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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: <0.00001 (indicating statistical significance)
    • Difference: -45.1% VAS pain reduction from Sham.
    • Additionally, QoL-DN and PGIC scales showed statistically significant improvements in quality of life outcomes.

• 2. Sample size used for the test set and the data provenance:

  • Sample Size (for Clinical Study): Not explicitly stated, but it's a clinical trial comparing two groups (Axon Therapy + CMM vs. Sham + CMM).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical trials are typically prospective.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • Ground Truth (for Clinical Study): This is based on patient-reported outcomes (Visual Analog Scale for pain, QoL-DN, and PGIC scales), which can be considered "outcomes data" indicating symptomatic relief.

• 8. The sample size for the training set:

  • Training Set (for AI/ML): Not applicable or not provided. This device is not described as an AI/ML device requiring a training set in the traditional sense. The "training" referred to in the document is likely the development and testing of the device hardware/software, not an AI model.

• 9. How the ground truth for the training set was established:

  • Ground Truth for Training Set (for AI/ML): Not applicable or not provided, as this is not an AI/ML device.

Information Missing or Not Applicable (for AI/ML Context):

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the clinical study is patient-reported outcomes, not expert labeling of images or data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to expert labeling, not patient-reported outcomes in a clinical trial.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or interpretative device; it's a therapeutic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for treatment, not an algorithm for diagnosis or image analysis.

In summary: The provided document is a 510(k) summary for a neuromodulation device, not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML device performance validation are not applicable or not present in this type of submission. The clinical study described focuses on validating the therapeutic effectiveness of the device for an expanded indication.

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