Search Results

The INNOVO® is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.

The INNOVO® is a powered transcutaneous electrical continence device intended for the treatment of stress urinary incontinence. The device is provided with an internally wired garment which locates eight conductive electrodes around the pelvic area. An electronic controller, which is attached to the garment using a leadwire, delivers an amplitude modulated symmetric biphasic stimulation current to the electrode array to evoke timed muscle contractions in the pelvic floor muscles. A neck strap clips to the unit to allow it to be worn around the neck. The neck strap contains a safety clip which pops open if there is a forceful pull on the neck strap The current amplitude is adjusted by the patient using a push-button intensity control. A treatment lasts for 30 minutes and is self-administered by the patient at home. The electronic controller operates from rechargeable batteries and a mechanical interlock is provided to prevent simultaneous connection to the patient and the charger. The INNOVO® is supplied with a non-sterile, electrically conductive, electrolyte spray.

The provided text describes a 510(k) summary for the INNOVO® device intended for treating urinary incontinence. While it details non-clinical performance testing and general acceptance criteria like compliance with electrical safety and EMC standards, it does not contain information about a study proving the device meets specific performance acceptance criteria for its effectiveness in treating urinary incontinence.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, adherence to safety standards (e.g., IEC 60601 series, ISO 14971, ISO 10993), and usability testing for over-the-counter use.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This document does not present quantitative performance metrics for treating urinary incontinence for the INNOVO® device.
2. Sample size used for the test set and the data provenance: No clinical test set data for performance is presented. The usability study involved 15 subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study (e.g., diagnostic accuracy for an AI/CAD system) is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is a medical device for treatment, not an AI/CAD diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described for device efficacy. Usability testing ground truth was expert observation.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

The "Summary of Non-Clinical Performance Testing" in section VII details testing against various electrical safety, usability, and biological compatibility standards. For example, usability testing involved 15 subjects to assess suitability for safe over-the-counter use, and its findings relate to users understanding instructions and applying treatment safely. However, this is not a clinical study proving the treatment efficacy of the device for urinary incontinence.

The document states: "Performance testing has demonstrated that the INNOVO® is substantially equivalent to the predicate INNOVO®." This implies that the effectiveness is established by comparison to a previously cleared device, not necessarily by new clinical efficacy data for this specific submission, especially when the changes are primarily related to making it available as an Over-The-Counter device (which required Human Factors testing).

Ask a specific question about this device