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The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is intended to be used as a functional restoration for primary teeth, including for a badly decayed deciduous (baby) tooth, until the adult tooth erupts. It is not intended for permanent restoration. The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is indicated for use in infants, children, and adolescents.

The EPI Ceramic Pediatric Preformed Crown is a temporary tooth restoration. The dental crown is a tooth-shaped "cap" that is placed over a tooth - covering the tooth to restore its shape and size, strength, and/or to improve its appearance. The preformed crowns are manufatured in specific sizes for a proper fit, which are contained within the range of sizes commonly available for existing preformed crowns. Sizing is exclusively determined by the dentist for their particular patient and the EPI crowns are not meant to undergo further manipulation by the dentist. The EPI Ceramic Pediatric Preformed Crown is secured within the patient's mouth using standard denal adhesion techniques. The crowns, when cemented into place, fully encase the entre visible portion of a tooth that lies at and above the gum line. The EPI Ceramic Pediatric Preformed Crown is made of Zirconia. Zirconia is a biologically inert, high-tech ceramic material (dental porcelain) intended for use in the construction of irentium oxide ceramic prosthetics. Because the EPI crowns are distributed in their final, finished form, there are no pellets, casting alloys, powders or auto mix systems that require firther manipulation by the dentist.

The provided text is a 510(k) summary for the EZ-Pedo Inc. Ceramic Pediatric Preformed Crown. It details the device, its indications for use, and its substantial equivalence to predicate devices, but does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, etc.

The summary focuses on establishing substantial equivalence based on indications for use, technological characteristics, sizing, performance characteristics (general material adequacy), and processing compared to already legally marketed predicate devices.

Therefore, many of the requested details (acceptance criteria table, sample sizes for test/training, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods) are not present in this type of regulatory submission because they are typically relevant for AI/ML-driven devices or devices requiring extensive performance validation against specific endpoints. This device is a preformed dental crown, and its evaluation relies on material properties and comparison with existing crowns.

However, I can extract the information that is present according to your request format:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "Non-clinical product testing was conducted on the preformed crown, including material adequate for its intended use," but does not detail the number of crowns tested or the methodology.
• Data Provenance: Not specified beyond "Non-clinical product testing." No mention of country of origin or retrospective/prospective nature as this typically applies to clinical data.

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

• Number of Experts: Not applicable/Not specified. This information is typically relevant for studies involving human interpretation (e.g., image reading) where ground truth is established by consensus. For a physical device like a dental crown, "ground truth" refers to objective physical and material properties (e.g., strength, biocompatibility), not expert consensus on an interpretation.
• Qualifications of Experts: Not applicable/Not specified.

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

• Adjudication Method: Not applicable. Adjudication methods are typically used for conflicting expert interpretations in diagnostic studies, which is not relevant for this device.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, not for a preformed dental crown.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This refers to the performance of an algorithm without human intervention, which is not relevant for a physical dental device.

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

• Type of Ground Truth: For this type of device, the "ground truth" would be objective specifications and material property testing results (e.g., biocompatibility testing, mechanical strength tests, dimensions). The summary only broadly states "material adequate for its intended use" from "Non-clinical product testing" without detailing the specific tests or their "ground truth" reference standards (e.g., ISO standards for dental materials).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This concept is relevant for machine learning models, not for a physical dental crown.

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

• Ground Truth Establishment for Training Set: Not applicable/Not specified.

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Nobel Biocare's Procera Bridge Alumina is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Alumina may be two, three, or four units and is cemented to natural or artificial tooth abutments.

Nobel Biocare's Procera® Bridge Alumina is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function.

The Procera® Bridge Alumina may be two, three, or four units and is precision milled. The Procera Bridge Alumina can be cemented or bonded to either natural or artificial tooth abutments. It is personalized according to the specific dimensions of the patient's so the bridge precisely fits, and properly functions, in the patient's jaw.

Nobel Biocare's Procera® Bridge Alumina is manufactured from one solid piece of densely sintered aluminum oxide (Alumina).

The provided text describes a medical device, the Nobel Biocare Procera® Bridge Alumina, and its regulatory clearance (510(k)). However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a 510(k) summary and the corresponding FDA clearance letter. These documents confirm that the device is substantially equivalent to a predicate device and is cleared for marketing. They specify the device's description, indications for use, and regulatory classification but do not include details about performance studies used to demonstrate safety and effectiveness for a new device submission or a comparative effectiveness study.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• 1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
• 2. Sample sized used for the test set and the data provenance: This information is not present in the provided text.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided text.
• 4. Adjudication method: This information is not present in the provided text.
• 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 present in the provided text. The device is a physical dental bridge, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present in the provided text. The device is a physical dental bridge, not an algorithm.
• 7. The type of ground truth used: This information is not present in the provided text.
• 8. The sample size for the training set: This information is not present in the provided text.
• 9. How the ground truth for the training set was established: This information is not present in the provided text.

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