(241 days)
The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.
The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a two piece abutment. The abutment is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment is used for single unit restorations in the anterior and posterior regions. The abutment base will be made available in 3.5, 4.5 and 5.7mm platforms. The Zimmer Zfx Titanium Base serves as a bonding base that allows for cementation of a patient-specific restoration. Copings, crowns and bridges can be used with the Zimmer Zfx Titanium Base.
The Zimmer Zfx Abutment Coping is a zirconia mesostructure component that would be cemented onto the Zimmer Zfx Titanium Base Abutment to form the two-piece abutment. These componenents will be manufactured from zirconia or IPS e.Max. The maximum angulation that is allowed is 20°. The two piece abutment would then be able to be used as a terminal or intermediate abutment for cement or screw retained prostheses that is for a single or multi-unit (bridge) restoration. The Zimmer Zfx Abutment Coping would require a separate crown to be cemented onto the coping or direct veneering to be applied.
The provided text is a 510(k) Pre-Market Notification for the Zimmer Zfx Titanium Base Abutment. This document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain a typical "acceptance criteria" table or a detailed "study" proving the device meets specific performance criteria in the way an academic or clinical study would.
Instead, the submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices. This means showing that the new device is as safe and effective as devices already on the market, rather than meeting novel performance metrics.
Here's an analysis based on the information provided, addressing your points where possible and noting where information is not applicable to this type of document:
1. A table of acceptance criteria and the reported device performance
This document does not present a formal "acceptance criteria" table with specific quantitative performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/algorithm-based medical device study.
Instead, the "performance" is demonstrated by showing "substantial equivalence" through:
- Identical intended use, materials, and abutment/implant interface design when compared to predicate devices.
- Non-clinical mechanical testing demonstrating equivalence in mechanical strength.
The table in Section 7 ("Technological Characteristics") compares features of the new device to predicate devices, showing similarities in:
- Indications for Use
- Implant Interface (Internal Hex)
- Abutment Platform Diameter (3.5mm, 4.5mm, 5.7mm)
- Material (Titanium 6Al-4V for base, Zirconia for coping/crown)
- Compatibility with CAD/CAM and Traditional patient-specific restorations
The implied acceptance criteria are that the new device's characteristics and mechanical performance should be no worse than the predicate devices. The reported "performance" is that it meets or exceeds these aspects.
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. The "tests" mentioned are non-clinical mechanical tests, not clinical trials with human subjects. Thus, there's no "test set" in the sense of patient 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)
Not applicable. This is a submission for a dental abutment, not an AI or diagnostic device that requires expert-established ground truth from images or patient data. The "ground truth" for mechanical testing would be engineering specifications and ASTM/ISO standards, assessed by engineers, not medical experts establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this is mechanical testing of a physical device, not an AI or diagnostic device that involves human perception or interpretation requiring adjudication.
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 is a physical dental device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical mechanical testing, the "ground truth" would be established by relevant engineering standards (e.g., ISO, ASTM for dental implants and abutments) and direct physical measurements of mechanical strength (e.g., fatigue strength, fracture resistance) evaluated against established benchmarks for similar devices, particularly the predicate devices. The text states:
- "The first test consisted of the Titanium base portion of the new device assembled in an abutment test setup. A hemispherical test cap, representing a final restoration, was cemented directly to the Titanium base portion of the device. The results demonstrated that the Titanium base portion of the new device is equivalent to the currently marketed Zimmer Hex Lock Abutment (K011028)."
- "The second test evaluated the new device as a two-piece abutment system... The results demonstrated that the two-piece abutment system is substantially equivalent to the currently marketed Zimmer Pre-Angled Ti Abutment (K011028)."
The ground truth here is the established mechanical performance of identical or very similar legally marketed devices.
8. The sample size for the training set
Not applicable. This is a physical 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 device.
Summary of Acceptance Criteria and Proving Device Meets Them for this 510(k) Submission:
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Acceptance Criteria (Implied - Substantial Equivalence):
- Indications for Use: Must be substantially similar to predicate devices.
- Technological Characteristics: Must have similar design features, materials, and dimensions to predicate devices.
- Safety & Effectiveness: Non-clinical mechanical testing must demonstrate performance (e.g., mechanical strength) equivalent to or better than predicate devices.
- No new questions of safety or effectiveness.
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Study Proving Acceptance:
- Non-Clinical Mechanical Testing:
- Device Tested: Zimmer Zfx Titanium Base Abutment (both as a single component and as a two-piece system with a zirconia mesostructure).
- Methodology: Two distinct mechanical tests were conducted:
- One for the Titanium base portion with a cemented hemispherical test cap.
- One for the two-piece abutment system (Titanium base + 20-degree angulated Zirconia mesostructure).
- Comparison: The results were compared to the already marketed predicate devices: Zimmer Hex Lock Abutment (K011028) for the base portion and Zimmer Pre-Angled Ti Abutment (K011028) for the two-piece system.
- Results: The tests demonstrated that the new device (both components and the system) is equivalent or substantially equivalent in mechanical strength to its respective predicate devices.
- MRI Compatibility Evaluation: Zimmer Dental implant systems were evaluated for interactions with magnetic fields during MRI, in accordance with FDA guidance. (No specific results provided, but implying compliance).
- Clinical Testing: Not performed. The justification was that the device is not significantly different from the predicate device and shares the same design features, technological characteristics, and indications for use.
- Non-Clinical Mechanical Testing:
In essence, for a 510(k) submission like this, the "study" demonstrating that the device meets "acceptance criteria" is a comparative analysis and non-clinical mechanical testing to prove it is as safe and effective as a device already approved for market (a predicate device), rather than meeting novel, pre-defined performance thresholds for a new capability.
§ 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.)