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Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.

The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown, Bridge, Veneer, Inlay) that will be cemented to a natural or artificial tooth abutment.

Additive Manufacturing Zirconia Customized Restoration is an individualized dental restoration (Crown,Bridge,Veneer,Inlay) made from zirconia slurry.

Additive Manufacturing Zirconia Customized Restoration is intended to be a replacement for a natural tooth.After finalizing the Additive Manufacturing Zirconia Customized Restoration in the laboratory.t is cemented or bonded onto a tooth or artificial abutment, by a clinician,to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.

To achieve esthetic and required value and chroma of the surrounding natural teeth the Additive Manufacturing Zirconia Customized Restoration is suitable for cut-back(veneering) or stain and glaze techniques.

The design of the Additive Manufacturing Zirconia Customized Restoration is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using or supported third party CAD systems. Once the restoration is ordered, it is sent electronically to Hangzhou Thales Medtech Co., Ltd. for fabrication.

The document provided is a 510(k) summary for a dental device, "Additive Manufacturing Zirconia Customized Restoration." It describes the device, its indications for use, and a comparison to predicate devices, along with performance and biocompatibility data to demonstrate substantial equivalence.

However, the provided text does not contain any information regarding a study involving human readers or AI assistance, or any performance data related to AI algorithms or human-in-the-loop performance. The performance data section refers to mechanical and biocompatibility testing of the physical dental restoration itself, not to the performance of any AI component.

Therefore, many of the requested details about acceptance criteria for AI performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not available in this document.

Below is a summary of the information that is present in the document.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally implied by adherence to ISO standards for dental ceramic materials. The performance values are reported in comparison to the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for mechanical or biocompatibility testing, nor does it refer to a "test set" in the context of data for an AI/software device. The data provenance (country of origin, retrospective/prospective) is not mentioned for any of the performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a physical dental restoration, not an AI or imaging device requiring expert interpretation for ground truth.

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

This information is not applicable.

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

This information is not applicable. The document describes a physical dental device; there is no mention of an AI component or MRMC study.

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

This information is not applicable as the device is a physical dental restoration, not an AI algorithm.

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

For the mechanical and biocompatibility testing, the "ground truth" is established by the relevant ISO standards and validated laboratory test methodologies. For example, for flexural strength, the ground truth is the measured force at fracture, evaluated against the standard's requirements.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not a machine learning model.

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

This information is not applicable.

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