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ZirAce™ abutments are indicated for use in partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function. They are especially applicable to anterior or canine teeth where the typical titanium color may show through the gum. In addition to the Branemark (Nobel Biocare) implants, the ZirAce™ abutments hexagon connector fits the external hexagon of the following implants:

• . 3i ,
• Lifecore Biomedical , .
• Sterngold Implamed. .

ZirAce "" is a ccramic abutment composed of zirconium oxide stabilized with yttrium oxide, and containing niobium oxide to improve the properties and color. The zirconium oxide stabilized with yttrium oxide ceramic has been used for about 25 years as hip-implant and other prostheses and is capable of machining by modern CAD-C'AM methods. Various versions of this ceramic have been cleared for dental uses as inlays onlays and vencers by Dentronic in K971414 and for such materials and crowns and copings by Cynovad in K033227 and Medin Tech in K043472. The material is radio-opaque, for ready visualization.

The provided text focuses on the 510(k) summary for a dental implant abutment, Zir Ace™. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood in the context of clinical performance or algorithm evaluation.

The "studies" mentioned are primarily physical tests comparing the Zir Ace™ material to predicate devices and recognized standards (like ISO 14801 for "Dynamic Continuous Fatigue Test") to demonstrate material equivalence and biocompatibility.

Therefore, for almost all points in your request, the information is not present in the provided text. I will indicate where information is missing.

Acceptance Criteria and Device Performance Study for K051501 (Zir Ace™ Dental Abutment)

Based on the provided 510(k) summary, detailed acceptance criteria and a study demonstrating the device's performance against clinical or diagnostic metrics (as would be typical for an AI/algorithm-based device) are not presented. The submission focuses on substantial equivalence to predicate devices primarily through material and mechanical property comparisons.

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical acceptance thresholds for mechanical properties (e.g., minimum compressive strength in MPa, number of cycles for fatigue).
• Quantitative results from the physical tests for direct comparison.

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

This information is not provided in the 510(k) summary. The "tests" referred to are physical, material-based tests, not clinical performance studies with patient or image data.

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

This information is not applicable and not provided. The ground truth for material properties would be established by laboratory testing methodologies and standards, not expert consensus in a clinical diagnostic sense.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies, not for material property testing.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned as this submission is for a physical medical device (dental abutment), not an AI/algorithm-based diagnostic or assistive system. Therefore, there is no mention of human readers, AI assistance, or effect sizes.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:

No. This is not an algorithm-based device, so a standalone performance study is not applicable.

7. The Type of Ground Truth Used:

The ground truth used for this submission is based on material science standards and laboratory measurements. This includes:

• Physical properties (compressive strength, fracture toughness, durability) tested according to established methods (e.g., ISO 14801).
• Biocompatibility evaluation against recognized standards for yttrium stabilized zirconia.
• Chemical composition analysis.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. There is no "training set" as this is not an algorithm or AI-based device.

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

This information is not applicable and not provided, as there is no training set mentioned in the context of an algorithm. For the material properties, the "ground truth" (i.e., the expected performance or characteristics) is established by existing material standards, previously cleared predicate devices, and scientific literature.

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