(115 days)
- Direct restorations
- Base and Liner
- Block out undercut
- Repair of (in)direct aesthetic restorations
- Core build-up
EsFlow PLUS is a light-cured radiopaque flowable composite resin used for direct restoration. It has a smooth surface, so it is applied smoothly to the teeth, and has good gloss and aesthetics. In addition, it has high mechanical strength, so it can sufficiently withstand the occlusal force. EsFlow PLUS has two types of viscosities, so it can be applied to various clinical cases. The inorganic filler of EsFlow PLUS has a particle size range of 0.01 to 0.5 μm, and a volume ratio of about 42 to 47% depending on the model.
I apologize, but the provided text from the FDA 510(k) Clearance Letter for "EsFlow PLUS" does not contain the information requested about acceptance criteria and the study proving the device meets those criteria, especially not in the context of an AI/ML medical device.
The document is for a "Tooth Shade Resin Material" (a dental composite material), which is a physical material, not an AI/ML software device. The clinical studies mentioned (depth of cure, flexural strength, compressive strength) are material performance tests, comparing the new dental resin to a legally marketed predicate dental resin, and ensuring both meet ISO standards.
Therefore, I cannot extract the following information from the provided text as it is not present for this type of device and study:
- A table of acceptance criteria and the reported device performance (for an AI/ML device)
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone (algorithm only) performance was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on the physical and mechanical properties of a dental composite material, comparing it to an existing material to demonstrate substantial equivalence, as required for a 510(k) clearance for this type of Class II device.
§ 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.