Search Results

Indications For Use:

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

The Pathway STM-10 is used to stimulate the pelvic floor muscles for the treatment of incontinence. The Pathway Vaginal or Anal EMG/Stim perineometer sensor is connected to the Pathway STM-10 device to provide stimulation to the patient. This assists the patient with muscle contractions.
The Pathway STM-10 uses Pathway EMG/Stim Perineometer Sensors which are single-user sensors. The patient inserts the sensor into the vagina or rectum and uses the Pathway STM-10 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.

The provided text describes a 510(k) summary for the Pathway STM-10 Pelvic Floor Stimulator. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials with acceptance criteria.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable (N/A) in this context as they pertain to clinical or algorithm-specific performance studies that were not part of this 510(k) submission.

Here's the information that can be extracted from the provided document:

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

The document does not explicitly define "acceptance criteria" in the way it would for a clinical trial (e.g., a specific sensitivity or specificity target). Instead, the "acceptance" for this 510(k) summary is demonstrating substantial equivalence to a predicate device (Pathway CTS 2000). The "device performance" is reported through a comparison of technical characteristics and bench test results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: N/A (No clinical test set described in this 510(k) for performance evaluation. The "bench tests" refer to testing the device's electrical outputs, not patient performance.)
• Data Provenance: N/A

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: N/A
• Qualifications of Experts: N/A

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: N/A

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

• MRMC Study: No. This is not an AI-assisted diagnostic device, but a therapeutic electrical stimulator.
• Effect Size: N/A

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

• Standalone Performance: Not applicable. This is not an algorithm, but a medical device for direct patient application. The "standalone" evaluation involved bench testing the electrical output of the device itself. The document states: "A series of bench tests were performed using the Pathway STM-10 to show the device accurately applies stimulation..."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For the "bench tests," the ground truth was the intended programmed stimulation outputs/signals. The measured waveforms were compared against these intended signals. For biocompatibility, the ground truth was established by laboratory testing standards for material safety.

8. The sample size for the training set

• Sample Size for Training Set: N/A (No training set described as this is not an AI/machine learning device.)

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

• How Ground Truth for Training Set Established: N/A

Ask a specific question about this device