(71 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 intended for over-the-counter use.
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 may be removed and the ring can remain on the penis for up to 30 minutes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vacurect Vacuum Constriction Device:
Based on the provided 510(k) summary, the device and its associated performance testing are extremely limited in scope for what would typically be expected for a detailed AI/ML device study. This device is a mechanical medical device, not an AI/ML diagnostic or therapeutic system. Therefore, many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pumping mechanism does not create a vacuum greater than 0.57 bar (17 inches) | Study indicates this was met. The text explicitly states, "Testing was performed to determine that the pumping mechanism does not create a vacuum greater than 0.57 bar = 17 inches." This implies the device met this specific criterion. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "Testing was performed," without details on the number of devices tested or the conditions.
- Data Provenance: Not specified. It's likely an in-house engineering test conducted by the manufacturer, Vacurect Manufacturing (PTY) Ltd. The country of origin would be the Republic of South Africa, where the sponsor is located. The description does not indicate if it was retrospective or prospective, but for an engineering test of this nature, it would typically be prospective (i.e., conducted specifically for this submission).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Number of Experts: Not applicable. For a direct measurement of vacuum pressure, expert opinion is not typically required. It's a quantitative engineering measurement.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The "ground truth" is a direct physical measurement. There is no mention of human interpretation or a need for adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. This device is a mechanical vacuum pump system, not an AI/ML diagnostic device that would involve human readers interpreting output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable as this is not an AI/ML algorithm. The "performance testing" described is the standalone functional testing of the mechanical pumping mechanism.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Direct physical measurement of vacuum pressure using appropriate calibration equipment.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable. As there's no training set for an AI/ML model, this question is irrelevant to the provided information.
Summary and Caveats:
The provided 510(k) summary is for a mechanical medical device (Vacuum Constriction Device), not an AI or machine learning-enabled device. Therefore, the bulk of your questions, which are highly relevant to AI/ML device studies (e.g., sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance), do not apply to this submission.
The "performance testing" mentioned is a basic engineering test to ensure the device operates within safe vacuum limits, which is a critical safety parameter for this type of device. The acceptance criterion is a maximum vacuum pressure, and the document states that testing was performed to determine that this limit was met. This implies compliance, though no raw data or detailed test reports are provided in this summary.
§ 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.