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• Definitive supported and veneered crowns and bridges with maximum two pontics. Can be veneered with bonded press crowns, with composites or prefabricated acrylic teeth and veneers.
• Definitive supported, veneered single crowns and bridges with maximum one pontic on natural teeth.
• Removable restoration such as secondary structures on bars and telescopic crowns, transversal connectors, occlusal splints and denture bases.

Pekkton® Ivory is a semi-crystalline thermoplastic supplied in milling blanks and press blanks. By application of CAD/CAM milling or pressing technology according to the instructions for use, it can be used by the dental technician to manufacture permanent crowns, bridges and denture frameworks.

This document is a 510(k) premarket notification for a dental material called Pekkton® Ivory. It does not describe an AI/ML powered device, but rather a physical dental product. Therefore, the information requested about acceptance criteria and study proving the device meets the criteria, particularly regarding AI/ML specifics like MRMC studies, training/test sets, and expert adjudication, is not applicable to this document.

The document discusses the substantial equivalence of Pekkton® Ivory to a predicate device (BioHPP-breCAM.BioHPP) and a reference device (Pekkton® Ivory K123638). The "studies" mentioned are primarily non-clinical tests to assess biological, chemical, and physical properties of the material.

Here's an analysis of what is provided, framed as closely as possible to your request, but acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparative table of technological characteristics between the predicate device (BioHPP-breCAM.BioHPP) and Pekkton® Ivory, along with relevant standards. These values serve as the "performance" data, and the comparison to the predicate and relevant ISO standards imply the "acceptance criteria."

Acceptance Criteria Statement: The document explicitly states: "Testing has shown that Pekkton® Ivory is equivalent in performance characteristics to the predicate device BioHPP. The acceptance criteria were met."

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

• Sample Size: The document does not specify exact sample sizes for each physical/chemical test (e.g., how many specimens were tested for flexural strength). It refers to "non-clinical test data."
• Data Provenance: The tests were conducted according to international standards (ISO, USP, ASTM). The country of origin of the data is implied to be Switzerland, where CENDRES+METAUX SA is based. The data is "retrospective" in the sense that the testing was completed prior to the 510(k) submission.

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

• This is not applicable as the "ground truth" for a physical dental material is established through objective, standardized physical and chemical tests, not through expert consensus on interpretations like medical images.

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

• Not applicable. Adjudication methods are relevant for subjective assessments, typically in image interpretation or clinical outcomes, not for objective material property testing.

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 for a physical dental material, not an AI-powered diagnostic device.

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

• Not applicable. This is a physical device.

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

• The "ground truth" for this device is based on objective, quantitative measurements of physical and chemical properties (e.g., melting temperature, bond strength, flexural strength, water absorption/solubility) derived from adherence to established international standards (ISO, ASTM, USP).
• For biological risks, the "ground truth" or assessment of safety is based on biocompatibility testing against recognized standards (ISO 10993 series and ISO 7405).

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for physical material properties in this context, as there is no machine learning model involved. The manufacturing process and material formulation are "trained" through R&D and quality control, but not in the AI/ML sense.

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

• Not applicable. See point 8. The "ground truth" for the material's properties is established through the test methods and standards mentioned in point 7.

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Pekkton® ivory is intended to be used for long-term, temporary dental crowns and bridges frameworks.

Pekkton® ivory is a semi-crystalline thermoplastic supplied in blanks. Pressing the blank gives a framework, from which the dental technician manufactures the final veneered dental crown and / or temporary dental bridge.

This document describes the premarket notification for the Pekkton® ivory dental device. The information provided focuses on demonstrating substantial equivalence to predicate devices and verifying the biological safety and performance of the device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, summarized format. However, it lists several biological evaluation tests and states that the "acceptance criteria were met."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes for each test in the test set. It mentions that the studies were performed "in compliance with international GLP regulations," which implies controlled laboratory settings. The data provenance is from Cendres+Métaux SA, Switzerland, and the testing was retrospective (meaning conducted specifically for the 510(k) submission, not as part of an ongoing clinical trial).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. The testing described is primarily laboratory-based (biocompatibility, chemical, physical) rather than relying on human expert interpretation for ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable/provided. The tests are objective laboratory measurements, not reliant on expert adjudication of results.

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/provided. The device is a dental material (Pekkton® ivory) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/provided. The device is a material, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test set was established through standardized laboratory testing protocols and established scientific methods, as defined by international standards (e.g., ISO 10993 series, USP 34 ) for biocompatibility, and material science methodologies for chemical and physical properties. For example:

• Biocompatibility: The "ground truth" for cytotoxicity was the observable impact on L929 mouse fibroblasts. For chemical characterization, it was the absence of product-related peaks in GG/MS / ICP analyses.
• Physical/Mechanical Properties: The "ground truth" was based on quantitative measurements (e.g., bond strength, fracture load, fatigue) compared against benchmarks from predicate devices or established material data sheets.

8. The Sample Size for the Training Set

This information is not applicable/provided. The submission describes a device validation through physical and biological testing, not a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided as there is no training set for a machine learning model.

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