(321 days)
BioHorizons Abutments for Zimmer® are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The contouring tissue and final rootena.vo and restoration and are compatible for abuthents may be assurfor a Single of the nal implant systems and Zimmer use with Blondons internal and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters.
BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used to be used as straight abutments.
BioHorizons Abutments for Zimmer are comprised of endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm. Abutment materials are titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), zirconia ceramic as specified in ISO 13356 Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP), Gold Alloy 6019 and PEEK as specified in ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications (temporary abutments only).
Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. Abutments provided sterile are packaged using materials known in the industry to be appropriate for medical device packaging and are provided with a minimum sterility assurance level of 108, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ANSI/AAMI/ISO 11137-2 Sterilization of healthcare products -- Radiation -- Part 2: Establishing the sterilization dose.
The provided document is a 510(k) Summary for the BioHorizons Abutments for Zimmer, which are dental implant abutments. This document does not describe an AI/ML device, nor does it conduct a study comparing the device's performance against acceptance criteria in the format typically used for medical devices that involve diagnostic or predictive capabilities. It primarily focuses on demonstrating substantial equivalence to predicate devices through material properties, design, and biocompatibility, as well as specific functional testing related to mechanical performance and tissue integration.
Therefore, many of the requested elements (like acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details) are not applicable and are not present in this type of submission.
However, I can extract the information that is present and relevant to the "acceptance criteria" and "study" as understood within the context of dental implant abutment regulatory submissions.
Here's a breakdown of the requested information based on the provided text, with clarifications where the concepts don't directly apply:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" for this type of device are implicitly met by demonstrating substantial equivalence to predicate devices through:
- Material properties: Matching specified ASTM and ISO standards.
- Design and intended use: Similar to existing cleared devices.
- Mechanical performance: Meeting standards like ISO 14801.
- Biocompatibility/tissue integration: Demonstrated through a canine study for the Laser-Lok feature.
- Sterilization: Validated to ANSI/AAMI/ISO 11137-1/2 standards.
The "reported device performance" is largely qualitative or indicates compliance with these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition: Conforming to specified standards. | Titanium Alloy: ASTM F136 |
| Zirconia Ceramic: ISO 13356 | |
| PEEK: ASTM F2026 (for temporary abutments only) | |
| Gold Alloy: 6019 | |
| (All materials, suppliers, processing, packaging remain the same as predicate BioHorizons implant systems.) | |
| Sterilization: Achieving a minimum sterility assurance level (SAL) of 10⁻⁶ and validation against ISO standards. | SAL: Minimum 10⁻⁶ |
| Validation: In compliance with ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2. | |
| Compatibility: Functional mating with specified implant systems. | Representative Subset Tested: Zimmer® Screw-Vent® and Tapered Screw-Vent® implants (specific item numbers listed). |
| Conclusion: Verifies compatibility of BioHorizons Abutments for Zimmer® with all Zimmer® Screw-Vent® and Tapered Screw-Vent® items based on equivalent mating platform geometry. | |
| Mechanical Performance: Withstanding maximum and fatigue loads according to industry standards. | Testing Standard: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, and ISO 14801. |
| Results: "The results of the maximum load and fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices." (Specific numerical results are not provided in the summary but would be in the full submission.) | |
| Biological Response (Laser-Lok feature): Promoting favorable hard and soft tissue healing and preventing epithelial downgrowth. | Canine Model Study: |
| Results: "demonstrate significant improvement in peri-implant hard and soft tissue healing on the Laser-Lok healing abutments as compared to traditional machined abutment surfaces." | |
| Nevins et al. Conclusion: "presence of the laser-ablated microchanneled zone consistently enabled intense fibroblastic activity to occur on the abutment-grooved surface, resulting in an interlacing complex of connective tissue fibers oriented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration." | |
| Substantial Equivalence: Overall design, materials, and intended use are equivalent to predicate devices, ensuring similar safety and effectiveness. | Conclusion: "The BioHorizons Abutments for Zimmer®, which are the subject of this 510(k), are substantially equivalent to all features of the predicate abutment and implant devices which could affect safety or effectiveness because of the similarities in design, materials and intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Compatibility Testing: A "representative subset" of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants was used, listing specific item numbers. The exact number of abutments tested is not specified but implies multiple units for each implant type.
- Sample Size for Biological Study (Canine Model): The study consisted of four cohorts, with "Each group received nine implants with abutments placed at the time of surgery." This totals 36 implants/abutments (9 implants x 4 groups).
- Data Provenance: The canine study was a prospective study. The country of origin is not explicitly stated in this summary.
- Sample Size for Mechanical Testing: Not specified, but mechanical testing typically involves multiple samples to assess load to failure and fatigue.
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. The ground truth in this context is established through objective material and mechanical testing standards (e.g., ISO 14801), and histological analysis in the canine study. It does not involve expert consensus on image interpretation or diagnostic outcomes in a way that requires a specific number of qualified human experts for ground truth establishment. The biological study would have been evaluated by veterinary pathologists or histologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As this is not an AI/ML diagnostic device, there is no "test set" in the sense of data needing adjudication for ground truth. Results from mechanical tests and histological analyses are objective measurements.
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
No. This is not an AI-assisted device. Therefore, no MRMC study was conducted, and this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (dental abutment), not an algorithm or AI. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Mechanical Testing: Compliance with ISO 14801 and FDA's "Class II Special Controls Guidance Document..." serves as the objective "ground truth" standard.
- For Biological Study (Laser-Lok): Pathology/histology data from the canine model, examining "peri-implant hard and soft tissue healing," "fibroblastic activity," and "epithelial cell downgrowth." The conclusions of Nevins et al. (a cited external reference) also contribute to the understanding of the mechanism.
8. The sample size for the training set
Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no AI/ML algorithm or training set, this question is not applicable.
§ 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.)