(25 days)
The Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction.
The Vacurect Vacuum Constriction Device is an over the counter device that consists of two main components: the vacuum tube and the constriction ring. The vacuum tube consists of the pump sleeve, spacer ring, dome/sleeve O-Rings, dome/valve stopper, and vacuum ring. The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube. Once the required penis rigidity is reached. the vacuum pump mav be removed and the ring can remain on the penis for up to 30 minutes.
Here's a breakdown of the acceptance criteria and study information for the Vacurect Vacuum Constriction Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Maximum Vacuum Level | 0.57 bar = 17 inches |
Note: The document only specifies one performance criterion. It states "Testing was performed to determine that the pumping mechanism does not create a vacuum greater than 0.57 bar = 17 inches." However, the results of this test are not explicitly stated as to whether it met this criterion, only that the test was performed to determine this. Given the FDA clearance, it's implied that the device did meet this safety threshold.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. (The document mentions the sponsor's location in South Africa, but this doesn't clarify the origin of any test data.)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. The device's performance testing described is a physical measurement (vacuum level), not one requiring expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. The performance testing described (measuring vacuum) does not involve subjective adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done or at least not described in this document. The testing focuses on the physical characteristics of the device (vacuum pressure) rather than human reader performance with or without AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study (algorithm only, though this is a mechanical device, not an algorithm) was done to evaluate the maximum vacuum level of the device. This is implied by the statement: "Testing was performed to determine that the pumping mechanism does not create a vacuum greater than 0.57 bar = 17 inches."
7. Type of Ground Truth Used
- The ground truth for the performance testing was an objective physical measurement of vacuum pressure. There is no mention of expert consensus, pathology, or outcomes data being used for the performance testing described in the document.
8. Sample Size for the Training Set
- Not applicable/provided. This device is a mechanical vacuum pump and constriction ring, not an AI or algorithm-driven device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable/provided, as there is no training set for this type of device.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.