(63 days)
The InnoSense System is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflexive mechanisms. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.
The InnoSense Pelvic Floor Stimulation and Electromyography (EMG) System is comprised of a external stimulator/electromyography reader, leadwires (for surface EMG only) and electrodes. The device has a one channel stimulation function and a two channel EMG function. It is battery powered by two 1.5 volt (AA) batteries, with a low battery indication shown on the LCD Panel. The electrodes used to stimulate the pelvic floor muscles consist of either a vaginal or rectal electrode. The EMG function uses two electrodes consisting at the most one Vaginal or Rectal electrode and/or one or two surface EMG electrodes. One electrode is used to sense pelvic floor muscle activity and one is to sense accessory muscle activity such as the abdominal or gluteal muscles.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a table of acceptance criteria or reported device performance metrics. It primarily focuses on the device description, regulatory classification, and a 510(k) clearance letter confirming substantial equivalence to predicate devices. There are no quantitative performance measurements or thresholds presented.
2. Sample size used for the test set and the data provenance
The document does not describe any clinical test set or data provenance for evaluating the device's performance against specific criteria. The 510(k) clearance is based on substantial equivalence to predicate devices, implying that the safety and effectiveness are inferred from the established performance of those existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no specific test set or clinical study is mentioned, there's no information regarding experts or ground truth establishment for a test set.
4. Adjudication method for the test set
Similarly, since no test set is described, there's no information on adjudication methods.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it describe any AI component in the device. The InnoSense system is a physical device for pelvic floor stimulation and electromyography, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The InnoSense system is a physical device used by individuals for therapy and biofeedback, often under guidance. It is not an algorithm-only device, so a standalone performance study in that context would not be applicable or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a specific type of ground truth used for evaluating the InnoSense device. The 510(k) process relies on demonstrating substantial equivalence to legally marketed predicate devices rather than independent verification of the device's efficacy through a new clinical dataset with established ground truth.
8. The sample size for the training set
The document does not mention a training set sample size. There's no indication of any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
As no training set is mentioned as applicable to this device, there's no information on how ground truth for a training set was established.
In summary, the provided document is a 510(k) premarket notification for a medical device (InnoSense Pelvic Floor Stimulation and Electromyography System). It focuses on regulatory approval based on demonstrating substantial equivalence to existing predicate devices. It does not contain details about specific clinical studies with acceptance criteria, test sets, expert-driven ground truth, or AI performance metrics that would typically be found in direct performance evaluations of new or AI-powered technologies.
§ 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).