provides beam uniformity to the treatment area within +/- 15% specification. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: 57 subjects were enrolled in the study for the submental area.
- 23 subjects had a BMI = 30.
- 5 patients received 1 treatment, the rest received 2 treatments.
- Efficacy analysis performed on 55 subjects (implied that 2 subjects were lost to follow-up or excluded from efficacy analysis, as 51/55 and 55/55 are reported).
- Safety analysis performed on all 57 subjects.
- Data Provenance: The study was a "prospective, controlled study" conducted at "3 study centers." The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it is highly likely the study was conducted in the United States, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document states "On an average, blind evaluators were able to identify 93% (51/55) of the post treatment photographs." The exact number of individual blind evaluators is not specified.
- Qualifications of Experts: The qualifications of these "blind evaluators" are not provided in the document.
4. Adjudication Method for the Test Set
- For the blind evaluation of photographs, the document only states "blind evaluation of pre- and post- final treatment (12 week) photographs." No specific adjudication method (e.g., 2+1, 3+1) is mentioned. It's unclear if multiple evaluators independently rated and then their results were averaged or if consensus was reached, or if there was a primary and secondary read.
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
- This document describes a clinical study for a medical device (laser system) for fat reduction, not a diagnostic AI system that assists human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and was not conducted for this device. The efficacy endpoints were direct measurements (fat reduction, patient satisfaction) and blind photo evaluation, not diagnostic accuracy requiring human reader interaction with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to the SculpSure device as it is a physical medical device (a laser system), not an algorithm or AI software for diagnostic purposes. Its performance is measured directly by its physical effect on the body, not as a standalone software output.
7. The Type of Ground Truth Used
The ground truth for the efficacy endpoints in this study was established using a combination of:
- Expert Consensus/Blind Evaluation: Implicitly, the ability of "blind evaluators" (human experts) to correctly identify post-treatment photographs served as a form of ground truth for visible changes.
- Objective Measurement: Percentage change in adipose tissue thickness from baseline, measured through ultrasound imaging, provided an objective, quantifiable ground truth for fat reduction.
- Patient-Reported Outcomes: Patient satisfaction measured via a 6-point Likert scale represents a subjective but crucial ground truth from the patient's perspective.
- Observed Clinical Outcomes: For safety, the reporting and assessment of adverse events observed during visits forms the ground truth for safety.
8. The Sample Size for the Training Set
- The document describes a clinical study to evaluate the device's performance, not to train an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The 57 subjects were part of the clinical test set (or study cohort) to assess the device's efficacy and safety.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there was no AI training set involved in this device submission.
§ 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.