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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.

• Stimulate healthy muscles to improve/facilitate muscle performance. | - Temporarily increase local blood circulation in healthy leg muscles.
• Stimulate healthy muscles to improve/facilitate muscle performance. | Same/Substantially Equivalent |
  | Mode of Action | Non-invasive tissue stimulation via skin electrodes. | Non-invasive tissue stimulation via magnetic field induction. | "Effectiveness: As the mode of action differs from direct induction (predicate device) to indirect induction (subject device), safety and effectiveness must be proven via a comparative series of measurements" |
  | Waveform | Pulsed symmetrical, constant amplitude during treatment. | Pulsed asymmetric, constant amplitude during treatment. | Minor difference, no impact on safety and effectiveness. |
  | Shape | Rectangular, bipolar. | Sinusoidal, monopolar. | Minor difference, no impact on safety and effectiveness. |
  | Pulse repetition rate | Foot: 20-53Hz; Body: 35-46Hz. | All accessories: 10-30Hz. | Minor difference, no impact on safety and effectiveness. |
  | Single pulse duration | Foot: 0.4 - 7.5µS; Body: 1.4 - 33.6µS. | All accessories: 10 - 33µS. | Minor difference, no impact on safety and effectiveness. |
  | Maximum Power density applied | Foot: 0.023 mA/cm2; Body: 0.082 mA/cm2. | All accessories: 35 - 100μT. | Minor difference, no impact on safety and effectiveness. |
  | Maximum output voltage | @500Ω: 20-32V; @2kΩ: 95-118V; @10kΩ: 138-169V. | N/A (Does not directly apply voltage). | "Safety: The subject device does not directly apply voltage to the human body. Therefore, no new hazards were identified." |
  | Maximum Output Current (directly applied) | @500Ω: 40-64mA; @2kΩ: 48-59mA; @10kΩ: 14-17mA. | All accessories:

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