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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 Erectlle 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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The provided text is a 510(k) clearance letter from the FDA for a device called the "SE-200 Vacuum Erection Device." It addresses the regulatory and marketing aspects of the device, including its classification, substantial equivalence to predicate devices, and general controls.

However, the document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These details are typically found in the scientific and clinical evidence submitted in a 510(k) application, which is not part of this clearance letter.

Therefore, I cannot provide the requested information based on the given input.

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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.

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

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.

Not Found

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter for the V.T.S., Inc. V.T.-3 device, which describes its indication for use (assisting men with erectile dysfunction to achieve an erection using a vacuum device).

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or details about the test set.
3. Information on experts, ground truth establishment, or adjudication methods.
4. Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect sizes.
5. Results of a standalone algorithm performance study.
6. The type of ground truth used.
7. Sample size for the training set or how its ground truth was established.

This document merely grants clearance based on substantial equivalence to a predicate device, as opposed to providing detailed performance study results that would typically be found in a clinical study report or a more comprehensive summary of safety and effectiveness data.

Ask a specific question about this device