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510(k) Data Aggregation

    K Number
    K220022
    Device Name
    TRATE Dental Implant System
    Manufacturer
    Trate AG
    Date Cleared
    2022-04-04

    (89 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K132125,K162482
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TRATE Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

    Device Description

    The TRATE Dental Implant System is an endosseous dental implant and abutment system consisting of screw-type implants manufactured of Titanium Alloy (Ti6AIV4. acc. to EN ISO 5832-3/ASTM F136). The implants are blasted with HAP / TCP for surface roughening, acid-etched and anodized. The cover screws, abutment fixation screws and abutments are made of Titanium Alloy (Ti6A14V). Some subject devices are surfaced anodized. TRATE Dental Implants are two-piece implants: TRATE Dental Implant System implant type is a two-component ROOTFORM implant with combined thread and tapered connection is intended for surgical placement in the upper or lower jaw to support crowns, bridges or overdentures in edentulous and partially edentulous jaws of patients in order to restore the patients chewing for single or multiple unit restorations. TRATE Dental Implant System implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the TRATE Dental Implant System, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    For medical devices like dental implants, "acceptance criteria" usually refer to performance specifications that the device must meet, often demonstrated through specific tests. The document mainly outlines a series of non-clinical tests rather than a statistical performance metric against clinical criteria.

    Acceptance Criteria (Test/Standard)Reported Device Performance / Evaluation Method
    Biocompatibility (ISO 10993)Testing conducted to evaluate biocompatibility. (Implied: Meets ISO 10993 standards).
    Bacterial Endotoxin Levels (ANSI/AAMI ST72)Batch testing conducted on samples of water used in manufacturing (bimonthly) and from sterilized product (quarterly) to demonstrate levels < 20 EU/device.
    Sterility Levels (ISO 11137-1, -2 for implants; ISO 17665-1, -2 for abutments)Implant sterilization validation conducted according to ISO 11137-1, -2. Abutment sterilization conducted according to ISO 17665-1, -2. (Implied: Meets standards).
    Total Organic ContentTesting conducted. (Implied: Meets acceptable levels).
    Dynamic Compression-Bending Fatigue (ISO 14801)Dynamic fatigue testing performed on worst-case subject device constructs. Additional collar lengths for abutments were addressed through bench testing (ISO 14801). (Implied: Demonstrated acceptable mechanical performance and similar maximum loads to predicate devices).
    Surface Analysis (SEM & EDX)Surface evaluation performed. (Implied: Confirmed the blasted, acid-etched, and anodized surface treatment).
    Package Integrity and Accelerated Aging (ISO 11607)Testing conducted. (Implied: Demonstrates package maintains integrity and sterility over time). Differences in sterile barrier packaging were addressed via labeling mitigations.
    MR Compatibility (FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque)Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods, Terry O., et al. 2019) to evaluate the entire system (all compatible implant bodies, dental abutments, and fixation screws). Reported: MR Conditional.

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

    • The document does not specify a separate "test set" in the context of clinical performance or a distinct dataset for algorithm validation. The evaluations performed are non-clinical bench and lab tests.
    • For the non-clinical tests (biocompatibility, endotoxin, sterility, mechanical fatigue, etc.), specific sample sizes for each test are not provided in this summary.
    • The data provenance is non-clinical bench testing and scientific rationale, implying laboratory-controlled environments rather than patient data from a specific country or retrospective/prospective study.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    • This information is not applicable as the evaluation is based on non-clinical testing and comparison to predicate devices, not human expert assessment of clinical data.

    4. Adjudication Method

    • This information is not applicable as there is no clinical data or expert review process described that would require an adjudication method.

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

    • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The submission focuses on substantial equivalence through non-clinical testing and technological comparison.

    6. Standalone Performance Study

    • Yes, a form of "standalone" performance was done in the sense of the device itself undergoing various non-clinical performance and safety tests (e.g., mechanical fatigue, sterility, biocompatibility). However, this is not a standalone algorithm-only performance evaluation, as this is a physical medical device, not an AI/software device.

    7. Type of Ground Truth Used

    • The "ground truth" for the non-clinical tests is established by conformance to recognized international standards and methodologies (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility, ISO 11137 for sterility) and scientific rationale. For substantial equivalence, the "ground truth" is largely the performance and characteristics of the legally marketed predicate devices.

    8. Sample Size for the Training Set

    • This information is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set.

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

    • This information is not applicable for the same reason as point 8.
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