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The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

Straumann® CARES® Abutments CoCr are used for the restoration of Straumann dental implant platforms RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). The Straumann® CARES® Abutments CoCr allow for individual customization regarding function and esthetics. Straumann® CARES® Abutments CoCr are designed by the dental laboratory technician either by means of a conventional wax-up model that is subsequently scanned or by scanning the intraoral situation and designing the shape by using a Straumann-approved software (such as Straumann® CARES® Visual). The design data is then transferred to a Straumann central milling center where the fabrication of the customized abutment is carried out. The Straumann® CARES® Abutments CoCr can be directly veneered.

The provided text describes the regulatory filing for a dental implant abutment and does not contain information about an AI/ML device. Therefore, it's not possible to extract the requested details regarding acceptance criteria, study design for AI models, or expert ground-truthing. The document pertains to a traditional medical device (Straumann® CARES® Abutments CoCr) and its equivalence to predicate devices based on material, design, and mechanical performance testing.

However, I can extract the acceptance criteria and performance data for the traditional medical device as described:

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
• ISO 10993-5:2009 "Tests for in vitro cytotoxicity"
• ISO 10993-18 "Chemical characterization of materials" |
  | Veneering Performance | Performed per ISO 9693-1 "Dentistry – Compatibility testing – Part 1: Metal ceramic systems". |
  | Corrosion Resistance | Demonstrated according to ISO 10271:2011 "Corrosion test methods for metallic materials". |
  | Sterilization Validation | Carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10^-6 in accordance to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2. |
  | Design Limits | Max Angulation 30°, Minimum thickness 0.33mm. Minimum surface area requirements based on tooth position were also identical to the predicate. |

The following information is not present in the provided document, as it describes a non-AI medical device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Additional Study Information (from the document for the traditional device):

• Study Type: Bench testing (mechanical, material, biocompatibility, corrosion, sterilization).
• Clinical Studies: "No animal or human clinical studies were conducted."
• Ground Truth: For traditional device testing, "ground truth" is typically defined by established engineering and material science standards (e.g., ISO, ASTM) and manufacturing specifications.

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