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IPS e.max® Press Abutment Solutions for Viteo Base Ti is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multi-unit cement retained restorations.

IPS e.max Press Abutment Solutions is recommended for the fabrication of:

Hybrid abutments for single-tooth restorations
Hybrid abutment crowns for restorations

Device Description

IPS e.max Press Abutment Solutions for Viteo Base Ti is a prefabricated prosthetic component for endosseous dental implants to support prosthetic restorations in partially or fully edentulous jaws. The Viteo Base-Ti is the apical component of a two-piece abutment. A separate mesostructure fabricated out of IPS e.max Press ceramic is attached to the Viteo Base-Ti extraorally using Multilink Hybrid Abutment Cement (K130436). This part then serves as an intermediary to facilitate the connection of the 2-part abutment to the prosthetic material (crown). The abutment as a whole is intended to be used as an aid in prosthetic rehabilitation for the purpose of providing a suitable chewing function. A compatible screw is included with the Viteo Base-Ti for attachment of the completed hybrid abutment to the implant body. Alternatively, the mesostructure may be fabricated into the prosthetic restoration and attached to the Viteo Base-Ti via the screw to form a hybrid crown/abutment, thereby incorporating the top half of the two-piece abutment into the body of the crown.

The Viteo Base Ti is made of Ti-6Al-4V ELI Titanium Grade 23 and is provided with a compatible screw made of the same materials. Viteo Base-Ti is available in two platform sizes (SD and MD) for various cleared implant systems as described in this summary. The upper part (pillar) of the Viteo Base Ti can be shortened individually, has a blasted surface to support bonding of the restorative part, and has an internal retentive lock to circumvent rotation. The IPS e.max Press Abutment Solutions for Viteo Base Ti are parts of the implant system which consists of:

Implant Body – marketed by the Implant Manufacturer
Viteo Base Ti - Titanium part Included in subject device
Screw - Titanium screw Included in subject device
IPS e.max Press either as a part of the abutment or a Hybrid Abutment crown included in the subject device.
Multilink Hybrid Abutment Cement – to bond together the Viteo Base Ti abutment part and the IPS e.max Press ceramic part included in the subject device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the IPS e.max® Press Abutment Solutions for Viteo Base Ti:

It's important to note that this document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report. Therefore, some information typically found in a full study report (like detailed statistical methods for performance or specific ground truth for training) might be aggregated or summarized to support the substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Benchmarking / Equivalence)	Reported Device Performance (IPS e.max® Press Abutment Solutions for Viteo Base Ti)
Mechanical Fatigue: The device should perform equivalently to the predicate devices in dynamic fatigue testing for endosseous implants according to ISO 14801, considering the FDA Guidance Class II Special Controls for Root form Endosseous Dental Implants and Endosseous Dental Abutments. This implies that the device, when integrated with various implant systems, should successfully "run-out" (withstand specified cyclic loading without failure) at a level comparable to or better than the predicate devices.	Mechanical Fatigue: "Worst case evaluation was done for each implant type listed in Table 1. The dynamic fatigue test for endosseous implants acc. ISO 14801 demonstrated that the tested implants systems containing the corresponding Viteo-Abutment run-out successfully. Fatigue results shown in previously cleared titanium bases for the predicate device did not substantially differ from the test results shown for Viteo Base Ti." This indicates successful run-out, demonstrating performance comparable to the predicate devices.
Sterilization Efficacy: The sterilization process for the device (if applicable) must be validated according to relevant ISO and ANSI/AAMI standards. (Though the device is "Not delivered sterile" and "Single use only," a steam sterilization is "recommended in the instructions for use" as a final cleaning step, implying validation of this recommended method if the component itself is affected by it).	Sterilization Efficacy: "Sterilization validation according to ISO 17665-1, ISO/TR 17665-2 and ANSI/AAMI ST79." While the device is not pre-sterilized, the cleaning process is validated, and a recommended steam sterilization method is referenced, suggesting its efficacy has been validated for the product's use case.
Dimensional Compatibility: The interface of the Viteo Base Ti with the listed compatible implant bodies must be verified for dimensional accuracy and fit. (No specific acceptance criterion value is given, but implied: it must be compatible).	Dimensional Compatibility: "Compatibility of the Viteo Base Ti interface to the implant bodies listed above was verified by measuring Data & tolerance analysis which demonstrated that the Viteo Base-Ti dimensional specifications are compatible with the appropriate implant system." This confirms the device meets the compatibility requirement.
Biocompatibility: The device materials must meet biocompatibility requirements according to ISO 10993-1 and ISO 7405. Materials should also meet corrosion resistance standards (ISO 10271:2011 and EN ISO 22674:2006) for total ion release and electrochemical performance. The chemical composition must conform to ASTM F136-08. Testing for hypersensitivity/sensitization, irritation, acute and subchronic systemic toxicity, genotoxicity, and implantation should yield passing results.	Biocompatibility: "The subject device was evaluated for Biocompatibility according to ISO 10993-1 and ISO 7405. The material was tested for corrosion according to ISO 10271:2011 and EN ISO 22674:2006 and met the requirements for those standards for total ion release and electrochemical test. The chemical composition is according to ASTM F136-08... The material was also evaluated for hypersensitivity/sensitization, irritation, acute and subchronic systemic toxicity - oral/inhalation, genotoxicity and Implantation with passing results." All listed biocompatibility criteria were met.
Cleaning Validation: A documented cleaning validation must prove the surface is free from any remaining contaminant after the surface blasting procedure.	Cleaning Validation: "A documented cleaning validation proves that the surface is free from any remaining contaminant after the surface blasting procedure." This criterion was met.

Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not explicitly stated with specific numbers of devices or tests beyond "Worst case evaluation was done for each implant type listed in Table 1." For fatigue testing, ISO 14801 typically requires a minimum of 5-10 specimens per test group, but the exact number for each implant system is not provided. For dimensional compatibility, "measuring Data & tolerance analysis" likely involved multiple measurements, but a sample size isn't given.
- Data Provenance: Not specified. These are typically laboratory bench tests, so geographic origin isn't critical. The nature is prospective in the sense that fresh devices are tested for performance.
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 document describes the performance of a mechanical and material dental implant component, not an AI or diagnostic device that requires expert-established ground truth. The 'ground truth' here is adherence to engineering standards and material specifications, verified by testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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/material device, not a diagnostic or AI-assisted system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "standalone" performance here relates to the physical and material properties of the device itself under specified test conditions, which were indeed performed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is adherence to established international and national standards (e.g., ISO 14801 for fatigue, ISO 10993-1 for biocompatibility, ASTM F136-08 for material composition). These standards define acceptable performance metrics and testing methodologies, which serve as the objective benchmarks for validation.
The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI, so there is no training set.
How the ground truth for the training set was established:
- Not applicable. See point 7.

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