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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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Powered Muscle Stimulator (Model name:MagGraver F200) is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
  · Strengthening, Toning and Firming of buttocks.

Powered Muscle Stimulator (Model name:MagGraver F200) is a non-invasive therapeutic device. The device produces electromagnetic field that stimulates the tissues of the human body, the device helps to strengthen, tone, and firm the abdomen and buttocks by stimulating muscle.
The device has two output channels and two applicators, one applicator (Form A) is applicable for abdomen and another (Form B) is applicable for buttocks. The applicator can plug in either output channels. The two outputs of device enable simultaneous treatment by two applicators.
The Form A applicator consists of round coil and cooling system. The Form B applicator consists of figure-of-eight coil and cooling system.
There is a pressure kit is used to monitor abdomen muscle contraction by monitor the pressure between applicator and abdomen, the pressure kit is only used with Form A applicator.
The device is equipped with a color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The screen angle can be adjusted.

I'm sorry, but this document does not contain the information required to fulfill your request. The document is an FDA 510(k) clearance letter and summary for a Powered Muscle Stimulator (MagGraver F200). While it addresses device safety and effectiveness in comparison to a predicate device, it does not describe:

1. Acceptance criteria for an AI/algorithm-based device and reported performance against those criteria. This device is a physical electromedical device, not an AI/algorithm-based diagnostic or therapeutic tool.
2. Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are relevant to the validation of AI/ML models, which is not the subject of this document.
3. Ground truth establishment or training set details. Again, these relate to AI/ML model development and validation.

The primary performance data presented relates to non-clinical bench testing of the magnetic field intensity and pulse characteristics, and compliance with general medical device standards (e.g., IEC 60601-1 for safety). There is no mention of a performance study proving the device meets acceptance criteria related to AI/ML.

Therefore, I cannot extract the requested information from the provided text.

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