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Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function.

Straumann CARES Screw-Retained Bridges and Bars are indicated for screw-retained restorations.

The Straumann CARES Screw-Retained Bars and Straumann CARES Screw-Retained Bridges are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms and Straumann Screw-Retained Abutments. The bars and bridges presented in the premarket notification submission (identified as “SRBB" for Screw Retained Bars and Bridges) are designed to interface with previously cleared screw-retained abutments (K133421). We also present "multi-level" bars and bridges in this submission designed to interface with any combination of screw-retained abutments (as cleared per premarket notification K133421), Bone Level (BL) implants (as cleared per premarket notification K062129) and Tissue Level (TL) implants (as cleared per premarket notifications K101465 and K112280) of the SDIS. When SRBB devices are attached directly to dental implants of the SDIS; the abutment/secondary part is an integral part of the SRBB device.

SRBB devices facilitate customization to meet the functional and esthetic requirements of the individual patient. They are patient-specific medical devices, i.e. they are designed by the clinician or dental technician and fabricated by Straumann specifically for an individual patient.

SRBB devices are designed via Straumann approved Computer Aided Design (CAD) software such as Straumann® CARES® Visual. After importing a scan of the patient model, the CAD software is used to generate digital restoration models incorporating the subject devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)- techniques.

This document describes the Straumann® CARES® Screw-Retained Bridges and Bars. The information provided is from a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document mentions "bench studies" and "dynamic fatigue test data," which typically involve a set number of samples for mechanical testing, but the exact quantity is not specified.
• Data Provenance: The document does not specify country of origin for the data. The data is retrospective in the sense that it relies on established standards (ISO 14801) and comparisons to previously cleared devices.

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

• This information is not applicable for this type of submission. The ground truth for this device is established through engineering and material science principles, compliance with ISO standards, and comparison to a predicate device's established safety and effectiveness through bench testing. Clinical expert consensus for "ground truth" (as in diagnostic accuracy studies) is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. As the "ground truth" is established through engineering and material standards, adjudication by human experts is not part of the evaluation process for this specific device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical dental prosthetic device, not a diagnostic AI algorithm. Therefore, such a study was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a physical dental prosthetic, not a software algorithm or AI.

7. The Type of Ground Truth Used:

• For physical properties and performance (e.g., fatigue strength, material biocompatibility), the ground truth is established by engineering standards (e.g., ISO 14801), material specifications, and regulatory guidance documents. The device's performance is compared against the known performance and characteristics of the predicate device (K132844) to establish substantial equivalence.

8. The Sample Size for the Training Set:

• Not applicable. This submission focuses on a physical medical device, not a machine learning model that requires a training set. The "design" of the device is developed by engineers and clinicians using CAD software, not "trained" on data in the AI sense.

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

• Not applicable. See point 8. The "design" is based on anatomical considerations, biomechanical principles, and the functional requirements for dental restorations, as implemented through CAD software. There isn't a "ground truth" for a training set in the context of an AI algorithm here.

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