(73 days)
Indication for Use - Stimulation: The electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed. Indication for Use - Sensing: The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable if reuse instructions are followed.
The Reusable Vaginal and Rectal Electrodes are identical to the predicate devices except for the addition of "multi-patient use" and reuse instructions. There were no design changes required or made to allow for this change.
This submission pertains to the Reusable Vaginal and Rectal Electrodes manufactured by Empi, Inc. The core change from predicate devices is the addition of "multi-patient use" and reuse instructions, indicating that the device itself is not new, but rather its usage paradigm has been expanded.
Therefore, the acceptance criteria and study information provided in the original document focus on validating the reuse aspect rather than the inherent performance of the electrode itself.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the acceptance is based on validating the sterilization process and reuse instructions to ensure the device remains safe and effective for multi-patient use.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Validate the sterilization process to ensure electrodes are safe for multi-patient use. | "Non-clinical tests were performed to validate the sterilization process and instructions." |
| Reuse Instructions | Validate that the reuse instructions are adequate to maintain the device's safety and effectiveness. | "Non-clinical tests were performed to validate... the reuse instructions." Device is "reusable if reuse instructions are followed." |
| Design Integrity for Reuse | No design changes required or made to allow for multi-patient use. | "There were no design changes required or made to allow for this change [multi-patient use and reuse instructions]." |
2. Sample Size for Test Set and Data Provenance
The document does not provide details on the sample size used for any specific tests. It only states that "Non-clinical tests were performed."
- Sample Size for Test Set: Not specified.
- Data Provenance: The tests were "Non-clinical," implying laboratory or bench testing rather than human subject data. Country of origin not specified, but the submission is to the U.S. FDA, suggesting testing likely occurred in the U.S. or under U.S. regulatory standards. The data is prospective for demonstrating the new reuse claim.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. For non-clinical tests validating sterilization and reuse instructions, "experts" in the sense of medical professionals establishing clinical ground truth are not relevant. The ground truth would be established by scientific methods for sterility, material integrity, and functionality after sterilization cycles, typically by microbiologists, materials scientists, or engineers. The document does not specify these roles.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data by multiple experts. The described tests are non-clinical validations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is designed to assess the impact of an AI algorithm on human reader performance, which is not relevant to validating the reuse of an electrode.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an AI algorithm was not done. This device is an electrode, not an AI algorithm. The core functionality of the device (stimulation/sensing) was already established by predicate devices. The study focused on the "standalone" aspect of its reusability through non-clinical validation.
7. Type of Ground Truth Used
The ground truth used was based on scientific validation of sterilization processes and materials science principles to ensure safety and functionality after multiple uses and reprocessing. This would involve:
- Microbiological testing: To confirm sterility (e.g., Sterility Assurance Level, SAL).
- Material integrity testing: To ensure the electrode material and electrical properties are maintained after reprocessing cycles.
- Engineering validation: To ensure the device remains functional and safe for electrical stimulation/sensing.
8. Sample Size for the Training Set
Not applicable. This device is a physical electrode, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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).