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510(k) Data Aggregation

    K Number
    K121843
    Device Name
    NP-CAST ABUTMENT SYSTEM
    Manufacturer
    OSSTEM IMPLANT CO.,LTD
    Date Cleared
    2012-12-11

    (169 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K112045,K110308,K081575
    Predicate For
    K140507,K150669,K160670,K192263
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

    Device Description

    NP-Cast Abutment System is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constraints. After customization, be sure to use only dental nonprecious metal (Co-Cr-Mo alloy) for casting to make the prosthesis When cast a prosthesis with NP-Cast Abutment System, Post height above the transmucosal collar of NP-Cast Abutment System has to be taller than 4mm and Maxmimum angulation has to be less than 30°. The NP-Cast Abutment System consists of Abutment and Abutment Screws.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device (NP-Cast Abutment System), not a study report detailing performance against acceptance criteria for an AI/ML diagnostic or predictive device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or available in this document.

    However, I can extract information related to the device's non-clinical testing which serves as the "study" for this type of device and the "acceptance criteria" through comparison with predicate devices.

    1. Acceptance Criteria and Reported Device Performance

    For this type of device (a dental abutment), "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices and meeting relevant performance standards, particularly mechanical safety. The document focuses on showing that the NP-Cast Abutment System is equivalent in material, indication for use, design, and technological characteristics to its predicates.

    Acceptance Criteria CategorySpecific Acceptance Criteria (Inferred)Reported Device Performance
    Substantial EquivalenceThe device should be similar to predicates in intended use, technology, claims, material composition, and performance characteristics.The NP-Cast Abutment System is "substantially equivalent in design, function and intended use" to the SimpleLine II Abutment System (K112045) and two OSSTEM Prosthetic Systems (K110308, K081575). The materials (Co-Cr-Mo Alloy) and intended use are identical or highly similar to predicates.
    BiocompatibilityThe device's materials must be biocompatible for their intended use within the human body."Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable international and US regulations." (Specific results not detailed, but conformance is stated).
    Mechanical Fatigue StrengthThe device must withstand expected physiological loading conditions without fracture or failure, as evaluated by relevant testing standards (e.g., "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment"). Specific acceptance limits would be defined by the standard and comparison to predicate performance for "worst-case scenario." Post height above transmucosal collar > 4mm and maximum angulation < 30 degrees for custom casting."Fatigue testing was conducted according to the 'Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment' with the worst case scenario of the NP-Cast Abutment System." (Specific results not detailed, but testing was performed to the standard). Additional performance constraints are provided for custom casting: Post height above transmucosal collar > 4mm and maximum angulation < 30 degrees.
    Design SpecificationsMust meet defined dimensional and functional parameters for prosthetic restoration.The system includes various models with specified connections (Mini Hex, Mini Non Hex, Standard Hex, Standard Non Hex, Mini Octa, Mini Non Octa, Standard Octa, Standard Non Octa) and diameters (Ø4.0mm, Ø4.5mm, Ø5.05mm, Ø6.3mm). This demonstrates adherence to design parameters.

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

    • Sample Size: Not applicable in the context of a clinical test set. For non-clinical (fatigue) testing, the sample size would typically be specified by the relevant ASTM or ISO standard used, but it is not explicitly reported in this document.
    • Data Provenance: Not applicable for clinical data. For manufacturing and testing, the company's address is listed as Busan, Republic of Korea.

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

    • Not applicable as this involves non-clinical (mechanical and biocompatibility) testing, not diagnostic performance assessed against a ground truth established by experts. The "ground truth" for mechanical testing is compliance with a recognized standard.

    4. Adjudication Method for the Test Set

    • Not applicable.

    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

    • No MRMC clinical study was performed or submitted. The document explicitly states: "No clinical studies are submitted." This device also does not involve AI.

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

    • Not applicable. This is a physical dental device, not an algorithm.

    7. The type of ground truth used

    • For biocompatibility: Adherence to international and US regulations/standards for material safety.
    • For mechanical fatigue: Compliance with the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and related ASTM/ISO standards. The "ground truth" is passing the specified mechanical performance thresholds.

    8. The Sample Size for the Training Set

    • Not applicable. There is no training set for an AI/ML algorithm.

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

    • Not applicable. There is no training set for an AI/ML algorithm.
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