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    K Number
    K133733
    Device Name
    WINSIX Implant System
    Manufacturer
    BIOSAF IN S.R.L.
    Date Cleared
    2015-01-28

    (418 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K073458,K053384,K050406,K063286,K063341,K033922,K073628,K061477
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    WINSIX Implant System is indicated for single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

    Device Description

    The family of WINSIX Implant System is intended for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The family of WINSIX Implant Systems can also be used for immediate or early load implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single tooth and/or appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). The family of WINSIX Implant System includes the following devices: Fixtures and Abutments. The fixtures are the endosseous dental implantable devices produced in commercially pure titanium (grade 4), available in following models: K Model, KT Model, Conical Model, TTi Model with various diameters and lengths in order to meet diverse anatomical requirements. They are single use devices, supplied sterile and cannot be re-sterilised. The abutments give at the physician a complete prosthetic solutions in order to use the WINSIX implant system as intended. They have been divided in followings main groups: COVER SCREWS, HEALING SREWS, and ABUTMENTS (straight, angulated, millable, and flat shift).

    AI/ML Overview

    The provided text does not describe an AI medical device. It is a 510(k) premarket notification for a dental implant system (WINSIX Implant System). Therefore, the requested information regarding acceptance criteria, study details, and AI-related performance measures (like human reader improvement with AI or standalone algorithm performance) is not available in the document.

    The document discusses the mechanical, biocompatibility, sterilization, and packaging shelf life tests performed on the dental implant system to demonstrate its substantial equivalence to predicate devices. However, these are not directly comparable to the metrics typically used for assessing AI-powered medical devices.

    Here's an overview of the performance data presented, which pertains to the physical dental implant device, not an AI system:

    1. Table of Acceptance Criteria and Reported Device Performance (for the dental implant system, not an AI device):

    Test CategoryAcceptance CriteriaReported Device Performance
    BiocompatibilityNot Cytotoxic; Satisfying requirements for intracutaneous reactivity test.WINSIX abutments are: Not Cytotoxic; Satisfying the requirements for intracutaneous reactivity test.
    Surface Validation (MRS)Chemical composition same as predicate; Absence of accumulations, residuals, stains; Not cytotoxic.Chemical composition of micro-rough surface is exactly the same as the predicate device. SEM analyses guarantee total absence of accumulations, residuals, and stains. Cytotoxicity test points out micro-rough surface is not cytotoxic. Overall results demonstrate equivalent performance and chemical characteristics as predicate devices.
    Surface Validation (FCC)Typical composition of Ti; Absence of accumulations, residuals, stains; Not cytotoxic.FCC surfaces have the typical composition of Ti; SEM analyses guarantee total absence of accumulations, residuals, and stains. Cytotoxicity test points out FCC surfaces are not cytotoxic. Overall results support technical and performance features.
    Mechanical TestsAble to resist 5,000,000 cycles (per ISO 14801:2007 guidance).Worst case chosen is able to resist to 5,000,000 cycles.
    Sterilization & Packaging Shelf LifeSAL level of 10^-9; 5-year shelf life.Sterilized with gamma ray sterilization to assure a SAL level of 10^-9. Shelf life granted is 5 years.

    The following information is not present in the document as it pertains to AI/algorithm-based devices:

    • Sample size used for the test set and the data provenance: Not applicable.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    • Adjudication method for the test set: Not applicable.
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
    • If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
    • The sample size for the training set: Not applicable.
    • How the ground truth for the training set was established: Not applicable.

    The document's purpose is to establish substantial equivalence of a physical dental implant device to existing predicate devices under its 510(k) premarket notification.

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