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    K Number
    K992416
    Device Name
    PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
    Manufacturer
    U.S. BIOMATERIALS CORP.
    Date Cleared
    1999-10-15

    (87 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K852682,K970321
    Predicate For
    K030682,K031073,K033994,K040278,K051443,K053387,K063549,K073070,K112428
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for oral/maxillofacial and dental intraosseous defects use. It is to be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (DFDBA demineralized freeze dried bone) or may be mixed with each as a bone graft extender. Typical uses include:

    • Periodontal/Infrabony defects .
    • Ridge augmentation .
    • Extraction sites .
    • Cranio-facial augmentation .
    • Cystic cavities .
    • . Sinus lifts
    Device Description

    PerioGlas® is a synthetic osteoconductive particulate bone/void filler that is intended for oral/maxillofacial and dental intraosseous defects use. The material composed of Bioglass® (24.5 wt % CaO, 24.5 wt % Na20, 45 wt % SiO2, 6 wt % P2O5) with a particle size range of 90-710 um. It is supplied sterile in a Tyvek sealed PET-G cup that is protected by a shrink wrapped cardboard box. It is mixed with sterile water (saline) or the patient's own blood to form a wet sandy paste which is applied to the defect.

    AI/ML Overview

    The provided text describes the device testing and clinical data supporting the safety and efficacy of PerioGlas®. However, it does not explicitly define acceptance criteria in a structured table or directly compare performance against such criteria. Instead, it describes comparative studies and observations of equivalence or improvement.

    Here's an interpretation of the implied acceptance criteria and reported performance, along with other requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not provide a formal table of acceptance criteria. However, based on the conclusions and device testing sections, the implied acceptance criteria revolve around substantial equivalence to predicate devices and demonstrating safe and efficacious use.

    Acceptance Criterion (Implied)Reported Device Performance
    Animal Models:
    Substantial equivalence in rate of bone formation to predicate devices.PerioGlas® was substantially equivalent to hydroxylapatite predicate devices in the rate of bone formation.
    Substantial equivalence in amount of bone formed to predicate devices.PerioGlas® was substantially equivalent to hydroxylapatite predicate devices in the amount of bone formed.
    Substantial equivalence in biomechanical properties (e.g., peak compressive loads, compressive stiffness) to predicate devices and normal bone.PerioGlas® was substantially equivalent to hydroxylapatite predicate devices and normal bone in biomechanical properties including peak compressive loads and compressive stiffness.
    Improved bone formation or graft site augmentation as a graft extender.As a graft extender with autogenous bone, bone formation or graft site augmentation was greater for the mixture of bone and Bioglass® than for either alone in both rabbit calvarial and canine split-rib models.
    Clinical Data:
    No significant differences in clinical parameters (e.g., CAL, PDR, osseous fill) when used alone or with bone graft mixtures in periodontal applications.Periodontal studies showed no significant differences between PerioGlas®/Bone graft mixtures and PerioGlas® alone for CAL, PDR, and osseous fill. (Note: suggested synergistic effect when combined).
    Safe and efficacious use in various dental/oral/maxillofacial defects (e.g., ridge augmentation, extraction sites, sinus augmentation, cystic defects).Ridge augmentation, extraction site, sinus augmentation, cystic defect, and general osseous reconstruction studies demonstrated safe and efficacious use of PerioGlas® alone and/or as a graft extender.
    Acceptable overall implant success rate (when applicable as a graft extender for ridge augmentation, extraction sites, sinus augmentation).A four-clinician retrospective study reported an overall implant success rate of 91%, indicating safe and efficacious use as a bone graft extender for ridge augmentation, extraction sites, and sinus augmentation.
    Support for safety and efficacy from documented case reports with clinical evaluations and radiographs.Documented case reports representing all summarized categories with clinical evaluations and radiographs support the safety and efficacy of PerioGlas® alone or as a bone graft extender in bone/void filling.
    Overall conclusion of performing as well as or better than predicate devices.The animal and/or clinical performance, safety and effectiveness data show that the device performs as well as or better than predicate hydroxylapatite devices as an osteoconductive bone void filler both alone or as a bone graft extender.

    2. Sample size used for the test set and the data provenance

    Animal Models:

    • Rabbit calvarial defect model: Sample size not specified.
    • Canine split-rib model: Sample size not specified.
    • Provenance: Not explicitly stated, but implies studies conducted in animal laboratories.

    Clinical Data:

    • Prospective, retrospective, and case studies: Sample sizes for individual clinical studies are not specified, except for:
      • Four clinician retrospective study: Focuses on implant success rate; the number of patients/cases included in this study is not specified, only the number of clinicians.
    • Provenance: The text indicates "Clinical Data including prospective, retrospective and case studies were reviewed and evaluated," suggesting a mix of data types from various clinical settings. Specific country of origin is not mentioned.

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

    • Animal Studies: Not explicitly mentioned, but typically, veterinary pathologists or researchers would evaluate outcomes in such studies.
    • Clinical Studies: The "four clinician retrospective study" implies four clinicians were involved in evaluating cases and determining the 91% implant success rate. Their specific qualifications (e.g., "oral/maxillofacial surgeon with X years of experience") are not specified beyond being "clinicians." For other clinical data and case reports, the number and qualifications of experts are not described.

    4. Adjudication method for the test set

    • Not explicitly stated. For the "four clinician retrospective study," it's not described how potential disagreements among the clinicians were resolved or if there was a consensus process. For other clinical data and case reports, no specific adjudication method is mentioned.

    5. 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

    • No. The provided text describes the evaluation of a bone graft material, PerioGlas®, and its performance in animal models and clinical use. It does not describe an AI medical device or a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance for human readers.

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

    • Not applicable. This question pertains to AI/algorithm performance. PerioGlas® is a medical device (bone graft particulate), not an algorithm.

    7. The type of ground truth used

    • Animal Studies: Comparisons against "normal bone" for biomechanical properties, and direct observation of bone formation/graft site augmentation. This could be considered a combination of histological/pathological assessment and biomechanical measurements.
    • Clinical Studies:
      • Periodontal studies: Clinical parameters (Clinical Attachment Level (CAL), Pocket Depth Reduction (PDR), osseous fill) are likely objective measurements taken directly from patients.
      • Implant success rate: This typically relies on established clinical criteria for implant stability, absence of infection, and functional integration, making it an outcomes-based ground truth determined by clinicians.
      • Case reports: These rely on clinical evaluations and radiographs interpreted by clinicians.

    8. The sample size for the training set

    • Not applicable. This question typically applies to machine learning models where a training set is used to develop the algorithm. PerioGlas® is a physical medical device. The animal and clinical studies described serve as testing/validation, not "training."

    9. How the ground truth for the training set was established

    • Not applicable. As above, this pertains to machine learning models.
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