(86 days)
BTL-899 FP 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-899 FP is intended for use with skin type I VI.
The BTL-899 FP is a non-invasive therapeutic device. BTL-899 FP consists of a main unit and applicator(s). 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 by two applicators. The system combines bipolar radiofrequency with electromagnetic stimulation.
Here's a summary of the acceptance criteria and study details for the BTL-899 FP device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for the BTL-899 FP device. Instead, it describes "endpoints" for its clinical studies focusing on safety and efficacy, which can be interpreted as the criteria for demonstrating the device's performance. The performance is compared to what was "previously evidenced" by a predicate device.
| Acceptance Criterion (Clinical Endpoint) | Reported Device Performance |
|---|---|
| Primary Endpoint (Efficacy): Reduction in fat thickness in the abdominal area (for FST IV-VI subjects) | All subjects exhibited reduction in the fat thickness in their abdominal area, "matching the efficacy previously evidenced in the 510(k) K192224." |
| Circumference reduction was seen in 75% of subjects in total. | |
| Secondary Endpoint (Satisfaction): Subjects' satisfaction with the therapy | 88% of subjects were satisfied with the achieved results. |
| Safety: Absence of adverse events, discomfort, inflammation, or post-inflammatory hyperpigmentation. | No adverse events were reported, particularly in subjects with FST IV-VI. |
| Subjects felt none (92%) to minimal (8%) discomfort. | |
| No inflammation or post-inflammatory hyperpigmentation was observed immediately after treatment or at follow-up. | |
| Mild erythema and muscle soreness were observed (resolved quickly). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 34 subjects with Fitzpatrick Skin Types (FST) IV-VI were recruited.
- Specific breakdown: 9 subjects with skin type IV, 8 subjects with skin type V, and 8 subjects with skin type VI completed the treatments (25 subjects explicitly mentioned as completing, though 34 recruited).
- Data Provenance: Prospective, clinical investigations conducted in the United States of America.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical endpoints (fat thickness reduction, circumference reduction, satisfaction, safety). The assessment appears to be based on direct measurements (ultrasound or MRI for fat/circumference) and patient self-reporting (Likert scale, VAS for discomfort and satisfaction). There is no mention of independent expert review of these assessments.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the clinical study results. Measurements appear to be taken directly or reported by subjects, with no indication of a separate expert review or consensus process for conflicting interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly done. The study focused on the performance of the BTL-899 FP device itself, primarily comparing it to "efficacy previously evidenced" by its predicate device (K192224), rather than comparing human readers with and without AI assistance. The BTL-899 FP is a therapeutic device, not an AI diagnostic/interpretive tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable. The BTL-899 FP is a physical therapeutic device with specific operational parameters, not an algorithm, AI, or software that can operate in a standalone manner without human interaction. The "algorithm" in this context refers to the device's internal firmware controlling the treatment, not an AI for interpretation or diagnosis.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established through:
- Objective Measurements: Diagnostic ultrasound or magnetic resonance for fat tissue reduction, and abdominal circumference measurements.
- Patient-Reported Outcomes: 5-point Likert scale questionnaire and 10-point visual analogue scale (VAS) for therapy comfort and subjective satisfaction.
- Observation/Clinical Assessment: Monitoring for adverse reactions (inflammation, post-inflammatory hyperpigmentation, erythema, muscle soreness).
8. The Sample Size for the Training Set
The device is a physical therapeutic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the device's parameters comes from pre-clinical engineering, safety testing, and potentially prior clinical studies that informed the predicate device's efficacy. The document does not describe a training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
As stated above, this question is not applicable as the device is not an AI/ML algorithm requiring a training set with established ground truth labels. The performance of the device's internal control firmware is evaluated through engineering verification and validation against safety and performance standards (e.g., IEC 60601-1, IEC 62304) and confirmed safe and effective via a clinical study with real subjects.
§ 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.