(41 days)
The Anal Stimulation/EMG Probe - w/Stop, is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Hollister Incorporated through it's InCare Division currently markets an Anal 2-electrode Stimulation/EMG Probe (K891773 and K930530) as an accessories to it's Pelvic Floor Therapy System product line. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed predicate devices.
The acceptance criteria and study proving device performance are not explicitly detailed in the provided documents. The documents are a 510(k) summary for a medical device (Anal Stimulation/EMG Probe - w/Stop) seeking substantial equivalence to a predicate device, rather than a clinical trial report or a performance validation study against specific acceptance criteria.
However, based on the information provided, we can infer the intent of the submission is to demonstrate that the new device is as safe and effective as the predicate device. The "study" in this context is the comparison of the technological characteristics and biological safety.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:
1. A table of acceptance criteria and the reported device performance
Since specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not provided for the new device, the "acceptance criteria" for a 510(k) submission seeking substantial equivalence are generally implied to be that the new device performs at least as well as or is functionally equivalent to the predicate device in terms of safety and effectiveness.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (Hollister Anal Stimulation/EMG Probe - w/Stop) |
|---|---|
| Safety: Biocompatibility with human tissue. | Meets: Biocompatibility assessed based on ISO 10993, FDA G95-1, USP guidelines. Materials deemed safe and effective. |
| Effectiveness: Achieve intended use (electromyographic feedback/electrical stimulation for pelvic musculature rehabilitation). | Meets: Identical intended use as predicate devices. Technological characteristics (e.g., number of electrodes, material, electrode placement, contact duration) are comparable or consistent with predicate. |
| Technological Characteristics: Similar materials, design principles, and functional capabilities to predicate devices. | Meets: Uses identical raw material components and manufacturing process as currently marketed predicate devices. Key technological characteristics are compared in a table and deemed substantially equivalent. |
| Performance: Maintain similar performance characteristics without raising new questions of safety or effectiveness. | Meets: No data on specific performance metrics (e.g., signal quality, stimulation efficacy) are provided, but the claim of substantial equivalence implies comparable performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a clinical test set. The assessment is primarily based on a comparison of device characteristics and material biocompatibility. There is no mention of a "test set" of patients or data in the provided document for evaluating performance.
- Data Provenance: The biocompatibility assessment relies on established international and national standards (ISO, FDA, USP) and laboratory evaluations. The information does not specify the country of origin for these laboratory evaluations, nor whether they were retrospective or prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" derived from expert consensus on a test set mentioned in this 510(k) summary. The ground truth for biocompatibility would be the results of the laboratory tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method described.
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 not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical electromedical probe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility, the "ground truth" would be the scientific data and established toxicological profiles of the materials, evaluated against international standards (ISO 10993) and regulatory guidelines (FDA, USP). For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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).