(158 days)
Intended to achieve a penile erection for men suffering from erectile dysfunction.
The Rapport VTD is a vacuum therapy impotence management system providing a simple, non-surgical, non-invasive method of creating and maintaining an erection in men with erectile dysfunction. The product consists of a hand pump and penile tube, used to create a vacuum, and loading cones, constriction rings and transfer sleeve used to maintain the erection.
The Rapport V.T.D. is a vacuum therapy impotence management system. The provided information leverages a previous 510(k) clearance (K971443) for the same device, stating that no new clinical trial data was generated for this submission. Therefore, the information below refers to the study cited in K971443.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Provide an answer to impotence problems. | "The data showed that the device provided an answer to the impotence problems in over 80% of the men used in study." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, but the submission indicates "over 80% of the men used in study."
- Data Provenance: The original 510(k) (K971443) likely contained the details. This specific submission (K982275) states "No additional trial data has been generated... as data supplied in the original 510(k) K971443 is considered adequate." Therefore, the provenance details are not available in the provided text for K982275. Given the previous clearance, it implies the data was retrospective from a previous study. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given text.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study in question evaluated the device's ability to help men achieve erections, not its performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a physical medical device (vacuum therapy pump), not an AI algorithm. Therefore, a standalone performance study in the context of AI algorithms is not applicable. The study evaluated the standalone performance of the physical device.
7. The Type of Ground Truth Used
- The ground truth was based on the ability of the device to "provide an answer to the impotence problems," which implies successful creation and maintenance of an erection in men with erectile dysfunction. This would likely be assessed by patient self-report or clinical observation of erectile rigidity, although specifics are not provided.
8. The Sample Size for the Training Set
- Not applicable in the context of an AI training set, as this is a physical medical device. The "sample size" refers to the patient cohort used in the study, not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is a physical medical device and not an AI algorithm requiring a training set. The ground truth for the study was established by observing the device's effectiveness in addressing impotence.
§ 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.