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Asiga DentaTOOTH is intended exclusively for professional dental work. Asiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers.

DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3.

DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce denture temporary dental restorations. DentaTOOTH resin has been validated for use with the Asiga Max Series and Pro Series printers for the manufacture of temporary dental restorations at 385nm wavelengths.

DentaTOOTH is a light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. DentaTOOTH is a Type 2, Class 2 resin per ISO 10477:2020 and Type 1, Class 2, Group 2 resin per ISO 4049:2019.

DentaTOOTH has a shelf life of 36 months. The device may be stored in Asiga Max and Pro Series printers for up to 4 weeks with hood closed.

DentaTOOTH is compliant to ISO 10477:2020 and ISO 4049:2019 for polymer based crown and veneering materials, and polymer based restorative materials, respectively.

The provided FDA 510(k) clearance letter for DentaTOOTH is for a temporary crown and bridge resin, not an AI-powered diagnostic device. Therefore, the information requested regarding acceptance criteria and studies that prove the device meets these criteria (such as MRMC studies, ground truth establishment, expert consensus, etc.) are not applicable to this type of device.

The 510(k) summary clearly states:

• Device Name: DentaTOOTH
• Common Name: Temporary crown and bridge resin
• Classification Name: Crown And Bridge, Temporary, Resin
• Regulation Number: 872.3770 (which corresponds to Temporary Crown And Bridge Resin)
• Product Code(s): EBG

The documentation details non-clinical tests performed in accordance with specific ISO standards relevant to dental materials (ISO 10477:2020 for Polymer-based crown and veneering materials and ISO 4049:2019 for Polymer-based restorative materials). These tests evaluate material properties such as:

• Depth of cure
• Surface finish
• Flexural strength
• Water sorption
• Solubility
• Shade consistency
• Color stability
• Packaging validation
• Shelf life
• Biocompatibility (according to ISO 10993-1:2018)

The clearance is based on the substantial equivalence of DentaTOOTH's material properties and indications for use to legally marketed predicate devices, as demonstrated by these material-specific performance tests.

Therefore, I cannot provide a response to your numbered points as they are designed for the evaluation of AI/ML or diagnostic devices, which is not what DentaTOOTH is.

The questions you posed are typical for the regulatory review of Software as a Medical Device (SaMD) with AI/ML components, particularly those involved in image analysis or diagnosis where performance is measured by metrics like sensitivity, specificity, or reader agreement. DentaTOOTH is a material, not a software or diagnostic device.

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The Straumann CARES P-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, a restorative acrylic resin, 3D printers, post-curing unit and associated accessories. The system is used to design and fabricate CAD/CAM 3D printed coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments that are affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

The Straumann P pro Crown & Bridge material in combination with the Straumann Variobase is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.

The Straumann CARES P-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow for 3D printing.

The Straumann CARES P-Series CAD/CAM System employs optical impression files that document the topoqraphical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the desired restorations. The CAM software converts the digital restoration design into the sequential slice geometries needed to 3D print a restoration or multiple restorations in a print job. The printing file is transferred to the Straumann P-Series 3D printer; where it is decoded into the defined printing slices and the user initiates the printing operation. The Straumann P-Series 3D printer will then print the designed restoration using the Straumann P Pro Crown & Bridge resin.

The user of a Straumann CARES P-Series CAD/CAM System can design dental implant borne restorations using Straumann Variobases as the connecting interface to the implant. By this, the user will create two-piece abutments with the 3D printed part being the upper part of the implant borne restoration.

The provided text is a 510(k) summary for the Straumann CARES P-Series CAD/CAM System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the manner of a clinical trial or performance study comparing a new algorithm's efficacy.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/algorithm-based device is not explicitly available in this document. The device in question is a CAD/CAM system for designing and fabricating dental restorations, not an AI diagnostic tool.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for a specific performance metric in the context of an AI algorithm. Instead, it describes "Design Specifications" which serve as internal parameters for the CAD/CAM system and performance testing related to mechanical properties.

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

This information is not provided in the document. The testing described primarily involves mechanical material testing and software verification, not clinical or diagnostic data analysis. Therefore, concepts like "test set" in the context of an AI algorithm are not applicable here.

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

This information is not applicable as the document describes a CAD/CAM system for fabricating dental prosthetics, not a diagnostic AI algorithm requiring expert ground truth for imaging or clinical decision support. The "ground truth" for the mechanical characteristics would be established by standardized testing protocols.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as in point 3.

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. The device is a CAD/CAM system for fabrication, not an AI for human reader assistance or diagnostic interpretation.

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

The "standalone" performance described relates to the verification of the 3D printer system and the CAD software.

• Software Verification and Validation: This was performed to demonstrate that the software's restrictions prevent designing components outside allowable limitations and that the design library is locked. This implies a standalone verification of the software's adherence to design rules.
• 3D Printer System Verification: This confirmed that "the design input matched the output, that the process is repeatable and independent of print orientation, build plate location effects, and the effects of material reuse." This is a form of standalone performance assessment for the manufacturing component.

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

The "ground truth" for the performance testing cited appears to be:

• Standardized Mechanical Testing: According to FDA guidance for dental implants and abutments. This involves objective measurements of strength and fatigue.
• Material Specifications: Biocompatibility data from a previously cleared 510(k) for the P pro Crown & Bridge material (K200039).
• Design Specifications: Defined parameters (e.g., minimum wall thickness, maximum angulation) that the CAD software must adhere to.

This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI diagnostic systems.

8. The sample size for the training set

This information is not provided and is not applicable as the device is not an AI/machine learning algorithm requiring a "training set" in the conventional sense.

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

This information is not provided and is not applicable for the same reasons as in point 8.

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