(84 days)
The BTL-084 RF device 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-084 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BTL-084 is a non-invasive therapeutic device enables the application of therapy by a high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For easier control, the handpiece is equipped with buttons, enabling operation of the device during therapy. The energy flow is indicated by the illuminated treatment tip. The BTL-084 consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, massage generator, user interface with 8.4" color touch screen, handpiece.
There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text.
The document is a 510(k) premarket notification clearance letter from the FDA for the BTL-084 device. It primarily discusses:
- The FDA's determination of substantial equivalence to a legally marketed predicate device (TR-100 (K161551)).
- The intended use of the device: "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" and "to provide a temporary reduction in the appearance of cellulite."
- Non-clinical testing for electrical safety and compliance with various medical device safety and quality standards (e.g., IEC 60601-1, ISO 14971).
- A brief mention of "Clinical testing" stating that "The substantial equivalence determination for the BTL-084 is based on clinical performance testing. The aim of the performance test was to prove that the device reaches the effective treatment temperature and maintain it for required time."
However, the document does not provide any specific acceptance criteria (e.g., specific thresholds for temperature, pain reduction, or cellulite reduction), nor does it detail the results of the "clinical performance testing" that would demonstrate these criteria were met.
Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text.
To address the specific points of your request:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not available. The document only mentions "clinical performance testing" but provides no details on participants, study design, or data origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available. The context of "ground truth" (e.g., for AI model validation) is not present as this is a medical device clearance document, not an AI efficacy study report.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/available.
- If a multi-reader multicase (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. This document describes a physical medical device, not an AI algorithm.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This document describes a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/available. The document mentions "clinical performance testing" to prove the device "reaches the effective treatment temperature and maintain it for required time," which implies physiological measurements, but no specific "ground truth" methodology is described.
- The sample size for the training set: Not applicable. This is not an AI model.
- How the ground truth for the training set was established: Not applicable. This is not an AI model.
§ 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.