(104 days)
The Zimmer® Contour Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit implant-supported restoration. The 3.5mm abutment is used in the anterior, cuspid, and premolar regions. The 4.5mm abutment can be used in any region of the mouth.
The Zimmer® Contour Ceramic Abutment is an abutment designed for use with endosseous dental implants to support single or multi tooth restorations. The abutment has a contoured emergence profile to create a more esthetic restoration. The abutment features a pre-machined margin to facilitate the restoration process. The abutment portion is composed of zirconia ceramic with a titanium alloy seating ring and separate titanium alloy screw for retention.
This document is a 510(k) premarket notification for the Zimmer® Contour Ceramic Abutment and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria. As such, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, and multi-reader multi-case studies is largely not present in the provided text.
The document indicates that the device is deemed "substantially equivalent" to predicate devices based on design, intended use, mechanical strength, and materials. This equivalency is the basis for its clearance, not a performance study against specific acceptance criteria as you've outlined.
However, I can extract what is available about the device and its comparison:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific quantitative performance acceptance criteria in a study. The comparison is qualitative and based on device characteristics, not detailed performance metrics from a study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. This document does not describe a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided. No ground truth establishment by experts is mentioned, as there is no described performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. No adjudication method is mentioned, as there is no described performance study.
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:
This information is not provided. This device is a dental abutment, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not provided. This device is a physical dental implant component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided. No ground truth is established for a performance study. The "truth" in this submission is the equivalency to already marketed devices.
8. The sample size for the training set:
This information is not provided. This document does not describe a study involving a training set.
9. How the ground truth for the training set was established:
This information is not provided. No ground truth for a training set is established.
Summary based on the provided document:
The supplied document is a 510(k) summary for the Zimmer® Contour Ceramic Abutment. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a study proving performance against specific acceptance criteria.
The key points from the document are:
- Device: Zimmer® Contour Ceramic Abutment
- Intended Use: Terminal or intermediate abutment for a cemented prosthesis, for single or multiple-unit implant-supported restorations.
- Materials: Zirconia ceramic abutment with a titanium alloy seating ring and separate titanium alloy screw.
- Predicate Devices: ASTRATech ZirDesign™ Ceramic Abutment and Zimmer® Hex-Lock Abutment.
- Basis for Clearance: Substantial equivalence in intended use, design, mechanical strength, and materials to the predicate devices.
- No performance study against specific acceptance criteria is described in this document. The FDA's clearance is based on the comparison to predicate devices, implying that if the predicates are safe and effective, and this device is substantially equivalent, then it is also safe and effective.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)