(82 days)
Rebilda SC is a self-curing, radiopaque, flowable composite intended to be used for core build-up in vital and non-vital teeth.
Rebilda SC is a self-curing, highly radiopaque, flowable composite for core buildup. Rebilda SC has excellent mechanical properties. Rebilda SC is available in two shades, light blue and dentine. The light blue shade shows the preparation two onado, light blue tin shade is for use under translucent crowns and bridges. margins, while the achieved by using Rebilda SC in conjunction with the light-curing dentin/enamal bonding agent Solobond Plus.
The provided document is a 510(k) summary for a dental core build-up material called Rebilda SC. It focuses on establishing substantial equivalence to a predicate device based on material properties rather than clinical performance or AI algorithm evaluation. Therefore, most of the requested information regarding acceptance criteria, study types (MRMC, standalone), ground truth establishment, expert qualifications, and sample sizes for AI model training/testing are not present in this document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a standalone section. Instead, it states that the device is "substantially equivalent with regard to such physical properties as compressive strength, flexural strength, working time, and hardness" to the predicate device, Luxacore (K982201). This implies that the performance of Rebilda SC in these physical properties met or was comparable to that of the predicate device, which would be the implicit acceptance criteria for these material characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies mentioned are "Preclinical Performance Studies," which typically refer to bench testing of material properties, not clinical trials with human subjects or AI model evaluation.
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)
This information is not applicable and therefore not provided, as this is not an AI or diagnostic imaging device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided.
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
No MRMC study was conducted or mentioned, as this is a dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was conducted or mentioned, as this is a dental material, not an AI-powered diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" equivalent for this type of device would be established through standardized material testing methods (e.g., for compressive strength, flexural strength, working time, and hardness) as defined by relevant ISO or EN standards (e.g., EN 24049/ISO 4049). The document states "Rebilda SC corresponds to EN 24049/ISO 4049," indicating compliance with these material standards.
8. The sample size for the training set
This information is not applicable and therefore not provided, as this is not an AI-powered device developed using machine learning.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided.
Summary of what is available from the document:
- Acceptance Criteria & Performance: "Substantial equivalence" to Luxacore (K982201) regarding physical properties like compressive strength, flexural strength, working time, and hardness. Compliance with EN 24049/ISO 4049.
- Study Type: Preclinical performance studies (bench testing of material properties).
- Ground Truth (for material properties): Established by standardized material testing methods according to EN 24049/ISO 4049.
§ 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.