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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)

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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.

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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 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.

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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.

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The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. This device is intended for over-the-counter use (OTC)

Nanma Adjustable constriction ring

This document is a 510(k) premarket notification decision letter from the FDA for a device called "Nanma non-adjustable constriction rings." The letter states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about specific acceptance criteria or a study that proves the device meets those criteria.

The letter is primarily focused on:

• Confirming the substantial equivalence determination for the device.
• Outlining the regulatory obligations and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
• Providing contact information for various FDA offices.
• Stating the intended use of the device ("external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence" and "intended for over-the-counter use").

Therefore, I cannot populate the table or provide answers to most of the requested questions because the necessary information is not present in the provided text.

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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.

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The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence.

Nanma non-adjustable constriction ring

This document is a 510(k) clearance letter from the FDA for the 'NANMA Non-adjustable Constriction Ring'. It does not contain information about the acceptance criteria, study details, or device performance metrics as requested in the prompt. The letter confirms substantial equivalence to a predicate device and permits marketing, but it does not include clinical trial data, sample sizes, expert qualifications, or ground truth establishment.

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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.

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The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the "NANMA Adjustable Constriction Ring." These documents do not contain information about:

• Acceptance criteria and reported device performance.
• The specifics of any study conducted to prove the device meets acceptance criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from these documents. The provided text is purely a regulatory clearance notice based on substantial equivalence, not a summary of performance study results.

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