Search Results

Stimulation of peripheral nerves for diagnostic purposes.

The MEGA-TMS is intended for stimulation of peripheral nerves for diagnostic purposes. The device introduces electrical stimulation to tissue through magnetic induction generated from the coil. The obtained responses of stimulated structures is recorded with an EMG system for further diagnostic evaluation. The MEGA-TMS device is intended to be paired with a Focus EMG device cleared under FDA 510(k): K102610. Magnetic stimulation is used for peripheral nerve conduction studies and to evaluate peripheral nervous system.

The provided text is a 510(k) summary for the MEGA-TMS device, which is an evoked response electrical stimulator used for diagnostic purposes. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study to establish acceptance criteria for an AI/CADe device's performance.

Therefore, I cannot extract the requested information regarding AI/CADe acceptance criteria or the study proving a device meets them. The document mentions performance testing, but this refers to safety, EMC, design verification, and risk management for the electrical stimulator, not an AI or CADe system.

The closest relevant information, though not directly applicable to an AI device's performance, is under "Electric and Magnetic Field Characteristics," where measurements and simulations were performed for electric and magnetic fields. However, this pertains to the physical and electrical characteristics of the stimulator itself, not the diagnostic performance of an AI.

To directly answer your request based on the provided text, the document does not contain the specific information you are looking for regarding acceptance criteria and a study proving an AI/CADe device meets those criteria.

Ask a specific question about this device