(83 days)
The Bortec Biomedical Analog Multiplexed cable Telemetry (AMT) electromyograph is intended for non-invasive use as a research or diagnostic sensing and processing instrument in studies of physiological signals. The AMT is indicated for use with active or passive adult or pediatric subjects in hospitals or clinics under the direction of a health care professional during electromyography, including bio-feedback, evoked potential, kinesiological, nerve conductance and sleep studies.
Analog Multiplexed cable Telemetry (AMT) electromyograph
The provided text is a 510(k) clearance letter from the FDA for the Bortec Biomedical, LTD. Analog Multiplexed Cable Telemetry (AMT) Electromyograph. This document is a regulatory approval and does not contain the acceptance criteria or details of a study proving the device meets those criteria, nor does it provide information about AI-specific performance metrics.
The letter states that the device has been reviewed and determined to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA found the new device to be as safe and effective as a device already on the market, but it does not require the submission of detailed performance studies in the same way a novel device might.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance studies based on the provided input. The document focuses on regulatory compliance and indications for use, not detailed technical performance data or specific study designs.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).