(90 days)
Sulzer Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.
Spline XI implants are available both with and without HA-coating. They are available in 3.75mm or 5.0mm diameters and are available in five lengths: 8, 10, 13, 15 and 18mm. A total of four surface styles are available: HA-coated, HAcoated/textured, HA-coated/machined and textured/machined. The implants are supplied sterile.
The provided document is a 510(k) summary for the Sulzer Calcitek Spline Dental Implant System - Spline XI. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel study to prove the device meets specific acceptance criteria in the way a new medical algorithm's performance would be assessed.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of submission.
Instead, the document's primary purpose is to compare the new device (Spline XI) to an existing, legally marketed predicate device (Sulzer Calcitek's existing Spline Dental Implant System) based on technological characteristics and intended use. The acceptance criteria are implicitly met if the device can demonstrate substantial equivalence to the predicate.
Here's an analysis of the provided information within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense for a 510(k) summary focused on substantial equivalence. The "acceptance criteria" are demonstrating that the new device shares fundamental technological characteristics and intended use with the predicate device, and that any differences do not raise new questions of safety and effectiveness.
The document provides a comparison table (Section 4) of features:
| Feature | Spline XI implant | Predicate Implants |
|---|---|---|
| Implant body geometry | screw type endosseous | |
| implants | screw type endosseous | |
| implants | ||
| Implant lengths | 8, 10, 13, 15, 18mm | 8, 10, 13, 15, 18mm |
| Implant diameters | 3.75, 5.0mm | 3.75, 5.0mm |
| Implant body material | Titanium alloy | Titanium alloy |
| Implant/abutment | ||
| interface | spline - 6 tines | spline - 6 tines |
| Manufacturing site | Carlsbad, CA | Carlsbad, CA |
| HA Coating | Available on some designs | Available on some designs |
| Sterile | Yes | Yes |
The reported "performance" is that the overall design of the Spline XI implants are identical to the predicate implants in these key characteristics, with a single modification: "There has been a modification to the apical portion of the implant body to provide the implant with self-tapping capabilities." The submission implicitly argues that this modification does not alter the fundamental safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a performance study on a test set of data. The "test set" in a sense is the predicate device itself, against which the new device is compared. The data provenance is the design and manufacturing specifications of both the Spline XI and the predicate Spline Dental Implant System.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of submission. The "ground truth" for substantial equivalence is based on regulatory standards and the established safety and effectiveness profile of the predicate device. The information provided in the Class III Summary (Sections 3 and 4) cites scientific literature and FDA guidance regarding potential complications associated with dental implants generally, which serves as a background for evaluating the safety of the device type.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication of a test set in the context of this 510(k) submission.
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 device is a dental implant, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is derived from:
- Regulatory definitions and established predicates: The FDA's classification of dental implants and the legal marketing status of the predicate device.
- Scientific and clinical literature: The Class III Summary (Sections 3 and 4) provides a detailed list of reported adverse safety and effectiveness information for endosseous dental implants, along with possible causes and citations to peer-reviewed journals and FDA documents (e.g., Federal Register). This serves as a comprehensive understanding of potential risks associated with this device type.
- Company documents and customer feedback: Mentioned in the Class III Certification as sources for understanding safety and effectiveness information, including specific issues like dental bur fracture, mal-positioned implants, and psychological rejection of implants (Section 4).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or complex algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above.
In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating an AI algorithm. The "acceptance criteria" and "study" described are fundamentally different, focusing on demonstrating equivalence to an existing device through a comparison of design, materials, and intended use, rather than a performance evaluation against a defined ground truth using statistical metrics.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.