(231 days)
The Zimmer Zfx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy abutinent our be access with a Narrow Platform (NP) Ø 3.5 mm, Regular Platform (RP) Ø 4.3 mm, Wide Platform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0 mm.
The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles. They frequently incorporate the modifications typically done at a dental laboratory or "chair-size" 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, the 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 Zimmer Zfx Abutment for NobelReplace Implant System is a dental implant abutment with a fixed competitor compatible interface. It is designed for use with NobelReplace endosseous dental implants to support single or multi tooth restorations. The abutment-implant interface is an internal tri-lobe. 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 (Ti6AI4V) and it is secured to the implant with a separate Titanium allov screw for retention.
The new abutment will be available with a choice of 3.5mm, 4.3mm, 5.0mm, and 6.0mm platform diameters. The maximum abutment anqulation will be 20°. The new abutment will interface with Nobel Replace implants with an internal tri-lobe connection.
This document describes the Zimmer Zfx Abutment for NobelReplace Implant System, a dental implant abutment. The submission is a Traditional 510(k) Premarket Notification (K120873) seeking to demonstrate substantial equivalence to legally marketed predicate devices.
Acceptance Criteria and Device Performance:
The document implicitly defines acceptance criteria through the comparison of the new device to established predicate devices and the performance of non-clinical mechanical fatigue testing. The primary acceptance criterion appears to be demonstrating substantial equivalence to the predicate devices regarding material, general design features, and mechanical suitability.
The device performance is reported as meeting these criteria, as stated in the conclusion: "Based on our analysis, the device is substantially equivalent to the predicate."
Here's the table of acceptance criteria and reported device performance, derived from the comparison to predicate devices and testing described:
| Feature/Criterion | Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance |
|---|---|---|
| Material | Titanium or Titanium 6Al-4V (Matching Predicates 1, 2, 3) | Titanium 6Al-4V (Matches predicates) |
| Implant Interface | Internal Hex (Predicate 1) or Internal Tri-lobe (Predicates 2, 3) | Internal Tri-lobe (Matches Predicates 2 & 3) |
| Emergence | Contoured, curved (Matching Predicates 1, 2, 3) | Contoured, curved (Matches predicates) |
| Margin | Pre-machined (Matching Predicates 1, 2, 3) | Pre-machined (Matches predicates) |
| Platform Diameter | Ranges including 3.5mm, 4.3mm, 5.0mm, 6.0mm (Consistent with various predicates) | 3.5mm, 4.3mm, 5.0mm, 6.0mm (Covers range of predicates) |
| Cuff Width | Range (e.g., 3.5mm-8.0mm, 3.5mm-16mm, 4.2mm for predicates) | 3.5mm-12mm (Within range provided by predicates) |
| Cone and Overall Cone Height | Range (e.g., 3mm-12mm, 15mm overall, 6.5-7.5mm for predicates) | 3.0-11.5 Cone, 3.5-12.0 Overall (Within range of predicates) |
| Maximum Angulation | Range (e.g., 30°, 25°, 15° for predicates) | 20° (Within range of predicates) |
| Retaining Screw | Functionally equivalent to screws used with predicates | New device (Implies functional equivalence to predicate retaining screws) |
| Mechanical Compatibility | Compatible fit with NobelReplace implants with tri-lobe connection. | Reverse engineering, tolerance analysis, and rotational analysis demonstrated compatibility with NobelReplace tri-lobe implant interface. |
| Mechanical Fatigue | Demonstrate mechanical suitability for placement in all regions of the mouth, comparable to predicate devices. | Fatigue testing using Zimmer fabricated abutments assembled to OEM implants demonstrated substantial equivalence to NobelReplace predicate device fatigue data. |
| Sterilization (End-User) | Sterilizable to a minimum sterility assurance level of 10-6. | Sterilization procedures listed in IFU validated to provide a minimum sterility assurance level of 10-6. |
Study Information:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size for the mechanical fatigue testing. It states that "all sizes" of the implant/abutment assembly were tested. The reference to "actual measurements taken off NobelReplace implants, abutments and retaining screws" suggests a physical sampling of these predicate devices for reverse engineering.
- Data Provenance: The testing was non-clinical. The information does not specify the country of origin for the components used in testing, but the company is US-based (Carlsbad, CA). The data is prospective in relation to the new device's design and verification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for the test set (e.g., dimensional specifications, mechanical performance) was established through engineering analysis, reverse engineering, and mechanical testing, not through expert consensus on medical images or clinical outcomes.
- Qualifications of Experts: The work was performed by Zimmer Dental Inc.'s engineering and regulatory teams, as implied by the non-clinical testing and internal documentation. Specific qualifications of individuals are not provided.
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Adjudication method for the test set:
- Adjudication method: Not applicable in the traditional sense (e.g., 2+1, 3+1 for clinical assessments). The "adjudication" of the non-clinical test results would have been an internal review and comparison by Zimmer Dental's engineering and regulatory personnel against established standards (e.g., FDA guidance, internal specifications, predicate device data).
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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:
- MRMC Study: No. This device is a dental abutment, a manufactured physical component, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI-related effectiveness are not relevant or discussed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type:
- For dimensional and interface compatibility: The "ground truth" was derived from physical measurements (reverse engineering) of the actual NobelReplace predicate implants and abutments. This provides a factual basis for interface design.
- For mechanical fatigue: The "ground truth" involved mechanical test data generated from the predicate NobelReplace device, established according to FDA guidance (Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). The new device's performance was then compared to this established predicate data.
- Ground Truth Type:
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a physical device, not a machine learning model.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. This is a physical device, not a machine learning model.
§ 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.)