Search Results

The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)

Not Found

This document is a marketing clearance letter for a medical device called the "Nanma Vacuum Pump ProXZEK, Model 2M9498S". It is a 510(k) clearance, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval (PMA) application.

A 510(k) clearance does not typically involve a new clinical study to establish acceptance criteria and prove performance in the same way a PMA does. Instead, it relies on demonstrating equivalence to an existing device. Therefore, the information requested regarding acceptance criteria and a study proving the device meets them, particularly with details like sample sizes, ground truth establishment, and MRMC studies, is not contained within this particular document.

This document primarily states the device's Indications for Use:
"The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)."

The basis for this clearance is a comparison to a predicate device, and the "proof" is the demonstration of substantial equivalence, not a direct clinical trial with specified acceptance criteria as would be found in a PMA.

Therefore, for your specific request, most of the information cannot be extracted from this 510(k) clearance letter.

Ask a specific question about this device

The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)

Nanma Vacuum Pump, Model 2M1333

I am sorry, but after carefully reviewing the provided document, I cannot identify any information regarding acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) premarket notification letter from the FDA to Nanma Manufacturing Co. concerning their Nanma Vacuum Pump. It declares the device substantially equivalent to legally marketed predicate devices and permits its marketing.

The document does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes for test sets, data provenance, or the number of experts used for ground truth.
• Details on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used, training set sample size, or how ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device

The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)

Nanma Vacuum Pumps Models 2M995, 2M438 .M330/3R. and 2M265

This document is a 510(k) clearance letter for the Nanma Vacuum Pump. It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the same way a PMA or de novo submission might.

Therefore, I cannot provide the requested information from this document. The document primarily confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the Nanma Vacuum Pump is substantially equivalent to legally marketed predicate devices for the indicated uses.

Ask a specific question about this device

The Nanma Vacuum Pumps are external penile rigidity devices designed to promote The Namma Vacuun I umps are extenzi points agency and supers are used to create erections in men with erectile dysfunction.

Nanma Vacuum Pump

This document does not contain information about acceptance criteria or a study proving a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a Nanma Vacuum Pump, indicating substantial equivalence to a predicate device. It specifies general information about regulatory classification, compliance, and marketing, but does not detail performance studies or specific acceptance criteria.

Ask a specific question about this device