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510(k) Data Aggregation

    K Number
    K210855
    Device Name
    Straumann BLX Implant System
    Manufacturer
    Institut Straumann AG
    Date Cleared
    2021-06-21

    (90 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K200586,K150938,K181703
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Straumann BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX implants can placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are connected to the implants through the corresponding abutment components.

    Device Description

    The BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and finished with the SLA or SLActive surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø3.75 and Ø4.0 mm with a length of 6 mm and are presented with one prosthetic platform: RB (Regular Base). The internal connection and the prosthetic platform are identical for all subject devices.

    AI/ML Overview

    This is a 510(k) summary for a dental implant system, which primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive clinical study performance against specific acceptance criteria. Therefore, the requested information (acceptance criteria, specific study details like sample size, ground truth methodology, expert qualifications, effect size with AI assistance, MRMC study, and training set information) is not typically found in this type of submission.

    The document describes bench testing to demonstrate equivalence, not clinical performance with acceptance criteria in the way one might see for an AI/ML medical device.

    However, I can extract information related to the performance testing described:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Dynamic Fatigue TestingNo failure after 2 million cycles in saline (2 Hz, 37°C)"demonstrated the subject BLX Implants System is equivalent to the predicate and reference devices."
    Insertion TorqueAdequate insertion torque in different bone classes"could be proven that there is an adequate insertion torque in different bone classes"
    BiocompatibilityMeets ISO 10993-1:2009 and FDA Guidance"no new issues regarding biocompatibility were raised" as materials are identical to predicate.
    Sterility Assurance Level (SAL)10⁻⁶Validated to SAL of 10⁻⁶
    PyrogenicityTesting limit of 20 EU/deviceMeets pyrogen limit specifications via LAL Endotoxin Analysis
    Shelf Life5 years sterility5 years for devices provided sterile

    2. Sample Size and Data Provenance:

    • Bench Testing (Dynamic Fatigue, Insertion Tests): The document does not specify exact sample sizes for these tests. The nature of these tests (comparing against established predicates) generally involves a representative number of units to ensure consistency and meet engineering standards, but it's not a clinical trial with human subjects.
    • Data Provenance: Not applicable in the context of clinical study data with geographic origin. The data is generated from laboratory bench tests.

    3. Number of Experts and Qualifications for Ground Truth:

    • Not applicable. These are bench tests for mechanical and material properties, not clinical studies requiring expert consensus for ground truth establishment.

    4. Adjudication Method for the Test Set:

    • Not applicable. This relates to clinical data review, not bench testing.

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

    • No. This is not a study involving human readers or AI assistance. It's a submission for an endosseous dental implant based on substantial equivalence to existing devices, primarily supported by bench testing.

    6. Standalone (Algorithm Only) Performance:

    • No. This device is a physical medical implant, not an algorithm or AI system.

    7. Type of Ground Truth Used:

    • For mechanical/material properties: The "ground truth" is defined by established engineering and biological standards (e.g., ISO for fatigue, ISO for biocompatibility, FDA guidance for pyrogenicity and sterility).
    • For substantial equivalence claim: Comparison against the characteristics and performance of legally marketed predicate devices.

    8. Sample Size for the Training Set:

    • Not applicable. This is not an AI/ML device that requires a training set.

    9. How the Ground Truth for the Training Set was Established:

    • Not applicable.

    In summary: This 510(k) submission demonstrates substantial equivalence for a dental implant system primarily through non-clinical bench testing rather than large-scale clinical studies with human subjects or AI performance evaluations. The "acceptance criteria" listed are engineering and biological performance targets derived from recognized standards and comparison to predicate devices, not diagnostic accuracy metrics.

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