(90 days)
BTL-899A is indicated to be used for:
Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-899A is intended for use with skin type I - VI. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.
The BTL-899A is a non-invasive therapeutic device.
BTL-899A consists of a main unit and applicators. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the BTL-899A device:
Device: BTL-899A (Non-invasive lipolysis device)
Study Purpose: To demonstrate the effectiveness and safety of the BTL-899A device for non-invasive lipolysis of the upper arms.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Efficacy Endpoint) | Reported Device Performance |
|---|---|
| Correct identification of pre-treatment and 3-month follow-up images by at least two out of three independent blinded evaluators with more than 75% success rate. | All three blinded evaluators correctly recognized the pre-/post-treatment images with more than 75% success rate. |
| Secondary Objectives: | |
| Evaluation of device safety. | The treatment with the BTL-899 device has shown to be both effective and safe. (Further details on satisfaction and comfort reported below). |
| Statistically significant reduction of upper arms fat thickness. | The treatment with the BTL-899 device has shown to be both effective and safe for ... fat thickness reduction of upper arms. (Implies statistical significance) |
| Participants' satisfaction from the therapy. | Overall satisfaction was 94% at 1-month and 97% at 3-months. |
| Comfort of the therapy. | All subjects found the therapy comfortable (7 reporting weak pain, 33 reporting no pain). |
2. Sample Size and Data Provenance
- Sample Size (Test Set/Clinical Study): Forty (40) participants.
- Data Provenance: Not explicitly stated, but the study was conducted by BTL Industries who are based in Marlborough, MA, USA, and the submission is for FDA clearance, implying the study was conducted in a manner acceptable for US regulatory review. The text does not specify if it was retrospective or prospective, but the description of "clinical investigation" with "follow-up intervals" and "participants received treatments" strongly suggests a prospective study.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three (3) independent blinded evaluators.
- Qualifications of Experts: Not specified. (e.g., "Radiologist with X years of experience" is not provided).
4. Adjudication Method for the Test Set
- Adjudication Method: "Correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators had to be reported." This indicates a 2-out-of-3 majority vote method for image recognition.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not conducted or described. This device is a therapeutic device (non-invasive lipolysis), not an AI-powered diagnostic tool assisting human readers. The clinical study evaluated the direct effect of the device on patients.
6. Standalone Performance
- Standalone Performance Done?: Not applicable in the context of this device. This is a therapeutic device, not an AI algorithm whose standalone diagnostic performance would be measured. The primary efficacy endpoint refers to human evaluators assessing the outcome of the device treatment.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the primary efficacy endpoint was established by the consensus of three independent blinded human evaluators (at least 2 out of 3 agreeing) on pre-treatment and 3-month follow-up images, as a proxy for the device's ability to induce lipolysis.
- For the secondary endpoint of fat thickness reduction, it implies some form of objective measurement (e.g., ultrasound, caliper measurements, or other imaging) that would be considered the ground truth, though the specific method is not detailed.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This document describes the clinical validation study of a physical therapeutic device, not the development or validation of an AI algorithm which typically involves training sets.
9. How Ground Truth for Training Set Was Established
- How Ground Truth Established: Not applicable, as there is no mention of a training set for an AI algorithm.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.