(111 days)
BTL-899 is indicated to be used for:
- · Non-invasive lipolysis (breakdown of fat) of the abdomen.
- · Reduction in circumference of the abdomen
- · The BTL-899 is intended for use with Skin Type I to Skin Type III.
The BTL-899 is a non-invasive therapeutic device is comprised of the main unit and applicators that deliver radiofrequency energy to the targeted tissue. The device two outputs enable hands-free simultaneous treatment by two applicators. The BTL-899 is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Here's a breakdown of the acceptance criteria and the study details for the BTL-899 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoints | |
| Abdominal circumference reduction of at least 1.5cm at the 3-month follow-up visit when compared to baseline. | Achieved: Responder analysis showed 88.1% (74%, 96%) subjects had a circumference reduction of 1.5cm or more. Average change was 3.2 ± 1.64 cm. |
| Evaluation of adverse events and side effects following the BTL-899 treatment throughout the study. | Achieved: No adverse events reported. Side effects were mild erythema, muscle soreness, improved body posture, and back pain relief. |
| Secondary Endpoints | |
| Correct identification of baseline and 3-month follow-up visit photographs in at least 70% of treated subjects by two blinded evaluators. | Achieved: 76.19% correct identification by both evaluators (N=32). |
| Abdominal circumference reduction of at least 1.5cm at each study visit after the first treatment when compared to baseline. | Not explicitly detailed for each visit, but the primary endpoint covers the 3-month follow-up, which is the most critical. |
| Abdominal fat reduction at the last therapy visit, 1-month follow-up visit and 3-month follow-up visit when compared to baseline, evaluated using the ultrasound imaging device. | Achieved: Average fat reduction using ultrasound images at 3-month follow-up was 29.8 ± 3.38%. |
| Subject's satisfaction with the BTL-899 treatment at each study visit after the first treatment assessed using the Subject Satisfaction Questionnaire. | Achieved: Subjects reported overall satisfaction at follow-up visits (83.3%, 83.3%, and 88.1% respectively). |
| Subject's discomfort (pain) level after each treatment evaluated using the Therapy Comfort Questionnaire. | Achieved: 92.9% of subjects reported none to minimal discomfort. |
| Temperature Performance | |
| Device to reach and maintain effective treatment temperature (40 - 43°C). | Achieved: Temperature Performance test shows the therapy temperature of 40 - 43°C was achieved and maintained for the remaining therapy time. |
| Histology | |
| Induces non-invasive lipolysis (breakdown of fat) in the abdominal area. | Achieved: Histology showed pyknotic nuclei and cell membrane degeneration leading to fat cell lysis and a decrease in fat tissue. |
| No damage to keratinocytes, melanocytes, hair follicles, sweat or sebaceous glands. | Achieved: Histology showed normal morphology of the dermal layer with no damage to these components. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: N=42 subjects completed the clinical study out of N=44 enrolled.
- Data Provenance: The text does not explicitly state the country of origin, but it is a "Prospective open-label single-arm self-controlled study," indicating it was conducted specifically for this regulatory submission. It is a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Two blinded evaluators for photograph identification.
- Qualifications: The specific qualifications of the evaluators are not mentioned, only that they were "blinded evaluators."
4. Adjudication Method for the Test Set
- The text mentions "two blinded evaluators" for photograph identification. It does not explicitly state an adjudication method (e.g., 2+1, 3+1). The criterion was "Correct identification... in at least 70% of treated subjects by two blinded evaluators," and the result states "Both evaluators correctly identified subject's photographs in 76.19% of cases." This implies consensus or agreement between the two was the standard for a correct identification for a given subject.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done to evaluate how human readers improve with AI vs. without AI assistance. This device is a treatment device, not an AI-assisted diagnostic or imaging interpretation tool.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
- This is not applicable as the BTL-899 is a medical device for treatment, not an algorithm, and its performance involves direct patient interface and effect. The clinical study evaluated the device's efficacy and safety in a human-in-the-loop context (administered by clinical staff).
7. Type of Ground Truth Used
- Clinical Measurements: Abdominal circumference reduction measured by tape.
- Imaging: Abdominal fat reduction measured by ultrasound images.
- Expert Consensus: Blinded evaluators for photograph identification.
- Histology: Biopsies from a separate study of 8 subjects confirmed fat breakdown and skin morphology.
- Patient Reported Outcomes: Subject satisfaction and discomfort questionnaires.
8. Sample Size for the Training Set
- The document describes a clinical study to evaluate the device's performance, not a training set for an AI algorithm. Therefore, there is no mention of a "training set" in this context. The N=42 subjects are the test set for its clinical efficacy and safety.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of an AI algorithm or a training set, this question is not applicable. The device's performance was established through the clinical efficacy and safety study on the N=42 subjects and confirmed by histology data.
§ 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.