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510(k) Data Aggregation

    K Number
    K223677
    Device Name
    Titanium Abutment Blank Nobel Biocare N1 TCC
    Manufacturer
    Nobel Biocare AB
    Date Cleared
    2023-04-28

    (141 days)

    Product Code
    NHA,CLE,PNP,SEC
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K222288,K122602,K212125,K220339,K222044
    Why did this record match?
    Reference Devices :

    K222288, K122602, K212125, K220339

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

    Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units.

    The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

    Device Description

    The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine.

    All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

    The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific.

    The subject device is available for NP and RP implant platforms.

    The subject device is used by dental healthcare professionals in dental offices and dental laboratories.

    The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109.

    It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient.

    The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.

    AI/ML Overview

    This document is a 510(k) summary for the Titanium Abutment Blank Nobel Biocare N1™ TCC. It is a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared predicate devices.

    Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly provide a table of "acceptance criteria" for the overall device. Instead, it details various non-clinical performance tests conducted and indicates that the device met established performance specifications. The "reported device performance" is described through the outcomes of these tests.

    However, based on the non-clinical test data section and the comparison table (Table 2), we can infer certain performance aspects that were evaluated against reference points (predicates or standards).

    Characteristic / TestAcceptance Criteria (Inferred from Predicate/Standards)Reported Device Performance
    End-User Cleaning and SterilizationIn accordance with FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance... issued March 17, 2015"Validation was conducted and met the guidance specifications.
    BiocompatibilityIn accordance with ISO 10993Testing was conducted, and no new issues regarding biocompatibility were raised.
    Fatigue TestingIn accordance with FDA Guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", issued May 12, 2004, and demonstrated substantial equivalence to predicate/reference devices.Testing conducted on the worst-case system demonstrated substantial equivalence to the predicate and reference devices.
    Software Verification and End-to-end Workflow ValidationApplicable restrictions are in place and cannot be modified by the user; avoidance of damage or modification of implant-abutment connection geometry during milling; locking of restriction zones from user editing.Validation was completed, demonstrating that applicable restrictions are in place and cannot be modified by the user, and showing avoidance of damage/modification of connection geometry, and locking of restriction zones.
    MRI CompatibilityMR Conditional classification (leveraged from K212125).Demonstrated that the subject device is MR Conditional.
    Minimum Wall ThicknessSimilar to predicate (0.4-0.5mm) and existing reference device #2 (0.3mm).NP 0.38mm; RP 0.49mm, deemed substantially equivalent as demonstrated by fatigue testing.
    Minimum Gingiva HeightSimilar to predicate (0.5mm) and existing reference device #1 (0.3mm).0.335mm, deemed substantially equivalent as demonstrated by fatigue testing.
    Minimum DiameterSimilar to predicate (3.0-6.0mm) and reference device #1 (2.52-6.0mm).NP Ø3.21mm; RP Ø3.49mm, deemed similar.
    Minimum Post HeightSimilar to predicate (4mm) and reference device #1 (4mm).4.05mm, deemed similar.
    Maximum Abutment AngulationSimilar to predicate (30°/20°) and reference device #1 (30°).30°, deemed identical.

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

    The document does not explicitly state the numerical sample sizes for each non-clinical test (e.g., number of abutments for fatigue testing, or number of software test cases). It refers to tests being conducted on "the worst-case system" for fatigue testing.

    The data provenance is internal testing conducted by the manufacturer, Nobel Biocare AB. The document does not specify a country of origin for the data itself, but the submitter is based in Sweden. These are retrospective tests conducted to support the premarket notification.

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

    This information is not applicable as the document describes non-clinical engineering and performance testing of a physical and software device, not a diagnostic or AI-driven decision support system requiring expert-established ground truth from patient data.

    4. Adjudication Method for the Test Set

    This information is not applicable for the same reason as point 3.

    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

    An MRMC study was not done. This device is a component for dental implants and does not involve human readers or AI in the context of comparative effectiveness for diagnostic or interpretive tasks.

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

    This concept is primarily relevant for AI/ML-enabled diagnostic or decision-support software. While the device utilizes CAD/CAM software, the "standalone performance" in this context refers to the software's ability to accurately design and a milling machine's ability to accurately produce the customized abutment according to the design parameters and restrictions. The "Software verification and End-to-end workflow validation" addresses this by demonstrating that the software ensures applicable restrictions are in place and cannot be modified by the user, and that damage to the connection geometry is avoided during milling. It implicitly assesses the algorithm's performance within the manufacturing workflow.

    7. The Type of Ground Truth Used

    For the non-clinical tests described:

    • Cleaning and Sterilization: The "ground truth" is adherence to established FDA guidance and validated protocols.
    • Biocompatibility: The "ground truth" is compliance with ISO 10993 standards.
    • Fatigue Testing: The "ground truth" is compliance with FDA guidance for dental implants and abutments and demonstrated substantial equivalence to the mechanical properties of predicate devices. This involves mechanical testing to failure or for a specified number of cycles under defined loads.
    • Software Verification and End-to-end Workflow Validation: The "ground truth" is the established design parameters, manufacturing specifications, and the functionality requirements for the software (e.g., locking restriction zones, avoiding damage to connection geometry). It's based on engineering specifications.
    • MRI Compatibility: The "ground truth" is the established MR Conditional specifications from the referenced K212125 clearance.

    8. The Sample Size for the Training Set

    This information is not applicable. This device is a physical medical device manufactured using a CAD/CAM workflow, not an AI/ML system that requires a "training set" in the conventional sense. The CAD/CAM software would have been developed and validated through its own software lifecycle, but that is distinct from an AI model 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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