Search Results

ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) is indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) is a computerized, electromechanical medical device that generates and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.

The provided text is a 510(k) Summary for the ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System). It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics, rather than presenting a performance study against acceptance criteria for a new clinical claim.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

• It does not provide a table of acceptance criteria and reported device performance.
• It does not detail a specific study with a test set, sample size, data provenance, ground truth establishment, or expert involvement to prove clinical performance.
• It does not mention an MRMC comparative effectiveness study or a standalone algorithm performance.
• It does not provide details on training set size or how its ground truth was established.

The document indicates that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use, indications for use, and technological characteristics without raising new questions of safety or effectiveness. The modifications made (change in inter-train intervals) are primarily assessed through engineering and electrical safety testing (IEC 60601, IEC 61000, IEC 62366) and biocompatibility testing (ISO 10993-1), not through a clinical performance study with defined acceptance criteria for efficacy.

The document states:

• "The favorable results of the design verification and electrical safety testing of the ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) have demonstrated that the proposed device has met the predetermined design requirements and the FDA's recognized standards, including the electrical safety and performance standards and EMC standards as the predicate device."
• "Electrical safety and performance testing have been successfully carried out in accordance with IEC 60601, IEC 61000, and IEC 62366. Additionally, biocompatibility test also has been successfully fulfilled following ISO 10993-1."

This indicates that acceptance criteria would be related to these technical and safety standards, rather than clinical efficacy metrics.

Ask a specific question about this device