(197 days)
The Zimmer® Patient Specific Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.
The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is designed for use with internal hex connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection. The proposed changes to the Zimmer Patient-Specific Abutment include changes to the design parameters with respect to the margin width and radius, the cuff height and the cuff width. The updated design parameters do not affect the device's intended use or alter the fundamental scientific technology of the device.
The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is a patient specific dental implant abutment. The purpose of a Patient-Specific abutment is to satisfy patient's needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.
The abutment is offered in 3.5mm, 4.5mm, and 5.7mm implant platforms.
The document does not describe a study involving AI or a comparative effectiveness study with human readers. The device in question is a dental abutment, and its evaluation relies solely on non-clinical performance testing.
Here's the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the non-clinical testing was performed "in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endossesous Dental Implant Abutments." While the specific numerical acceptance criteria (e.g., minimum fatigue strength in Newtons) are not explicitly listed in the provided text, the document indicates compliance with this guidance.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Withstand anticipated forces (Fatigue Testing) | Strong enough to withstand anticipated forces |
| Withstand anticipated forces (Compression Testing) | Strong enough to withstand anticipated forces |
| Sterility Assurance Level (SAL) | Minimum SAL of 10^-6 for sterilization procedures |
| MRI Safety & Compatibility | No additional restrictions on MRI compatibility |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. The document refers to "testing" but does not give the number of samples tested for fatigue, compression, or sterilization validation.
- Data Provenance: Not explicitly stated as retrospective or prospective, but given it's non-clinical lab testing, it would be considered prospective for the specific tests performed. The country of origin of the data is not mentioned but can be inferred as likely from the U.S. based on the applicant's location (Carlsbad, CA) and submission to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a physical medical device (dental abutment), and its performance is evaluated through non-clinical engineering tests (fatigue, compression, sterilization validation, MRI compatibility) rather than through expert-driven ground truth assessment of medical images or diagnoses.
4. Adjudication Method for the Test Set:
Not applicable. No expert adjudication was involved in the non-clinical engineering tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The study described is entirely non-clinical performance testing of a physical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical dental abutment, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical testing comprises established engineering standards and FDA guidance documents for mechanical performance (fatigue, compression), sterilization efficacy (SAL), and MRI safety. The success of the device is determined by its ability to meet these predefined technical specifications.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical medical device.
§ 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.)