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The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

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This is a 510(k) premarket notification for the VT-1 Vacuum Erection Device. The provided text is a letter from the FDA to the manufacturer, confirming that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets them.

Therefore, I cannot answer your request based on the provided text. To answer your questions, I would need a document that describes the clinical or performance study conducted for this device, including details about its methodology, results, and acceptance criteria.

Ask a specific question about this device

The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

VT-1 Vacuum Erection Device

The provided text is a clearance letter for a medical device (VT-1 Vacuum Erection Device). It states that the device is substantially equivalent to a legally marketed predicate device.

However, the document DOES NOT contain information about:

• Acceptance criteria for device performance.
• Any specific study that proves the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• How ground truth for the training set was established.

The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." This indicates that the clearance is based on equivalence to an existing device, rather than a detailed performance study with specific acceptance criteria outlined in this document.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device