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STIM: Electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in adult women.
EMG: Relaxation muscle training and muscle re-education.
ETS: Treatment of stress, urge or mixed urinary incontinence by assessing EMG activity of the pelvic floor and strengthening pelvic floor muscles using electrical stimulation.
This device is intended to be used by adult women (aged above 22 years).

The NeuroTrac® MyoPlus Pro is a single-channel pelvic floor muscle stimulator (STIM) designed to assist patients with urinary incontinence to increase muscle control and overcome pelvic muscle dysfunction. It can also act as an electromyograph (EMG) and features an EMG-triggered stimulation (ETS) mode. The stimulation waveform is symmetrical, rectangular and biphasic. Stimulation is delivered using a vaginal probe. The vaginal probe included with the subject device was cleared under K122194. The subject device may either be operated directly by the prescribing physician, or by the patient as instructed by the physician.

I apologize, but the provided text from the FDA 510(k) Clearance Letter for the NeuroTrac® MyoPlus Pro (MYO120U) does not contain any information regarding the specific acceptance criteria for a study proving device performance, nor details about such a study itself.

The document primarily focuses on:

• The FDA's determination of substantial equivalence of the NeuroTrac® MyoPlus Pro to predicate devices.
• Regulatory information such as classification, product codes, general controls, and compliance requirements.
• Device description: its functions (STIM, EMG, ETS), and technical specifications.
• Comparison of technological characteristics with predicate devices.
• A list of nonclinical testing performed (Electrical Safety, EMC, Software V&V, Cybersecurity).

While it states, "All pre-determined acceptance criteria were met" under the "SUMMARY OF NONCLINICAL TESTING" section, this refers to the engineering and software testing listed (e.g., meeting IEC standards for electrical safety, validating software functionality, managing cybersecurity risks). It does not refer to a clinical performance study evaluating the device's effectiveness in treating urinary incontinence or muscle re-education against specific clinical performance metrics.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: This level of detail about clinical performance criteria and results is not present.
2. Sample size used for the test set and data provenance: No clinical test set details are provided.
3. Number of experts and their qualifications for ground truth: Not applicable as no clinical study for ground truth establishment is mentioned.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study details: No such study is mentioned.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm being evaluated in isolation.
7. Type of ground truth used: Not applicable for a clinical performance study. The "ground truth" implicitly for the engineering tests is compliance with specified standards.
8. Sample size for the training set: Not applicable as this document does not describe the development or validation of a machine learning model.
9. How ground truth for the training set was established: Not applicable.

To answer your request, clinical study reports with detailed performance results against pre-specified acceptance criteria would be necessary, which are not included in this 510(k) clearance letter. Manufacturers typically submit such reports as part of their 510(k) submission, but this public letter only summarizes the outcome and key points.

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