(231 days)
Treatment of erectile dysfunction in adult males aged 22 years and over.
Eroxon is a non-medicated, hydro-alcoholic gel formulation for topical application to the glans penis prior to sexual intercourse. Eroxon is intended as a topical treatment for male erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for satisfactory sexual performance.
Upon application, Eroxon stimulates blood flow through the penis. The volatile components of the formulation (alcohol, water) evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect. This stimulates nerve endings leading to tumescence and erection.
Eroxon is supplied in single-dose aluminum tubes. Each tube is designed to dispense approximately 300 mg of gel.
The device is supplied non-sterile and is for single use only.
Here's an analysis of the acceptance criteria and study findings for Eroxon, structured according to your request:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Study Endpoint) | Reported Device Performance (Eroxon) |
|---|---|
| Primary Effectiveness Endpoints: | |
| 1. Mean change from baseline in IIEF-EF at 24 weeks > 0 | Mean change of 5.73 (p-value 4) was 62%. |
| Secondary Effectiveness Endpoints: | |
| 1. Mean percentage of Eroxon uses where erection starts within a certain period > 30% | 62.6% of subjects noticed an erection by 10 minutes (for the unspecified "certain period of time"). |
| 2. Mean percentage of Eroxon uses where penetrative sex is possible within a certain period > 30% | 55.7% of subjects were able to have penetrative sex within 15 minutes (for the unspecified "certain period of time"). |
| Safety Endpoints: | |
| Treatment emergent adverse events (TEAEs) considered treatment related. | One patient (2.1%) in Eroxon group reported a treatment-related TEAE (burning sensation at application site), which resolved after discontinuation. Total TEAEs: Eroxon group 36.2%, Tadalafil group 46.8%. |
| Non-clinical Performance: | |
| Biocompatibility | Demonstrated to be biocompatible (cytotoxicity, sensitization, irritation, acute systemic toxicity tests passed). |
| Condom compatibility | Not significantly affected tensile or airburst properties of natural rubber latex, polyurethane, and polyisoprene condoms. |
| Temperature profile evaluation | Created rapid cooling followed by recovering warming effect ex-vivo. |
| Device specifications verification | Met specifications as described in Table 2. |
| Shelf-life support | Met all specifications (appearance, odor, alcohol content, pH, viscosity, minimum fill, osmolality, microbial quality, antimicrobial effectiveness, weight change) over 12 months. |
Study Details
-
Sample sizes used for the test set and data provenance:
- Test Set (Clinical Study): 96 patients were randomized (48 to Eroxon, 48 to Tadalafil 5mg).
- Eroxon Arm: 48 patients were randomized.
- Data Provenance: Multi-center, international study conducted in Georgia (n=30), Poland (n=54), Bulgaria (n=3), and the US (n=9). The study was prospective.
- Test Set (Clinical Study): 96 patients were randomized (48 to Eroxon, 48 to Tadalafil 5mg).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number or qualifications of experts used to establish "ground truth" for the test set in the traditional sense (e.g., expert consensus on image interpretation).
- Instead, the "ground truth" for effectiveness was based on quantitative and patient-reported clinical endpoints (IIEF questionnaire scores, patient reports of erection onset and ability to have penetrative sex, and self-reported adverse events), as assessed by the investigators and patients themselves within the confines of the study protocol. The IIEF-EF MCID of 4 was based on published literature (Rosen et al. 2011).
-
Adjudication method for the test set:
- The document does not describe an adjudication method for the clinical study data in the same way one might adjudicate imaging reads. Clinical endpoints were primarily quantitative scores (IIEF-EF) and patient self-reports. Adverse events were collected and classified by investigators.
- For the usability study, "the single user who incorrectly self-diagnosed was judged by the sponsor as likely to have previous or episodic (not current) experience of ED," which suggests a form of sponsor-led adjudication for that specific event. However, this is not for the primary clinical effectiveness data.
-
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 performed. Eroxon is a topical formulation for ED, not an AI-assisted diagnostic or interpretive device involving human "readers." The clinical study compared Eroxon to tadalafil, but this was for exploratory purposes regarding tadalafil, not to demonstrate human improvement with or without AI.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. Eroxon is a non-medicated topical formulation, not an algorithm or AI device. Its performance is evaluated directly through its physical and clinical effects.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for establishing device effectiveness primarily relies on patient-reported outcomes (PROs) from validated questionnaires (International Index for Erectile Function - IIEF-EF) and direct patient reports (onset of erection, ability to have penetrative sex).
- Safety ground truth was based on treatment-emergent adverse events (TEAEs) reported by patients and assessed by investigators.
- Non-clinical ground truth was established through standardized bench testing protocols and biocompatibility evaluations against established standards (e.g., ISO 10993).
-
The sample size for the training set:
- Not applicable for this type of device. There isn't an "algorithm" with a training set for Eroxon. The "training" for the device's development involves formulation research, bench testing, and iterative design, which doesn't fit the typical definition of a training set for AI/ML.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set in the context of an algorithm. The "ground truth" for the development and validation of Eroxon as a physical product (its formulation, stability, and physical effects) was established through chemical analysis, physical property testing, and pre-clinical biocompatibility studies against scientific standards.
N/A