(140 days)
BTL-499 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-499 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-499 is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-499 massage function is intended to provide a temporary reduction in the appearance of cellulite.
The BTL-499 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators. The BTL-499 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 displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The system console consists of the RF, HV and massage generators, computer, and a touch-screen control panel. The system combines bipolar radiofrequency with electromagnetic stimulation and mechanical massage. The device is accompanied by the following applicators: 499-AP-MRA-1, 499-AP-MR-2, 499-AP-MRA-4 & 499-AP-MRA-5
Given the provided document, the device in question is the BTL-499, an electrosurgical device. The document states "Clinical Testing: Not applicable to this submission" on page 5. This explicitly indicates that no clinical studies were performed for this submission, and therefore, no data exists to answer questions regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for clinical performance.
The document primarily focuses on non-clinical testing for electrical safety and compliance with medical device standards, and a comparison to predicate devices to demonstrate substantial equivalence based on technological characteristics and intended use, rather than direct comparative clinical performance.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance evaluation, which was explicitly stated as "Not applicable to this submission."
Here's a breakdown of what can be determined from the document:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Non-Clinical/Safety Standards): The document lists several IEC and ISO standards that the BTL-499 device was found to comply with. These standards implicitly serve as the acceptance criteria for the non-clinical performance (safety, EMC, software lifecycle, risk management, biocompatibility).
- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 62304: Medical device software - Software life cycle processes
- ISO 14971: Medical devices – Application of risk management to medical devices
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
- Reported Device Performance (against standards): The document states: "The BTL-499 device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards." This is the reported performance – that it complies with the listed standards. No specific quantitative performance metrics beyond compliance are provided in this summary.
The following information is NOT available in the provided text because clinical testing was not applicable to this submission:
- 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established from experts for this submission.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. The device is not described as an AI-assisted device in this context, and no clinical comparative effectiveness study against human readers was performed.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an energy delivery system, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth data was used for this submission.
- 8. The sample size for the training set: Not applicable. No training set for clinical performance was used.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.