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510(k) Data Aggregation

    K Number
    K192153
    Device Name
    Portux CAD/CAM Disc
    Manufacturer
    New Stetic S.A.
    Date Cleared
    2019-11-07

    (90 days)

    Product Code
    EBG,EBI,MQC
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K180578
    Why did this record match?
    Applicant Name (Manufacturer) :

    New Stetic S.A.

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

    For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.

    • Provisional anterior and posterior crowns & bridges
    • Implant and abutment supported prosthetics.
    • Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)
    Device Description

    The Subject device are discs made of poly methyl methacrylate (PMMA), a known material used in the dental field due their physical-chemical and biocompatibility properties. These discs are intended use with dental CAD/CAM equipment to produce a variety of provisional prosthetic restorations or devices. The discs are available in a variety of disc configurations to accommodate different commercial dental CAD/CAM machines fixture requirements. In addition, the CAD/CAM discs are available in a wide variety of heights and colors to facilitate matching of patient tooth or tissue shades.

    AI/ML Overview

    The given text is a 510(k) Summary for a dental device (Portux CAD/CAM Disc). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

    However, this document does not describe acceptance criteria for an AI/software device, nor does it provide information about a study proving an AI device meets acceptance criteria. Instead, it focuses on the physical and chemical properties of a dental disc material and its equivalence to another dental disc.

    Therefore, most of the requested information regarding AI device performance, sample sizes for AI model testing, expert involvement in ground truth establishment, MRMC studies, and training set details cannot be extracted from this document.

    The only "acceptance criteria" and "performance data" mentioned in the document relate to the physical properties of the PMMA material, not the performance of an AI or software algorithm.

    Here's a breakdown of what can and cannot be answered based on the provided text:

    What can be extracted:

    • Acceptance Criteria (for the dental material, not AI): The document lists performance testing standards (ISO 10477 and ISO 20795) and specific physical property requirements for the dental disc material. These are akin to "acceptance criteria" for the material itself.
    • Reported Device Performance (for the dental material, not AI): The document provides the device's measured physical properties alongside the ISO standard requirements.

    What cannot be extracted (as it pertains to AI/software device studies, which are not described in this document):

    • A table of acceptance criteria and reported device performance for an AI/software device.
    • Sample sizes used for the test set for an AI/software device.
    • Data provenance for an AI/software device test set.
    • Number of experts used to establish ground truth for an AI/software device.
    • Qualifications of experts for an AI/software device.
    • Adjudication method for an AI/software device test set.
    • If a multi-reader, multi-case (MRMC) comparative effectiveness study was done for an AI/software device.
    • Effect size of human readers improving with AI vs. without AI assistance.
    • If a standalone (algorithm only) performance study was done for an AI/software device.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
    • The sample size for the training set for an AI/software device.
    • How the ground truth for the training set was established for an AI/software device.

    Based on the provided text, here is the information that can be extracted, framed within the context of the physical dental disc material:

    1. A table of acceptance criteria and the reported device performance (for the dental material):

    Physical PropertyAcceptance Criteria (ISO Standards)Reported Device Performance (Portux CAD/CAM Disc)Equivalence Discussion
    Flexural StrengthISO 10477 ≥50 MPa
    ISO 20795 ≥65 MPa> 65 MPaSubstantially Equivalent (Slightly different values doesn't affect intended use; meets both ISO standards)
    Flexural ModulusISO 20795 ≥2000 MPa> 2000 MPaSubstantially Equivalent (Slightly different values doesn't affect intended use; meets ISO standard)
    Water AbsorptionISO 10477 ≤40 µg/mm³
    ISO 20795 ≤32 µg/mm³≤32 µg/mm³Substantially Equivalent (Slightly different values doesn't affect intended use; meets both ISO standards)
    Water SolubilityISO 10477 ≤7.5 µg/mm³
    ISO 20795 ≤1.6 µg/mm³≤1.6 µg/mm³Substantially Equivalent (Slightly different values doesn't affect intended use; meets both ISO standards)
    Residual monomer contentISO 20795 ≤2.2%≤2.2 %Substantially Equivalent (Slightly different values doesn't affect intended use; meets ISO standard; comparable to predicate
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