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    K Number
    K243452
    Device Name
    Orthoscan VERSA Mini C-Arm
    Manufacturer
    Ziehm-Orthoscan, Inc.
    Date Cleared
    2025-01-14

    (68 days)

    Product Code
    OXO,JAA,MQB
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K113708,K213113
    Why did this record match?
    Device Name :

    Orthoscan VERSA Mini C-Arm

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Orthoscan VERSA Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgency, traumatology, orthopedic, critical care, or physician office environments.

    Device Description

    The proposed modifications to Ziehm-Orthoscan, Inc. VERSA Mini C-Arm series (which we will refer to internally and in this submittal as Orthoscan VERSA, for distinction from predicate Orthoscan TAU and Orthoscan Mobile DI) retain identical function as the predicate TAU Mini C-arm (K2131130) and predicate Mobile DI (K113708) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees. The system consists of C-arm support attached to the image workstation.

    The changes to the Orthoscan VERSA Mini C-arm X-ray system represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm K213113 and Orthoscan Mobile DI Mini C-arm (K113708). The proposed modifications to the predicate encompass the implementation of a LINUX based operating system upgrade from Ubuntu version 16.04 to Ubuntu version 20.04 and related software revisions, modification to the mechanical design to further facilitate desk top use, revisions to generator printed circuit board to improve power management efficiency, implementation of an alternate generator radiation shielding material to reduce environmental impact of lead and an update to wireless footswitch communication protocol.

    AI/ML Overview

    The provided text describes the Orthoscan VERSA Mini C-Arm, a fluoroscopic X-ray system. The 510(k) summary outlines the device's characteristics, modifications, and the studies conducted to demonstrate substantial equivalence to predicate devices (Orthoscan TAU Mini C-Arm K213113 and Orthoscan Mobile DI Mini C-Arm K113708).

    Acceptance Criteria and Device Performance

    The document does not explicitly present a table of acceptance criteria with numerical performance targets and reported device performance based on objective metrics. Instead, the "acceptance criteria" are implied through the statement that the device was tested to be "certified compliant with 60601-1 ED 3.2 series, including IEC 60601-2-54" and "met all applicable sections of 21 CFR Subchapter J performance standards." These regulatory and consensus standards serve as the de facto acceptance criteria.

    The "reported device performance" is qualitative and comparative, focusing on maintaining or improving image quality and safety compared to the predicate devices.

    Implied Acceptance Criteria and Reported Performance (from the text):

    Acceptance Criteria (Implied)Reported Device Performance
    Compliance with IEC 60601-1 ED 3.2 series, including IEC 60601-2-54 (Medical Electrical Equipment - General requirements for basic safety and essential performance, and particular requirements for medical electrical equipment for X-ray equipment)"The device was tested by certified test laboratory resulting in device being certified compliant with 60601-1 ED 3.2 series, including IEC 60601-2-54."
    Compliance with 21 CFR Subchapter J performance standards (Performance Standards for Diagnostic X-Ray Systems and Their Major Components)"Further, the device met all applicable sections of 21 CFR Subchapter J performance standards."
    Image quality and dose levels (relative to predicate)"The proposed device replicates the features and functions of the predicate devices without impacting image clarity or dose levels."
    "His conclusion was that the image quality at same or similar patient dose rates will result in equivalent or slight improvement in patient care (images) for the proposed modified VERSA device over the predicate device. Therefore, Ziehm-Orthoscan, Inc. believes the VERSA Mini C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Orthoscan TAU (K213113) and Orthoscan Mobile DI (K113708)."
    Usability and User Interface"Usability testing concluded that there were no previously unknown use errors or hazardous situations and no unacceptable residual risks due to the changes in user interface from the predicate device Orthoscan TAU (K213113) and Orthoscan Mobile DI (K113708)."
    Safety and Effectiveness (overall substantial equivalence)"Ziehm-Orthoscan, Inc. considers the proposed modified VERSA Mini C-arm to be as safe, as effective, and performs substantially equivalent to the predicate device Orthoscan TAU Mini C-arm (K213113) and Orthoscan Mobile DI Mini C-arm (K113708) in accordance with its labeling."
    "The proposed modified Ziehm-Orthoscan, Inc. VERSA Mini C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management and controlled by meeting the applicable CDRH 21CFR subchapter J performance requirements, Recognized Consensus Standards, designing and manufacturing under Ziehm-Orthoscan, Inc. Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable regulations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness."

    Study Details:

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

      • Sample Size: "Numerous image comparison sets were taken" using anthropomorphic (PMMA) phantoms and anatomical simulation phantoms. The exact number of images or comparison sets is not specified.
      • Data Provenance: The data was generated through "Non-clinical image and dose lab testing" using phantoms. This implies the data was generated specifically for this study, likely in the US, and is prospective in nature as it involved creating new images with the proposed and predicate devices.

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

      • Number of Experts: "A Radiologist" (singular) performed the assessment.
      • Qualifications: The qualification mentioned is "Radiologist." No further details on experience or specialization are given.

    3. Adjudication Method for the Test Set:

      • Method: "A Radiologist performed an assessment of individual images arranged in groups of image sets." It appears to be a single-reader assessment without an explicit multi-reader adjudication process (e.g., 2+1 or 3+1) mentioned.

    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:

      • Not Applicable: This was not an MRMC study and did not involve AI assistance. The study was a direct image comparison between the modified device and predicate devices performed by a single radiologist.

    5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

      • Not Applicable: This device is an X-ray imaging system, not an AI algorithm. Its performance is assessed through its ability to produce images and meet regulatory standards, with human assessment of image quality.

    6. The Type of Ground Truth Used:

      • Ground Truth: The ground truth for image quality comparison was established by the qualitative "assessment" of the single radiologist, who concluded that the image quality was "equivalent or slight improvement" over the predicate device. This is effectively an expert consensus (single expert) on image quality, derived from images of phantoms. It is not pathology or outcomes data.

    7. The Sample Size for the Training Set:

      • Not Applicable: This is a hardware modification submission for a medical imaging device, not an AI/machine learning device. Therefore, there is no "training set" in the context of data science.

    8. How the Ground Truth for the Training Set Was Established:

      • Not Applicable: As there is no training set mentioned, this question is not relevant to this submission.

    In summary, the substantial equivalence demonstration for the Orthoscan VERSA Mini C-Arm primarily relied on non-clinical bench testing, compliance with international and federal standards, and a qualitative image quality comparison by a single radiologist using phantom images, rather than human clinical studies or complex AI validation methods. The acceptance criteria were broadly defined by compliance with specified regulatory and consensus standards, and the reported performance was a qualitative assessment of non-inferiority or slight improvement in image quality.

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