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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.

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