LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K193369
    Device Name
    Xelis Dental 2.0
    Manufacturer
    Infinitt Healthcare Co.,Ltd.
    Date Cleared
    2020-04-14

    (131 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K102684
    Predicate For
    K230607
    Why did this record match?
    Reference Devices :

    K102684

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

    Xelis Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, refering physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software. Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.

    Device Description

    Xelis Dental 2.0, is a software device used for viewing and manipulating DICOMcompliant images from CBCT (Cone beam computed tomography). Xelis Dental 2.0 is an advanced, easy-to-use dental software providing various tools to dental facilities. Xelis Dental 2.0. provides a practical tool for 3D (three dimensional) and 2D (two dimensional) viewing to optimize dental treatment planning and placement. This stand-alone, Windows-compatible software provides 3D volume rendering (VR), multi-planar reconstruction (MPR) and image segmentation. Xelis Dental 2.0, offers dental implant planning, canal draw, bone density assessment, segmentation and report functionalities. The subject device (Xelis Dental 2.0) is based upon the predicate device, Xelis Dental, (K102684). Xelis Dental 2.0 has updated the software from the predicate to reflect current computer technology and also has a number of new/improved functions. Both the subject device and the predicate are from INFINITT Healthcare Co. Ltd.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Xelis Dental 2.0 device, structured to answer your specific questions.

    Based on the provided document, Xelis Dental 2.0 is a Picture Archiving and Communications System (PACS) software, which is traditionally not subject to the same kind of performance studies as AI/CADe medical devices that provide diagnostic interpretations or measurements. The document indicates that this is software for display, 3D visualization, 2D analysis, MPR functions, and pre-operative planning for dental implants. Its premarket notification (K193369) focuses on demonstrating substantial equivalence to a predicate device (Xelis Dental, K102684) rather than proving performance against specific clinical acceptance criteria in a comparative effectiveness study.

    The document emphasizes that "The new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices."

    Therefore, many of your requested items will be "Not Applicable" or refer to general software validation rather than clinical performance for diagnostic accuracy.

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria (Implied from the document)Reported Device Performance and Evidence
    Functional EquivalenceDevice functions similarly to the predicate device (Xelis Dental, K102684) in general function, application, and intended use.Reported: "The subject device and primary predicate are both PACS, which are indicated for dental medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use."
    Demonstrated through a detailed comparison table.
    Safety and EfficacyAny new/improved functions or technological advancements do not introduce new or increased safety risks and maintain equivalent efficacy.Reported: "Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices."
    Specific differences (e.g., Computer platform & OS, Image Layout, Common toolbar edits, Implant report, Annotation List, DICOM Report Send, Arch List, Bone density color map, Canal Thickness, Auto Project Save) are addressed individually, stating no impact on safety or efficacy.
    Software ValidationAll input functions, output functions, and actions performed by Xelis Dental 2.0 meet predetermined acceptance criteria from a Validation Test Plan.Reported: "The Xelis Dental 2.0. PACS has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by Xelis Dental 2.0, and followed the process documented in the Validation Test Plan. ... Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."
    Regulatory ComplianceAdherence to relevant standards and regulations (e.g., DICOM, risk management, cybersecurity, software lifecycle processes).Reported: "The following Standards were used to develop Xelis Dental 2.0, and the device has met all the requirements listed in the Standards except for inapplicable requirements: ISO14971, NEMA PS 3.1 - 3.20 (DICOM), IEC 62304, FDA Guidance on Cyber Security, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

    Additional Requested Information:

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

      • Test Set Sample Size: Not explicitly stated as a separate clinical test set for diagnostic performance. The validation testing likely involved a set of DICOM images and system functionalities, but specific numbers for "cases" are not provided. The focus is on software functionality and equivalence, not diagnostic accuracy of an AI algorithm on a patient dataset.
      • Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The testing appears to be internal software validation ("assessed and tested at the factory").

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

      • Not Applicable. The approval is for a PACS and visualization software, not a diagnostic AI/CADe device that requires expert-established ground truth for performance evaluation in a clinical context. The "ground truth" for software validation would be adherence to functional specifications and absence of bugs, not a medical diagnosis.

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

      • Not Applicable. As this is not a clinical study assessing diagnostic performance, an adjudication method for ground truth is not relevant.

    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. An MRMC study was not done. Xelis Dental 2.0 is described as a visualization and planning tool, not an AI or CADe device intended to assist human readers in making a primary diagnosis or as a detection aid where reader improvement would be measured.

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

      • Not Applicable. Xelis Dental 2.0 is a software application for human users to review and manipulate images; it is not an "algorithm" with a standalone diagnostic performance claim.

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

      • Not Applicable in the clinical diagnostic sense. The "ground truth" for this device's validation relates to whether the software functions as designed, displays images correctly, and performs its visualization and planning tasks accurately, as per its specifications and intended use. This is validated through internal software testing against requirements.

    7. The sample size for the training set:

      • Not Applicable. Xelis Dental 2.0 is not described as an AI/machine learning device that requires a training set. It is a traditional medical imaging software.

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

      • Not Applicable. As it’s not an AI/ML device, there's no training set or ground truth in that context.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1