(137 days)
Indications For Use:
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- Urinary Incontinence : Stress, Urge and Mixed Incontinence
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- 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.
| Parameter (Acceptance Criteria) | Pathway STM-10 (Reported Device Performance) | Predicate Device: Pathway CTS 2000 (Performance for comparison) |
|---|---|---|
| Intended Use (Substantially equivalent) | Treatment of Urinary Incontinence; Neuromuscular Reeducation | Treatment of Urinary Incontinence; Neuromuscular Reeducation |
| Stimulator Output (Comparison) | 0-60 mA | 0-100 mA |
| Waveform (Substantially equivalent) | Asymmetrical Balanced Pulsed Current | Asymmetrical Balanced Pulsed Current |
| Charge/pulse at 500 ohms (Comparison) | 17uC | 28uC |
| Frequency (Substantially equivalent) | 12.5, 50, 100, 200 Hz | 12.5, 50, 100, 200 Hz |
| Peak pulse intensity (Comparison) | 60 mA | 100 mA |
| Pulse width (Substantially equivalent) | .3 ms fixed | .3 ms fixed |
| Ramps (Substantially equivalent) | 2 sec on ramp, one sec off ramp | 2 sec on ramp, one sec off ramp |
| Duty Cycle (Comparison) | Work/Rest of 5 seconds on, 5 seconds off (5/5), 5/10, 10/10, 10/20. | Work Time: 1 - 60 Seconds, Rest Time: 0 - 60 Seconds |
| Session Duration (min) (Comparison) | 5, 10, 15, 20, 25, or 30. | 0-60 |
| Programmable features (Substantially equivalent) | None by Patient; Frequency, Duty cycle, Session length by physician | None by Patient; Frequency, Duty cycle, Session length by physician |
| Vaginal EMG/Stim Probe Used (Substantially equivalent) | Pathway Vaginal EMG/Stimulation Sensor K993976 | Pathway Vaginal EMG/Stimulation Sensor K993976 |
| Anal EMG/Stim Probe Used (Substantially equivalent) | Pathway Anal EMG/Stimulation Sensor K993976 | Pathway Anal EMG/Stimulation Sensor K993976 |
| Vaginal EMG/Stim probe electrode surface area (Equivalent) | 2.31 cm² | 2.31 cm² |
| Anal EMG/Stim probe electrode surface area (Equivalent) | 2.12 cm² | 2.12 cm² |
| Current Density (full output @ 500 ohms) (Comparison) | Pathway Vaginal: 26.0 mA/cm²; Pathway Anal: 28.3 mA/cm² (Max. Instantaneous) | Pathway Vaginal: 43.3 mA/cm²; Pathway Anal: 47.2 mA/cm² (Max. Instantaneous) |
| Power Density (full output @ 500 ohms) (Comparison) | Pathway Vaginal: 5.6 mW/cm²; Pathway Anal: 6.1 mW/cm² (maximum intensity, .3ms pulse width 200Hz) | Pathway Vaginal: 15.6 mW/cm²; Pathway Anal: 17.0 mW/cm² (maximum intensity, .3ms pulse width 200Hz) |
| Bench Test Results (Accurate application of stimulation) | The Pathway STM-10 was used to apply programmed stimulation outputs and the resulting waveforms were measured and compared to the intended signals. The tests show the device accurately applies muscle stimulation. | N/A (Comparison is implicit against intended signals and substantial equivalence to predicate which also accurately applies stimulation) |
| Biocompatibility Testing (Safety of materials) | Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor were laboratory tested and found safe under required standards. | N/A (The sensors are the same as used by the predicate and were previously tested) |
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
§ 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).