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Indications For Use:

• • Urinary Incontinence : Stress, Urge and Mixed Incontinence
• • Fecal Incontinence
• • Neuromuscular Reeducation

The Pathway Vaginal/Rectal Perineometer Probe is an EMG perineometer probe used to monitor the pelvic floor muscles for the treatment of incontinence. This probe 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.
The Pathway Vaginal/Rectal Perineometer Probe is a single-user plastic probe with three metal electrode contacts. The patient inserts the probe 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 aim is to improve the strength and control of the pelvic floor muscles.

The provided document describes a device called the Pathway Vaginal/Rectal Perineometer Probe and its substantial equivalence to a predicate device. The information requested pertains to the acceptance criteria and the study that proves the device meets those criteria.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabular format with defined thresholds. Instead, it presents performance data used to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion is that the Pathway probe performs "similarly" to the predicate device and accurately measures EMG signals.

2. Sample size used for the test set and the data provenance

• Non-clinical (Bench Tests): The document states "A series of bench tests were performed" and "A matrix of different frequencies and amplitudes was measured." It does not specify a numerical sample size for these tests (e.g., number of measurements or repetitions).
• Clinical Tests: The document states "A number of Male and Female subjects were instructed to perform a series of contractions and relaxations." It does not specify the exact number of subjects or the sample size of the clinical test set.
• Data Provenance: The document does not explicitly state the country of origin. The submission is from a US company (The Prometheus Group, Portsmouth, NH) to the FDA, suggesting the studies were likely conducted in the US. The studies are prospective in nature, as they involve performing tests and gathering data specifically for the device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document describes tests to measure EMG signals and compare the Pathway probe's performance to a predicate device. These tests involved instrumental measurements (non-clinical) and subject-performed contractions/relaxations (clinical). The "ground truth" here is the physical EMG signal itself and the performance relative to a known predicate device. There is no mention of human experts establishing ground truth in the context of interpretation or diagnosis for the test set. The ground truth for the non-clinical tests was the input signals, and for clinical tests, it was the recorded muscle activity during contractions/relaxations, compared against the predicate device.

4. Adjudication method for the test set

Not applicable. The tests measured physical properties (EMG signals, biocompatibility) or compared performance to a predicate device. There was no diagnostic interpretation or subjective assessment that would require an adjudication method.

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. This device is an EMG perineometer probe, not an AI-powered diagnostic tool requiring human readers or interpretation of complex cases. Therefore, no MRMC study or AI assistance effect size is relevant or reported.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device for monitoring physiological signals, not an algorithm. Its performance is inherent to its physical design and sensor capabilities.

7. The type of ground truth used

• Non-clinical (Bench Tests): The ground truth was the known input signals (specific frequencies and amplitudes) generated for the test setup, against which the probe's readings were compared.
• Clinical Tests: The ground truth was the EMG activity generated by subjects' pelvic floor muscle contractions and relaxations, measured by both the Pathway probe and the predicate device. The performance of the predicate device (Perrymeter probe, K911190/A) served as a comparative ground truth for "similar" performance.
• Biocompatibility Tests: The ground truth was established by standardized laboratory test protocols for biocompatibility, using accepted criteria for safety (e.g., 0% sensitization, negative reactions, non-cytotoxic, non-pyrogenic).

8. The sample size for the training set

Not applicable. This device is not an algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this device is not an algorithm, there is no training set or associated ground truth establishment process.

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