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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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BEMER therapy systems (BEMER Classic Set, BEMER Pro-Set) are indicated for:

• To temporarily increase local blood circulation in healthy leg muscles
• To stimulate healthy muscles in order to improve and facilitate muscle performance

BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission.

BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.

Acceptance Criteria and Device Performance:

The provided document is a 510(k) summary for the BEMER Classic Set and BEMER Pro-Set. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit acceptance criteria with specific performance metrics for the BEMER device itself.

However, the "Performance Testing" section states that "BEMER therapy systems are compliant with the following standards and have outputs that are within the same range as the predicate devices". This implies that the 'acceptance criteria' for the BEMER device's performance are that it meets these standards and operates within a comparable range to the predicate.

The "Technical and Performance Comparison" table (Table 12.1) details the comparison between the BEMER Therapy Systems (Subject Device) and the predicate device (Revitive IX, K143207) and a reference device (Neotonus MS-101 Magnetic Muscle Stimulator System, K973929).

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, direct acceptance criteria with specific numerical thresholds for increased blood circulation or improved muscle performance are not provided. Instead, the acceptance is based on demonstrating substantial equivalence by meeting regulatory standards and having comparable technical characteristics and functionality to the predicate device.

Study Information:

The document (510(k) summary) describes the basis for a Substantial Equivalence (SE) determination to a predicate device, rather than a de novo clinical trial with specific performance endpoints. The primary "study" proving the device meets the (implied) acceptance criteria is the comparative analysis to the predicate device and compliance with recognized standards.

Key points from the document regarding studies:

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

• The document mentions "clinical performance data" to support its safety and suitability for OTC use but does not provide details on the sample size of any specific clinical test set.
• It states that "safety and effectiveness must be proven via a comparative series of measurements" due to the different mode of action, but the details of these measurements (sample size, data provenance) are not included in this summary.
• The provenance of data for any comparative measurements or clinical studies is not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the 510(k) summary. The document does not describe a process where experts established ground truth for a test set in the context of typical diagnostic device evaluation (e.g., imaging studies). The evaluation appears to be based on engineering principles, compliance with standards, and comparison of technical specifications and intended use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• As there's no mention of a traditional "test set" and expert ground truth establishment for diagnostic performance, no adjudication method is described.

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:

• No MRMC study was described. The BEMER device is a physical medicine device (a powered muscle stimulator), not an AI-powered diagnostic tool, so such a study would not be applicable.

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

• This concept is not applicable to this type of medical device (physical stimulator).

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

• The "ground truth" for the device's claims (temporarily increase local blood circulation, stimulate healthy muscles) is primarily established through scientific literature on electromagnetic stimulation, engineering principles, and comparison to the predicate device's established efficacy and safety.
• The document implies that "clinical performance data" was used, and the "Usability study" serves as "performance data" for safe and effective use by lay and professional users based on their knowledge and instructions. The ground truth for usability would be the users' ability to correctly and safely operate the device as observed during the usability study.

8. The sample size for the training set:

• There's no mention of a "training set" as this is not an AI/machine learning device. The design and development would follow traditional medical device engineering processes.

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

• This concept is not applicable as there is no "training set."

Summary of the "study" proving acceptance:

The primary "proof" relies on demonstrating that the BEMER Therapy Systems are substantially equivalent to legally marketed predicate devices. This involves:

• Comparison of Indications for Use: Showing identical intended uses for the BEMER device and the predicate.
• Comparison of Technological Characteristics: Analyzing features like mode of action, waveform, pulse repetition rate, output parameters, and identifying any differences. For differences, the document provides comments on whether these differences impact safety and effectiveness (e.g., "Minor difference, no impact on safety and effectiveness").
• Compliance with Recognized Standards: Declaration of conformity to numerous IEC standards (e.g., IEC 60601-1 for safety, IEC 60601-1-2 for EMC) and ISO standards (e.g., ISO 10993-1 for biocompatibility). These standards inherently contain their own acceptance criteria for safety and performance under various conditions.
• Usability Study: A usability study was explicitly conducted and followed FDA's human factors guidance to ensure that intended users can operate the device safely and effectively. The results confirmed its suitability for Over-The-Counter (OTC) use.
• Clinical Performance Data (mentioned but not detailed): The document generally states that "Clinical performance data demonstrate that BEMER therapy Systems are as safe as the predicate device and it is suitable for Over-The-Counter (OTC)." However, the specifics of these clinical studies (methodology, sample size, endpoints, results) are not elaborated in this summary. It's possible these details were provided in other parts of the 510(k) submission, but not in this public summary.

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