(114 days)
The Lipofina Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
The Lipofina Laser System (Figure 1) consists of a main console and 8 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 12 laser emission diode sources at a power output of 35mW per laser diode. These treatment paddles are non-thermal and noninvasive, at a wavelength of 658 (central).
The provided document is a 510(k) summary for the Lipofina Laser System, which is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist. The document details a clinical study conducted to demonstrate the device's safety and effectiveness.
Here's an analysis of the acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Lipofina Laser System) |
|---|---|
| Primary Efficacy Endpoint: Achievement of at least 1 inch loss from baseline in averaged waistline measurement at the final visit. | 95% of subjects treated with the Lipofina Laser System lost at least 1 inch in their waistline. |
| Safety Endpoint: No device-related Adverse Events (AEs) or skin color changes. | No device-related AEs or skin color changes were reported for any subject. |
2. Sample Size and Data Provenance
- Sample Size (Test Set):
- Lipofina Laser System treated group: 20 subjects
- Control (sham) device group: 21 subjects
- Data Provenance: The study was "at the request of CDRH," implying it was conducted as part of the FDA regulatory process. The geographical origin of the data (country) is not explicitly stated, but the sponsor, YOLO Medical Inc., is located in British Columbia, Canada, and the submission correspondent Rockin' Regulatory, Inc. is in California, USA, suggesting a North American context. The study was prospective as it was a "randomized, double blind clinical study."
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the test set in the conventional sense of medical image interpretation (e.g., radiologists reviewing images). The ground truth here is directly measured waistline circumference loss and observed adverse events.
4. Adjudication Method for the Test Set
Not applicable in the context of this study. The "ground truth" was objective measurement (waistline circumference) and direct observation for adverse events.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers evaluating medical images or data, with and without AI assistance, to assess the impact of AI on diagnostic accuracy or efficiency. The Lipofina Laser System is a physical device used for aesthetic treatment, not an AI-powered diagnostic tool.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's effect was directly measured on subjects without human intervention in the treatment application that would alter the device's output. The clinical study was a randomized, double-blind trial demonstrating the device's efficacy on its own when applied as intended.
7. Type of Ground Truth Used
The ground truth used was objective measurement (waistline circumference loss) and clinical observation (for adverse events and skin color changes).
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning. The Lipofina Laser System is a low-level laser system, not an AI/ML-based device that would typically have a training set. The clinical study described served as the primary validation set to demonstrate the device's safety and efficacy.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or indication of an AI/ML training set for this device.
§ 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.