(109 days)
The device is indicated for aesthetic use including facial and neck or body skin stimulation.
The BTL-785BNF-E is a state-of-the-art electrostimulation device that enables the application of therapy by electrical stimulation to patient's skin for aesthetic use. The main control unit is equipped with a large color touch screen that 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 set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, the remaining therapy time and the main therapy parameters on the screen. The generated electrical stimulation is intenact with the tissues of the human body in order to achieve skin stimulation in the face. The device consists of the following main components: BTL-785 main unit, BTL-785-7 Handpiece, Single-use application electrodes, Holding arm, Connection cables, Therapy discomfort button.
The provided document is a 510(k) summary for the BTL-785BNF-E device. It describes the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed.
Crucially, the document explicitly states under the "Clinical performance data" section: "A clinical study was not conducted."
This means that the information typically required to answer your questions regarding acceptance criteria and performance studies (such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not available within this document because no clinical study was performed.
The substantial equivalence determination for this device is based on its similarity to a legally marketed predicate device (BTL-785BNF Handpiece, K233604) and non-clinical testing (electrical safety, EMC, usability, risk management, and biocompatibility standards compliance), not on a new clinical performance study. The key difference in the subject device is the introduction of a new disposable applicator (BTL-785-7-11), which the manufacturer asserts does not significantly influence safety or effectiveness given its similar materials, manufacturing, and technology.
Therefore, I cannot provide a table of acceptance criteria and proven performance based on a clinical study for this device, nor can I answer the specific questions about clinical study design parameters.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).