(382 days)
BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established.
Full OSSEOTITE® Certain® II Dental Implants are substantially equivalent to BIOMET 3i's OSSEOTITE® Dental Implants which have been previously cleared in K063286 and K063341. The device is an endosseous dental implant made of Commercially Pure Titanium. It is available in various lengths and diameters with a straight-walled implant body, Incremental Cutting Edge (I.C.E.) with apical taper, and a Full OSSEOTITE® surface. It has an Internal Hexagon Connection for mating with BIOMET 3i Certain® Restorative Components. The implants are packaged in a sterile tray with a cover screw and sterilized by Gamma Irradiation with a shelf life of 5 years.
This document describes the 510(k) summary for the Full OSSEOTITE® Certain® II Dental Implant, focusing on its substantial equivalence to predicate devices rather than a study with a traditional AI-specific acceptance criteria framework. Therefore, many of the typical categories for AI/ML performance studies (like sample size for test sets, expert ground truth, MRMC studies, or training set details) are not directly applicable or reported in this type of submission.
Here's an analysis of the provided text based on your request, with a focus on what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on design verification testing, ensuring proper device functioning and substantial equivalence to legally marketed predicate devices. The performance is demonstrated by meeting these engineering and material standards, rather than statistical performance metrics for diagnostic accuracy.
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material | Commercially Pure Titanium (same as predicate) | Commercially Pure Titanium. |
| Thread Design | Same thread design (pitch, thread angle, minor/major diameters) as various predicate BIOMET 3i Straight-Walled or Tapered implants. | For Ø3.25 & Ø4.0mm: Same as predicate Straight-Walled. For Ø5.0 & Ø6.0mm: Same as predicate Tapered, and same thread dimensions as predicate Straight-Walled. |
| Implant Surface | Full OSSEOTITE® (same as predicate) | Full OSSEOTITE®. |
| Biocompatibility | Yes (same as predicate) | Yes. |
| Mechanical/Structural Integrity | Meet criteria from cyclic fatigue and static angle bend testing. Conform to FDA Guidance Document - Special Control Class II Root-Form Dental Implants (May 2004). | Stated to have successfully conducted design verification and performance testing as indicated by risk analysis. Results "demonstrate that the BIOMET 3i Full OSSEOTITE® Certain® II Dental Implants are substantially equivalent to their predicate designs." |
| Sterilization & Shelf Life | Sterile (Gamma Irradiation), 5 Years | Sterile (Gamma Irradiation), 5 Years. |
| Indications for Use | Intended for surgical placement in either jaw for anchoring/supporting single- and multiple-unit prostheses; can be immediately loaded if primary stability and proper occlusion established. | Same as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of clinical or data-driven validation. The testing performed is "design verification testing," likely involving a set number of implants for mechanical and material property assessments, as per engineering and regulatory standards (e.g., ISO, ASTM, or specific FDA guidance for dental implants). However, the exact sample sizes for these engineering tests are not provided in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to engineering test results and manufacturing specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the device is not an AI/ML diagnostic or assistive tool requiring expert-labeled ground truth from medical images or clinical data. The "ground truth" for device performance is based on established engineering standards and regulatory guidance for dental implants.
4. Adjudication Method for the Test Set
- Not applicable for this type of device submission. Adjudication methods are typically relevant for clinical studies where human reviewers assess diagnostic outputs, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of a dental implant submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study in the context of an algorithm is not applicable. This device is a physical dental implant, not a software algorithm. Its performance is assessed through physical and material property tests.
7. The Type of Ground Truth Used
- The "ground truth" here is based on engineering standards, material specifications, and regulatory guidance documents (specifically, the "FDA Guidance Document - Special Control Class II Root-Form Dental Implants (May 2004)"). This includes established benchmarks for mechanical strength, biocompatibility, and dimensions of dental implants.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a machine learning model.
§ 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.