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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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The MagVita TMS Therapy - w/MagPro R20 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The MagVita TMS Therapy w/MagPro R20 is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex. The MagVita TMS Therapy w/MagPro R20 is indicated for Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons.

In the MagVita TMS therapy w/MagPro R20 TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be as effective as the predicate device in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10Hz) repetitive transcranial magnetic stimulation has been shown to persist beyond the duration of the train of stimulation. Repetitive Magnetic stimulation with the Mag Vita TMS therapy w/MagPro R20 is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).

The MagVita TMS Therapy w/MagPro R20 is an integrated system consisting of the following components:

• . MagPro Stimulator and Trolley
  • MagPro R20 o
  • Trolley with holding arrangements o
• Coils for MT determination and Depression Treatment .
  • o Coil MCF-B65
  • Marking apparatus for locating treatment area
    • Marking plate for Coil MCF-B65 o
    • Pen for marking, Cap, Ruler o
• Patient head fixation

.

• Treatment Chair o
• Vacuum Pump and Vacuum pillow o
• Super Flexible Arm mounted on the trolley o
• . Isolation Transformer

This document is a 510(k) Summary for the MagVita TMS Therapy w/MagPro R20 device, comparing it to a predicate device, the MagVita TMS Therapy System (K150641).

Based on the provided text, there is no acceptance criteria or study outlined to prove the device meets acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device. This means the manufacturer is asserting the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Therefore, many of the requested details about acceptance criteria and a specific study proving it are not present in this type of FDA submission. Here's what can be inferred or explicitly stated based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there are no explicit "acceptance criteria" presented in the document in the format of a performance study with defined thresholds. The document instead presents a comparison of the new device's performance characteristics to those of the predicate device to demonstrate substantial equivalence.

Implicit Acceptance Criteria: The device is "accepted" if it is shown to be substantially equivalent to the predicate device, meaning its differences do not raise new questions of safety or effectiveness. The document asserts that "all other identified differences between the two systems are minor and without any known impact on safety or efficacy."

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a clinical study with a "test set" in the context of diagnostic accuracy, image interpretation, or treatment efficacy data from the new device. The data presented is a technical comparison of device specifications.

The "non-clinical performance data" section refers to previous FDA clearances for components (K160280 for MagPro R20, K150641 for chair/arm/etc., K071821 for Coil MCF-B65). This indicates that the safety and performance of individual components were evaluated and cleared through separate processes, but it does not represent a specific "test set" for the entire integrated system in a clinical performance study.

Data Provenance: The technical specifications are derived from the device's design and engineering. Any clinical data implicitly relied upon would be from trials that supported the original predicate device's clearance and the understanding of rTMS efficacy for Major Depressive Disorder, not new data for this specific 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is not a study requiring expert-established ground truth. The comparison is based on technical specifications and functional equivalence.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" or adjudication process described for diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not present an MRMC comparative effectiveness study. The submission is for substantial equivalence based on technical and functional comparison to a predicate device. The device is a therapeutic electromagnetic stimulator, not an imaging or diagnostic device typically subject to MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The device is a therapeutic system with human interaction. While it includes software, it is not an "algorithm only" device in the sense of AI for diagnostic interpretation.

7. The Type of Ground Truth Used

Not applicable in the context of a "ground truth" for a diagnostic or AI performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the existing predicate device and the recognized scientific understanding of repetitive transcranial magnetic stimulation (rTMS) for Major Depressive Disorder as supported by clinical evidence for that class of devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm that undergoes a training phase with a labeled dataset in the typical sense. It is a hardware and software system for delivering a physical therapy.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as point 8.

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