(90 days)
The CURVE Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
The CURVE Laser System consists of a main console and 4 treatment paddles. The console houses the main electronics, controls and embedded software. The liquid crystal display (LCD) identifies all key treatment parameters. The main console is also equipped with a micro controller that provides automatic calculation of energy output for a specific set of treatment parameters. The treatment paddles are constructed so that each paddle contains 8 laser emission diode sources at a power output of 40mW per laser diode. These treatment paddles are non-thermal and non-invasive, at a wavelength of 630-680.
The provided document is a 510(k) summary for the CURVE Laser System and details the device's indications for use, substantial equivalence, and performance data, including a clinical study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Primary Efficacy Endpoint) | Reported Device Performance |
|---|---|
| Achievement of at least 1 inch loss from baseline in averaged waistline measurement at the final visit. | 100% of subjects receiving treatment with the CURVE device lost at least 1 inch in their waistline. |
(Note: The document doesn't explicitly state the acceptance criteria as a separate "acceptance criteria" section but directly presents the primary efficacy endpoint of the clinical study as the measure for success.)
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- CURVE Laser System treatment group: 19 subjects
- Control (sham) device group: 18 subjects
- Total: 37 subjects
- Data Provenance: The document does not explicitly state the country of origin of the data. The study was a "randomized, double blind clinical study," indicating it was prospectively collected.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish ground truth for the test set in the context of image analysis or diagnostic interpretation. The primary outcome was a physical measurement (waistline circumference).
4. Adjudication Method for the Test Set:
Not applicable. The study involved direct physical measurements of waistline circumference, not interpretive assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study involved a comparison between a device and a sham, not a comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone study was not done. The CURVE Laser System is a physical device that delivers laser treatment, not an algorithm, and its performance is evaluated in direct application to subjects.
7. Type of Ground Truth Used:
The ground truth used was direct physical measurement of waistline circumference.
8. Sample Size for the Training Set:
The document does not mention a training set. This is a clinical study for a physical device, not an AI/algorithm where a separate training set is typically used to develop the model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no mention of a training set.
§ 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.