K Number
K980752
Device Name
XTEND
Date Cleared
1998-05-06

(75 days)

Product Code
Regulation Number
876.5020
Panel
GU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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.

AI/ML Overview

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

Acceptance CriteriaReported Device Performance/Evidence
Safety: Device must be removable within 30 minutes and not cause harm.The rings "MAY be worn for a maximum of thirty minutes before it MUST be removed." This is a critical instruction for safe use. The safety removal loops were "performance tested for strength."
Material Quality: Rings are made of suitable material.The rings "are elastic pharmaceutical quality material."
Kit Completeness: Kit includes necessary components for use and removal.The kit "consists of a set of 4 rings... come with an applicator and ring removal hooks."
Substantial Equivalence: Device is equivalent to a legally marketed predicate device.The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." The predicate device is named: "Reliant ring."
Labeling Compliance: Warnings and precautions are included as per FDA guidelines."All warnings and precautions from the FDA internet address, www.fda.gov/cdch/ode/oxponrig.html, are included in the premarket notification."

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.

§ 876.5020 External penile rigidity devices.

(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.