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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 Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction.

The Vacurect Vacuum Constriction Device is an over the counter device that consists of two main components: the vacuum tube and the constriction ring. The vacuum tube consists of the pump sleeve, spacer ring, dome/sleeve O-Rings, dome/valve stopper, and vacuum ring. The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube. Once the required penis rigidity is reached. the vacuum pump mav be removed and the ring can remain on the penis for up to 30 minutes.

Here's a breakdown of the acceptance criteria and study information for the Vacurect Vacuum Constriction Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only specifies one performance criterion. It states "Testing was performed to determine that the pumping mechanism does not create a vacuum greater than 0.57 bar = 17 inches." However, the results of this test are not explicitly stated as to whether it met this criterion, only that the test was performed to determine this. Given the FDA clearance, it's implied that the device did meet this safety threshold.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. (The document mentions the sponsor's location in South Africa, but this doesn't clarify the origin of any test data.)

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not provided in the document. The device's performance testing described is a physical measurement (vacuum level), not one requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The performance testing described (measuring vacuum) does not involve subjective adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done or at least not described in this document. The testing focuses on the physical characteristics of the device (vacuum pressure) rather than human reader performance with or without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study (algorithm only, though this is a mechanical device, not an algorithm) was done to evaluate the maximum vacuum level of the device. This is implied by the statement: "Testing was performed to determine that the pumping mechanism does not create a vacuum greater than 0.57 bar = 17 inches."

7. Type of Ground Truth Used

• The ground truth for the performance testing was an objective physical measurement of vacuum pressure. There is no mention of expert consensus, pathology, or outcomes data being used for the performance testing described in the document.

8. Sample Size for the Training Set

• Not applicable/provided. This device is a mechanical vacuum pump and constriction ring, not an AI or algorithm-driven device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable/provided, as there is no training set for this type of device.

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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 Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction. The Vacurect Vacuum Constriction Device is intended for over-the-counter use.

The Vacurect Vacuum Constriction Device is an over the counter device that consists of two main components: the vacuum tube and the constriction ring. The vacuum tube consists of the pump sleeve, spacer ring, dome/sleeve O-Rings, dome/valve stopper, and vacuum ring. The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube. Once the required penis rigidity is reached, the vacuum pump may be removed and the ring can remain on the penis for up to 30 minutes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vacurect Vacuum Constriction Device:

Based on the provided 510(k) summary, the device and its associated performance testing are extremely limited in scope for what would typically be expected for a detailed AI/ML device study. This device is a mechanical medical device, not an AI/ML diagnostic or therapeutic system. Therefore, many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document only mentions "Testing was performed," without details on the number of devices tested or the conditions.
• Data Provenance: Not specified. It's likely an in-house engineering test conducted by the manufacturer, Vacurect Manufacturing (PTY) Ltd. The country of origin would be the Republic of South Africa, where the sponsor is located. The description does not indicate if it was retrospective or prospective, but for an engineering test of this nature, it would typically be prospective (i.e., conducted specifically for this submission).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

• Number of Experts: Not applicable. For a direct measurement of vacuum pressure, expert opinion is not typically required. It's a quantitative engineering measurement.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "ground truth" is a direct physical measurement. There is no mention of human interpretation or a need for adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No. This device is a mechanical vacuum pump system, not an AI/ML diagnostic device that would involve human readers interpreting output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable as this is not an AI/ML algorithm. The "performance testing" described is the standalone functional testing of the mechanical pumping mechanism.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Direct physical measurement of vacuum pressure using appropriate calibration equipment.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This device does not use machine learning, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Ground Truth for Training Set: Not applicable. As there's no training set for an AI/ML model, this question is irrelevant to the provided information.

Summary and Caveats:

The provided 510(k) summary is for a mechanical medical device (Vacuum Constriction Device), not an AI or machine learning-enabled device. Therefore, the bulk of your questions, which are highly relevant to AI/ML device studies (e.g., sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance), do not apply to this submission.

The "performance testing" mentioned is a basic engineering test to ensure the device operates within safe vacuum limits, which is a critical safety parameter for this type of device. The acceptance criterion is a maximum vacuum pressure, and the document states that testing was performed to determine that this limit was met. This implies compliance, though no raw data or detailed test reports are provided in this summary.

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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 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.

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The intended use of the device is to assist users by supporting the penis during intimacy. Used by men with the inability to achieve vaginal penetration, due to a flaccid or partially erect penis.

Support Sleeve

This document is a 510(k) clearance letter from the FDA for a device called "Support Sleeve." It does not contain information about acceptance criteria or a study proving the device meets said criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was cleared based on its substantial equivalence to an existing device, not on new performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

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