(5 days)
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The ITI tapered implant is an addition to the currently distributed ITI Dental Implant System. The tapered implant is a solid screw with a TPS (titanium plasma sprayed) coating or an SLA surface (grit blasted then acid etched). The implants are composed of Grade 4 commercially pure titanium and is available in a range of lengths and diameters. This submission also includes abutments and healing caps which are used as accessories to dental implants.
The provided documentation describes a 510(k) premarket notification for the ITI® Dental Implant System, specifically the ITI tapered implant. This submission focuses on establishing substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against acceptance criteria. Therefore, several aspects of your request, such as specific acceptance criteria and detailed study results, cannot be fully addressed from the given text.
Based on the provided information, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Identical intended use to predicate device. | The ITI tapered implant's intended use is identical to the cleared ITI self-tapping implant: "immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients." |
| Material Composition | Same material composition as previously cleared ITI implants. | The subject tapered ITI implant has the same material composition (Grade 4 commercially pure titanium) as previously cleared ITI implants. |
| Surface Treatment | Same surface treatment as previously cleared ITI implants. | The tapered implant has the same surface treatment (TPS coating or SLA surface) as previously cleared ITI implants. |
| Design | Similar design to previously cleared ITI self-tapping implant. | The design of the tapered implant is similar to, and in some respects identical to, the previously cleared self-tapping ITI implant. |
| Substantial Equivalence | Demonstrated substantial equivalence to identified predicate devices (K003271, K990342). | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
Explanation: The "acceptance criteria" in this context are primarily based on demonstrating substantial equivalence to predicate devices, as this is a 510(k) submission. Therefore, the "reported device performance" is essentially the applicant's claim and the FDA's concurrence that the new device meets the criteria for substantial equivalence in terms of intended use, materials, design, and surface treatment. No specific quantitative performance metrics from a formal study are provided in this document.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission for substantial equivalence. It does not present a clinical study with a "test set" or data provenance in the way one would for a new clinical efficacy or safety trial. The assessment is based on a comparison to existing predicate devices and their known performance, along with material and design similarities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This document does not describe the establishment of a "ground truth" through expert review for a clinical test set. The "ground truth" for a 510(k) is effectively the established safety and efficacy profile of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication method is described in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention or present any MRMC comparative effectiveness study, nor does it discuss AI assistance in the context of human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This document is about a physical dental implant device and does not involve an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" in the context of this 510(k) submission is the established safety and effectiveness profile of the legally marketed predicate devices (ITI Self-Tapping Implants K003271 and ITI Temporary Abutment K990342). The new device's characteristics (intended use, materials, design, surface treatment) are compared against these known, approved devices to demonstrate substantial equivalence.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/algorithm submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set described in the document.
In summary: This 510(k) document is a regulatory submission focused on demonstrating that a new dental implant (ITI tapered implant) is substantially equivalent to existing, legally marketed predicate devices. It achieves this by showing identical intended use and similar material composition, surface treatment, and design. It does not present data from a new clinical study with acceptance criteria, test sets, or ground truth establishment as would be seen in a clinical trial report or an AI device submission.
§ 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.