(59 days)
The BTL-785BNF Handpiece device has the following indications for use: The device is indicated for aesthetic use including facial and neck stimulation or body skin stimulation.
The BTL-785BNF Handpiece is a state-of-the-art electrostimulation device that enables the application of therapy by an electromagnetic field. The subjected device is intended to be used together with a main control unit that 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 BTL-785BNF Handpiece is a specially developed device that can be used with the applicators and the main control unit. The generated electromagnetic field is interact with the tissues of the human body in order to achieve neuro-muscle stimulation. The radiofrequency is providing a low degree of warming to enhance the patient's comfort during the treatment. The BTL-785BNF Handpiece consists of the following main components: BTL-785BNF Handpiece, Single-use application electrodes, Holding arm, Connection cables, Therapy discomfort button.
This document, primarily a 510(k) summary for the BTL-785BNF Handpiece, does not contain information about acceptance criteria for a device's performance in a clinical study, nor does it describe a study that explicitly proves the device meets specific acceptance criteria. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance metrics against pre-defined acceptance criteria from a clinical trial.
However, it does provide information about non-clinical testing performed to establish safety and compliance with relevant standards, which can be thought of as a form of "acceptance criteria" for safety.
Here's a breakdown of the requested information based on the provided text, noting where information is explicitly stated or absent:
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A table of acceptance criteria and the reported device performance
- Not explicitly provided in the context of clinical performance. The document states, "A clinical study was not conducted."
- The document does list compliance with voluntary standards as a form of performance or acceptance criteria for safety. The reported device performance is that it "has been found to comply with applicable medical device safety standards."
Acceptance Criteria (Safety Standards) Reported Device Performance (Compliance) IEC 60601-1 (Basic safety & essential performance) Complies IEC 60601-1-2 (EMC) Complies IEC 60601-2-10 (Nerve & muscle stimulators) Complies IEC 60601-1-6 (Usability) Complies IEC 62304 (Software life cycle) Complies ISO 14971 (Risk management) Complies ISO 10993-1 (Biological evaluation) Complies ISO 10993-5 (In vitro cytotoxicity) Complies ISO 10993-10 (Irritation & sensitization) Complies -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document explicitly states, "A clinical study was not conducted." Therefore, there is no test set in the traditional sense of a clinical trial. The "test set" for substantiating safety and performance was the device itself subjected to non-clinical laboratory testing against international standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements of the referenced international safety standards. These do not involve human experts establishing ground truth in the context of interpreting clinical outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical study was conducted. Adjudication methods are typically relevant in clinical trials for resolving disagreements among readers or evaluators of clinical data.
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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. This document is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and not an AI-assisted diagnostic or predictive device. Therefore, an MRMC study and AI assistance are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm; it is a physical electrostimulation device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical safety and performance aspects, the "ground truth" would be the requirements and specifications outlined in the international consensus standards (e.g., IEC 60601-series, ISO 14971, ISO 10993-series). The device was tested to demonstrate compliance with these standards.
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The sample size for the training set
- Not applicable. No clinical study was conducted, and this is not an AI/algorithm-based device that would typically involve a "training set."
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How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/algorithm was used or established.
§ 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).