(199 days)
The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.
The Genesis Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence). The Prosthesis (used in pairs) is inserted into the corpora cavernosa. Each Prosthesis consists of a r roothed in panel in panel is a silver wire coil and silver wire coil and silver wire core in the flexible center section and a trimmable proximal section. The distal end is shaped to provide an anatomical fit under the glans penis. The silver wire coil and core in the flexible center section anatelinear in antost the gost into an erect position for intercourse, and then moved into a lowered position for concealment under clothing. Placed within the corpus cavernosum and crus of the penis, the Prosthesis will fit firmly at the ischial tuberosity. The ends fit the proximal culde-sacs of the cavernosa and provide support to the Prosthesis.
All components of the Genesis Penile Prosthesis incorporate a hydrophilic coating on all external surfaces.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary for a penile prosthesis and not an AI/ML device. Therefore, many standard AI/ML study components will not be present.
Device: Mentor Genesis™ Penile Prosthesis
Device Type: Penile Rigidity Implant (not an AI/ML device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Physical and Mechanical | Package Integrity | Met all test specifications |
| Water Uptake | Met all test specifications | |
| Lubricity | Met all test specifications | |
| Coating Coverage | Met all test specifications | |
| Retention Angle | Met all test specifications | |
| Column Strength | Met all test specifications | |
| Device Length | Met all test specifications | |
| Cyclic Fatigue | Met all test specifications | |
| Tail Cap Separation Force | Met all test specifications | |
| Biocompatibility | Cytotoxicity (in accordance with ISO10993-5) | Met all specifications and passed all testing |
| Systemic Toxicity (in accordance with ISO10993-5) | Met all specifications and passed all testing | |
| Intracutaneous Reactivity (in accordance with ISO10993-5) | Met all specifications and passed all testing | |
| Sensitization (30-Day and 12-Week) (in accordance with ISO10993-5) | Met all specifications and passed all testing | |
| Mouse Lymphoma (in accordance with ISO10993-5) | Met all specifications and passed all testing | |
| Bacterial Reverse Mutation (AMES) (in accordance with ISO10993-5) | Met all specifications and passed all testing |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes (number of units/samples) used for each physical, mechanical, or biocompatibility test. It only states that "Physical and Mechanical testing" and "Biocompatibility testing" were conducted.
- Data Provenance: Not applicable in the context of this device. The testing describes lab-based performance verification, not data from human subjects or clinical populations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The "ground truth" here refers to the pre-defined engineering specifications and biocompatibility standards that the device had to meet. The determination of whether a test result "met all specifications" would typically be done by qualified testing personnel and reviewed by engineering/quality control teams, not "experts establishing ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
- Not applicable. Performance was assessed against pre-defined specifications for each test, not by adjudication of different evaluations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This is a physical medical device (penile prosthesis), not a diagnostic algorithm or AI system. Such studies are not relevant for this type of product.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
- Engineering Specifications and Biocompatibility Standards: The "ground truth" for this device's performance was established by internal engineering design specifications for physical and mechanical properties (e.g., specific thresholds for column strength, desired lubrication properties) and recognized international standards for biocompatibility (ISO 10993-5).
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set was used.
§ 876.3630 Penile rigidity implant.
(a)
Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.(b)
Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”