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510(k) Data Aggregation

    K Number
    K013570

    Validate with FDA (Live)

    Device Name
    OSSEOTITE DENTAL IMPLANTS
    Manufacturer
    IMPLANT INNOVATIONS, INC.
    Date Cleared
    2001-12-17

    (52 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K983347,K980549,K935544
    Predicate For
    K014235,K022009,K022113,K022258,K031055
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

    Device Description

    The proposed OSSEOTITE® implants are identical to the predicate implants currently on the market, K983347, K980549, K935544.

    AI/ML Overview

    The provided 510(k) summary for the OSSEOTITE® Dental Implants does not describe an AI/ML powered device, therefore, many of the requested details about acceptance criteria, study methods, and ground truth are not applicable. This document is a summary for a traditional medical device (dental implants) and focuses on substantial equivalence to predicate devices rather than performance metrics typically associated with AI.

    However, I can extract the relevant information presented in the document pertaining to the closest equivalent of "acceptance criteria" and the study that supports it.

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device PerformanceStudy Type
    No significant difference in long-term cumulative survival of OSSEOTITE® implants in smokers and non-smokers (compared to previous labeling which might have included smoking as a warning/precaution).A meta-analysis of clinical data indicated no significant difference in the long-term cumulative survival of OSSEOTITE® in smokers and non-smokers.Meta-analysis of clinical data
    Long-term survival of OSSEOTITE® implants in smokers to be greater than that of 3i machined implants in smokers.A second analysis demonstrated that the long-term survival of OSSEOTITE® implants in smokers is greater than that of 3i machined implants in smokers.Meta-analysis/Clinical data analysis
    Substantial equivalence of OSSEOTITE® implants with revised Instructions for Use labeling to predicate OSSEOTITE® implants.The presented data supports the conclusion that the OSSEOTITE® implants with revised Instructions for Use labeling are substantially equivalent to the predicate OSSEOTITE® implants.Comparison to predicate devices

    Detailed Study Information (where applicable and extractable)

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

      • Sample size: Not explicitly stated. The document refers to a "meta-analysis of clinical data" and "a second analysis" but does not provide the number of patients or implants included in these analyses.
      • Data provenance: Not explicitly stated. It is inferred that the data is clinical, but the country of origin, whether retrospective or prospective, is not mentioned.

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

      • Not applicable/Not provided. The "ground truth" here is implied to be clinical outcomes (implant survival), which would be derived from patient data, not expert consensus on an image or diagnostic output.

    3. Adjudication method for the test set:

      • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or diagnostic assessments. This study relies on clinical outcomes data.

    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 not an AI/ML device, and no MRMC study was performed or is relevant to this submission.

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

      • Not applicable. This is not an AI/ML device.

    6. The type of ground truth used:

      • Clinical outcomes data (specifically, long-term cumulative survival of dental implants).

    7. The sample size for the training set:

      • Not applicable/Not provided. Dental implants do not typically have "training sets" in the context of AI/ML. The "meta-analysis of clinical data" would represent the overall dataset analyzed for the study.

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

      • Not applicable. The "ground truth" (clinical survival) would have been established through follow-up observations of patients who received the implants in clinical studies. The details of how this was measured (e.g., specific criteria for survival, follow-up period) are not provided in this summary.
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