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Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations.

The Straumann Dental Implant System is an integrated system of endosseous dental implants designed to support prosthetic restorations (crowns, bridges, overdentures). The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The subject device, the Straumann C.A.R.E.S. Ceramic Coping, is designed to be custom modified for a particular patient, the coping is fixed to a synOcta® 1.5 abutment which is then fixed to the implant. The ceramic coping provides support for prosthetic reconstructions, such as crowns or bridges.

The Straumann C.A.R.E.S. Ceramic Coping is intended for cemented restorations and can be customized to meet high anatomical and esthetic demands. The esthetic properties of the Straumann C.A.R.E.S. Ceramic Coping are designed to create a natural appearance of the soft tissue margin as well as excellent results for crown restoration.

The provided text describes a 510(k) submission (K061277) for the Straumann C.A.R.E.S. Ceramic Coping. This is a premarket notification for a medical device aiming to demonstrate substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific acceptance criteria through performance data.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training and test sets.

The relevant sections of the document focus on:

• Device Identification: Trade Name, Common Name, Classification.
• Predicate Devices: Listing previously cleared devices to which equivalence is claimed.
• Device Description: What the Straumann C.A.R.E.S. Ceramic Coping is and its function (custom-modified coping for cement-retained restorations, providing support for crowns/bridges).
• Intended Use: Similar to the description, detailing its use in aesthetic regions for cemented restorations.
• Basis for Substantial Equivalence: Arguing that the subject device is similar in design, indications for use, technological characteristics (material, principles of operation, basic design), and manufacturing process (software and milling) to the predicate devices.

Conclusion:

The 510(k) submission for K061277 does not detail specific acceptance criteria, performance data from a clinical or technical study, sample sizes, expert involvement, or ground truth methodologies as it relies on demonstrating substantial equivalence to predicate devices rather than providing new performance outcome data.

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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations.

The Straumann Dental Implant System is an integrated system of endosseous dental implants designed to support prosthetic restorations {crowns, bridges, overdentures}. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The subject device, the Straumann C.A.R.E.S. Titanium Abutment, is designed to be custom modified for a particular patient, then inserted into the implant with a basal screw. The titanium abutment provides support for a prosthetic reconstruction, such as a crown. The Straumann C.A.R.E.S. Titanium abutment is intended for cemented restorations and can be customized to meet high anatomical and esthetic demands. The esthetic properties of the Straumann C.A.R.E.S. Titanium Abutment are designed to create a natural appearance of the soft tissue margin as well as excellent results for crown restoration.

This document is a 510(k) summary for the Straumann C.A.R.E.S. Titanium Abutment. It details the device's identity, intended use, and claims of substantial equivalence to a predicate device. However, it does not contain information about formal acceptance criteria, studies, or performance data in the way typically expected for a detailed device validation and verification report.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific, quantitative acceptance criteria for performance.
• Reported Device Performance: Not reported in terms of specific metrics or quantitative data from a study. The document states that "Technological characteristics of the device, including material composition, principles of operation, and basic design are identical to the predicate device." This is a qualitative statement of equivalence, not a report of performance against defined criteria.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. The document does not describe a clinical or performance "test set" in the context of an algorithm or AI. It describes a medical device, an abutment, whose design and materials are compared to a predicate.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No data in this sense is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This document is not about an AI/algorithm-based device requiring expert ground truth for a test set.

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

• Not applicable. No test set requiring adjudication is described.

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 device is a physical dental abutment, not an AI or algorithm. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not applicable. This is not an algorithm.

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

• Not applicable. No ground truth in the context of an AI/algorithm is relevant here. The "ground truth" for this device's safety and effectiveness relies on its similarity to a previously cleared device and the established performance of its materials and design, which are generally well-understood in the dental industry.

8. The sample size for the training set

• Not applicable. No training set for an AI/algorithm is mentioned.

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

• Not applicable. No training set ground truth to establish.

Summary of what the document does provide regarding "proof of meeting acceptance criteria":

• Basis for Substantial Equivalence: The primary "proof" in this 510(k) is the claim that the Straumann C.A.R.E.S. Titanium Abutment is substantially equivalent to the Straumann synOcta Meso Abutment (K033243).
• Method of demonstrating equivalence: This equivalence is asserted because the "Technological characteristics of the device, including material composition, principles of operation, and basic design are identical to the predicate device."
• Acceptance by FDA: The FDA's letter (pages 2-4) formally acknowledges the substantial equivalence (K052272), allowing the device to be marketed. This regulatory approval is the "acceptance" in the context of a 510(k) submission, indicating that the FDA finds the device as safe and effective as the predicate.

In essence, for this specific type of medical device (a physical implant component), the "acceptance criteria" are demonstrating substantial equivalence to a predicate device, and the "study that proves the device meets the acceptance criteria" is the 510(k) submission itself, along with the FDA's clearance letter. This is a very different paradigm than validating an AI/algorithm's performance against specific metrics using a test set.

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