(253 days)
The BTL-9000 device is a low level laser system that can be used for the non-invasive temporary reduction of waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
The BTL-9000 consists of a control unit, connection lead to a BTL-9000 Laser Applicator and other accessories. (A full list of system contents is included in the operator's manual). The Laser Applicator is containing four cold red (660 nm) laser-emitting diodes and is designed to be placed on the skin. The output of the diode (four per applicator) is limited to 50mW ± 15% by a power limiting PCB from the central processing unit. The system can operate using 1 applicator that is connected to the control unit. The control unit is an electrically powered unit (100-240V, 50-60Hz auto-ranging). Once enabled it is controlled using a touchscreen interface. When the Laser Applicator is placed on the skin, the cold red laser beams penetrate the skin just deep enough to reach the layers of fat. When the light hits the fat cells, a rapid chain of events takes place. Firstly, pores form on the cells causing them to spill out. The water, Glycerol and fatty acids move into the interstitial space beneath the fatty layer in the skin. Then further water, fatty acids and Glycerol spill out. The adipocyte cells and therefore reduced in size. The BTL-9000 is a stand-alone device which can be used together with other modalities which are not part of this submission.
Here's an analysis of the provided text regarding the BTL-9000 device, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
The core acceptance criterion for the BTL-9000 device is the temporary reduction of waist circumference by a minimum of 3 cm at a 30-day follow-up as compared to the baseline evaluation.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Treatment Group) |
|---|---|
| Minimum of 3 cm reduction in waist circumference at 30-day follow-up as compared to baseline evaluation. | Average recorded loss: 3.53 ± 0.40 cm (meeting and exceeding the 3 cm criterion) |
| Statistical significance of waist circumference reduction. | Statistically significant difference between Treatment and Placebo Groups (pre-treatment vs. 30-day follow-up). |
| No adverse events. | No adverse events were experienced by any subjects. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 30 subjects (15 in the BTL-9000 LLLT treatment group and 15 in the placebo group).
- Data Provenance: The document does not specify the country of origin. It indicates it was a prospective, double-blind clinical study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The study focuses on objective measurements of waist circumference and patient-reported adverse events. There is no mention of experts being used to establish a subjective "ground truth" for the test set; the ground truth is derived from direct anthropometric measurements.
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Adjudication method for the test set:
- Not applicable as the ground truth is based on objective measurements (waist circumference) and adverse event reporting, not on expert interpretation requiring adjudication.
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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:
- No, this was not an MRMC comparative effectiveness study and does not involve AI or human readers for diagnostic interpretation. It's a clinical trial comparing a medical device to a placebo for a therapeutic outcome.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (low-level laser system) used for treatment, not an algorithm, and its performance is assessed directly on human subjects.
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The type of ground truth used:
- The ground truth was based on objective anthropometric measurements of waist circumference (in centimeters) and observation of adverse events.
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The sample size for the training set:
- Not applicable. This device is a hardware-based low-level laser system, not an AI or machine learning algorithm that requires a "training set" of data.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
Summary of the Study:
The study was a double-blind clinical trial designed to assess the effectiveness and safety of the BTL-9000 device for temporary waist circumference reduction. It involved 30 subjects randomly assigned to either a treatment group (receiving BTL-9000 LLLT) or a placebo group. Both groups received 8 twice-a-week treatments. Waist circumference and weight were measured at baseline, after the 8th treatment, and at a 30-day follow-up. The primary endpoint measured was the change in waist circumference. The results demonstrated a statistically significant reduction in waist circumference in the treatment group compared to the placebo group, meeting the internal acceptance criterion of a minimum 3 cm reduction at 30-day follow-up. No adverse events were reported.
§ 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.