(14 days)
A non-implanted electrical stimulator for urinary incontinence is intended to retrain the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. Typically, these devices are indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence (a combination of stress and urge incontinence).
Intended for use in acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, strengthening of pelvic floor muscles, Inhibition of the detrusor muscle through reflexive mechanisms.
Non-implanted electrical stimulator for urinary incontinence
This document is an FDA 510(k) clearance letter and an "Indications for Use" statement for the Omnistim® Continence+ Pelvic Floor Stimulation System. Unfortunately, this type of regulatory document does not typically contain the detailed information required to answer your specific questions about acceptance criteria and the underlying study data.
Regulatory clearance for medical devices like this often relies on demonstrating "substantial equivalence" to a predicate device, rather than requiring new, extensive clinical trials that would generate the detailed performance metrics you've requested.
Therefore, I cannot provide the following information based on the text provided:
- A table of acceptance criteria and the reported device performance: This document specifies the intended use but not specific performance metrics or their acceptance criteria.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device (it's a physical stimulator, not an AI algorithm).
- The type of ground truth used: Not applicable or available.
- The sample size for the training set: Not applicable or available.
- How the ground truth for the training set was established: Not applicable or available.
What the document does tell us:
- Device Name: Omnistim® Continence+ Pelvic Floor Stimulation System
- Regulation Number: 21 CFR 876.5320
- Regulation Name: Non-implanted electrical continence device
- Regulatory Class: II
- Product Code: KPI
- Indications for Use: A non-implanted electrical stimulator for urinary incontinence, intended to retrain urinary continence mechanisms by electrical stimulation to pelvic floor musculature and surrounding structures. Indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence. It aims to improve urethral sphincter closure, strengthen pelvic floor muscles, and inhibit the detrusor muscle through reflexive mechanisms to improve urinary control.
- Approval Status: Received 510(k) clearance, deemed substantially equivalent to legally marketed predicate devices.
To get the type of detailed study information you're asking for, you would typically need to consult the full 510(k) submission summary (if available publicly, often redacted), peer-reviewed publications about the device, or clinical trial reports, which are not part of this FDA clearance letter.
§ 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).