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The 3i Patient-Specific CAM StructSURE® Precision Milled Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient.

All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then machined using a CAD/CAM software system. The bars are milled from either titanium alloy or CP titanium.

The provided text describes a 510(k) premarket notification for BIOMET 3i Patient Specific CAM StructSURE Bars, focusing on the change from using Delcam and 3Shape scanning and milling systems to the Renishaw system.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical performance metrics. Instead, it describes "Validation performed on scanning equipment and software to ensure accuracy of scanning 3D models and performed Install Qualification." The reported "device performance" is an assertion of substantial equivalence based on this validation.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The validation appears to be a general process for the new Renishaw system rather than a study on a specific cohort of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The study focuses on equipment and software validation, not on clinical outcomes assessed by human experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided, as the validation described does not involve expert adjudication of clinical cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission is for a material and process change (new scanning/milling system), not an AI-assisted diagnostic tool that would typically involve human reader performance evaluation.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The "validation performed on scanning equipment and software to ensure accuracy of scanning 3D models" can be considered a standalone performance assessment of the Renishaw system's ability to accurately capture 3D models, independent of human interaction beyond operating the equipment. No specific metrics are given, but the statement implies this standalone assessment was successful.

7. Type of Ground Truth Used

The ground truth for the validation appears to be based on physical measurements and technical specifications of the 3D models produced by the scanning and milling systems, as well as the functional verification of the installation. For example, comparing the scanned 3D model to the physical casting, or comparing the milled bar to the CAD design. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

This information is not provided. The document describes a CAD/CAM system, which would involve training data for its algorithms, but details on the size and nature of this training data are not included in this summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. For CAD/CAM systems, ground truth for training would typically involve precise 3D models, either physical or digitally generated, used to teach the system how to accurately interpret scans and generate designs.

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