(76 days)
Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.
Beautifil Flow Plus is a light-curing dental filling material having low viscosity.
This document is a 510(k) premarket notification for a dental filling material, Beautifil Flow Plus. It is a letter from the FDA confirming substantial equivalence to a predicate device. This type of document, particularly for a dental filling material, is unlikely to contain information about acceptance criteria and a study proving device performance in the way requested for software or AI-based medical devices.
Medical devices like dental fillings are typically evaluated based on material properties, biocompatibility, and clinical performance through different types of studies (e.g., in vitro, in vivo, clinical trials for safety and effectiveness). The acceptance criteria would relate to these aspects rather than metrics like sensitivity/specificity for diagnostic devices.
Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sample size for test sets, expert ground truth, MRMC studies) will not be present in this FDA letter for a dental filling material.
Let's break down what can be inferred or stated based on the provided text, and what cannot.
1. A table of acceptance criteria and the reported device performance
- Cannot be provided from this document. This document is an FDA clearance letter confirming substantial equivalence, not a detailed study report. It does not contain a table of acceptance criteria or performance metrics for diagnostic accuracy. For a dental filling material, acceptance criteria would typically involve physical properties (e.g., compressive strength, wear resistance), chemical properties (e.g., leachables), and biocompatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided from this document. This information pertains to a performance study for diagnostic AI/software, which is not relevant to this type of device and document.
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)
- Cannot be provided from this document. This is not applicable to a dental filling material.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided from this document. This is not applicable to a dental filling material.
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
- Cannot be provided from this document. This type of study is for diagnostic devices with AI assistance, not for a dental filling material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided from this document. This is not applicable to a dental filling material.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided from this document. This is not applicable to a dental filling material.
8. The sample size for the training set
- Cannot be provided from this document. This information is for AI/machine learning models, not for a dental filling material.
9. How the ground truth for the training set was established
- Cannot be provided from this document. This information is for AI/machine learning models, not for a dental filling material.
Summary based on the document:
The provided document is an FDA 510(k) clearance letter for a dental filling device, "Beautifil Flow Plus." The letter states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... to legally marketed predicate devices."
This document confirms regulatory clearance based on substantial equivalence, but it does not contain the detailed technical study information (acceptance criteria, performance metrics, sample sizes for diagnostic accuracy studies, expert ground truth, etc.) that would typically be part of a submission for an AI-powered diagnostic device. The evaluation for a dental filling material would focus on material properties, biocompatibility, and clinical safety and effectiveness data (often comparing to a predicate device), which are not detailed in this specific FDA clearance letter.
§ 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.