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MFG-05 is intended to provide entirely non-invasive electromagnetic stimulation of the 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.

Device Description

The MFG-05 is a non-invasive therapeutic device produces a magnetic field that interacts with the tissues of the human body. By stimulation of the pelvic floor musculature, the MFG-05 helps to treat of male and female urinary incontinence. The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels. One applicator is available for therapy and is positioned centrally under the pelvic floor of the patient while the patient is wearing sport pants or any other pants without metallic parts. The device is for prescription use and used by a trained medical professional in a professional healthcare facility. The main body of MFG-05 is used to control the function of magnetic stimulation. It is operated with parameters such as frequency, time and intensity. These parameters can be controlled by the user on screen display and with the help of a rotary knob at the user control panel.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Expected Outcome)	Reported Device Performance (MFG-05)
Voluntary Standards Compliance	Compliance with various IEC/ISO standards for medical electrical equipment, usability, software lifecycle, and risk management.	The MFG-05 was investigated, tested, and complies with the following voluntary standards: ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text), IEC 60601-1-2 Edition 4.1 2020-09, IEC 60601-1-6 Edition 3.1 2013-10, IEC 60601-2-10 Edition 2.1 2016-04, IEC 62366-1 Edition 1.0 2015-02, IEC 62304 Edition 1.1 2015-06, ISO 14971 Third Edition 2019-12.
Performance Testing (Magnetic Field)	Applicator operates within magnetic field intensity specifications (0.5 - 1.5 T +/-20%).	Magnetic field testing confirmed that the applicator operates within the magnetic field intensity specifications (0.5 - 1.5 T +/-20%).
Performance Testing (Tissue Heating)	The tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient.	SAR analysis and Tissue Heating study confirmed that the tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient.
General Performance (Components & Subassemblies)	All components, subassemblies, and/or full devices and systems meet required specifications for completed tests.	Testing has been performed, and all components, subassemblies, and/or full devices and systems have met the required specifications for the completed tests.
Safety and Effectiveness	The device is as safe and effective as the predicate device (HPM-6000UF). Differences in technological characteristics do not raise new questions of safety or effectiveness.	The performance testing provided supports that the MFG-05 is as safe and effective as the predicate device, demonstrating substantial equivalence.

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

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing described is primarily device performance testing (e.g., electromagnetic compatibility, electrical safety, magnetic field intensity measurement, tissue heating simulation), not clinical studies involving patient data.

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

This information is not applicable or provided in the context of this regulatory submission. The document focuses on technical performance and compliance with recognized standards rather than expert-derived ground truth from clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The testing described is against technical specifications and standards, not a review of clinical cases requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned. The device, MFG-05, is a therapeutic device for muscle stimulation, not an imaging or diagnostic device that typically involves human readers or AI assistance in interpretation. The document compares the device to a predicate based on technical characteristics and performance standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable to the MFG-05. The device is a physical therapeutic device, not an AI algorithm. Its performance is evaluated through physical and electrical testing.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing is based on:

Compliance with established voluntary standards: These standards define acceptable limits and testing methodologies for medical devices.
Engineering specifications and design requirements: The device's performance (e.g., magnetic field intensity, temperature rise) is compared against its own design specifications.
Comparison to predicate device's established performance: The safety and effectiveness are established by demonstrating that the MFG-05 performs comparably or within acceptable deviations from the legally marketed predicate device (HPM-6000UF).

8. The Sample Size for the Training Set

This information is not applicable as the MFG-05 is a physical medical device, not a machine learning or AI model that requires a training set.

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

This information is not applicable for the same reason as above.

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