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NobelProcera® HT ML FCZ Bridge is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera® HT ML FCZ Bridge is indicated for use as a bridge that will be cemented on natural teeth or artificial abutments.

NobelProcera®HT ML FCZ Bridge is an individualized cement retained dental restoration manufactured from translucent multi-layered zirconia material.
NobelProcera® HT ML FCZ Bridge is intended to be a replacement for a natural teeth. After finalizing the NobelProcera®HT ML FCZ Bridge in the dental laboratory, it is cemented or bonded on prepared teeth or artificial abutments by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth. To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Bridge is suitable for cut-back (veneering) or stain and glaze techniques.
The design of the NobelProcera® HT ML FCZ Bridge is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the bridge using NobelDesign or supported third party CAD systems. The bridge, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.
The NobelProcera® HT ML FCZ Bridge is manufactured from a solid piece of yitria-stabilized tetragonal zirconia. It is available in 6 shades and for bridges between 2 and 14 units.

This looks like a 510(k) summary for a dental bridge, and as such, it does not contain the kind of performance study details you'd typically find for a device with complex algorithms or AI components that require clinical validation against acceptance criteria. The device is a physical dental prosthetic, not a software or AI-driven diagnostic tool.

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way you've outlined for AI or software validation.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described.

Here's an attempt to address your request based only on the provided text, noting where information is not available or not applicable:

Acceptance Criteria and Device Performance Study for NobelProcera® HT ML FCZ Bridge

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for this type of dental prosthetic primarily revolve around the biocompatibility and mechanical properties of the material, and its equivalence to already cleared devices. The document explicitly states that the device leverages the clearance of its material and the substantial equivalence to predicate devices, thus directly addressing these aspects rather than presenting specific numerical acceptance criteria for a new performance study.

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

• Sample Size: Not applicable. No dedicated "test set" in the context of a performance study for AI/software is mentioned. The assessment relies on the properties of the material and comparison to predicate devices, not on a new clinical or observational study with a test set of data.
• Data Provenance: Not applicable. The data primarily consists of the chemical composition and established properties of the ziconia material (Katana Zirconia K143439) and the characteristics of predicate devices (K153534, K071182).

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

• Not applicable. This is not a study requiring human expert assessment for ground truth determination, as it's a physical dental device. The determination of "ground truth" for a physical material typically comes from standardized material testing and regulatory guidelines.

4. Adjudication method for the test set

• Not applicable. There was no test set requiring adjudication in this submission.

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 is not an AI/software device. No MRMC study was conducted.

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

• Not applicable. This is a physical medical device (dental bridge), not an algorithm or AI.

7. The type of ground truth used

• Ground Truth: For a physical device like this, "ground truth" pertains to the established material properties (e.g., strength, biocompatibility) of the zirconium oxide, as well as the manufacturing consistency according to established quality systems. The document states the material (Katana Zirconia) is cleared for its intended use, implying its properties meet regulatory standards.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As there is no training set mentioned or implied, the method of establishing its ground truth is irrelevant.

In summary, this 510(k) submission for the NobelProcera® HT ML FCZ Bridge is based on demonstrating the safety and effectiveness through substantial equivalence to legally marketed predicate devices and by leveraging the prior clearance of the material used. It does not present a de novo performance study with acceptance criteria in the manner one would see for an AI or software-as-a-medical-device (SaMD) product.

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