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K Number
K211090
Device Name
ZENEX Implant System
Manufacturer
Izenimplant Co., Ltd.
Date Cleared
2022-04-13

(366 days)

Product Code
DZE,NHA
Regulation Number
872.3640
Type
Traditional
Panel
DE
Reference & Predicate Devices
K182091,K181138,K161604
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ZENEX Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region

Device Description

ZENEX Implant System is consisted with ZENEX Fixtures (ZENEX MULTI Fixture and ZENEX PLUS Fixture) and Izenimplant Abutment System. The implant fixtures come in two unique systems, the I-System and the T-System, each with their own abutment compatibilities.

  1. ZENEX Fixtures: This product is a dental implant which is put into the alveolar bone in order to support, or maintain the prosthetic tooth or denture when a patient's teeth are partially lost. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA surface. As a dental implant which is put into the alveolar bone to support the dental prostheses such as the artificial teeth which are used to rehabilitate a patient's masticatory function, it is used as a substructure which is implanted into the human body. This product is a dental implant fixture to be inserted into the bone and is intended to be used in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations. It is connected to the upper structure with Internal Hex fastening structure. In the surface treatment, machined surface was sanded with alumina (Al2O3) powder and acid (hydrochloric acid, sulfuric acid) etching process was applied to the surface to increase the contact surface with the bone. ZENEX PLUS is a design that adds a micro-groove at the collar compared to ZENEX MULTI.

  2. Izenimplant Abutment System: Izenimplant Abutment System is compatible with the ZENEX Fixtures (ZENEX MULTI Fixture, ZENEX PLUS Fixture). Izenimplant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Separate sets of abutments are presented for compatibility with each I-System and T-System. Some subject abutments undergo Titanium Nitride (TiN) coating. Dental Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

AI/ML Overview

The provided text is a 510(k) Summary for the ZENEX Implant System, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical characteristics rather than presenting a study of its performance against specific acceptance criteria for an AI/ML-enabled device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-enabled device. The questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this document describes a traditional medical device (dental implant).

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted on the dental implant system (e.g., sterilization validation, packing validation, biocompatibility, mechanical properties, surface treatment, endotoxin batch test). The acceptance criteria for these tests are typically defined by recognized standards (e.g., ISO, ASTM, FDA guidance documents) rather than specific metrics like sensitivity or specificity for an AI algorithm.

Summary of what is present:

  • Acceptance Criteria for Non-Clinical Testing: The document states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the acceptance criteria are adherence to the relevant ISO, ASTM, and FDA guidance documents for each specific non-clinical test (e.g., ISO 11137 for sterilization validation, ISO 10993 for biocompatibility, ISO 14801 for fatigue testing).
  • Reported Device Performance: The document confirms that "the performance test reports are supported to the substantial equivalence of the subject device, the performance test reports are provided to demonstrate substantial equivalence of the subject devices." It lists various tests performed:
    • Sterilization Validation (Gamma and User Moist Heat)
    • Packing Validation (Shelf-life and Integrity)
    • Biocompatibility Test (ISO 10993-1, 10993-5, FDA Guidance)
    • Performance (Mechanical properties, Fatigue testing per ISO 14801)
    • Surface Treatment Test (SEM, EDS, ICP, IC analysis for SLA; thickness, abrasion, roughness for TiN coating)
    • MR Environment Condition review
    • Endotoxin Batch Test (USP, USP, ANSI/AAMI ST72)
  • No ML/AI Component: The device is a dental implant system. There is no mention of any AI or machine learning component, therefore the subsequent questions about AI/ML specific study designs are not relevant.

The requested table and other specific information related to an AI/ML device would be empty or inapplicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Focus):

Test CategoryAcceptance Criteria (Implied by adherence to standards)Reported Device Performance
SterilizationAdherence to ISO 11137-1:2006+A2:2018, ISO 11137-2:2013, ISO 11137-3:2017 (Gamma). Adherence to ISO 11138-1:2017, ISO 11138-3:2017, ISO 17665-1:2006, ISO/TS 17665-2:2009, ISO 11737-1:2018, ISO 11737-2:2019 (Moist Heat).Tests performed and met criteria, demonstrating appropriate sterilization.
Packing ValidationAdherence to ISO 11607-1:2019, ISO 11607-2:2019, ISO 11137, ASTM F1980, ASTM F88, ASTM F1140, ASTM F1929, ASTM F1140.Stability and effectiveness of packaging demonstrated over time.
BiocompatibilityAdherence to ISO 10993-1, ISO 10993-5, and FDA Guidance "Use of International Standard ISO 10993-1".Tests performed and met criteria, demonstrating material safety and absence of undue biological risks.
Performance (Mechanical)Adherence to "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801 for fatigue testing.Mechanical properties tests performed, including fatigue testing on worst-case constructs. Results met criteria, demonstrating effectiveness and substantial equivalence to predicate device performance.
Surface TreatmentDemonstration of surface modification characteristics including removal of manufacturing residuals (SLA) or physical properties like thickness, abrasion, and roughness (TiN).SEM, EDS images, ICP, IC analysis (SLA) and surface characteristic data (TiN) provided; demonstrated substantial equivalence.
MR EnvironmentAdherence to FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque.
Endotoxin BatchEndotoxin level within the limit of 20 EU/device, adhering to USP, USP, ANSI/AAMI ST72, and FDA Guidance.Endotoxin level determined to be within the limit for the test item.

Inapplicability of AI/ML-specific questions:

  1. Sample size for the test set and data provenance: Not applicable. This refers to physical device testing, not data-driven model evaluation.
  2. Number of experts and qualifications for ground truth: Not applicable for non-clinical lab testing.
  3. Adjudication method for the test set: Not applicable.
  4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
  5. Standalone (algorithm-only) performance: Not applicable.
  6. Type of ground truth used: Not applicable. Ground truth for a physical device is established by validated measurement techniques and adherence to engineering and material standards.
  7. Sample size for the training set: Not applicable.
  8. How the ground truth for the training set was established: Not applicable.

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.