LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K063321
    Device Name
    D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
    Manufacturer
    NEKS TECHNOLOGIES, INC.
    Date Cleared
    2007-03-30

    (148 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K991098,K043156,K023367
    Why did this record match?
    Device Name :

    D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138

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

    Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus.

    Device Description

    The D-Carie probe contains optical fibers that read the optical scattering characteristic of dental carie thru healthy enamel structure above (the marginal ridge over the vulnerable inteproximal area) and convert it into an electrical signal. From that signal a computer analysis identifies the dental caries. The device can be in either in a new handheld or a tabletop (original) format with the addition or not of the calculus detection feature of the Detectar.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Neks Technologies, Inc. D-Carie/Detectar device based on the provided text:

    Acceptance Criteria and Device Performance

    The FDA 510(k) summary does not explicitly state numerical acceptance criteria in a table format. Instead, it indicates that the device's performance for interproximal caries detection is "at least equivalent in efficiency to the FOTI/DIFOTI devices or visual examination."

    Acceptance Criteria (Stated Goal)Reported Device Performance
    At least equivalent in efficiency to FOTI/DIFOTI devices or visual examination for interproximal caries detection.Found to be "at least equivalent in efficiency to the FOTI/DIFOTI devices or visual examination" for interproximal caries detection.
    D-Carie and Detectar performance equivalent when combined in a single unit.Bench tests, in vitro, and in vivo trials showed "D-Carie and Detectar performance are equivalent to when they these functions are combined in a single unit."
    Handheld format (Mini) equivalent to tabletop version in all important aspects.Bench tests, in vitro, and in vivo trials showed "the handheld format (Mini) is at least equivalent to the tabletop version originally presented in all important aspects."

    Study Details

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

      • Test Set Sample Size: Not explicitly stated. The document mentions "in vitro and in vivo studies" but does not quantify the number of cases or subjects.
      • Data Provenance: Not specified, but given the company is based in Quebec, Canada, it's plausible data was collected in Canada, though this is not confirmed. The document doesn't mention if it was retrospective or prospective.

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

      • Number of Experts: Not specified.
      • Qualifications: Not specified.

    3. Adjudication method for the test set:

      • Not mentioned.

    4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

      • No MRMC comparative effectiveness study is described where human readers improve with AI vs. without AI assistance. The comparison is between the device and existing methods (FOTI/DIFOTI, visual examination, bitewings x-rays) as a standalone diagnostic aid.

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

      • Yes, the studies described assess the D-Carie/Detectar device as a standalone aid for diagnosis. The phrase "computer analysis identifies the dental caries" suggests an algorithmic analysis.

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

      • "bitewings clichés or histological observation as a gold standard" were used. This indicates a combination of imaging (bitewings) and definitive histological examination (pathology).

    7. The sample size for the training set:

      • Not specified. The document only refers to "in vitro and in vivo studies" and "bench tests" without providing sample sizes for any training that might have occurred for the "computer analysis."

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

      • Not specified. Given the lack of detail on a training set, the method for establishing its ground truth is also not provided.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1