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els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.

els extra low shrinkage® composite is indicated for:

• Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
• Indirect anterior and posterior restorations including inlays, onlays and veneers
• Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
• Splinting

els extra low shrinkage® flow is indicated for:

• Restorations with minimally invasive preparation technique
• Restorations of small cavities and extended fissure sealing
• Alternate restorations for undercut cavities
• Restorations of class III V including wedged shaped defects and cervical caries
• Repair of fillings, veneers and methacrylate-based temporary restorations
• First layer of fillings for Class I and II
• Interlocking of loosened teeth
• Adhesive attachment of indirect composite and ceramic restorations

els extra low shrinkage® composite is classified as a Type 1, Class 2, Group 1 & 2 Polymerbased restorative material according to ISO 4049:2009 - Dentistry - Polymer-based restorative materials.

els extra low shrinkage® flow is classified as Type 2, Class 2, Group 1 Polymer-based restorative material according to ISO 4049:2009 – Dentistry – Polymer-based restorative materials.

els extra low shrinkage® composite & els extra low shrinkage® flow are light-cured methacrylate-based resins that are intended to fill and restore small to large defects or carious lesions in teeth.

els extra low shrinkage® composite & els extra low shrinkage® flow are light cured radiopaque microhybrid composites with extremely low shrinkage stress.

This document is a 510(k) summary for the "els extra low shrinkage® composite" and "els extra low shrinkage® flow" dental restorative materials. It does not describe a study involving an AI/software device that requires intricate details on acceptance criteria and performance evaluation against a defined ground truth. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance (bench testing) and material comparison.

Therefore, many of the requested categories for AI/software studies are not applicable to the information provided in this document.

However, I can extract the information that is relevant to the non-clinical performance and acceptance criteria for these dental materials:

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

The acceptance criteria for "els extra low shrinkage® composite" and "els extra low shrinkage® flow" are based on meeting the requirements of the ISO standard ISO 4049:2009 - Dentistry - Polymer-based restorative materials. The tables below show a comparison of the device's physical properties against predicate devices, indicating that the device performance meets these standards.

els extra low shrinkage® composite (els composite) Performance vs. Predicate Devices

els extra low shrinkage® flow (els flow) Performance vs. Predicate Devices

The following points are not applicable as this submission is for dental restorative materials, not an AI/software device. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of els extra low shrinkage® composite & els extra low shrinkage® flow."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable (no human clinical test set).
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 (ground truth not established by experts as there are no human clinical outcomes).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable (ground truth is derived from compliance with ISO standards for physical and chemical properties).
8. The sample size for the training set: Not applicable as there is no training set for an AI/software device. The product underwent non-clinical bench testing.
9. How the ground truth for the training set was established: Not applicable.

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saremco print BRIDGETEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print BRIDGETEC material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. saremco print BRIDGETEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

saremco print BRIDGETEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.

The provided text describes the regulatory clearance of a dental product, "saremco print BRIDGETEC," based on its substantial equivalence to existing predicate devices. It does not present a study proving the device meets acceptance criteria in the way an AI/ML medical device would be evaluated (e.g., using a test set, ground truth, expert readers, etc.).

Instead, the submission focuses on bench testing and comparison of physical and chemical properties to established standards and predicate devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria in the context of AI/ML evaluation. The information provided is about a material, not a diagnostic or prognostic AI algorithm.

However, I can extract the "acceptance criteria" and "reported device performance" from the document in the context of the material's properties and compliance with standards.

Here's the closest possible interpretation of your request based on the provided text:

Acceptance Criteria and Device Performance (for a Dental Material, not an AI/ML Device)

The "acceptance criteria" for saremco print BRIDGETEC are primarily based on its compliance with international standards for dental materials and its substantial equivalence to existing predicate devices in terms of intended use, material composition, and physical properties.

1. Table of Acceptance Criteria and Reported Device Performance

The following points cannot be addressed as they are relevant to AI/ML device studies, not traditional material clearances:

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance was based on bench tests of the material, not a "test set" of patient data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing, not expert interpretation of cases.
4. Adjudication method for the test set: 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: Absolutely not applicable. This is a material, not an AI assisting human readers. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of saremco print BRIDGETEC."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For material properties, the "ground truth" is derived from physical and chemical measurements performed according to established ISO standards. For the "substantial equivalence" claim, the ground truth is the documented performance and indications of the legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This is a manufactured product, not a software algorithm that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a regulatory submission for a dental material, not an AI/ML medical device. Therefore, the questions related to AI/ML study design, such as ground truth establishment via experts, reader studies, and training/test sets, are not relevant to this content. The "proof" of meeting "acceptance criteria" for this device lies in its compliance with material standards and demonstrating substantial equivalence through bench testing.

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saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

saremco print CROWNTEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.

The provided document does not contain information related to an AI/ML device or a multi-reader, multi-case (MRMC) study. The device, "saremco print CROWNTEC," is a light-curing 3D-printed material for dental restorations (e.g., crowns, inlays, veneers, artificial teeth).

The "study" described in the document is a non-clinical performance testing and biocompatibility evaluation of this dental material, specifically to demonstrate its substantial equivalence to predicate devices for FDA 510(k) clearance.

Therefore, I cannot provide answers to the requested information about acceptance criteria, study details, expert involvement, or AI/ML performance metrics, as these are not relevant to the described device and its evaluation process.

Instead, the document details the following:

• Acceptance Criteria (inferred from testing): The device (material) was tested and met the applicable requirements of the following ISO standards:
  • ISO 4049:2019 - Dentistry - Polymer-based restorative materials
  • ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials
  • ISO 22112:2017 – Dentistry – Artificial teeth for dental prostheses
  • ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
  • ISO 7405:2018 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
• Reported Device Performance:
  • Flexural Strength: Average ≥ 135 MPa (compared to predicate devices ranging from > 50 MPa to 148.73 MPa).
• Study Type: Non-clinical bench testing and biocompatibility assessment.
• Ground Truth: The "ground truth" in this context refers to the established requirements and performance metrics defined by the aforementioned ISO standards, against which the material's properties were measured.
• Clinical Performance Data: The document explicitly states, "No human clinical testing was performed to support the substantial equivalence of saremco print CROWNTEC."
• Training Set/Test Set (as per ML context): Not applicable, as this is a material science characterization, not an AI/ML model development.
• Data Provenance: The tests were conducted by the manufacturer (Saremco Dental AG). Data provenance for the material properties would be from the laboratory tests.
• Experts and Adjudication: Not applicable in the context of an AI/ML study, but the ISO standards represent a consensus of expert knowledge in dental material science.

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