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The NEOTONUS Model 1000 Muscle Stimulator System is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

The Model 1000 Muscle Stimulator System consists of a stimulator control unit and a treatment chair. The stimulator control unit is used to generate a voltage signal that periodically charges an "E" shaped magnetic coil located beneath the seat of the treatment chair. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-cycle "Rest" period (0-60 sec).

During treatment, the patient sits on the treatment chair with the pelvic floor area centered over the magnetic coil. The magnetic field emitted by the coil induces an electric field in the target tissue that causes contraction of the pelvic floor musculature. The patient is treated fully clothed and there is no need for an invasive electrode probe. Treatment is suggested as up to 30 minutes per sessions separated by at least 2 days.

Here's an analysis of the provided text regarding the Neotonus Model 1000 Muscle Stimulator System, extracting the requested information:

Understanding the Device and its Context:

The Neotonus Model 1000 Muscle Stimulator System is a non-invasive device designed for the electromagnetic stimulation of pelvic floor muscles to treat urinary incontinence in women. The submission is a 510(k) premarket notification, meaning it seeks to demonstrate substantial equivalence to previously marketed devices, rather than proving novel efficacy.

Acceptance Criteria and Device Performance

The provided document describes a clinical evaluation to demonstrate substantial equivalence, not a study against pre-defined acceptance criteria in the traditional sense of a performance goal (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" here are implied by the desired outcome of the study: to show that the Model 1000 has a physiological effect at least equivalent or superior to existing electrical stimulators for the treatment of incontinence.

The study aims to show that the Model 1000 works similarly or better physiologically, and is preferred by patients, which would support its claim of substantial equivalence.

Table of "Acceptance Criteria" and Reported Performance (inferred):

Study Details:

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

   • Sample Size: Ten (10) females.
   • Data Provenance: Not explicitly stated, but clinical evaluations for 510(k)s are typically conducted in the country where the device is being submitted for regulatory approval (in this case, presumably the US). The study design (clinical evaluation comparing two devices) suggests it was a prospective study.

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

   • The study design focuses on physiological measurements (EMG activity, urethral pressure) and observable/palpable muscle contractions, along with patient preference. It does not describe a process where "experts" establish a ground truth in the sense of labeling data.
   • The "ground truth" here is the physiological response as measured by objective instruments and subjective patient feedback, reported by the study investigators. The qualifications of these investigators are not provided.

3. Adjudication method for the test set:

   • Not applicable. This study does not involve image interpretation or diagnostic labeling that would require an adjudication method like 2+1 or 3+1. The outcomes are physiological measurements and direct observation.

4. 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, an MRMC study was not done. This device is a muscle stimulator, not an AI-powered diagnostic tool requiring human reader interpretation of data.

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

   • This question is not applicable. The Model 1000 is a physical medical device, not an algorithm, and it directly delivers therapeutic stimulation. It doesn't perform "standalone" diagnostic tasks apart from human interaction.

6. The type of ground truth used:

   • The ground truth was based on physiological measurements (EMG activity of the urethral sphincter muscle, pressure in the urethra) and direct observation (visual and palpable muscle contractions). Patient preference (comfort) also served as a qualitative outcome. This is akin to physiologic response data.

7. The sample size for the training set:

   • This concept is not applicable to this submission. The Model 1000 is a hardware device, not an AI/ML algorithm that requires a "training set." The clinical evaluation served as empirical evidence for its performance and substantial equivalence.

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

   • This question is not applicable as there is no training set for a hardware device.

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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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