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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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The MyOnyx System is indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the pelvic floor muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence.

The MyOnyx System includes a palm-sized, multi-functional, 4-channel device with embedded firmware and accessories designed for use under medical supervision to provide:

• electromyographic (EMG) biofeedback;
• pressure biofeedback from pelvic floor muscles;
• electrical stimulation (ES); and
• ES with EMG biofeedback (EMG-triggered stimulation or ETS).
  Up to two stimulation programs may run simultaneously. The device can send a gentle, clinician-adjustable electrical current via surface electrodes on purpose-designed probes. The specified off-the-shelf probes are suitable for EMG biofeedback and electrical stimulation. A small electronic pneumatic pump and pressure sensor device is used with a vaginal provide biofeedback from pelvic floor muscles.
  The MyOnyx device may be used in one of the following operating modes:
• as a standalone device for electrical stimulation only (autonomous mode); or
• with the MyOnyx Mobile App running on an off-the-shelf tablet for biofeedback, electrical stimulation and EMG-triggered stimulation (remote control mode); or
• with the company's BioGraph® Infiniti software running on a personal computer for biofeedback only (computerized mode).
  The device is operated via a graphical interface on an LCD screen and a capacitive touch pad with haptic and audio feedback. The connection to a tablet or personal computer is wireless, via Bluetooth". Visual, audio and voice feedback and prompts are provided to facilitate device operation on the standalone device, the MyOnyx Mobile App and the BioGraph® Infiniti software.
  When used in remote control mode for biofeedback or EMG-triggered stimulation, the device can record on the tablet root-mean-square (RMS) EMG signal and pressure data at 20 samples/s. Stimulation data are not recorded.
  When used in computerized mode, up to 4 devices may be connected to a personal computer for physiological data acquisition and biofeedback. In this mode, the device can record on the PC raw EMG and pressure data at 2048 samples/s. For use in this mode with the BioGraph® Infiniti software the device must be configured through a firmware parameter setting ('extended' configuration).
  The device is powered by an internal rechargeable Li-ion polymer battery or via a medical grade power supply / battery charger. The internal battery offers up to 8 hours of autonomous device operation.

The provided document, a 510(k) summary for the MyOnyx System (K201014), primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about a clinical study involving human participants or a multi-reader multi-case (MRMC) comparative effectiveness study, which would typically involve human experts for ground truth and evaluation of AI assistance.

Therefore, many of the requested details, such as sample size for test and training sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, and MRMC study effect sizes, are not present in this document because the device clearance was based on non-clinical engineering and performance testing rather than a clinical efficacy trial.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document provides a table outlining acceptance criteria for various non-clinical tests. The "Reported Device Performance" is generally stated as "Conformity to applicable requirements" or meeting specific design specifications. While the table clearly lists the acceptance criteria, the detailed quantitative results of the tests themselves are not provided within this summary document, only the conclusion that they were met.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests conducted by the manufacturer, Thought Technology Ltd. These include electrical safety, electromagnetic compatibility (EMC), biocompatibility, hardware verification, usability, and software life-cycle processes, as detailed in the "Summary of Non-Clinical / Performance Testing" section on page 5.

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

• Sample Size: Not applicable in the context of human patient data for an AI/ML device, as this summary describes engineering and performance testing of the device hardware and software, not a clinical trial with patient data. The "sample size" here refers to the number of units or components tested. This information is not specified in this summary document.
• Data Provenance: Not applicable in the context of patient data. The tests are general engineering and performance tests of the device itself.

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

• Not applicable as this is a non-clinical submission. Ground truth, in the AI/ML context, usually refers to labeled data for diagnostic tasks established by human experts. Here, "ground truth" for the device's technical performance is the expected behavior and measurements based on engineering specifications and international standards (e.g., IEC standards).

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert labeling of clinical data, which is not relevant for this type of non-clinical device clearance. The "adjudication" for these tests would be the comparison of test results against predefined acceptance criteria.

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:

• No. The document makes no mention of an MRMC study or AI assistance. The device in question is a biofeedback and electrical stimulation system for incontinence, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable in the context of AI/ML algorithm performance. The "standalone" mode mentioned in the document (page 4) refers to the device's ability to operate for electrical stimulation only without being connected to a mobile app or computer. This is a functional description, not an AI/ML performance metric.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (e.g., ISO, IEC), and established medical device testing protocols. For example, for biocompatibility, the ground truth is "noncytotoxic, non-sensitizing, non-irritant" as defined by ISO standards. For electrical safety, the ground truth is "conformity to applicable basic safety and performance requirements" of IEC standards.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set of patient data. The "firmware development" mentioned (page 5) refers to traditional software engineering processes, not machine learning model training.

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

• Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for it.

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For EMG mode:

• Relaxation muscle training and muscle re-education

For NMES (also known as STIM) mode:

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

For TENS mode:

• Symptomatic relief and management of chronic (long-term), intractable pain
• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):

• Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
• Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)

For FES

• Helps to relearn voluntary motor functions of the extremities

The Medline DeNovo 4Pro Electrical Stimulation Device is a four-channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The proposed device is controlled by a MCU (Microcontroller Unit) that supports device functionality, display functionality. Bluetooth, and audio. The subject device is intended to be used for muscle stimulation for the purposes of urinary incontinence treatment, pain management, muscle strengthening and training, as well as muscle relaxation and re-education. The device is a TENS (Transcutaneous Electrical Nerve Stimulator), ETS (Electrical Muscle Stimulator) and NMES (Neuromuscular Electrical Stimulator also known as STIM) including FES (Functional Electrical Stimulation) with EMG biofeedback.

The Medline DeNovo 4Pro Electrical Stimulation Device features four channels for NMES (Neuromuscular Electrical Stimulator also known as STIM), with two that utilize Electromyography (EMG). Multiple stimulation protocols are pre-programed for three general categories of applications: muscle strengthening (i.e. biofeedback training), pain control, and neuromuscular re-education. Each category contains up to eight protocols to address the specific needs of the patient.

The Medline DeNovo 4Pro Electrical Stimulation Device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrodes applied on the skin or through a vaginal probe (for incontinence treatment protocols only). The parameters of the unit are controlled by the +/push buttons and touch screen (refer to Figure 1 and 2 below). The pre-programed protocols on the Medline DeNovo 4Pro Electrical Stimulation Device are all fully automatic and controlled by the device, and it is also capable of manual control in hand switch mode. The levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers. The device can be used with or without linkage to a PC and includes a color, pressure sensitive touch-screen. This unit also comes with a wireless charger that is capable of charging during NMES (Neuromuscular Electrical Stimulator also known as STIM) via inductive charging. Batteries will not need to be regularly replaced, and charging will be made so much easier. The proposed device also has Bluetooth capabilities that will allow the device to connect to a computer for screen mirror imaging.

The provided text is a 510(k) Summary for the Medline DeNovo 4Pro Electrical Stimulation Device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.

The document primarily focuses on non-clinical testing (functional performance, electrical safety, EMC, software verification/validation, usability) to demonstrate that the device itself functions as intended and safely, rather than a clinical study assessing its diagnostic or prognostic performance with a test set, ground truth, and expert readers, which would be typical for many AI/ML-driven medical devices.

Therefore, most of the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML or diagnostic/prognostic tasks cannot be extracted from this document because such a study is not described. The "Summary of Clinical Testing" explicitly states, "This section does not apply."

Here is a breakdown of what can be inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. The acceptance criteria implied are primarily related to safety, electrical performance, software functionality, and usability, as demonstrated by compliance with various IEC standards and internal verification/validation.
• Reported Device Performance: The document states that "The results of these tests demonstrate the overall safety of the subject device and ultimately support a substantial equivalence determination." This is a general statement of compliance, not a quantitative measure of performance against a specific clinical acceptance criterion.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable as no clinical test set or data provenance for a performance study is described. The "test set" and "data" here refer to testing the device's electrical, mechanical, and software functions, not a cohort of patient data for a clinical outcome.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as no clinical ground truth establishment process is described. The "ground truth" for the non-clinical tests would be the established engineering specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as no clinical test set requiring adjudication is described.

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:

• No, an MRMC comparative effectiveness study was not done. The device described is an electrical stimulation device, not an AI/ML-driven diagnostic or image analysis tool that would typically involve human readers.

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

• Not applicable for a medical device of this type (electrical stimulator). This concept typically applies to AI/ML algorithms independently making a diagnosis or classification.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical testing, the "ground truth" or reference was compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304) and the device's own design specifications. There is no clinical ground truth as defined for diagnostic studies.

8. The sample size for the training set:

• Not applicable as no AI/ML training set is described. The "training set" related to this device would be the engineering development and verification process, not a data set for model training.

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

• Not applicable as no AI/ML training set is described.

In summary, the provided document is a regulatory submission for a physical electrical stimulation device, not an AI/ML-driven medical device requiring the type of clinical performance study details you are asking for. The "study that proves the device meets the acceptance criteria" in this context refers to functional, electrical, software, and usability testing to ensure safety and performance of the device hardware and embedded software against engineering specifications and regulatory standards, not a clinical trial evaluating its diagnostic or treatment efficacy using patient data and expert interpretations.

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Everyway Incontinence Stimulation System is intended to provide 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 women and to maintain urinary continence in women.

The Everyway Incontinence Stimulation System is a dual channel powered muscle stimulator intended to provide 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 women and to maintain urinary continence in women.

The EV-805I stimulator is basically an Everyway's existing K071951-510(K) cleared model for power muscle stimulator. To make it delivery the same stimulation output as that of chosen predicate device, we made some change in software so as to generate muscle stimulation current that is discharged through the PR-02A, PR-04A, PR-14A Life-Care Vaginal Probe on the vaginal skin for the treatment of urinary incontinence.

The device is operated in such a way that turn on the intensity control knob and adjust the intended intensity or turn off the device during operation through the same control knob. While device is turned on for operation, the related LCD icons then illuminate for indicating the device is in operation condition. User then follow the instruction for use to get appropriate stimulation treatment for urinary incontinence.

With the combination of the main device parts as above mentioned , the device can be used as recommended in manual for the treatment of urinary incontinence for over-the-counter (OTC) use as that of the chosen 510(K) predicate device.

The Everyway Incontinence Stimulation System is an electrical muscle stimulator intended for the rehabilitation of weak pelvic floor muscles to treat stress, urge, and mixed urinary incontinence in women and maintain urinary continence.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold for a performance metric in the way it might for a diagnostic device (e.g., sensitivity of X, specificity of Y). Instead, the study's goal was to demonstrate substantial equivalence to a predicate device. This is primarily achieved through comparing technical characteristics and demonstrating comparable safety and effectiveness.

The table below outlines the comparison of key parameters between the proposed device and its predicate:

Reported Device Performance:
The document states that a "Usability Study was conducted for the Everyway Incontinence Stimulation System to support the device design and labeling for over-the-counter use of the device." Specific performance metrics from this usability study (e.g., success rates, time to task completion, error rates) are not provided in this summary. The conclusion is that "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."

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

The document mentions a "Usability Study" but does not specify the sample size used for the test set. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

The document mentions a "Usability Study" but does not describe the establishment of a "ground truth" in the context of expert review for a diagnostic or classification task, as the device is a therapeutic stimulation system. Therefore, no information is provided on the number or qualifications of experts for ground truth establishment.

4. Adjudication Method for the Test Set:

Given that the study described is a "Usability Study" for a therapeutic device and not a diagnostic efficacy study involving expert review for ground truth, an adjudication method for a test set (like 2+1 or 3+1) is not applicable and therefore not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on how human readers improve with AI vs. without AI assistance was not mentioned or performed. This type of study is typically relevant for diagnostic AI applications, not for an electrical stimulation system for incontinence.

6. Standalone (Algorithm Only) Performance:

The device is an electrical stimulation system, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance without human intervention is not applicable and not reported.

7. Type of Ground Truth Used:

For the usability study, the "ground truth" would likely relate to objective measures of user interaction, user feedback, and successful operation of the device according to instructions. However, the document does not explicitly state the type of ground truth used for the usability study. It is not pathology, expert consensus on images, or long-term outcomes data as might be seen for other device types.

8. Sample Size for the Training Set:

The document describes a "Usability Study," not an AI model. Therefore, there is no training set in the context of machine learning, and thus no sample size is applicable or reported for such a set.

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

As there is no training set for an AI model mentioned in the context of this device, the question of how its ground truth was established is not applicable.

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