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K Number
K061676
Device Name
RIGIDOMETER, MODEL DIR-4U
Manufacturer
UROAN 21
Date Cleared
2006-12-27

(196 days)

Product Code
LIL
Regulation Number
N/A
Type
Traditional
Panel
GU
Reference & Predicate Devices
K000194
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Uroan DIR-4U Rigidometer measures penile axial rigidity.

Device Description

The DIR-4U Rigidometer consists of an instrument and attached sensor that measures penile axial rigidity. It has been designed, so that men can use this instrument in the privacy of their homes to measure their penile axial rigidity.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Uroan DIR-4U Rigidometer, based on the provided text:

Acceptance Criteria and Device Performance

The provided text for K061676 does not explicitly state quantitative acceptance criteria for the Uroan DIR-4U Rigidometer. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Uroan Model DIR-101C Rigidometer). The supporting information mentions "Bench, biocompatibility and clinical testing supported the substantial equivalency of the DIR-4U Rigidometer," but does not provide specific performance metrics or thresholds.

Therefore, the table below reflects that the primary "acceptance criterion" was substantial equivalence to the predicate, and the "reported device performance" is that it met this criterion as determined by the FDA.

Acceptance Criteria (Quantitative/Qualitative)Reported Device Performance
Substantial equivalence to predicate device (Uroan Model DIR-101C Rigidometer) in measuring penile axial rigidity.Achieved substantial equivalence, as determined by FDA. The device uses the same sensor and principle of operation as the predicate.

Study Details

Based on the provided text, detailed information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not included. The document is a 510(k) summary and FDA clearance letter, which typically provides high-level information rather than granular study methodology.

Here's what can be inferred or explicitly stated from the text:

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

    • Sample Size: Not specified.
    • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "clinical testing," but no details.

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

    • Not specified.

  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not specified.

  4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No indication of an MRMC study. This device is described as a direct measurement tool (penile axial rigidity monitor) rather than an AI-assisted diagnostic or interpretive system. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this type of device.

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

    • The device is a physical instrument that measures penile axial rigidity and uses indicator lights to show the result. It operates as a "standalone" device in the sense that it doesn't require human interpretation of complex outputs; it directly displays a measured value via indicator lights. However, the term "standalone algorithm performance" typically refers to AI/software performance. Since this is a hardware measurement device, this question is not directly applicable in the typical AI context. The document indicates it "measures penile axial rigidity" and "uses indicator lights to indicate the measured axial rigidity," which implies its performance is intrinsic to its measurement capability.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not specified. Given it's a measurement device for "penile axial rigidity," the ground truth would likely be established through a gold-standard physical measurement technique, but this is not detailed.

  7. The sample size for the training set:

    • Not applicable as this is a physical measurement device, not an AI/machine learning algorithm that requires a "training set."

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

    • Not applicable for the same reason as above.

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