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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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