(90 days)
The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.
The proposed Microgyn Plus is a battery-powered device that delivers a regulated stimulus to the nerves and muscles of the pelvic floor. The stimulus is administered by attaching an anatomically shaped probe to the device and then inserting the probe into the patient's vagina or anus. When stimulation is delivered the body responds by contracting the muscles of the pelvic floor. The Microgyn Plus provides balanced biphasic stimulation pulse. The pulse has a positive and negative phase such that the net charge applied to the patient is zero. The proposed Microgyn Plus is a current controlled device that provides an output that is adjustable from 0-60 milliamperes. The device also has the ability to select between three frequencies (10, 50, 100 Hz) depending on the frequency selected by the caregiver and the individual needs of the patient.
This submission is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to demonstrate substantial equivalence, rather than needing to meet specific acceptance criteria through a novel clinical study. Therefore, the information typically associated with acceptance criteria and a study proving a device meets them (like detailed performance metrics of a new device against predefined thresholds, large-scale clinical trial data with effect sizes, ground truth establishment for a test set, etc.) is not present in this document.
Instead, the "study" demonstrating the device meets the acceptance criteria is the comparison to the predicate device as outlined in the 510(k) submission. The "acceptance criteria" are implicitly met if the FDA determines the device is "substantially equivalent" in terms of safety and effectiveness to the predicate device.
Here's an analysis based on the provided text, addressing your points where possible, and indicating where information is not applicable due to the nature of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document because this is a 510(k) submission focused on demonstrating substantial equivalence to a predicate device, not on meeting specific, prospectively defined clinical performance acceptance criteria for a novel device. The "performance" is implicitly considered equivalent to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as there is no specific clinical "test set" and associated study described to demonstrate performance against predefined criteria. The submission relies on a comparison to a predicate device.
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)
This information is not provided as there is no specific clinical "test set" with ground truth established by experts described in this 510(k) notification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no specific clinical "test set" with expert adjudication described in this 510(k) notification.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more relevant for diagnostic devices involving human interpretation, especially when AI is used as an aid. The device here is a therapeutic stimulation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This device is a physical, battery-powered electrical stimulation device for rehabilitation, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no specific ground truth for a clinical study is described. The basis for safety and effectiveness is through demonstration of substantial equivalence to a predicate device.
8. The sample size for the training set
This information is not provided as the device is a physical medical device, not an AI/ML algorithm that would typically require a training set.
9. How the ground truth for the training set was established
This information is not provided as it's not applicable to the type of device and submission.
Summary of the "Study" and "Acceptance Criteria" for this 510(k) Submission:
- Acceptance Criteria (Implicit): The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device regarding intended use, technological characteristics, safety, and effectiveness. This implies that the new device should be as safe and effective as the predicate.
- The "Study" (Demonstration of Substantial Equivalence):
- Basis: Comparison to legally marketed predicate devices:
- Methodology:
- Intended Use Comparison: The proposed Microgyn Plus Stimulation Device has the same intended use as the predicate device: "to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women."
- Technological Characteristics Comparison:
- It is a battery-powered device delivering regulated stimulus to pelvic floor nerves and muscles.
- Administered via an anatomically shaped probe inserted vaginally or anally.
- Provides balanced biphasic stimulation pulse with net zero charge.
- It is a current-controlled device with adjustable output (0-60 mA).
- It has selectable frequencies (10, 50, 100 Hz).
- Key Difference and Justification: The only noted difference from the primary predicate (K963222) is that 10 Hz has been substituted for 20 Hz in selectable frequencies. The submission implicitly argues that this change does not raise new questions of safety or effectiveness, or that the device is still substantially equivalent despite this change.
- Conclusion: "Based upon the information presented within this pre-market notification it is concluded that the proposed Microgyn Plus Stimulation Device is safe and effective for its intended use and is substantially equivalent to the predicate device."
In essence, for a 510(k), the "study" is the analytical comparison provided by the submitter to the FDA, demonstrating that the new device is fundamentally the same as (or as safe and effective as) a device already on the market. Clinical performance data against predefined metrics is generally not required unless the differences from the predicate raise new safety or effectiveness concerns.
§ 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).