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The Nanma adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma adjustable constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)

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I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, the study that proves the device meets the acceptance criteria, or any details about a clinical study.

The document is a 510(k) clearance letter from the FDA to Nanma Manufacturing Co., Ltd. for their "Nanma Adjustable Constriction Rings." This letter indicates that the device has been found substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

The document does NOT contain:

• A table of acceptance criteria or reported device performance.
• Information on sample size, data provenance, number of experts, adjudication methods for a test set.
• Details about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• Information on the type of ground truth used or the sample size and establishment of ground truth for a training set.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparative performance, materials, and intended use, rather than extensive new clinical studies with detailed acceptance criteria as one might find for a novel or higher-risk device PMA submission.

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The Nanma constriction rings (adjustable and stretchable) are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)

Nanma Adjustable and Stretchable Constriction Rings

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance described in a table, or any study details that prove the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Nanma Adjustable and Stretchable Constriction Rings."

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It discusses regulatory classifications, general controls, and other compliance requirements, but does not include any performance data or study results.

To answer your request, I would need a document that specifically details the device's technical specifications, performance metrics, testing methods, and the results of studies conducted to demonstrate its efficacy and safety.

Ask a specific question about this device