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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

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.

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Intended to achieve a penile erection for males suffering from erectile dysfunction.

The Rapport Vacuum Therapy Device is an impotence management system providing men with erectile dysfunction to create and maintain an erection. The device works on a vacuum principle, creating a negative pressure around the penis thus creating an erection. The device construction is detailed in the section on PRODUCT DESCRIPTION.

The provided text is a 510(k) submission for the Rapport V.T.D. (Vacuum Therapy Device), seeking substantial equivalence to the Osbon Erec-Aid. The document primarily focuses on the description and intended use of the device, and its operational similarity to the predicate device. Crucially, it does not include a dedicated study section with specific acceptance criteria or an analysis of performance against those criteria.

Instead, the submission states: "The vacuum performance of the Rapport VTD is similar to the Osbon Erec-Aid (as detailed in Section 6). The device is safe and effective when used as directed." This indicates that the "study" demonstrating performance was likely a comparison of vacuum characteristics between the Rapport VTD and the Osbon Erec-Aid, rather than a clinical trial with predefined acceptance criteria.

Given the limited information, I will infer the acceptance criteria and study details based on the statements provided and typical 510(k) submission practices for non-clinical performance.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative metrics for "vacuum performance" and the tolerance for "similar" are not provided in this summary. Section 6, mentioned in the document, would contain these details.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical test set or human subject data. The "study" appears to be a bench test comparison of the physical characteristics (vacuum performance) of the Rapport VTD against the Osbon Erec-Aid.

• Test Set Sample Size: Not applicable in the context of human subjects. For a bench test, it would refer to the number of Rapport VTD units and Osbon Erec-Aid units tested. This number is not specified in the provided text.
• Data Provenance: Not applicable in the context of human data. The data would be generated from laboratory measurements of the devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for a bench test comparison of vacuum performance would be the measured vacuum characteristics of the predicate device, the Osbon Erec-Aid, established through engineering specifications and calibration. No human experts are used to "establish ground truth" in this type of comparison beyond potentially calibrating equipment and interpreting technical specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC study is relevant for diagnostic imaging or subjective assessment tasks involving multiple human readers. This submission describes a physical device for erectile dysfunction and its performance relative to a predicate device, not a diagnostic or interpretive task.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for the performance comparison was the vacuum performance characteristics of the predicate device, the Osbon Erec-Aid, likely derived from its established specifications or direct measurement.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device's design would be based on engineering principles and the design of the predicate device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth in that context.

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