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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:

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The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and postsurgical pain for 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 text describes the 510(k) premarket notification for Axon Therapy by NeuraLace Medical, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel acceptance criteria in the traditional sense of a clinical trial for a new drug or high-risk device. Therefore, the "acceptance criteria" here largely refer to meeting the requirements for substantial equivalence to a legally marketed predicate device, primarily through non-clinical and clinical testing designed to show that the new device is as safe and effective as the predicate.

Given this context, I will interpret "acceptance criteria" as the performance and safety benchmarks established by the predicate device and the relevant FDA standards, which the Axon Therapy must meet or surpass. The "study that proves the device meets the acceptance criteria" refers to the set of tests and clinical data provided to demonstrate this substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implicitly defined by the characteristics of the predicate device (Shenzhen Roundwhale Technology Co., Ltd. R-C1 TENS and EMS Stimulator; K181688) and other reference devices, along with relevant industry standards (IEC, etc.). The reported device performance demonstrates how the Axon Therapy aligns with or improves upon these.

Table of (Implicit) Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Clinical Studies:
     • Total subjects: n=105.
     • Subgroup 1: 25 subjects.
     • Subgroup 2: 80 subjects (105 - 25).
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It states "NeuraLace conducted multiple clinical studies," implying prospective studies conducted by the company.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This information is not explicitly provided. For a pain relief device, "ground truth" is typically subjective patient-reported pain scores (NRS/MVAS) rather than readings established by experts.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned, as the primary outcome (pain scores) is patient-reported.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. The clinical studies focused on the effectiveness and safety of the device itself (with or without a human in the loop, but the device is user-applied in a clinical setting). It was not a comparative study of human readers assisted by AI vs. unassisted human readers.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is generally relevant for AI/software-based diagnostic devices. For a physical medical device like Axon Therapy, a "standalone algorithm" is not applicable in the same way. The device functions to stimulate nerves, and its performance is measured by its physical output (magnetic pulses) and clinical outcomes (pain relief), not by an algorithm making a diagnosis or interpretation. The software validation mentioned (IEC 62304) ensures the software controlling the device operates correctly, which is part of the integrated device performance.

6. The Type of Ground Truth Used:

   • Clinical Efficacy: Patient-reported outcome measures (PROMs) using the Numeric Rating Scale (NRS) or Mechanical Visual Analog Scale (MVAS) for pain. This is a subjective patient outcome as ground truth for pain relief.
   • Safety: Occurrence of adverse events, evaluated by clinicians and reported.
   • Technical Performance: Quantitative measurements from performance testing (e.g., magnetic field characteristics, stimulation protocol accuracy, temperature). Compliance with electrical safety, EMC, and usability standards are also part of the "ground truth" for device safety and functionality.

7. The Sample Size for the Training Set:

   • This document describes a premarket notification for a physical medical device, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The term "training set" is not applicable here. The clinical studies described (n=105 total subjects) are the testing/validation set for the device's clinical performance and safety.

8. How the Ground Truth for the Training Set was Established:

   • See point 7; "training set" in the AI/ML sense is not relevant. The device's "training" refers to its design, engineering, and manufacturing process, optimized through non-clinical and preclinical testing to ensure it meets its intended function prior to clinical evaluation.

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