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Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Zirl3lank-PS and ZirBlank-FS is a yttrium oxide-stabilized zirconia (Y-ITZP) capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay, onlay or other prosthesis is prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. ZirBlank-PS and ZirBlank-FS prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

This submission does not contain information about an AI/ML device or a medical device that would have acceptance criteria and a study to prove it meets them in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity).

The document is a 510(k) summary for a dental restorative material, ZirBlank-PS and ZirBlank-FS, which are yttrium oxide-stabilized zirconia (Y-TZP) powders/blocks. The purpose of a 510(k) submission for such a device is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove diagnostic performance.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth types) because this type of evaluation is not applicable to this particular device and its regulatory submission.

The "study" mentioned in the document refers to the demonstration of substantial equivalence based on:

1. Same intended use as predicate devices.
2. Similar technological characteristics, with well-understood differences.
3. Well-established materials (components of ZirBlank-PS and ZirBlank-FS have prior successful use in legally marketed devices, including hip implants).
4. Comparison to predicate devices for safety and effectiveness.

The "acceptance criteria" here are implicitly satisfying the FDA's requirements for substantial equivalence, primarily by demonstrating that the device is as safe and effective as predicate devices. The performance is assessed by material properties and intended use, not by diagnostic accuracy.

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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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