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510(k) Data Aggregation
(228 days)
The MOR System is indicated for the stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
The MOR System is a drug-free wearable patch system with single-use electrode patches, a reusable pulse generator, and a smartphone app. Together, these components deliver user-defined electrical stimulation to the perineal region.
The provided text is a 510(k) premarket notification document for a medical device called the "MOR System," a non-implanted electrical stimulation device intended to improve or enhance male sexual performance.
This document describes the device, its intended use, and its similarities to a predicate device (vPATCH). It details non-clinical testing performed, including electrical safety, EMC testing, software verification and validation (per IEC 62304), and biocompatibility testing (per ISO 10993-1).
However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/algorithm performance metrics like sensitivity, specificity, or AUC, or comparative effectiveness studies with human readers.
The questions in the prompt refer to criteria and studies typically associated with the evaluation of AI/ML-driven medical devices, especially those involving image analysis or diagnostic aid, which require quantitative performance metrics and rigorous validation against expert ground truth.
Since the provided text does not contain the information required to answer the prompt's specific questions about acceptance criteria, performance studies, AI training/test sets, or ground truth establishment, I must state that this information is not available in the provided document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and non-clinical safety testing, rather than reporting on the performance of an AI/ML algorithm or its impact on human reader performance.
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(150 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. It contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles during intercourse to help the user postpone ejaculation. The patch works by delivering shortduration, low-intensity EMS to the perineal muscles and nerves during intercourse. The stimulation contracts the pelvic floor muscles, which consequently delays rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation. The vPATCH is comprised of several layers which include the cover, electrical circuit board including batteries, and adhesive electrodes. The skin-contacting materials are hydrogel, polyolefin foam, and thermoplastic elastomer (TPE). The vPATCH is available in two intensity levels (High and Low).
The provided text describes a 510(k) submission for the vPATCH device, which manages premature ejaculation, to expand its indication from prescription use (Rx) to over-the-counter (OTC) use. The key study supporting this expansion is a Human Factors (HF) validation study that included label comprehension and self-selection components.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria for the vPATCH relate primarily to demonstrating its safety and effectiveness for OTC use, specifically that users can understand how to use it safely and effectively without a healthcare professional's guidance. The core performance is derived from the Human Factors study.
| Acceptance Criterion (Implicit) | Reported Device Performance and Study Findings |
|---|---|
| Label Comprehension: Intended users can correctly understand the instructions for use (IFU) and labeling without healthcare professional guidance. This includes understanding the indications, contraindications, warnings, and how to use the device. | The human factors validation study included a label comprehension study. The results supported the expanded indication, demonstrating that the intended user population is able to correctly identify themselves as intended users and correctly use the device. While specific quantitative metrics (e.g., % correct responses) are not provided in this summary, the conclusion states that the study demonstrates users "are able to correctly identify themselves as intended users as well as correctly use the device without the need for guidance or intervention of a healthcare professional." |
| Self-Selection: Users can correctly identify whether the device is appropriate for them based on the labeling, including recognizing if they are an intended user, not intended user, or contraindicated user. | The human factors validation study included a self-selection study. The study was completed using representative users from three groups: Indicated, Not Indicated, and Contraindicated. The results supported the expanded indication, demonstrating that the intended user population is able to correctly identify themselves as intended users. |
| Usability (Safe & Effective Use without Professional Intervention): Users can safely and effectively perform the tasks necessary to use the vPATCH as intended in a real-world (simulated) environment without errors that could lead to harm or ineffective treatment. | The human factors validation study was conducted in a simulated-use format. Participants had access to the patch, IFU, and accessories. The study's purpose was to identify root causes of difficulties or use errors. The conclusion states, "The vPATCH has been found to be safe and effective for the intended users, uses, and use environments," and that users can "correctly use the device without the need for guidance or intervention of a healthcare professional." A supplemental study was conducted for a minor design change to further improve usability. |
| Biocompatibility: The device materials in contact with the body are biocompatible and do not cause adverse reactions (cytotoxicity, sensitization, irritation). (This is a general safety criterion for the device itself, reinforced due to minor device differences, and implicitly part of "safe and effective.") | Biocompatibility tests were repeated: Cytotoxicity, Sensitization, and Irritation. These were performed in accordance with FDA Guidance ISO 10993-1. The successful completion of these tests (implied by the submission's conclusion of safety and effectiveness) means the materials meet acceptance criteria for biological safety. |
| Non-Clinical Performance (Device Functionality and Integrity): The device functions as intended over its shelf-life and in various specified conditions (e.g., dimensional integrity, bonding strength, liquid ingress protection, power performance). (Again, a general safety/effectiveness criterion for the device itself, not specific to OTC.) | Non-clinical performance tests were performed: Shelf-Life testing (packaging integrity and functionality), Dimensional validation (critical measurements), Cover bonding strength, Liquid ingress protection, and Power performance. The successful completion of these tests (implied by the submission's conclusion of safety and effectiveness) means the device meets acceptance criteria for its physical and electrical performance. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for the Test Set: Not explicitly stated in the provided text. The text only mentions "representative users of the vPATCH from three (3) groups (Indicated, Not Indicated, Contraindicated)."
- Data Provenance: Not explicitly stated in the provided text. It is implied to be prospective, as it describes a study conducted for the submission. The country of origin for the data is also not explicitly stated, though the applicant's address is Israel and the regulatory consultant is in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the text. For a Human Factors study, "experts" typically establish the study design and analysis, rather than the ground truth of a medical condition itself. The "ground truth" in this context would be the correct performance of tasks and understanding of information, as defined by the device's intended use and labeling. The text mentions "analyzed to identify root causes of any difficulties or use errors observed during testing," implying a standard HF evaluation process.
4. Adjudication Method for the Test Set
- This information is not provided in the text. For Human Factors studies, adjudication often involves observation and structured debriefing rather than traditional "reader" adjudication. Errors or difficulties are recorded and categorized, then analyzed by the HF team.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is pertinent for diagnostic AI devices where human readers (e.g., radiologists) interpret images with or without AI assistance. The vPATCH is a direct-to-consumer electrical stimulation device, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable directly. The vPATCH is an active medical device, not an AI algorithm. Its performance is intrinsically tied to human use. However, the "non-clinical performance testing" and "biocompatibility testing" can be considered analogous to "standalone" testing in that they evaluate the device itself (components, electrical performance, materials) independent of a human user's interaction beyond applying the patch.
7. The Type of Ground Truth Used
- For the Human Factors study (label comprehension and self-selection), the "ground truth" was defined by the device's intended use, labeling (Instructions for Use - IFU), and the design of the tasks. For example, the ground truth for a comprehension question would be the correct answer as stated in the IFU/labeling. For a self-selection task, the ground truth would be whether the participant accurately categorized themselves (e.g., "indicated user" if they met the criteria, "contraindicated" if they had a contraindication).
- For the biocompatibility and non-clinical performance tests, the "ground truth" was established by recognized international standards (e.g., ISO 10993-1) and internal design specifications of the device.
8. The Sample Size for the Training Set
- Not applicable. The vPATCH is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this type of device.
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(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.
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