(84 days)
The emField is indicated to be used for:
*Relaxation of muscle spasms;
*Prevention or retardation of disuse atrophy;
*Increasing local blood circulation;
*Muscle re-education;
*Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
*Maintaining or increasing range of motion.
emField is a non-invasive therapeutic device. The device produces a magnetic field that interacts with the tissues of the human body. By muscle stimulation, the emField is indicated for bulk muscle excitation in the legs or arms for rehabilitative purposes.
The device housing protects the patient from electrical shock and mechanical injuries. The device is mobile standalone equipment with four wheels. Two applicators are available for therapy: a large and a small one. The main body of emField is used to control function of magnetic stimulation. It is operated with parameters such as Frequency, Time and Intensity. These parameters can be controlled by the user on LCD and with the help of a rotary knob at the user control panel.
The provided document is a 510(k) Pre-market Notification from the FDA regarding the Zimmer MedizinSysteme GmbH emField device. It outlines the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
However, the document does not contain information about acceptance criteria for a study proving device performance in the context of an AI/ML medical device. The emField device is a "Powered Muscle Stimulator" that generates a magnetic field for therapeutic purposes, which falls under conventional medical devices, not AI/ML-driven devices.
Therefore, I cannot provide the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) for an AI/ML device, because this document is not about such a device.
The "Performance data" section (starting on page 7) refers to the device's compliance with voluntary standards (like IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, and IEC 60601-2-10 for nerve and muscle stimulators) and preclinical testing for magnetic field output and tissue heating. These are standard performance tests for electromechanical medical devices, not AI/ML performance metrics.
In summary, the provided document does not contain the information needed to answer the prompt, as it concerns a non-AI/ML medical device.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).