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Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) 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 male and female urinary incontinence.

The Pelvic Floor Muscle Stimulator (model: MagBelle AF180) is a non-invasive therapeutic device which produces electromagnetic field that interacts with the tissues in the pelvic region of the human body. The electromagnetic field delivered in the muscular tissue area triggers the muscle stimulation. MagBelle AF180 consists of the main unit and the chair applicator. The MagBelle AF180 is equipped with a color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters can also be set using the touch screen, buttons and knob on the device. During the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The subject device should only be used under the continued supervision or licensed practitioner. The device supports 3 different function modes: Magnetic stimulation function, Kegel biofeedback training function and Triggering magnetic stimulation function of Magnetic stimulation function and Kegel biofeedback training function).

The provided text describes a 510(k) premarket notification for a "Pelvic Floor Muscle Stimulator" (MagBelle AF180). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through a comprehensive clinical study with extensive statistical analysis of acceptance criteria. Therefore, the details requested in the prompt, such as specific acceptance criteria and detailed study outcomes with statistical measures, are not fully elaborated in the provided document in the typical format of a standalone clinical trial report.

However, based on the information provided, here's a summary of the available details regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All pre-determined acceptance criteria were met" for non-clinical testing. For the clinical data, the acceptance criterion was implicitly that the subject device's pelvic floor muscle strength measurements were "comparable" to a reference device. Specific quantitative criteria and detailed performance metrics are not provided in this regulatory summary.

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

• Sample Size for Kegel Biofeedback functionality test: 100 urinary incontinence patients (male and female, age range: 22-70).
• Data Provenance: The study was conducted "in a hospital set-up," implying a prospective study. The country of origin of the data is not explicitly stated but is likely China, given the submitter's location.

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

• Number of Experts: At least one clinician was involved in manually testing pelvic floor muscle strength using the modified Oxford Grading Scale. The document doesn't specify the number of additional clinicians or their specific qualifications (e.g., years of experience, specialty beyond "clinician").

4. Adjudication Method for the Test Set

• The document implies a comparison method where the subject device's measurements were calibrated and compared against manual assessment by a clinician and a reference device. It does not describe a formal expert adjudication method like "2+1" or "3+1." The clinician's manual assessment appears to serve as a form of ground truth or benchmark activity.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or described. This device is a therapeutic device, not an AI diagnostic algorithm that assists human readers.

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

• The device itself is a standalone therapeutic device with a "Kegel Biofeedback functionality." The study assessed the performance of this functionality in measuring pelvic floor muscle strength, comparing its output to manual assessment and a reference device. This qualifies as evaluating a standalone function of the device.

7. The Type of Ground Truth Used

• For the Kegel Biofeedback functionality, the ground truth was established by:
  • Expert Clinical Assessment: Manual testing of pelvic floor muscle strength by a clinician using the modified Oxford Grading Scale.
  • Comparison to a Reference Device: Measurements from the subject device were compared to those from the legally marketed reference device, K201014 (MyOnyx System).

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of the clinical data presented. The 100 patients were used for verification and calibration of the Kegel biofeedback mode, which might imply a form of internal "training" or adjustment during development, but it's not described as a distinct training set for an AI/algorithm in the traditional sense. The focus here is on device function verification.

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

• As a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. However, for the verification of the Kegel biofeedback mode, the calibration and comparison process involved manual assessment by a clinician and comparison with a reference device.

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The MyOnyx System is intended for use as a powered muscle stimulation device for relaxation of muscle spasms and muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

The MyOnyx System may also be used for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET) for the symptomatic relief of acute and chronic intractable pain.

The MyOnyx System is a multi-functional, palm-sized, 4-channel device with embedded firmware and accessories designed for use in physical therapy and rehabilitation under medical supervision. The system that is subject to this 510(k) provides pre-loaded programs and allows users to define programs for electrical muscle stimulation (EMS), transcutaneous electrical nerve stimulation (TENS), and microcurrent stimulation (MET).

Biofeedback and incontinence-related indications for use of the device have been cleared under K201014.

The device can send a gentle, clinician-adjustable electrical current to underlying nerves and muscles via off-the-shelf surface electrodes cleared by the FDA for this purpose. EMG signals may also be acquired using off-the-shelf, FDA-cleared surface EMG electrodes.

The device may be used for muscle and nerve stimulation in one of the following operating modes:

• . As a standalone device (autonomous mode); or
• . With the MyOnyx Mobile App running on an off-the-shelf tablet (remote control 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 is wireless, via Bluetooth®. Visual, audio and voice feedback and prompts are provided to facilitate device operation.

Stimulation data are not recorded. When used in remote control mode, the device can record on the tablet root-mean-square (RMS) EMG signal data at 20 samples/s.

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 MyOnyx System is a multi-functional, palm-sized, 4-channel device with embedded firmware and accessories designed for use in physical therapy and rehabilitation. It is intended for use as a powered muscle stimulation device and for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET).

Here's an overview of the acceptance criteria and the study performance for the MyOnyx System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provided details of verification and validation testing of system specifications, basic safety, and essential performance, conforming to recognized consensus standards.

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

The document does not specify a distinct "test set" in the context of clinical or performance data for AI/ML algorithms. The performance data section refers to "verification and validation testing of system specifications, basic safety and essential performance" conducted in conformance with recognized consensus standards. These are typically engineering and bench tests, not evaluations involving human subjects or clinical data in the way a diagnostic AI might be.

The provenance of data for these non-clinical tests would typically be from the manufacturer's internal testing labs. The document does not provide details on country of origin for any data or whether it was retrospective or prospective, as these are not relevant for the type of testing described (which is not a clinical study on diagnostic accuracy).

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

This information is not applicable to the provided document. The evaluation of the MyOnyx System primarily focused on engineering and performance standards (e.g., electrical safety, EMC, software reliability, usability) rather than clinical accuracy or diagnostic capabilities requiring expert-established ground truth. No experts for ground truth establishment are mentioned.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in clinical studies or studies evaluating the accuracy of AI algorithms against a reference standard with human expert disagreement. The tests described are engineering validations against predefined specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence for this device type. The clinical literature supports the safety and clinical utility of the stimulation modes for the stated indications for use." Therefore, an MRMC comparative effectiveness study was not conducted or reported.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, in essence, the majority of the reported "Performance Data" represents a standalone evaluation of the device's technical specifications and compliance with standards. The tests such as "Electrical safety," "EMC," "Basic safety and essential performance of nerve and muscle stimulators," "Verification of hardware device controls and interfaces," "Software life-cycle processes," and "Stimulation firmware unit testing" are all evaluations of the device's inherent performance as an algorithm-driven system or hardware.

The usability testing (IEC 60601-1-6 / IEC 62366-1) involves human interaction but evaluates the device's interface and the safety of that interaction, not the diagnostic or therapeutic performance in a "human-in-the-loop" clinical decision-making context with an AI.

7. The Type of Ground Truth Used

For the engineering and performance tests, the "ground truth" is defined by the technical specifications outlined in the relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2) and the internal hardware and software design specifications of the MyOnyx System. The device's outputs and functionalities are measured and compared against these established technical criteria and limits.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of AI/ML or a clinical study. The device contains "embedded firmware" and "pre-loaded programs," which implies pre-determined algorithms and settings rather than adaptive AI models that undergo continuous training with a dataset.

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

This information is not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided document. The device uses pre-programmed logic for its stimulation modes.

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