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The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Neotonus MS-101 is indicated for use in stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of call muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

The MS-101 Magnetic Muscle Stimulator System consists of a stimulator Control Unit and a Treatment Wand. The Control Unit is used to generate a voltage signal that periodically charges a "C" shaped magnetic coil which is held against the patient's skin nearest the muscle group to be stimulated. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-duty "Rest" period (0-60 sec).

Here's a breakdown of the acceptance criteria and study details for the Neotonus MS-101 Magnetic Muscle Stimulator System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implicit Criteria: The 510(k) summary doesn't explicitly list "acceptance criteria" in the way one might see for a diagnostic device (e.g., specific sensitivity/specificity targets). Instead, the established "acceptance criteria" are implied by the nature of a substantial equivalence claim: that the new device (MS-101) performs in a physiologically comparable manner to a legally marketed predicate device (RICH-MAR Theratouch electrical muscle stimulator) for its intended use. The study directly addresses this by demonstrating similar physiological responses.

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

• Sample Size: Nine healthy volunteers.
• Data Provenance: The document does not specify the country of origin of the data. It was a prospective study, as it involved stimulating volunteers and observing their responses.

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

• Number of Experts: Not applicable in the context of this study. This study was a physiological comparison, not one that relied on expert interpretation for ground truth. The "ground truth" was the observed physiological responses (muscle torque, fatigue, etc.) themselves, measured directly from the volunteers.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study involved direct physiological measurements and comparisons, not subjective interpretations requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: N/A, as this type of study was not conducted. This device is a therapeutic stimulator, not an AI-based diagnostic tool for human readers.

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

• Standalone Performance: Not applicable in the traditional sense of an algorithm. The MS-101 is a physical medical device. The study evaluated the device's physiological effects directly, without a human-in-the-loop scenario as might be seen with an AI diagnostic. The closest analogy would be that the "standalone" performance was the direct measurement of its effect on muscle responses in volunteers.

7. The Type of Ground Truth Used

• Type of Ground Truth: Physiological measurements and observations. These included:
  • Skeletal muscle responses.
  • Relationships between stimulus amplitude and muscle torque.
  • Relationships between stimulus frequency and muscle torque.
  • Muscle fatigue and one-half relaxation time with repeat contractions.
    The "ground truth" was established by directly measuring these effects in the human subjects.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Research studies for 510(k) submissions of this nature typically don't involve a separate "training set" for an algorithm. This study was a direct comparison of physiological effects. If any preliminary work or predicate device data informed the design or parameters of the MS-101, it's not detailed here, but it wouldn't be referred to as a "training set" in the context of an AI/ML algorithm.

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

• Ground Truth for Training Set: Not applicable as there was no explicit "training set" or AI/ML algorithm involved.

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