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Visalys® CemCore is a dual-curing, adhesive cementation and core build-up composite, which is intended to be used for: a) Permanent cementation of · crowns, bridges, inlays, veneers and adhesive bridges made of metal, ceramic, composite, hybrid and oxide ceramics • root posts and indirect core build-ups b) Composite for · adhesive core build-ups Visalys® CemCore Try In Paste is a water-soluble polyethylene glycol paste for shade matching: · To check the shade selected prior to permanent cementation with Visalys® CemCore. · For covering the cement joint to reduce a layer of inhibition.

Visalys® CemCore is a dual-curing composite containing fluoride for adhesive cementation of indirect restorations and root posts and can be used to fabricate radiopaque core build-ups and abutment fillings. Due to the Active-Connect-Technology (ACT) Visalys® CemCore includes an additional initiator system for the optimization of the adhesive bond. BPA or BPA precursors are not used in the manufacturing process of this device. Visalys® CemCore shall only be used in combination with self-etching Visalys® Tooth Primer. Visalys® Restorative Primer is recommended as the primer for the restoration surfaces. Visalys® CemCore is easy to use and has high adhesive strength and good flowability with stable consistency. Visalys® CemCore is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste should be mixed and dispensed directly from a double syringe with the corresponding mixing tips blue (MLø 3.2 mm). Visalys® CemCore Try in Paste serves to simulate the shade effect of the selected Visalys® CemCore shade on ceramic restorations and for covering the cement joint to reduce a layer of inhibition. The water-soluble paste corresponds in shade and translucence with the completely cured Visalys® CemCore. Visalys® CemCore Try In Paste is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste is dispensed from a syringe and syringe tip.

The provided text describes a 510(k) premarket notification for a dental device, Visalys® CemCore and Visalys® CemCore Try In Paste. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical performance testing results.

However, the document does not contain information about a study proving the device meets specific acceptance criteria related to AI/algorithm performance, nor does it refer to human reader studies, ground truth establishment by experts, or training/test set data for an AI system. The assessments are based on bench testing for mechanical properties, biocompatibility, and visual comparisons for shade consistency, all against established ISO or ASTM standards, or internal methods.

Therefore, I cannot fulfill the request as it pertains to AI/algorithm performance and human expert studies because such information is not present in the provided text. The device is a dental material, not an AI-powered diagnostic or assistance tool.

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L-OVC is intended for restoration of permanent teeth with a single unit crown.

The L-OVC is a ceramic crown, and includes an anatomic occlusal layer made of lithium disilicate, a thin priming/bonding layer that assists with bonding the occlusal layer to the sub-layer of uncured hybrid ceramic that allows for customization of the L-OVC to the specific tooth preparation. The customized L-OVC is bonded to the prepared natural tooth. The L-OVC is for restoring structurally compromised posterior teeth in cases normally restored with an onlay or a partial crown in a single dental visit. The L-OVC is selected based on tooth location and size and therefore no impressions are necessary. The L-OVC is provided in designs for the upper and lower first and second premolars and second molars, and each design is provided in five (5) sizes (extra-small (XS), small (S), medium (M), large (L), and extra-large (XL)). The L-OVC is made from lithium disilicate and high-strength ceramic composite resin. The L-OVC is provided nonsterile for singlepatient, single-use only.

Accessories to the L-OVC device include the L-OVC Replica, a replica of the ceramic occlusal portion of the L-OVC. The L-OVC Replica is used to confirm that sufficient occlusal clearance was obtained during tooth preparation and to provide direct visualization of the overall 3D position of the L-OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The L-OVC Replica is manufactured from a thermoplastic elastomer resin. L-OVC Wedges are accessories provided in four configurations (small right, large left and large right), and are placed interproximally to create a working surface and to block out undercuts of the preparation. The Wedges are manufactured from polyacetal resin. The Selector Keys are accessories that allow the clinician to measure the mesial-distal distance in order to choose the appropriate size L-OVC for the restoration, and are used during the curing of the uncured resin to prevent disturbing the placement of the crown. The Selector Keys are manufactured from polycarbonate resin. All accessories are provided nonsterile for singlepatient, single-use only. The Class I accessories are provided for informational purposes only.

The provided text is a 510(k) Summary for a dental device called L-OVC, which is a ceramic crown. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. However, it explicitly states: "No clinical data were included in this submission." This means that the document does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance with human subjects.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical outcomes, nor details about sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. These types of studies and associated data are typically part of clinical trials, which were not included in this submission.

The "Performance Data" section solely mentions non-clinical testing data used to demonstrate substantial equivalence. This non-clinical data includes:

1. Biocompatibility evaluation: According to ISO 10993-1, 10993-5, 10993-6, 10993-10, 10993-11, and 10993-12.
2. Ceramic material characterization: Flexural strength, solubility, and radioactivity according to ISO 6872.
3. Shelf life testing: According to ASTM F1980.

These non-clinical tests are conducted in a laboratory setting to ensure the material safety and physical properties of the device, rather than its clinical effectiveness or accuracy in a diagnostic context. The document also notes that biocompatibility testing was performed for the L-OVC Replica material due to its difference from the predicate's replica material.

The acceptance criteria in this context would be meeting the specified standards (e.g., ISO, ASTM) for these non-clinical tests, indicating the device's materials are safe and perform as designed in a laboratory environment. The "study that proves the device meets the acceptance criteria" refers to these non-clinical tests.

Summary of available information based on the provided document:

1. Table of acceptance criteria and reported device performance:

Note: The document states these tests were performed and provided for substantial equivalence, implying they met the relevant criteria of these standards, but does not provide specific numerical results or thresholds.

2. Sample size used for the test set and data provenance:
Not applicable for clinical performance data, as "No clinical data were included in this submission." For non-clinical tests, the sample sizes and specific test methodologies would be detailed in the test reports referenced by the ISO and ASTM standards, but these details are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable. No clinical test set to establish ground truth for clinical performance.

4. Adjudication method for the test set:
Not applicable. No clinical test set.

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 a dental ceramic crown, not an AI/diagnostic imaging device, and "No clinical data were included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental ceramic crown, not an algorithm.

7. The type of ground truth used:
For non-clinical tests (biocompatibility, material properties, shelf life), the "ground truth" would be established by the objective measurements and standards defined by the ISO and ASTM protocols.

8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable. No training set.

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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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