(140 days)
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging, is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration.
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.
The purpose of an abutment with Cast-to capabilities is to satisfy customer needs of attaching cast framework prostheses to an abutment. The nonengaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The engaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast a single abutment for a cement-retained crown or bridge and frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System is designed for use with Zimmer 3.1mmD Dental Implant System to support cast framework prostheses. The engaging abutment/implant interface is an internal conical connection with a hex. The non-engaging abutment/implant interface is a connection that sits on top of the implant but does also has cylindrical features that sit passively within the implant.
The abutment is composed of Gold Alloy 6019 and secured to the implant with a separate Titanium alloy screw for retention.
The provided text is a 510(k) Premarket Notification for a medical device (Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed acceptance criteria table and a study proving the device meets those criteria in the way a clinical trial or performance study for a novel device would.
Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert consensus, and comparative effectiveness studies is not present in this document, as it is not typically required or included in a 510(k) submission for this type of device.
However, I can extract the information that is available and indicate where the requested information is not provided.
Acceptance Criteria and Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data for the Zimmer Cast-to Gold Abutments in isolation. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical testing.
The acceptance criteria are implicitly met by showing that the device performs at least as well as the predicate device in relevant non-clinical tests, and that differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Material Biocompatibility | Same biocompatible Gold Alloy 6019 as predicate (K011028), previously tested and cleared. |
| Mechanical Performance | Sustained fatigue and compression testing in accordance with ISO 14801:2007 (dynamic fatigue) and FDA guidance for Class II root-form dental implants. Testing indicates "substantially equivalent to the predicate device in terms of static and fatigue testing." |
| Sterilization | User sterilization procedures (listed in IFU) validated to provide a minimum sterility assurance level (SAL) of 10⁻⁶. |
| MRI Compatibility | Evaluated for interactions with magnetic fields during MRI per FDA guidance and ASTM F 2182 (heating). Results support MR conditional labeling. |
| General Design & Manufacturing Process | "Equivalent to predicate devices in general abutment design, manufacturing process, material, indications, mechanical performances, and risk." |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The non-clinical testing involved fatigue and compression tests on physical samples of the device. The exact number of samples used for these tests is not provided in this summary.
- Data Provenance: Not specified, but likely from in-house or contracted laboratory testing based on the standards cited. The document does not mention country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies.
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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)
- Not applicable/Not specified. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on diagnoses) is not relevant for this type of mechanical engineering performance testing. The "ground truth" for the mechanical tests would be the established engineering standards and physical measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in clinical imaging studies to resolve discrepancies in expert interpretations. This document describes mechanical testing.
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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
- No. This is a mechanical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical device. Standalone algorithm performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests would be the physical and mechanical properties measured against established engineering standards (ISO 14801:2007) and FDA guidance limits. For biocompatibility, the ground truth was based on previous testing of the predicate device's material (Gold Alloy 6019) in compliance with ISO 10993-1.
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The sample size for the training set
- Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established
- Not applicable. There is no training set for this type of mechanical device submission.
§ 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.)