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510(k) Data Aggregation

    K Number
    K083279
    Date Cleared
    2009-01-28

    (82 days)

    Product Code
    Regulation Number
    888.3045
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    CALTRIX RESORBABLE BONE VOID FILLER

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

    CALTRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or created from traumatic injury to the bone. The pellets resorbs and is replaced with new bone during the healing process. When used in the spine, the device is limited to posterolateral fusion procedures only.

    Device Description

    The CALTRIX Resorbable Bone Void Filler are made of high purity pharmaceutical grade calcium sulfate. It is bio-degradable, biocompatible and radiopaque pellets. CALTRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the CALTRIX Resorbable Bone Void Filler, structured to answer your questions:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly list specific numerical acceptance criteria for performance beyond conforming to standards. It states the device "conforms to applicable standards." The "reported device performance" is primarily presented as meeting these standards and having similar performance characteristics to the predicate device.

    Acceptance Criteria CategorySpecific Acceptance Criteria (from text)Reported Device Performance (from text)
    BiocompatibilityConforms to ISO 10993 series: Biological evaluation of medical devicesDevice is "bio-degradable, biocompatible." Conforms to ISO 10993 series.
    Material PurityConforms to ASTM F2224-03: Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical ImplantsMade of "high purity pharmaceutical grade calcium sulfate." Conforms to ASTM F2224-03.
    SterilizationConforms to ANSI/AAMI/ISO 11137 Sterilization of Health Care Products - Radiation SterilizationSupplied sterile. Conforms to ANSI/AAMI/ISO 11137.
    Resorption & Bone Growth(Implied: Resorbs and is replaced by new bone within a clinically acceptable timeframe, and acts as an osteoconductive scaffold.)"It is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process."
    Safety & Effectiveness(Implied: No new questions of safety or effectiveness compared to the predicate device.)"Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." "Substantially equivalent to the predicate devices."
    Intended Use(Implied: Device meets the requirements for its indicated uses.)Meets the stated intended use: "to fill bony void or gaps of the skeletal system... that are not intrinsic to the stability of the bone structure," with specific limitations for spinal use.

    2. Sample Size Used for the Test Set and the Data Provenance

    The document mentions "bench testing contained in this submission." However, it does not specify any sample sizes for this testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). The study primarily relies on demonstrating conformity to existing standards and comparison to a predicate device.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    There is no information provided in the text regarding the number or qualifications of experts used to establish a ground truth for any test set. The submission focuses on compliance with established material and sterilization standards, and substantial equivalence to a predicate device.

    4. Adjudication Method for the Test Set

    As there is no mention of a clinical test set or human-derived data analysis requiring adjudication, there is no information on any adjudication method.

    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

    This section is not applicable. The device described is a medical implant (bone void filler), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

    This section is not applicable. The device is a physical product, not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's effectiveness and safety is primarily based on:

    • Adherence to recognized industry standards: ISO 10993, ASTM F2224-03, ANSI/AAMI/ISO 11137.
    • Demonstrated material properties: "high purity pharmaceutical grade calcium sulfate," "bio-degradable, biocompatible, and radiopaque pellets," "osteoconductive," "resorbed in approximately 14 weeks and be replaced by new bone."
    • Substantial equivalence to a legally marketed predicate device: "Osteo-Link Bone Void Filler Pellets (K060809)." The performance and safety profile of the predicate device serves as an established baseline.

    8. The Sample Size for the Training Set

    There is no mention of a training set. This device is a physical product, not an AI model, and therefore the concept of a training set does not apply in this context.

    9. How the Ground Truth for the Training Set Was Established

    As there is no training set, this question is not applicable.

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