LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K192007
    Device Name
    TheraBase, TheraBase Ca
    Manufacturer
    Bisco, Inc.
    Date Cleared
    2020-03-17

    (232 days)

    Product Code
    EMA,CLA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K161256,K123265
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Metal crowns, bridges, inlays (includes porcelain-fused -to- metal and composite-to-metal)
      1. Porcelain, Ceramic Crowns, inlays, and onlays (includes alumina and zirconia)
      1. Resin crowns, bridges, inlays, and onlays (resin-based composite-ceramic hybrid)
      1. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
      1. Implant supported restorations
      1. Orthodontic Appliances (brackets, bands)
      1. Lining and basing applications under restorations
    Device Description

    TheraBase and TheraBase Ca are a self-etching, self-adhesive, dual-cured resin luting cement and base/liner that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and non-metal/fiber posts, as well as cast posts) and basing/lining under restorations. TheraBase is a paste/paste, fluoride- and calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. TheraBase Ca is a paste/paste, calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. They are easy-to use, require only a short chair time, and produce a good bond to most dental materials. The cements are available in a Natural shade. They are radiopaque, allowing for easy identification on radiographs.

    AI/ML Overview

    The document you provided is a 510(k) summary for a dental device, TheraBase / TheraBase Ca. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

    Crucially, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or a comparative effectiveness study with human readers.

    Instead, it presents performance data for the physical and mechanical properties of the dental cement, comparing them to established ISO standards or internal benchmarks.

    Therefore, I cannot fulfill all parts of your request as it pertains to an AI/ML device with ground truth, expert adjudication, or MRMC studies. However, I can extract the relevant information regarding the device's physical and mechanical properties and present it in your requested format.

    Here's the breakdown based on the provided document:

    1. A table of acceptance criteria and the reported device performance

    Physical / Mechanical PropertyAcceptance Criteria (from document)Reported Device Performance (TheraBase)Reported Device Performance (TheraBase Ca)
    Bond StrengthHigher than or equivalent to 6.9 MPa, and bond to all substrates (Modified ISO 29022 and Gel-Cap method)Higher than or equivalent to 6.9 MPa, and bond to all the substrates.Higher than or equivalent to 6.9 MPa, and bond to all the substrates.
    Diametral Tensile StrengthGreater than or equal to 32 MPaGreater than or equal to 32 MPa.Greater than or equal to 32 MPa.
    Film Thickness< 50 µm (ISO 4049:2009 requirement)< 35 µm< 35 µm
    Flexural StrengthGreater than the minimum flexural strength of 50 MPa (ISO 4049:2009)Greater than the minimum flexural strength of 50 MPa.Greater than the minimum flexural strength of 50 MPa.
    RadiopacityGreater than or equal to 2.0 (ISO 4049:2009)Greater than or equal to 2.0.Greater than or equal to 2.0.
    Working Time / Setting TimeWorking time: > 1 minute at room temperature (22±1°C)Setting time: < 5 minutes at 37±1°CWorking time: > 1 minute at room temperature (22±1°C)Setting time: < 5 minutes at 37±1°CWorking time: > 1 minute at room temperature (22±1°C)Setting time: < 5 minutes at 37±1°C
    Compressive StrengthEquivalent to or greater than 189 MPaEquivalent to or greater than 189 MPa.Equivalent to or greater than 189 MPa.
    Calcium ReleaseGreater than or equal to 3.3 µg Ca/cm²Greater than or equal to 3.3 µg Ca/cm².Greater than or equal to 3.3 µg Ca/cm².
    Fluoride Release(TheraBase only): Explicit criteria not stated, but "releases fluoride" is the performance metric.Releases fluoride.N/A (Does not contain fluoride)

    Regarding the AI/ML specific questions:

    1. Sample size used for the test set and the data provenance: Not applicable. This document describes physical material testing, not an AI/ML algorithm's performance on a test set of data.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties are measured objectively according to standard protocols (e.g., ISO standards), not by expert consensus on data.
    3. Adjudication method: Not applicable.
    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 is a dental cement, not an AI assistant for human readers.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used: Not applicable in the context of AI/ML. The "ground truth" for the material properties are the objective measurements obtained through standardized physical and chemical tests (e.g., ISO standards for film thickness, flexural strength, radiopacity).
    7. The sample size for the training set: Not applicable. This document refers to a physical product, not a machine learning model.
    8. How the ground truth for the training set was established: Not applicable.

    Summary of the study that proves the device meets the acceptance criteria (based on the document):

    The device's performance was evaluated through a series of physical and mechanical property tests. These tests were conducted according to established industry standards such as ISO 29022 (modified), ISO 4049:2009, and the Gel-Cap method for bond strength. The document also mentions a Biocompatibility evaluation conducted using ISO 7405:2008 and ISO 10993-1, including an Oral Toxicity Study (10 mice, 14 days) which found the materials non-toxic.

    The studies collectively demonstrated that both TheraBase and TheraBase Ca met or exceeded the specified acceptance criteria for each tested property (bond strength, diametral tensile strength, film thickness, flexural strength, radiopacity, working/setting time, compressive strength, calcium release, and fluoride release for TheraBase). The conclusion is that the devices are substantially equivalent to the predicate devices based on these chemical composition characteristics, biocompatibility, and physical properties.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1