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510(k) Data Aggregation

    K Number
    K980332
    Device Name
    MTA MATERIAL
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    1998-02-24

    (27 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K964174
    Predicate For
    K981620
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MTA MATERIAL is indicated for the repair of root canals as an apical plug during Apexification, and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.

    Device Description

    MTA MATERIAL is identical to K964174, Mineral Trioxide Aggregate (found substantially equivalent February 10, 1997). This submission is for a new intended use. MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.

    AI/ML Overview

    This 510(k) submission (K980332) for "MTA MATERIAL" describes a device that is identical in composition to a previously cleared device (K964174, Mineral Trioxide Aggregate) but is seeking clearance for new intended uses. Therefore, the acceptance criteria and performance data presented relate to the suitability of the existing material for these new indications.

    1. Table of Acceptance Criteria and Reported Device Performance

    Since this is a submission for a new intended use of an identical material, the acceptance criteria are implicitly tied to demonstrating the effectiveness of the material for the specified new indications through various in-vitro and animal studies. There aren't explicit quantifiable "acceptance criteria" presented in the manner of a typical performance study for a novel device, but rather a demonstration of biological and functional performance in relevant models.

    Acceptance Criterion (Implicit)Reported Device Performance
    For Non-Apical Root Perforation Repair:
    Ability to effectively seal non-apical (lateral) root perforations, demonstrating less leakage than existing materials.Study: In-vitro extracted tooth model (dye penetration study) comparing MTA MATERIAL to IRM® filling material and amalgam. Performance: MTA MATERIAL showed the least degree of dye leakage. Significantly less leakage (p<0.05) than IRM and amalgam. Even with overfilled or underfilled perforations, MTA MATERIAL had the least dye penetration (p<0.05).
    For Furcal Perforation Repair:
    Ability to promote healing and minimize inflammation in furcal perforations, performing comparably or better than existing materials.Study: In-vivo study with seven dogs, comparing MTA MATERIAL to amalgam. Evaluation included immediate and delayed repair with bacterial contamination. Performance (Immediate Repair): Only 1 of 6 teeth repaired immediately with MTA MATERIAL exhibited inflammation, while all amalgam-filled perforations had often moderate to severe inflammation. 5 of 6 MTA-filled teeth had cemental repair over the material. Performance (Delayed Repair): Inflammation in 4 of 7 MTA-filled teeth, while all amalgam-filled teeth had frequently severe and more extensive inflammation.
    For Apical Plug During Apexification (Ability to serve as an apical barrier):
    Ability to induce hard tissue formation and minimize lesion size at the apex in immature roots, performing comparably or better than existing materials.Study (Exhibit 3): In-vivo study with seven dogs to evaluate apical barrier function in induced periapical lesions. Performance: MTA MATERIAL had the smallest lesions histologically and radiographically among experimental materials and functioned well as a one-step apical plug material in an open apex. Study (Exhibit 4): In-vivo study with dogs comparing MTA MATERIAL to osteogenic protein-1 (OP-1) and calcium hydroxide for hard tissue barrier formation in immature roots. Performance: MTA MATERIAL induced apical hard tissue formation more often than other test materials (p=0.004). The degree of inflammation was lowest for MTA MATERIAL.
    For Biocompatibility/Safety:
    Continued demonstration of biocompatibility and safety for the new intended uses.Performance: MTA MATERIAL is identical to K964174. Prior biocompatibility studies (not detailed in this document) for K964174, along with the animal study performance data provided for the new intended uses, support the safety.

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

    • Non-Apical Root Perforation Repair (Exhibit 1):

      • Test Set Sample Size: "an in-vitro extracted tooth model" - specific number of teeth not provided, but comparisons were made between MTA, IRM, and amalgam groups.
      • Data Provenance: In-vitro study. Country of origin not specified, but typically conducted in a laboratory setting. No indication of retrospective or prospective for this in-vitro model.

    • Furcal Perforations (Exhibit 2):

      • Test Set Sample Size: Seven dogs. Each dog likely provided multiple teeth, as the study mentions "In half of the teeth..." and "all six teeth" or "four of seven teeth."
      • Data Provenance: Prospective in-vivo animal study (dogs). Country of origin not specified.

    • Apical Plug During Apexification (Exhibit 3):

      • Test Set Sample Size: Seven dogs.
      • Data Provenance: Prospective in-vivo animal study (dogs). Country of origin not specified.

    • Apical Plug During Apexification (Exhibit 4):

      • Test Set Sample Size: Not explicitly stated, but "dogs" were used.
      • Data Provenance: Prospective in-vivo animal study (dogs). Country of origin not specified.

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

    For the animal studies, the ground truth was established through histological and radiographic examination. The number and qualifications of the experts performing these evaluations are not specified in the provided text. It is assumed these would be veterinary pathologists or experienced researchers in the field of endodontics, but no explicit details are given.

    4. Adjudication Method for the Test Set

    The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the studies. Given the nature of animal model evaluations (histology, radiology), it's common for a single expert or a panel to evaluate, but the method isn't detailed here.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No. The studies described are not MRMC studies comparing human readers with and without AI assistance. This submission is for a material (MTA MATERIAL), not an AI device.

    6. Standalone (Algorithm Only) Performance Study

    No. This submission is for a material, not an algorithm.

    7. Type of Ground Truth Used

    The ground truth for the performance studies was primarily based on:

    • In-vitro Measurement: Dye penetration (Exhibit 1).
    • Histology: Examination of tissue samples for inflammation, cemental repair, and lesion size (Exhibits 2, 3, 4).
    • Radiography: Assessment of lesion size (Exhibit 3).
    • Hard Tissue Formation: Quantified visually or histomorphometrically (Exhibit 4).

    8. Sample Size for the Training Set

    This submission is for a material, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The performance data presented relates to experimental validation studies for the material itself.

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

    Not applicable, as there is no training set for an AI algorithm. The material's properties and performance are established through scientific studies using the methods described in point 7.

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