(288 days)
The Talent-Pro™ Electromagnetic Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The Talent-Pro™ Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- 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
- Maintaining or increasing range of motion
The Talent-Pro Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes, prevention or retardation of disuse atrophy. Talent-Pro Electromagnetic Stimulator consists of the Main body, Transducer for magnetic stimulation
The provided text describes the Talent-Pro Electromagnetic Stimulator, a device for neuromuscular tissue stimulation, and assesses its substantial equivalence to a predicate device (HPM-6000, K160992) for FDA 510(k) clearance. However, the document does not contain acceptance criteria or study results for a device that relies on artificial intelligence (AI) or machine learning.
The document outlines performance and safety data relevant to an electromagnetic stimulator, which is a physical device, not an AI/ML algorithm. Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria or studies proving device performance based on the input document.
The "Safety & Performance Data" section primarily addresses:
- Biocompatibility Testing: Ensuring the materials are safe for human contact.
- Design Verification and Validation Testing: Verifying the device meets predefined safety and performance requirements (e.g., magnetic field output, intensity control, pulse width/frequency, stability, safety devices, simultaneous operation prevention).
- Electrical Safety and Performance Testing: Compliance with IEC standards.
- Shipping Validation: Ensuring the device withstands transport.
These tests are standard for medical hardware devices and do not involve AI/ML performance metrics such as AUC, sensitivity, specificity, or human-in-the-loop studies for AI assistance.
§ 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).