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The Xtend ring is used to maintain engorgement of the penis for men that are having difficulty with organic or psychological erectile dysfunction.

The Xtend rings are used by men with erectile dysfunction to improve their ability to have sexual intercourse. When they have a sufficient erection for intercourse a Xtend constriction ring (K980752) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The Xtend ring kit consists of a set of 4 rings. The rings are elastic pharmaceutical quality material which come with an applicator and ring removal hooks. The ring safety removal loops were performance tested for strength. All warnings and precautions from the FDA internet address, www.fda.gov/cdch/ode/oxponrig.html, are included in the premarket notification.

The provided text describes a medical device called the "Xtend Ring Kit" and its 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. The core of this submission is about regulatory approval based on equivalence, rather than a clinical study demonstrating performance against specific medical criteria.

Therefore, the specific quantitative details regarding acceptance criteria, study design parameters (like sample size for test/training sets, expert qualifications, adjudication methods), and statistical outcomes (like effect size for MRMC studies or standalone algorithm performance) are not present in the provided document. The document focuses on regulatory compliance and mechanical performance testing, not diagnostic or therapeutic efficacy studies with clinical endpoints.

However, based on the information available, we can infer some "acceptance criteria" from a regulatory/engineering perspective and the "study" that proves these criteria were met, though it's not a clinical effectiveness study in the typical sense for AI/diagnostic devices.

Here's an analysis based on the provided text:

Acceptance Criteria and device performance

Study that proves the device meets the acceptance criteria:

The "study" in this context is primarily the 510(k) premarket notification process itself, which relies on demonstrating substantial equivalence to a predicate device and fulfilling general control provisions, rather than a prospective clinical trial.

1. Sample size used for the test set and the data provenance:

   • Test Set: Not applicable in the traditional sense of a clinical test set. The performance testing mentioned ("ring safety removal loops were performance tested for strength") would have involved a sample of the manufactured rings. The specific sample size for this mechanical strength test is not mentioned.
   • Data Provenance: Not applicable. This is not a study using patient data but rather documentation and mechanical testing of the device itself.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The ground truth for this device's "performance" is based on mechanical properties (strength of loops), material specifications (pharmaceutical quality), and compliance with FDA regulations and labeling requirements, not expert interpretation of clinical data.

3. Adjudication method for the test set:

   • Not applicable. There was no human interpretation of data requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This type of study is typically done for diagnostic imaging or AI-assisted diagnostic devices to assess the impact on human reader performance. The Xtend Ring Kit is a physical medical device (an external penile rigidity device ring), not an imaging or AI diagnostic tool.

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

   • No. This is not an algorithmic device. Mechanical performance tests were conducted on the device components (e.g., ring safety removal loops).

6. The type of ground truth used:

   • The "ground truth" here is primarily engineering specifications for material quality and strength, and regulatory compliance (e.g., inclusion of required warnings, substantial equivalence to a predicate device). For the strength of the removal loops, the ground truth would be a defined force or stress threshold that the loop must withstand.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable.

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The Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.

The Charger is used by impotent men to allow them to resume having sexual intercourse. It consists of a clear polycarbonate cylinder used as a vacuum chamber, that fits over the penis, and a vacuum pump with vacuum release trigger to evacuate air from the cylinder. As the air is removed from the chamber the negative pressure allows blood engorgement of the penis. When a sufficient erection occurs for vaginal penetration a Reliant constriction ring (K980567) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The kit comes with a set of 4 ring sizes. The pumps' ability to create a vacuum is limited by an automatic vacuum release valve so it cannot exceed the known safe limit of 17 in. Hg. The rings are elastic pharmaceutical quality material. The ring safety removal loops were performance tested for strength.

The provided text describes a 510(k) summary for a medical device called "Charger" (VCD - vacuum constriction device) and its corresponding FDA clearance letter. However, it does not contain information about specific acceptance criteria for device performance, nor details about a study designed to prove the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Reliant VCD) and confirming safety aspects.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

Key Takeaways from the Text:

• Device Purpose: The Charger is used by impotent men to allow them to resume sexual intercourse.
• Mechanism: It's a vacuum constriction device that creates negative pressure to engorge the penis with blood. A constriction ring retains the erection.
• Safety Features:
  • Automatic vacuum release valve limits pressure to a safe limit of 17 in. Hg.
  • Constriction rings are made of elastic pharmaceutical quality material.
  • Ring safety removal loops were "performance tested for strength." (Details of this "performance test" are not provided).
  • All warnings and precautions from the FDA internet address are included.
• Equivalence: The device is deemed substantially equivalent to the Reliant VCD (K980567). This regulatory assessment does not typically require a new, full-scale clinical trial to establish performance against pre-defined acceptance criteria, but rather a demonstration that the new device is as safe and effective as the predicate.

Given this, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I answer many of the specific questions about a performance study, because the document does not contain this information.

Missing Information/Cannot Answer Based on Provided Text:

• Acceptance Criteria Table: No specific performance metrics (e.g., success rate of achieving erection, duration of erection, user satisfaction scores) or acceptance criteria for those metrics are mentioned.
• Sample Size (Test Set) and Data Provenance: No clinical study involving a "test set" to evaluate device performance is described. The mention of "ring safety removal loops were performance tested for strength" refers to a mechanical test, not a clinical one.
• Number of Experts/Qualifications (Ground Truth): Not applicable, as no clinical study with ground truth established by experts is described.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No information suggests such a study was performed, or any effect size for human readers improving with AI assistance (which is irrelevant for this non-AI device).
• Standalone Performance Study: No details on a standalone performance study in a clinical setting against specified criteria are provided. The "performance test" of the loops is a partial engineering test, not a full device performance study.
• Type of Ground Truth: Not applicable, as no clinical ground truth is established or discussed.
• Sample Size for Training Set: Not applicable, as this is not an AI/ML device requiring a training set.
• How Ground Truth for Training Set was Established: Not applicable.

What the Text Does Tell Us (Limited Scope):

The provided text describes a 510(k) premarket notification which focuses on demonstrating substantial equivalence to a previously legally marketed device (Reliant VCD). This regulatory pathway generally relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as the predicate device, rather than requiring a detailed clinical performance study with predefined acceptance criteria.

The only "performance test" mentioned is for the "ring safety removal loops for strength," which is a device component's mechanical integrity test, not a study of the overall clinical performance of the VCD system in achieving erections in patients. The text states the pump could not exceed 17 in. Hg., which is a safety limit, not a performance criterion for efficacy.

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The Reliant Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Reliant Charger (RC-1)" and its "Indications for Use." This document is a regulatory approval letter and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was approved based on its substantial equivalence to a predicate device already on the market, not necessarily through a new study demonstrating its efficacy against specific acceptance criteria. The 510(k) process often relies on comparison to existing legally marketed devices rather than requiring de novo clinical trials with predefined acceptance criteria.

Therefore, I cannot provide the requested information for the Reliant Charger (RC-1) based solely on these documents. The information requested (acceptance criteria, performance data, study details, expert qualifications, etc.) is typically found in a clinical study report or a more detailed technical submission, not in the FDA's regulatory approval letter itself.

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