Search Results

fillings requiring minimally invasive preparation
fillings for small cavities
extended fissure sealing
substitute fillings of cavities with undercuts
Class III-V fillings including V-shaped defects and cervical caries
repair of fillings and veneers
luting of translucent prosthetic pieces (e.g., procelain-only crowns)

Arabesk Flow is a light-curing and radiopaque glass ceramic microhybrid composite. It is suited for fillings in both anterior and posterior applications. Arabesk Flow's low viscosity results in excellent wetting and adhesion to the tooth. Arabesk Flow produces a high strength and color stable restoration that can be polished to a high gloss. Arabesk Flow is polymerized (cured) by halogen light. Arabesk Flow conforms well to cavity surfaces, helps to avoid trapped air, and speeds cavity filling.
Arabesk Flow contains 69% inorganic fillers (highly pure silica and barium/strontium borosilicate glass particles - average size 0.7um) and 30% dimethacrylates (BIS-GMA, urethane dimethacrylate, triethyleneglycol dimethacryrlate).
Arabesk Flow is available in bulk dispensing syringes (3gm each) and in single-use applicator-tip capsules (0.25 gm each).

This document is a 510(k) Summary for a dental composite filling material, ARABESK® FLOW. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria in the way one might expect for a diagnostic or AI-driven device.

Therefore, much of the requested information regarding acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment cannot be directly extracted from the provided text. The document does not describe a clinical study of ARABESK® FLOW against specific performance metrics with acceptance criteria, but rather a preclinical comparison to predicate devices.

Here's what can be extracted and what cannot:

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

The document does not explicitly state acceptance criteria or provide a table of performance data against those criteria. Instead, it makes a general statement about technological comparison.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified. The document refers to "preclinical performance studies" but does not detail the methodology, sample sizes, or data provenance.
• Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a material science characterization, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication is mentioned or implied for the preclinical performance studies.

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 filling material, not a diagnostic device involving human readers or AI assistance.

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

Not applicable. This is a dental filling material, not an algorithm or AI device.

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

The "ground truth" for the preclinical performance studies would be the actual measured physical and chemical properties of the material, using standardized laboratory methods, and then compared against similar measurements of the predicate devices. This isn't "ground truth" in the clinical sense (like pathology for cancer diagnosis), but rather established material properties.

8. The sample size for the training set

Not applicable. This is a material, not a machine learning model requiring a training set.

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

Not applicable. This is a material, not a machine learning model requiring a training set.

Summary of Preclinical Performance Studies and Conclusions (from the document):

The document states:
"SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES"
However, the actual details of these studies are not provided in the excerpt. It only concludes that the chemistry of Arabesk Flow "raises no new issues or questions that effect safety, effectiveness, or biocompatibility for a dental composite product" and that the product is "substantially alike" to predicate devices in performance properties.

Ask a specific question about this device