(64 days)
Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Honorst Implant System are devices made of titanium 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, and to restore the patients chewing function. Honorst Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantial equivalent to the predicate devices in the market. Honorst Implant System offers two different implants in SLA treatment and also offers two different onebody implants in SLA treatment. The Milling Abutment is only to be hand milled and not undergo CAD/CAM fabrication.
This is a 510(k) premarket notification for a medical device called "Honorst Implant System," a dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about the performance criteria of a device or a study proving that it meets them in the way described in your request.
The document is a submission to the FDA for market clearance, arguing that the new device is as safe and effective as devices already on the market. It describes the Honorst Implant System's features and compares them to predicate devices, particularly the "CHAORUM Implant System (K160536)" by the same manufacturer.
Here's why the requested information cannot be extracted from this document:
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Acceptance Criteria and Reported Device Performance: This document does not list explicit performance acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity, etc.) for the Honorst Implant System. Instead, it argues that the device is "substantially equivalent" to existing devices based on similar design, materials, and intended use. The "Performance Data" section (page 6) states that "The verification/validation testing activities were conducted on the subject device for the modifications made" and that a "worst-case analysis demonstrated that the primary predicate remains the worst-case scenario with respect to fatigue testing." It also explicitly states that "Sterilization, shelf life, endotoxin, and biocompatibility testing were not conducted since the materials, surface treatments, packaging, and sterilization have not changed from the primary predicate device (K160536) and the device modifications do not raise a concern for the worst case for these tests." This means the performance data is primarily focused on mechanical aspects and demonstrating that changes did not negatively impact the existing safety/effectiveness profile, rather than establishing new performance metrics.
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Sample Size for Test Set and Data Provenance: Not applicable. There is no clinical trial or performance study detailed with a "test set" in the context of AI/diagnostic device performance. The testing mentioned is engineering/materials-based.
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Number of Experts and Qualifications: Not applicable. There are no experts establishing ground truth in the context of diagnostic performance for this type of device submission.
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Adjudication Method: Not applicable.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a physical dental implant system, not an AI-assisted diagnostic tool.
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Standalone Performance (Algorithm only): Not applicable. This is a physical device.
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Type of Ground Truth Used: Not applicable in the context of AI/diagnostic performance. The "ground truth" here is implied by the established safety and effectiveness of the existing predicate devices through their long-standing use and prior FDA clearances. The applicant validates the new device's engineering and material properties against industry standards and comparisons to these predicate devices.
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Sample Size for Training Set: Not applicable. There is no AI component or training set in this submission.
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How Ground Truth for Training Set Was Established: Not applicable.
In summary, this document is a regulatory submission for market clearance based on substantial equivalence, not a performance study that measures and reports against acceptance criteria for a diagnostic/AI device.
§ 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.