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510(k) Data Aggregation
(97 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 Body Mass Index (BMI) of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the 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 document describes a clinical study conducted to evaluate the safety and efficacy of the Cynosure SculpSure laser system with a new petite mask for non-invasive fat reduction and improvement of lax tissue appearance in the submental area.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state the acceptance criteria as a separate table. Instead, it describes the endpoints that were evaluated and the results. I will infer the acceptance criteria from the "met all three endpoints to prove safety and efficacy" statements.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| For Non-Invasive Fat Reduction: | |
| 1. Significant change in adipose tissue thickness from baseline. | Reduction in adipose tissue measured by ultrasound imaging at 12-week post follow-up visit showed a p-value of <0.001 for all subjects, indicating a statistically significant reduction. Average reduction was 1.4mm. (Met) |
| 2. Positive blind evaluation of pre- and post-photographs. | On average, blind evaluators were able to identify 91% (53/58) of all post-treatment photographs. (Met) |
| 3. High patient satisfaction. | The patient satisfaction survey at 12-week post follow-up visit showed a 91% (53/58) satisfaction rate. (Met) |
| For Improvement of Lax Tissue Appearance: | |
| 1. Measurable improvement in lax tissue (quantitative). | 86% of subjects (50/58) showed a measurable improvement in lax tissue in the submental area, defined as a ≥20mm² decrease in lax tissue via photographic analysis. (Met) |
| 2. Positive patient perception of chin toning. | 86% (49/57) patients responded that they agreed that the treatment made their chin look more toned. (Met) |
| For Both Indications (Safety): | |
| Low incidence of significant adverse events. | All subjects (n=61) were included in the safety analysis. Most events were transient, and a majority was mild in nature. No significant safety concerns were identified, and it was concluded that the device is safe. (Met) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): 61 subjects were enrolled in the study. 58 subjects were included in the efficacy analysis for fat reduction and lax tissue improvement (implied by 53/58 and 50/58). 57 subjects were evaluated for patient satisfaction regarding chin toning (49/57). 61 subjects were included in the safety analysis.
- Data Provenance: The study was a prospective, controlled study conducted at 3 study centers. The document does not specify the country of origin, but given the FDA submission, it is likely the US or a region with comparable clinical trial standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document states "blind evaluators" were used for assessing pre- and post-treatment photographs for fat reduction. The number and qualifications of these evaluators are not specified.
4. Adjudication Method for the Test Set:
- The document implies a "blind evaluation" for the photographic assessment, suggesting that the evaluators were blinded to the treatment status (pre vs. post). However, it does not explicitly describe an adjudication method (e.g., 2+1, 3+1) if there were multiple evaluators and their assessments differed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This study focused on the performance of the device itself.
6. Standalone (Algorithm Only) Performance:
- This is a medical device (laser system), not an AI algorithm. Therefore, the concept of "standalone performance" of an algorithm is not applicable here. The study evaluated the device's performance directly on human subjects.
7. Type of Ground Truth Used:
- For Fat Reduction:
- Objective/Quantitative: Ultrasound imaging measurements of adipose tissue thickness.
- Subjective/Qualitative: Blind evaluation of pre- and post-treatment photographs.
- Patient-Reported: Patient satisfaction survey (Likert scale).
- For Lax Tissue Improvement:
- Objective/Quantitative: Photographic analysis with anatomical points to measure reduction in submental area and neck lax tissue (defined as ≥20mm² decrease).
- Patient-Reported: Subject questionnaire on 'chin toning'.
8. Sample Size for the Training Set:
- The document describes a clinical study for the evaluation of the device, not the training of an AI model. Therefore, there is no mention of a training set sample size in the context of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
- As this is not an AI algorithm study, the concept of a training set and its ground truth establishment is not applicable. The "ground truth" in this context refers to the methods used to assess the efficacy and safety of the device in the clinical trial.
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