(100 days)
The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The Axon Therapy is for use on patients 18 and older.
The Axon Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. The subject device is intended to be used in clinics such as pain management clinics and physical therapy clinics. The device consists of Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. The Axon Therapy includes a thermal shutdown feature which is activated once the inside temperature of the stimulation coil either: (A) reaches 45°C or (B) exceeds 41°C for a total of nine minutes during a 20-minute session.
The provided document is a 510(k) summary for the Axon Therapy device, which is a magnetic stimulator system intended for pain relief. The submission seeks to establish substantial equivalence to a previously cleared device (K210021, also Axon Therapy by NeuraLace). This document does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical format of an AI/ML medical device submission.
Instead, it focuses on demonstrating substantial equivalence by highlighting that the subject device has identical design, dimensions, materials, intended use, and technological characteristics to the predicate device. The primary change is an expansion of the Indications for Use to include "chronic painful diabetic peripheral neuropathy in the lower extremities."
Therefore, the information regarding acceptance criteria, test set details, expert ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not present in this document. The document describes a clinical study done to support the expanded indication, which is different from a performance study for an AI/ML algorithm.
Here's a breakdown of what can be extracted and what is missing/not applicable based on the provided text, assuming the request is looking for AI/ML device study details:
Information Present or Inferable:
- 1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferable for Clinical Study): The primary efficacy objective for the clinical study was to compare the proportion of "responders" (>=50% reduction from baseline in neuropathic pain intensity as measured by an in-clinic visual analog score (VAS) for the primary area of pain at Day 30, with no increase over baseline pain medications within four weeks of the Day 30 visit) between the Axon Therapy plus CMM group and the Sham plus CMM group. While not a formal "acceptance criteria" table for AI/ML, this is the clinical endpoint criteria.
- Reported Device Performance:
- Axon Therapy group: -57.6% reduction in VAS pain scores.
- Sham group: -12.5% reduction in VAS pain scores.
- p-value:
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).