Indications for Use for Zirconia Implants, Cover Screw and Healing Abutment:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.
Indications for Use for Zirconia Bases:
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
- Intended for single use;
- Zirconia implants provided sterile via Ethylene Oxide; Zirconia Base abutments are provided sterile but require end user sterilization via moist heat following cementation of the restoration and before use
- All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide), except for the Zirconia Implant Cover Screw and the Basal Screw, which is manufactured of titanium alloy according to ASTM F136 standard;
- ZiLock prosthetic interface with internal indexer;
- Apically tapered implant with trapezoidal thread profile;
- Implant provided with sand-blasted, acid etched surface finish to facilitate osseointegration.
- The final finished Zirconia Base abutments are two-piece abutments composed of a zirconia base bottom-half bonded to a CAD-CAM zirconia top-half.
The provided text describes a medical device submission (K201491) for the Neodent Implant System - Zirconia Implant System to the FDA. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance results for a new AI/software device.
Therefore, the requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies cannot be extracted from this document as it pertains to a different type of medical device submission (dental implants and their components) and regulatory pathway (510(k) for substantial equivalence).
The document details the comparison of the subject device (Neodent Implant System - Zirconia Implant System) to predicate and reference devices in terms of indications for use, technological characteristics, and performance data from various tests. However, these are evaluations against established standards and comparisons to existing devices, not metrics of an AI's performance.
Here's what can be extracted, though it doesn't directly answer the detailed questions about AI performance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of acceptance criteria for software performance in the typical sense (e.g., sensitivity, specificity, AUC). Instead, it presents a comparison of technological characteristics and states that the "tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices" in mechanical testing.
Here's a summary of the performance data presented, which implies meeting an "equivalent" performance to predicates rather than specific numerical acceptance criteria for a new software.
| Performance Area | Reported Device Performance |
|---|---|
| Biocompatibility | Representative samples of each device subjected to tests per ISO 10993-1, ISO 10993-5, ISO 10993-12, and ISO 10993-18. (Implied acceptance is successful completion according to these standards). |
| Mechanical Testing | Dynamic Fatigue Test (per ISO 14801): "exhibit a level of performance equivalent to that reviewed for the predicate devices." |
| Wear Assessment (Titanium/Ceramic contacting pieces): "concluded of comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection." | |
| Torsion Test: Performed to evaluate static torsional loading. (Implied acceptance is meeting design specifications and being comparable to predicates). | |
| Insertion Test: Performed to evaluate insertion torque in sawbones materials (bone type I, II, III, IV). (Implied acceptance is meeting design specifications and being comparable to predicates). | |
| Sterilization | Achieved a "Sterility Assurance Level of 1x10⁻⁶" via Ethylene Oxide per ISO 11135-1. Residuals according to ISO 10993-7. Not represented as "pyrogen free." |
| MRI Testing | Done according to documents presented in K182620 (a previously cleared device for MRI compatibility). (Implied acceptance is being MRI compatible as per the reference device). |
| Shelf Life | 5 years. Packaging assessment per ISO 11607-1, with maintenance of sterile barrier and sealing integrity confirmed by Dye Penetration, Sealing Strength, and Bubble Test after Accelerated Aging. |
No information is available regarding points 2-9 as they are specific to AI/software device studies to establish performance against a ground truth. This document is a 510(k) summary for a physical dental implant system and components, establishing substantial equivalence to existing devices.
§ 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.