(185 days)
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.
| Acceptance Criteria Category | Specific Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Non-Clinical Testing | ||
| Biocompatibility | Compliance with ISO 10993-1:2018 and FDA Guidance | Successfully completed |
| Electrical Safety | Compliance with IEC 60601-1: 2020 | Successfully completed |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2020 | Successfully completed |
| Nerve and Muscle Stimulator Specific Requirements | Compliance with IEC 60601-2-10:2016 | Successfully completed |
| Software Verification and Validation | Compliance with FDA Guidance for Software in Medical Devices | Successfully completed |
| Service Life Verification | Device meets expected service life parameters | Test completed successfully |
| Stimulation Coil Surface Temperature Rise | Temperature rise within acceptable limits | Test completed successfully |
| Maximum Magnetic Field Strength | Magnetic field strength within specified range | Test completed successfully |
| Cybersecurity | Device meets cybersecurity requirements | Test completed successfully |
| Clinical Data (Kegel Biofeedback Functionality) | ||
| Pelvic Floor Muscle Strength Measurement Comparison | Measurements by subject device are comparable to a reference device (K201014 MyOnyx System) and manual Oxford Grading Scale. | Pelvic floor muscle conditions evaluated by both the subject and the reference devices were found to be comparable to each other. |
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.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).