Search Results

The Universal Base Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The Universal Base Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Device Description

The Universal Base Abutment is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing external hex style connections. The Universal Base Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process. The Universal Base Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Abutment is made of titanium vanadium alloy.

AI/ML Overview

This document describes the Universal Base Abutment, a dental implant abutment. The information provided outlines the device's technical specifications, comparisons with predicate devices, and performance data from various tests. However, it does not include specific acceptance criteria with numerical targets for clinical performance, nor does it detail a study proving the device meets those specific acceptance criteria in the context of clinical accuracy or diagnostic efficacy.

Therefore, the following information is extracted based on the provided text, and points that cannot be addressed due to the nature of the document (a 510(k) summary for a dental abutment, not an AI/diagnostic device) are explicitly stated as "Not Applicable".

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical device (dental abutment) and not an AI or diagnostic device, the acceptance criteria are based on mechanical and biological safety and performance, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC. The "performance" reported is related to adherence to established standards for dental implants and abutments.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit from Text)	Reported Device Performance and Compliance
Mechanical Performance	Dynamic fatigue testing per ISO 14801 (sufficient fatigue properties compared to predicate)	"Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the Universal Base Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed Universal Base Abutments were equivalent to the predicate devices."
Biocompatibility	Biological evaluation according to ISO 10993-1. Cytotoxicity (ISO 10993-5). GC-MS for leachables/extractables (CEN EN ISO 10993-12, CEN EN ISO 10993-18)	"Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. GC-MS analysis was performed to gualify any orqanic leachables/ extractables according to CEN EN ISO 10993 12 and CEN EN ISO 10993-18. Results indicate that the devices met biocompatibility requirements for its intended use."
Software V&V	Validation of workflow (scanner, software, milling unit). Verification of design restrictions. Validation of encrypted library to prevent modification.	"Validation was completed on the Universal Base Abutment with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORiTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment DesignerTM Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library."
Sterilization	Steam sterilization analysis following AAMI-TIR30, ISO 17665-1, and ISO 17665-2 for non-sterile devices.	"Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2."
Device Packaging	Packaging and shelf life performance (comparable to predicate)	"The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required."

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 Test Set: Not explicitly stated in terms of a "test set" for clinical performance. The mechanical testing (dynamic fatigue) would have used a sample size determined by ISO 14801 standards (e.g., typically N=10 or more per group for fatigue testing), but this is not a diagnostic test set.
Data Provenance: Not applicable in the context of clinical patient data for a diagnostic device. The testing described (mechanical, biocompatibility, software V&V) is laboratory-based.

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 device is a dental abutment, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis. Ground truth in this context relates to engineering standards and material science.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy to reconcile conflicting expert opinions. This document describes non-clinical, laboratory-based performance testing against ISO standards.

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 dental abutment, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a dental abutment. While there is "Software Verification and Validation" for the design library to ensure it prevents designs outside limitations, this is about the design tool's functionality, not about an AI algorithm's standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation is based on established international standards for medical device performance (e.g., ISO 14801 for dynamic fatigue, ISO 10993 for biocompatibility) and engineering specifications for the CAD/CAM workflow.

8. The sample size for the training set

Not Applicable. This device submission does not describe an AI algorithm that requires a training set. The software mentioned (3Shape Abutment Designer Software) is a CAD/CAM design tool, not a machine learning model.

9. How the ground truth for the training set was established

Not Applicable. As no AI training set is described, this question is not relevant.

Ask a Question

Ask a specific question about this device

Page 1 of 1