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Extraoral, permanent cementation of ceramic structures made of lithium disilicate glass ceramic (LS2) or zirconium oxide on titanium/titanium alloy or zirconium oxide bases.

Multilink® Hybrid Abutment is a self-curing luting composite for the extraoral, permanent cementation of ceramic structures made of lithium disilicate glass-ceramic (LS2) or zirconium oxide on titanium alloy or zirconium oxide bases (e.g. abutment or adhesive basis) in the fabrication of hybrid abutments or hybrid abutment crowns.

This is a 510(k) summary for a dental cement, not an AI/ML powered device. Therefore, many of the requested criteria regarding AI device studies are not applicable. I will address the applicable criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified.
• Data provenance: Not specified, but likely from in-house laboratory testing based on the standards cited (ISO 4049:2000, ISO 10993). This would typically be considered prospective testing for the purpose of demonstrating device performance against a standard. The country of origin is not explicitly stated beyond "Ivoclar Vivadent, Inc. 175 Pineview Drive, Amherst, NY 14228".

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

Not applicable. This device is a material, not a diagnostic or AI device that requires expert ground truth for its performance evaluation in the context of the reported tests. Its performance is measured against physical and chemical standards.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements of physical and chemical properties based on ISO standards.

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 not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used

For the performance tests (Water Absorption, Solubility, Radiopacity, Flexural Strength, Modulus of Elasticity, Compressive Strength, Shear Bond Strength), the "ground truth" or reference is the standards set forth by ISO 4049:2000. The biocompatibility "ground truth" is defined by ISO 10993. The device's performance is compared against these established material performance criteria and against the performance of its predicate device to claim substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device. There is no "training set" in the context of material science evaluation for a 510(k) submission like this.

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

Not applicable. As this is not an AI/ML powered device, there is no training set or associated ground truth establishment process in the AI sense.

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Multilink Automix is used for the permanent cementation of indirect restorations where a strong bond is desired:

• Inlays, onlays, crowns, bridges and root posts made of: –
  • o Metal and metal ceramics
  • o All-ceramics, in particular opaque zirconium oxide ceramics
  • o Composites and fibre-reinforced composites

Multilink Automix is a self-curing and self-etching luting composite system for the adhesive luting of indirect restorations made of metalceramic all-ceramic and composite. Multilink Automix is applied together with the selfetching and self-Ocuring Multilink Primer. Monobond Plus is recommended as a coupling agent to achieve a strong bond to precious and non-precious alloys, as well as to all ceramics made of zirconium and aluminum oxide and silicate ceramics.

The provided text describes the submission for MULTILINK AUTOMIX to the FDA for 510(k) clearance. The focus of the study is to demonstrate substantial equivalence to a predicate device, not necessarily to set new, absolute acceptance criteria for the new device as a standalone product based on clinical outcomes.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance of the predicate device, Multilink (K032470), as the new device, Multilink Automix, aims to show substantial equivalence. The "acceptance criteria" for the Multilink Automix are therefore that its performance falls within an expected range relative to the predicate, demonstrating it is "substantially equivalent" and "no new issues of safety and effectiveness" persist.

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Multilink Sprint is a self-adhesive, dual curing luting composite for the permanent cementation of direct restorations made of:

• Metal and metal-ceramic (inlays, onlays, crowns, bridges and posts) .
• High-strength all ceramic: zirconiumoxide-, Lithiumdisilicate and . Aluminum oxide ceramic (crowns, bridges, and posts)
• Fiber-enforced composites (posts:) .

Multilink Sprint is a self-adhesive, dual curing luting composite.

This document is a 510(k) clearance letter from the FDA for a dental cement called "Multilink Sprint." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Outlines general regulatory requirements the manufacturer must comply with.
• Lists the "Indications for Use" for the Multilink Sprint, which specify the types of restorations it can permanently cement.

Therefore, I cannot provide the requested information based on the provided text. The document is regulatory approval, not a scientific study report.

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Multilink® is a self-curing and self-etching luting composite system for the adhesive whiles is a coll cannons made of metal, metal-ceramic, all-ceramic and composite.

It is Contraindicated if the patient has allergies to any ingredient; and no direct application on pulpa-near dentin or on the open pulp or irritations of the pulp may occur.

Multilink® is a self-curing and self-etching luting composite system

I am sorry, but the provided text from the FDA 510(k) summary for the Multilink device (K032470) does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is a clearance letter from the FDA to Ivoclar Vivadent, Inc., confirming that their Multilink dental cement is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory approval, classification, and general controls provisions of the Federal Food, Drug, and Cosmetic Act.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study with sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set sample sizes or how their ground truth was established.

Therefore, I cannot provide the requested information based on the input text.

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