(238 days)
The vPatch is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.
The vPatch is a single-use disposable patch designed to manage premature ejaculation. The vPatch contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles and nerves during intercourse to help the user postpone ejaculation. The patch works by delivering short duration. low intensity EMS to the target muscles and nerves. The stimulation contracts the pelvic floor muscles, which consequently, delays the rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation. The vPatch is intended to be applied by the user to the perineum prior to intercourse and removed immediately after intercourse.
Here's a breakdown of the acceptance criteria and study details for the vPatch device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Effectiveness) | Reported Device Performance (Active vs. Sham Arm, ITT Population) |
|---|---|
| Average change from baseline IELT at least 50% higher in active arm | Met: Average improvement of IELT over baseline among vPatch subjects was 50.2 sec, which was more than 50% greater than the 16.9 sec improvement among sham subjects (Difference: 33.3 sec, p=0.0073). |
| Proportion of subjects with improvement in CGIC at least 50% higher in active arm | Not Met in ITT: 62.5% of active arm subjects experienced improvement vs. 42.11% in sham. Met in mITT and PP: Improvement percentage for active subjects was significantly higher than sham subjects (mITT: 73.53% vs 44.44%, p=0.0371; PP: 73.53% vs 41.18%, p=0.0274). |
Safety Acceptance Criteria (Implicitly met by low AE rate):
- Low incidence of adverse events, with any AEs being mild and resolving upon cessation of device use.
Reported Safety Performance:
- AE rate: 1.08% (2/186 sessions) in the active arm vs. 0% (0/70 sessions) in the sham arm (not a statistically significant difference).
- Both AEs were mild and resolved upon cessation of use (discomfort due to device vibration, pain/discomfort in pelvic area).
2. Sample Size and Data Provenance
- Test Set (Clinical Study):
- Screened: 70 male subjects
- Eligible: 62 subjects
- Randomized/Enrolled (ITT Analysis Set): 59 subjects (40 Active, 19 Sham)
- mITT Analysis Set: 52 subjects (34 Active, 18 Sham)
- Per-Protocol (PP) Analysis Set: 51 subjects (34 Active, 17 Sham)
- Data Provenance: Multi-center, international, prospective clinical investigation.
3. Number of Experts and Qualifications for Test Set Ground Truth
The provided text does not specify the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for Test Set
The provided text does not specify any adjudication method for establishing ground truth for the test set. Ground truth for IELT was measured by the patient's partner using a stopwatch. Other endpoints (CGIC, PEP, Orgasmometer) were patient-reported outcomes via questionnaires.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study evaluated the clinical effectiveness of the device itself (device with human user) against a sham, not the improvement of human readers with AI assistance. The vPatch is an electrical stimulation device, not an AI-powered diagnostic or assistive tool for human interpretation.
6. Standalone (Algorithm Only) Performance
Not applicable. The vPatch is a physical electrical stimulation device, not an algorithm or software-only device in the traditional sense of "standalone performance" for AI-driven systems. Its software is embedded and controls the stimulation; its performance is intrinsically linked to its physical application and interaction with the user.
7. Type of Ground Truth Used
- Intravaginal Ejaculatory Latency Time (IELT): Measured objectively by the patient's partner using a stopwatch during the home-use phase. This can be considered a direct, objective measurement.
- Clinical Global Impression of Change (CGIC): Patient-reported outcome (PRO).
- Premature Ejaculation Profile (PEP): Patient-reported outcome (PRO).
- Orgasmic Intensity (Orgasmometer): Patient-reported outcome (PRO).
- Adverse Events (AEs): Reported by patients and verified by investigators.
8. Sample Size for Training Set
The provided text does not mention a separate training set in the context of an algorithmic or AI model. The "training" in the clinical study refers to subjects receiving training on how to use the device. The study itself served as the primary data collection for validating the device's efficacy and safety.
9. How Ground Truth for Training Set Was Established
As there is no mention of a separate training set for an AI/algorithm, this question is not applicable. The clinical study data was used to assess overall device performance.
§ 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation.
(a)
Identification. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical performance;
(ii) Electrical stimulation parameters; and
(iii) Battery performance.
(4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include:
(i) Specific instructions regarding safe placement and correct use of the device;
(ii) Warning(s) against use by patients with active implanted medical devices; and
(iii) A shelf life.