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Intended to restore carious lesions or structural defects in teeth.
Intended to restore carious and and II. V. V. V. V. V. V. V. V. Intended to restore carrous rollows for the V (Inlays & Onlays)
It is intended for use in cavities Classes I, II, V (Inlays & Onlays) It is intended for use in cavities Classes it, in (223)
and as a restorative material intended for veneers, crowns, and bridges.

CeraSys - ZR is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentists prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or only prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesive materials. CeraSys - ZR ceramic is an alternative to gold, amalgam, porcelain, or composite filling materials, except that their application more closely resembles gold inlys 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 document is a 510(k) summary for the CeraSys - ZR dental restorative material and does not contain a study demonstrating the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy.

The document focuses on establishing substantial equivalence to existing legally marketed devices, rather than conducting a performance study with defined acceptance criteria and statistical analysis.

Therefore, I cannot provide the requested information in the format given because the input document does not contain a study that proves the device meets acceptance criteria you've outlined.

However, I can extract information related to the substantial equivalence claim, which is the basis for FDA clearance for this device:

Basis for Substantial Equivalence (as presented in the document):

1. Same Intended Use: To be luted/cemented permanently into place as inlays and onlays; also for veneers, crowns, and bridges. (Pages 1 & 4)
2. Similar Technological Characteristics: The technological characteristics are similar to those for predicate devices and those currently on the market, with differences noted in methods of use. The device is a zirconium dioxide-yttrium oxide ceramic capable of machining by modern methods. (Page 1)
3. Well-Established Material: Zirconium dioxide-yttrium oxide ceramic is a material well-established as the basis of many different kinds of hip implants (requiring significantly greater forces than in the mouth). Zirconia has been repeatedly tested throughout the medical and dental industry and research and has shown to be highly biocompatible. The luting/cementing materials are traditional and well known to the dental industry. (Pages 1 & 2)

Predicate Devices for Substantial Equivalence:

• Cercon K-013230
• CynoVad Zirkon K-023327
• Denzir 2-984201
• 3M ESPE AG K-011394
• Austenal K-001815
• Devices described in K-973221, K-971869, K-943168

Missing Information (not applicable to a 510(k) substantial equivalence submission of this type):

The following points from your request are not applicable to this document as it describes a 510(k) premarket notification based on substantial equivalence, not a direct performance study with defined acceptance criteria for a new device's efficacy or accuracy against a ground truth:

• A table of acceptance criteria and the reported device performance: No specific performance metrics like sensitivity, specificity, or accuracy with corresponding acceptance criteria are reported.
• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described for a test set.
• Adjudication method for the test set: Not applicable.
• 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 is a dental material, not an AI device).
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document asserts the safety and effectiveness of the CeraSys - ZR device by demonstrating its substantial equivalence to currently marketed devices, primarily based on intended use, technological characteristics, and material biocompatibility, rather than through a a new performance study with acceptance criteria against a defined ground truth.

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