(212 days)
BTL-899F 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-899F is intended for use with skin types I VI.
- Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I IV.
- Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.
The BTL-899F is a non-invasive therapeutic device.
BTL-899F 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.
The provided text describes a 510(k) premarket notification for the BTL-899F device, a non-invasive therapeutic device intended for lipolysis and circumference reduction in various body areas. The submission aims to demonstrate substantial equivalence to a predicate device (BTL-899A).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Primary Objective) | Reported Device Performance |
|---|---|
| Mean population reduction of flanks' fat thickness pre- vs 3-months post-treatment | 5 mm reduction in the mean fat thickness (measured by ultrasound) |
| Acceptance Criterion (Secondary Objectives) | Reported Device Performance |
|---|---|
| Safety of the device (non-invasive lipolysis of flanks) | Considered safe. Only one anticipated side effect reported: mild erythema in one patient, lasting 1 hour after the second procedure, which resolved without medical intervention (erythema is an expected and declared side effect). |
| Minimum 75% of subjects' pre-treatment and 3-month follow-up post-treatment images correctly identified by at least two of three independent blinded evaluators. | Rate of successful recognition of the subject's pre-/post-treatment photographs was 88.2%. All three independent blinded evaluators identified images with more than 75% accuracy. |
| Participants' satisfaction and comfort level | All participants found the procedure comfortable and virtually painless, agreeing or strongly agreeing with comfort levels. All were satisfied or very satisfied with the procedure at 3-month follow-up. All reported improved, much improved, or very much improved appearance of the flanks area at 3-month follow-up. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 55 subjects were enrolled in the study. 51 participants attended the final 3-month follow-up. The performance metrics are based on these 51 participants.
- Data Provenance: The document does not explicitly state the country of origin for the data. It is a clinical investigation conducted by BTL Industries Inc., a company with a Marlborough, Massachusetts address. The study design is described as single-arm, open-label, and interventional, indicating it was 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: Three independent blinded evaluators were used to assess the pre- and post-treatment images.
- Qualifications of Experts: The document does not specify the qualifications (e.g., radiologist with years of experience) of the evaluators. They are simply referred to as "independent blinded evaluators."
4. Adjudication Method for the Test Set
- The acceptance criterion for image identification was "at least two of three independent blinded evaluators." This implies a 2 out of 3 consensus or similar majority-based adjudication method for image recognition. The exact adjudication method for other observations (e.g., fat thickness measurement, side effect assessment) is not explicitly detailed, but the fat thickness reduction seems to be a measured outcome, not subjected to expert adjudication in the same way.
5. 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, an MRMC comparative effectiveness study involving human readers assisting with or without AI was not conducted. This study's primary focus was on the device's direct effect on fat thickness and subjective patient outcomes, with independent evaluators assessing before/after images. The device itself is a therapeutic device, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a therapeutic device (electrosurgical cutting and coagulation device) that performs non-invasive lipolysis. It is not an AI algorithm in the context of image analysis or diagnostic support. Therefore, a "standalone algorithm performance" evaluation as typically understood for AI software was not applicable and not performed. The device's performance is driven by its physical application and effect.
7. The Type of Ground Truth Used
- The ground truth for the primary objective (fat thickness reduction) was based on objective measurements (ultrasound).
- For the secondary objectives:
- Safety was assessed through clinical observation and patient reporting of adverse events.
- Image evaluation involved a form of expert consensus (at least 2 out of 3 independent blinded evaluators).
- Patient satisfaction and comfort were based on patient-reported outcomes.
8. The Sample Size for the Training Set
- The document does not describe a separate "training set" in the context of an AI model. The clinical investigation appears to be a single study evaluating the device's performance. The device is a physical therapeutic device, not a software algorithm that would typically undergo a separate training phase with a distinct dataset.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a separate training set for an AI model, this question is not applicable based on the provided document. The device's validation is based on the clinical investigation described for its performance.
§ 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.