(48 days)
Arabesk® Top is a light-curing, radiopaque ceramic microhybrid composite filling material for both anterior and posterior applications, as well as for inlay techniques. Arabesk® Top is intended for use in restoring:
- · Class I-V fillings
- Reconstruction of traumatically affected anteriors
- Facetting of discolored anteriors
- · Color and/or shape corrections to improve asthetic appearance
- · Locking or splinting of loose anteriors
- · Extended fissure sealaing for molars and premolars
- · Repairing veneers
- Core build-up under crowns
- · Especially suited for composite inlays
Arabesk Top is a light-curing, radiopaque ceramic microhybrid composite filling material for both anterior and posterior applications, as well as for inlay techniques. Arabesk Top contains 77% by weight (56% by volume) inorganic fillers, microfillers (~ 0.05um), and small particle fillers (~0.71m). The methacrylate monomers consist of BIS-GMA, UDMA, and TEDMA.
Arabesk Top is available in bulk dispensing syringes (4gm each) and in singleuse applicator-tip capsules (0.25 gm each).
The provided text is a 510(k) summary for a dental composite filling material named ARABESK® TOP. It focuses on establishing substantial equivalence to existing predicate devices based on material composition and performance properties. The document does not describe a study that uses a test set, experts, ground truth, or an AI algorithm to measure device performance against acceptance criteria. Therefore, most of the requested information cannot be extracted.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a direct measurement of ARABESK® TOP's performance against such criteria. Instead, it claims substantial equivalence to predicate devices (Tetric Ceram and Charisma) based on similar compositional and performance properties.
| Acceptance Criteria | Reported Device Performance (ARABESK® TOP) |
|---|---|
| Compositional Similarity: | Formulated from chemical components common in marketed dental composites (BIS-GMA, UDMA, TEDMA, inorganic fillers). |
| - Inorganic silicates (w/w) | ~72-77% (similar to predicates) |
| - Methacrylates (w/w) | ~20-22% (similar to predicates) |
| - Photoinitiators and Pigments (w/w) | ~1% (similar to predicates) |
| Performance Properties: | Substantially alike with predicate devices. |
| - Compressive strength | Not explicitly quantified, but claimed to be "substantially alike" with predicates. |
| - Polymerization shrinkage | Not explicitly quantified, but claimed to be "substantially alike" with predicates. |
| - Color stability | Not explicitly quantified, but claimed to be "substantially alike" with predicates. |
| - Resistance to abrasion | Not explicitly quantified, but claimed to be "substantially alike" with predicates. |
| Safety, Effectiveness, Biocompatibility: | "Raises no new issues or questions" regarding these aspects compared to existing dental composite products. |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a comparison to predicate devices, not a study involving a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving human experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication.
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 material submission, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental material submission, not an AI-driven algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices. The claim is that ARABESK® TOP performs "substantially alike" to these already regulated products.
8. The sample size for the training set
Not applicable. The document does not describe a training set as it is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set or its ground truth establishment.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.