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510(k) Data Aggregation

    K Number
    K193212
    Device Name
    DSM Biomedical Dental Bone Graft Plus
    Manufacturer
    DSM Biomedical
    Date Cleared
    2020-09-10

    (294 days)

    Product Code
    NPM
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K170245,K122894
    Why did this record match?
    Device Name :

    DSM Biomedical Dental Bone Graft Plus

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

    The DSM Biomedical Dental Bone Graft Plus is indicated for:

    • Augmentation or reconstructive treatment of the alveolar ridge
    • Filling of infrabony periodontal defects
    • Filling of defects after root resection, apicoectomy, and cystectomy
    • Filling of extraction sockets to enhance preservation of the alveolar ridge
    • Elevation of the maxillary sinus floor
    • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
    • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
    Device Description

    The DSM Biomedical Dental Bone Graft Plus is a non-pyrogenic porous bone mineral and collagen matrix for use in periodontal, oral, and maxillofacial surgery. The DSM Biomedical Dental Bone Graft Plus is composed of anorganic porcine bone granules combined with bovine collagen to form small cylinders. The device is provided in sizes ranging from 100 - 500mg. DSM Dental Bone Graft Plus is supplied sterile by gamma irradiation and is for single use only.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding the "DSM Biomedical Dental Bone Graft Plus." It concerns the substantial equivalence of this new device to a predicate device, not the results of a clinical study demonstrating the device's performance against predefined acceptance criteria for a new AI/software medical device.

    Therefore, I cannot provide the requested information as the document does not contain:

    1. Acceptance criteria and reported device performance (table): The document discusses the equivalence of a bone graft material to a predicate, focusing on material properties, indications for use, and a demonstration in an animal model. It does not present quantitative performance against specific clinical acceptance criteria typically seen for AI/software medical devices (e.g., sensitivity, specificity, AUC).
    2. Sample size and data provenance for a test set: The document mentions an "animal study" but does not detail the sample size (number of animals or cases in a test set), nor does it describe data provenance in terms of country of origin or retrospective/prospective nature, as would be relevant for clinical data in AI/software evaluation.
    3. Number and qualifications of experts for ground truth: This is relevant for AI/software devices whose ground truth is often established by expert consensus. This document pertains to a physical bone graft material, and the ground truth for an animal study would be based on histological or imaging analysis, not expert interpretation of outputs of an AI algorithm.
    4. Adjudication method for the test set: Not applicable for a physical medical device.
    5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a study design specifically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a bone graft material.
    6. Standalone (algorithm only) performance: This is for software, not a physical device.
    7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): While animal study results (likely histological or imaging evidence of bone formation) serve as ground truth for the performance of the bone graft, the nature of "ground truth" establishment for AI/software (e.g., expert reads, pathology reports) is not present.
    8. Sample size for the training set: This refers to AI/machine learning models, which are not discussed in this document.
    9. How ground truth for the training set was established: Also refers to AI/machine learning models.

    The document primarily focuses on establishing "substantial equivalence" of the new bone graft material to an existing one, based on:

    • Non-clinical testing data: Mechanical and physical testing, biocompatibility testing (ISO standards), and pyrogenicity testing.
    • Animal Testing: A canine intrabony defect animal study comparing the new device to the predicate device to evaluate bone healing.

    In essence, this document is a regulatory submission for a physical medical device, not a performance study report for an AI/software medical device.

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