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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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artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.

A rectangular solid block of PMMA with post attachment for use in a CAD-controlled milling device for production of long-term temporary crowns and bridge abutments.

The provided text describes a medical device, artBloc® Temp, which is a PMMA block for CAD-controlled milling machines. The document is a 510(k) premarket notification summary. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with detailed acceptance criteria and performance metrics typically associated with AI/software devices.

As such, the information requested below, particularly related to acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment, is largely not applicable or not provided in this type of regulatory submission for a physical dental material. There is no mention of an algorithm, AI, or software performance in the context that would require these specific metrics.

Here's a breakdown based on the provided document:

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

   Acceptance Criteria	Reported Device Performance
   Compliance to ISO 10477 (Polymer-based crown and veneering materials)	Not explicitly stated: The document only states "Tested for compliance to ISO 10477". Specific performance values (e.g., flexural strength, water sorption) are not reported. The implication is that it met the standard's requirements, which serves as the acceptance criteria for material properties.
   Compliance to ISO 3336 (Dental ceramic applied to metal restorations)	Not explicitly stated: The document only states "Tested for compliance to ISO 3336". Specific performance values are not reported. This standard might be referenced for general dental material quality and methods, but PMMA is not ceramic. It's possible this is a general reference or an error in the summary. The core material is PMMA.
   Compliance to ISO 10993 (Biological evaluation of medical devices)	Not explicitly stated: The document only states "Tested for compliance to ISO 10993". Specific biocompatibility results (e.g., cytotoxicity, sensitization) are not reported. The implication is that it met the standard's requirements, which serves as the acceptance criteria for biocompatibility.
   Substantial Equivalence to Predicate Devices: artegral ImCrown and VITA CAD-Temp	Achieved: The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the primary "performance" criterion for a 510(k), meaning its characteristics and intended use are similar enough to existing devices not to raise new questions of safety and effectiveness.
   Indication for use with inLab, CEREC, or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.	Supported by Predicate Equivalence: The intended use statement confirms this (Page 3 of 48). The predicate devices also serve as evidence that such materials can be used for temporary crowns and bridges with CAD/CAM systems. The "performance" here is functional compatibility and suitability for the intended anatomical and clinical application, implicitly covered by compliance to ISO standards and substantial equivalence.

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

   • Not provided. This document is a regulatory summary for a physical material, not for an AI/software device involving test sets of data. Testing mentioned (ISO standards) would typically involve material samples, but the number of such samples is not specified.

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):

   • Not applicable/Not provided. Ground truth, in the context of expert review, is not relevant for this type of material submission. Compliance to ISO standards is typically assessed by laboratory testing against pre-defined physical/chemical/biological metrics.

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

   • Not applicable/Not provided. This refers to expert review processes, which are not detailed or implied for 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 a physical dental material, not an AI or imaging device that would involve human readers or AI assistance.

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

   • Not applicable. There is no algorithm discussed in this document.

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

   • Material property standards: The "ground truth" for this device would be its physical, chemical, and biological properties meeting the specifications outlined in the referenced ISO standards (ISO 10477, ISO 3336, ISO 10993). This is typically determined through laboratory testing against established benchmarks.

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/software device. For a physical material, development would involve R&D and quality control, but not a "training set" in this sense.

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

   • Not applicable. As there is no training set mentioned or implied, this question is not relevant to the provided document.

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