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VarseoSmile Crown plus is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown Plus material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.

VarseoSmile Crown plus is a light-cured, methacrylate-based resin used in 3D printers for the production of permanent crowns, inlays, onlays and veneers. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of permanent dental restorations such as inlays, onlays, veneers and full crown prosthetics in compatible 3Dprinters. Restorations fabricated using the Subject device are one-time use, permanent, prescription-only devices. VarseoSmile Crown is suitable for restoration of occlusal surfaces. VarseoSmile Crown is cured externally to the patient by light sources within a 3D printer and post-curing device. The Subject device is a viscous solution consisting of methacrylate-based resins, dental glass filler, photo initiators and pigments. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration.

This document is for a dental material (VarseoSmile Crown Plus), not an AI/ML powered medical device. Therefore, a table of acceptance criteria and reported device performance for an AI/ML device, as well as the other requested information related to AI/ML device studies (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), are not applicable to the provided text.

The information provided focuses on demonstrating substantial equivalence of the dental material to predicate devices based on indications for use, technological characteristics, and non-clinical performance testing against established ISO standards for dental materials.

Here's a breakdown of the relevant information from the document regarding the device's acceptance criteria and how it was shown to meet them:

Acceptance Criteria and Reported Device Performance (Non-AI/ML Device):

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• Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure
• Individualization of and layering on VITA ENAMIC®
• Layering-over long-term temporaries made from VITA CAD-Temp®
• Individualization of acrylic teeth
• Reproduction of gingival components
• Metal-free crowns and three-unit anterior bridges as long-term temporary restorations
• Veneering of removable and partially removable dentures (according to the manufacturer's information)
• Inlays
• Veneers

VITA VM LC Flow is a light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication.

This document describes the VITA VM® LC Flow, a dental veneering material. It does not describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device testing (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance:

The primary acceptance criteria mentioned are adherence to the FDA recognized standard, ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials. The device's performance is compared against this standard and predicate devices.

Study Information:

1. Sample size used for the test set and the data provenance: Not explicitly stated for each specific test, but the testing was "bench testing" performed in accordance with ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials standard. The country of origin for the data is not specified, but the submitter is based in Germany. The data is retrospective as it refers to performance data from tests conducted prior to the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device relying on expert interpretation of results. The "ground truth" for the physical property tests is based on the methods described in the ISO standard.

3. Adjudication method for the test set: Not applicable.

4. 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.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the device's performance validation is based on the physical and chemical property testing methodologies outlined in the ISO 10477:2004(E) and related biocompatibility standards (ISO 10933-1:2009, ISO 7405:2008). These are objective measurements rather than expert consensus or patient outcomes.

7. The sample size for the training set: Not applicable as this is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable.

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Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.

TempXN28 is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.
Like Protemp™ 3 Garant™, TempXN28 is available in the proven Garant™ mixing and dispensing system.

The provided text is a 510(k) Summary for a dental material (TempXN28) and not a study describing the performance of an AI/ML powered device. As such, the requested information pertaining to AI/ML device acceptance criteria, study design, and performance metrics (e.g., sample size for test set, ground truth establishment, MRMC studies, standalone performance) is not available in the given document.

The document discusses the safety and effectiveness of the dental material TempXN28 by demonstrating its substantial equivalence to predicate devices (Protemp™ 3 Garant™, Luxatemp Fluorescence, and Sinfony).

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for a software/AI device. For this dental material, acceptance criteria would typically involve biocompatibility, mechanical properties (e.g., flexural strength, wear resistance), polishability, color stability, and ease of use, all within acceptable ranges or comparable to predicate devices.
• Reported Device Performance: The document generally states: "To provide evidence for safety biocompatibility testing was carried out. The results show that TempXN28 is a safe device. The comparison for chemistry, performance data and indications for use shows that TempXN28 is substantially equivalent to the predicate devices."
  • No specific performance values (e.g., strength in MPa, fill rate, etc.) are provided in this summary.

The following questions cannot be answered from the provided text as they relate to AI/ML device evaluation, which is not the subject of this 510(k) summary:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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• All classes of fillings (according to Black) with lightcuring composite or compomer
• Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX™ ARC, manufactured by 3M ESPE
• Core build-ups made of light-curing composite
• Root surface desensitization
• Repair of composite or compomer fillings
• Repair of restorations veneered with composite or ceramic
• Bonding orthodontic appliances to teeth for orthodontic treatment

Uno is classified Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Uno offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itself, Uno is well suited for bonding methacrylate based composites to dentin and enamel. Uno is also indicated to seal sensitive root surfaces as is Adper Prompt L-Pop. Furthermore, Uno is suited to bond orthodontic appliances to teeth for orthodontic treatment as is Prompt L-Pop. Like Adper Prompt L-Pop, Uno will be available in single dose applicators and in a vial version.

This document pertains to a 510(k) summary for a dental adhesive product called "Uno" and does not contain information about the acceptance criteria or a study proving its performance against such criteria in the context of an AI/ML device.

The provided text describes a "Resin Tooth Bonding Agent" and its substantial equivalence to predicate devices, focusing on its chemical composition, intended use (bonding restorative materials, sealing root surfaces, bonding orthodontic appliances), and biocompatibility.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance: This document is for a physical dental adhesive, not an AI/ML device.
• Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, or ground truth establishment for a test set: These concepts are relevant to the evaluation of AI/ML devices, not a resin tooth bonding agent.

The document states, "To provide evidence for safety biocompatibility testing was carried out. The results show that Uno is a safe device." This is the extent of any "study" mentioned, and it only addresses biocompatibility for safety, not performance against specific clinical efficacy metrics. The primary mechanism for clearance is demonstrating "substantial equivalence" to existing, legally marketed predicate devices.

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