(87 days)
Abutments are designed for use in dental implant surgery. The 3i system includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants and abutments. The implants are surgically inserted into upper and/or lower jawbones and upon healing an abutment may be placed on the implant, extending the implant's coronal aspect through the soft tissues and into the oral cavity. A prostheses is then attached to the Abutment.
3i's various abutment systems have historically been constructed of CP Titanium per ASTM specifications. This material change covers all styles and sizes of transmucosal abutments as listed herein, and pertains exclusively to a new alloy, that will be used in the production of the abutment components; from CP Titanium, to a Titanium, Niobium, Zirconium (Ti-13Nb-13Zr).
Abutment systems include: Standard Abutments, Emergence Profile Abutments, Conical Abutments, Pre-Angled Abutments, Temporary Screws, Tapered Abutments, Temporary Healing Abutments, Abutment Posts, Overdenture Abutments, Temporary Cylinders.
This document is a 510(k) submission for a material change (addition) to transmucosal abutments for a dental implant system. It details the change from CP Titanium to a Titanium, Niobium, Zirconium (Ti-13Nb-13Zr) alloy. The document focuses on regulatory compliance and demonstrating substantial equivalence, rather than presenting a study with specific acceptance criteria and performance data in the context of device accuracy or effectiveness for a diagnostic or AI-driven medical device.
Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this type of regulatory submission document.
However, I can extract the relevant information regarding the material change and its justification:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Criteria/Justification | Reported Device Performance/Justification |
|---|---|---|
| Material Composition | New alloy: Titanium, Niobium, Zirconium (Ti-13Nb-13Zr) | Ti-13Nb-13Zr (Ti1313) is a titanium alloy consisting of Titanium, Niobium, and Zirconium. |
| Physical Properties | Improvement in fatigue properties over commercially pure titanium. | "Extensive physical and biological testing of the Alloy has been performed and the material is currently used in orthopedic applications." "Physical testing by both the developer of Til313 and Implant Innovations, Inc. indicates an improvement in fatigue properties over commercially pure titanium which has previously been used in the construction of the transmucosal abutment and retaining screw systems." |
| Biological Safety | Biologically tested and currently used in orthopedic applications. | "Extensive physical and biological testing of the Alloy has been performed and the material is currently used in orthopedic applications." (Implies biological acceptance for previous orthopedic clarity) |
| Sterilization | Sterilization by Co60 Irradiation at a minimum dose of 25.0 kGy (2.5 mRads), achieving a Sterility Assurance Level (SAL) of 10^(-6). Validation per AAMI Guidelines and Harmonized European Standard EN 552. Irradiation by FDA registered facility. | Sterilization (where indicated) shall be accomplished using Co60 Irradiation, at a minimum dose of 25.0 kGy (2.5 mRads), achieving a Sterility Assurance Level (SAL) of 10(-6). Validation of sterilization process is accomplished as specified by the AAMI (Association for the Advancement of Medical Instrumentation) Guidelines and the Harmonized European Standard EN 552. Irradiation sterilization is accomplished by an FDA registered irradiation sterilization facility. |
| Manufacturing Process | No change in manufacturing or processing operations from those used with original titanium material. | "For Abutment Systems included in this submission, there is no change in manufacturing or processing operations from those employed using the original titanium material." |
| Design | No change in component design. | "The material change has not alter the previously obtained substantial equivalence determination, for the various abutment systems. This is based on the fact that there has been no change in component design, other than the proposed change to Til313, and there are no other changes in manufacturing or processing." |
| Indications for Use | No change in indications for use. | "3i is making no claims relative to these changes at this time, and indications for use of the various abutment systems have not changed." |
| Substantial Equivalence | The material change does not alter the previously obtained substantial equivalence determination. | "The material change has not alter the previously obtained substantial equivalence determination, for the various abutment systems. This is based on the fact that there has been no change in component design, other than the proposed change to Til313, and there are no other changes in manufacturing or processing." |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This document describes a material change for existing devices, relying on prior clearances and material testing, not a new clinical study with a "test set" of patients for performance evaluation in the context of device accuracy or effectiveness for a new diagnostic claim. The "test set" mentioned refers primarily to physical and biological testing of the alloy, not human clinical data for a device performance study as typically understood in AI/diagnostic device submissions. The text mentions "physical testing by both the developer of Til313 and Implant Innovations, Inc." but doesn't specify sample sizes for this testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in this context, would relate to material properties and biological response, not clinical diagnoses made by experts on a patient test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This is relevant for clinical studies involving human interpretation or outcomes, not for material property validation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document is a 510(k) submission for a material change in a dental implant component, not an AI-driven medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a medical device component material change, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here relates to the physical and biological properties of the Ti-13Nb-13Zr alloy itself, as determined by laboratory testing and previous use in orthopedic applications. It's grounded in material science and biocompatibility standards rather than clinical patient outcomes for this specific submission, as the claim is substantial equivalence after a material change.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning submission.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/machine learning 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.