(90 days)
Indications For Use:
-
- Urinary Incontinence : Stress, Urge and Mixed Incontinence
-
- Neuromuscular Reeducation
-
- Fecal Incontinence (EMG use only)
The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are EMG OR Stimulation perineometer sensors used to monitor OR stimulate the pelvic floor muscles for the treatment of incontinence. This sensor is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles. This sensor is connected to a stimulator device to provide stimulation to the patient. This assists the patient with muscle contractions.
The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are single-user plastic sensors with stainless steel electrode contacts. The patient inserts the sensor into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The patient can instead use a stimulator to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.
Here's a summary of the acceptance criteria and the studies performed for the Pathway Vaginal EMG/Stimulation Perineometer Sensor and Pathway Anal EMG/Stimulation Perineometer Sensor, based on the provided text:
Acceptance Criteria and Device Performance
The device aims to accurately measure EMG signals and provide stimulation for pelvic floor muscles, performing similarly to predicate devices. The acceptance criteria used are based on demonstrating equivalence rather than specific performance metrics for novel technology.
| Acceptance Criteria / Feature (from summary of technical characteristics comparison to predicate device) | Reported Device Performance |
|---|---|
| Accurately measures EMG signals (Non-Clinical) | "accurately measure EMG signals" |
| Performs similarly to predicate device (Non-Clinical) | "perform similarly to the predicate device" |
| Readings obtained generally within 2% of predicate device (Non-Clinical) | "readings obtained using ... were generally within 2% of the readings obtained using the predicate device." |
| Accurately monitors and provides stimulation to pelvic floor muscles (Clinical) | "accurately monitor and provide stimulation to the pelvic floor muscles." |
| Performs similarly to predicate device (Clinical) | "perform similarly to the predicate device." |
| Biocompatibility (Safety of materials) | Found to be safe under required standards. |
| - Skin Sensitization (Kligman Maximization Test) | 0% Sensitization; Weak allergenic potential |
| - Systemic Injection Test | Negative; No significant biological reaction |
| - L929 MEM Elution Test | Non-cytotoxic |
| - Pyrogen Test (Material Mediated) | Non-pyrogenic |
| - Primary Vaginal Test - Repeated Exposure | Minimal irritant |
| - Rectal Irritation Test - Repeated Exposure | Non-irritant |
Detailed Study Information:
The document describes both non-clinical (bench) and clinical performance testing, along with biocompatibility testing. The studies focus on demonstrating substantial equivalence to existing predicate devices.
2. Sample size used for the test set and the data provenance:
- Non-Clinical Performance Data (Bench Tests): Not explicitly stated. The tests involved measuring known input signals and comparing them to predicate device readings.
- Clinical Performance Data: "A test subject" was used. This indicates a very small sample size, likely N=1.
- Data Provenance: Not explicitly stated but implied to be internal testing by The Prometheus Group (US company). The data would be prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No external experts are mentioned for establishing ground truth in the performance studies.
- For the non-clinical tests, the "ground truth" was a "known input signal."
- For the clinical tests, the "ground truth" was likely inferred from the pressure perineometer sensor used in an alternate placement, and visual/qualitative assessment of muscle contractions, all relative to the predicate device, rather than an expert medical diagnosis.
4. Adjudication method for the test set:
- No formal adjudication method (like 2+1, 3+1) is mentioned. The comparison seems to be direct against known inputs (bench tests) or direct comparison against the predicate device's performance (clinical tests).
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 MRMC comparative effectiveness study was done.
- This device is a perineometer sensor for EMG and stimulation, not an AI or imaging diagnostic device where human reader performance with/without AI assistance would be a relevant metric. The focus is on the sensor's ability to accurately measure and stimulate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone sensor that measures EMG signals and provides stimulation. Its performance was evaluated without explicit human interpretation in the loop for the performance metrics shown, though a human would be using the device. The non-clinical tests directly assess the sensor's measurement capabilities.
7. The type of ground truth used:
- Non-Clinical Performance Data: "Known input signal."
- Clinical Performance Data: Comparison to the predicate device, and monitoring of resulting contractions using a pressure perineometer sensor. This acts as a comparative measurement, rather than an independent "gold standard" ground truth like pathology for a diagnostic device.
8. The sample size for the training set:
- Not applicable. This device is a sensor and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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).