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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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Asiga DentaBASE is intended exclusively for professional dental work.
Asiga DentaBASE is a 3D print resin intended for the manufacturing of 3D printed denture bases.
The denture bases produced are suitable for dental indications including removable dentures.

Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin has been validated for use with the Asiga Max Series and Pro Series 3D printers.

Asiga DentaBASE is a Type 4 light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments.

Asiga DentaBASE resin material is used in a DLP 3D printer, which prints the denture base from CAD data. The denture base is built by solidifying successive layers of photopolymer against each other. Each layer is light cured before adding the next layer, with post-curing in a light chamber unit. The 3D printer and light-curing unit are not included with the device.

The device is supplied as a pre-mixed resin in one color, natural pink. The device is supplied non-sterile, and it not intended to be sterilized.
Asiga DentaBASE has a shelf life of 36 months.
AsigaDentaBASE is compliant to ISO 20795-1 for Type 4 materials.
AsigaDentaBASE is a surface device with mucosal membrane contact for >30 days and is compliant to ISO 10993-1 and ISO 7405.

The provided FDA 510(k) clearance letter for Asiga DentaBASE does not contain information relevant to AI/ML device performance or clinical study details as described in the prompt's request. This is a clearance for a 3D printing resin for denture bases, which is a physical material, not an AI/ML diagnostic or assistive device.

Therefore, I cannot provide the requested information regarding:

• Acceptance criteria and reported device performance related to AI/ML metrics. The document refers to physical and chemical properties of the resin, not AI performance metrics like sensitivity, specificity, or AUC.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (NextDent Denture 3D+) and compliance with relevant ISO standards and FDA guidance for denture base resins (e.g., ISO 20795-1:2013 for Type 4 materials, ISO 10993-1:2018 for biocompatibility). The "tests" mentioned are bench tests for material properties (flexural strength, modulus, water sorption, solubility, residual monomer, biocompatibility), not performance evaluation of an AI algorithm.

The only "performance criteria" mentioned are those for the physical resin as outlined in FDA guidance "Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway (April 13, 2022)" and ISO 20795-1:2013.

In summary, this document is about a material used in dentistry, not an AI product, so the requested AI-centric information is not present.

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