Search Results

• Anterior and posterior restorations
• Repair of restorations and prostheses
• Core-build up
• Direct laminate veneer

Not Found

The provided text is a standard FDA 510(k) clearance letter for a dental resin material, "Beautifil II." This document confirms that the device has been cleared for marketing based on its substantial equivalence to previously marketed devices.

*Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-based medical device. The product, "Beautifil II," is a physical dental material (tooth shade resin), not an AI/ML software device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance
• Sample sizes for test sets or data provenance
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• MRMC study details or effect sizes
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size or how its ground truth was established

The 510(k) clearance process for a material like Beautifil II typically involves different types of testing (e.g., biocompatibility, physical properties, mechanical strength, chemical composition) to demonstrate safety and effectiveness, rather than a clinical study with image-based ground truth and human reader performance evaluation as would be done for an AI/ML diagnostic aid.

If you have a document describing the testing for an AI/ML device, please provide that, and I would be happy to analyze it against your request.

Ask a specific question about this device

• Anterior and posterior restorations • Repair of restorations and prostheses

Not Found

I am sorry but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is an FDA 510(k) clearance letter for a dental device, indicating it has been deemed substantially equivalent to a predicate device. It defines the device name, regulation number, and indications for use, but does not include any performance study details.

Ask a specific question about this device

BEAUTIFIL II LS is a light-cured (400-500nm), radiopaque restorative material indicated for anterior and posterior restorations including occlusal surfaces.
(Indications)
· Anterior and posterior restorations
· Repair of restorations and prostheses

BEAUTIFIL II LS is a light-cured (400-500nm), radiopaque restorative material.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental resin material. It does not contain any information about acceptance criteria, device performance, study details, ground truth, or statistical analyses typically found in a scientific study or clinical trial report. Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

• Class V restorations (Cervical caries, root caries, wedge-shaped defects)
• Covering of exposed or discolored necks of teeth
• Restoration of esthetic appearance of gingival areas

Not Found

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided document is an FDA 510(k) clearance letter for a dental device (Beautifil II Gingiva) and its Indications for Use. It does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies with specific acceptance criteria in the manner often seen for novel AI/medical imaging devices.

Therefore, many of your requested points cannot be answered from this document.

However, I can extract the following based on the nature of the document:

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

• Not available in this document. This document is a clearance letter, not a performance study report. For a dental restorative material like this, acceptance criteria would typically involve physical, chemical, and biological properties (e.g., flexural strength, wear resistance, biocompatibility, color stability) established through ISO standards or similar benchmarks. The document doesn't detail these or the device's specific performance against them.

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

• Not available in this document. This document does not describe a test set or data provenance from a device performance study.

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/available in this document. This document does not pertain to an AI device or a study requiring expert ground truth establishment for a test set.

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

• Not applicable/available in this document.

5. If a multi-reader multicase (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/available in this document. This is a dental restorative material, not an AI-powered diagnostic device.

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

• Not applicable/available in this document.

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

• Not applicable/available in this document. For dental materials, the "ground truth" for demonstrating substantial equivalence often relies on adherence to material standards and potentially in-vitro or ex-vivo testing, rather than clinical ground truth as defined for diagnostic devices.

8. The sample size for the training set

• Not applicable/available in this document. This document does not describe a training set as it's not an AI device.

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

• Not applicable/available in this document.

Summary of what the document DOES provide:

• Device Name: BEAUTIFIL II Gingiva
• Regulatory Status: 510(k) cleared, Class II (Special Controls)
• Regulation Number/Name: 21 CFR 872.3690 / Tooth Shade Resin Material
• Product Code: EBF
• Indications for Use:
  • Class V restorations (Cervical caries, root caries, wedge-shaped defects)
  • Covering of exposed or discolored necks of teeth
  • Restoration of esthetic appearance of gingival areas
• Type of Use: Prescription Use
• Predicate Device Information: While not explicitly named in this letter, the 510(k) process is based on demonstrating substantial equivalence to a legally marketed predicate device. The actual submission (K151700) to the FDA would contain details about the predicate.

To obtain the detailed performance data, acceptance criteria, and specific study reports, one would typically need to refer to the full 510(k) submission (K151700) available through the FDA's public database, or directly from the manufacturer if they publish such data. The clearance letter itself is a regulatory outcome, not a detailed technical report.

Ask a specific question about this device

BEAUTIFIL II Enamel is a light-cured radiopaque restorative material, designed for anterior restorations as well as posterior restorations including for restorations involving occlusal surfaces. It can also be used for repair of restorations and prostheses.
(Indications)
· Direct anterior and posterior restorations (except for tooth root)
· Repair of restorations and prostheses

BEAUTIFIL II Enamel is a light-cured radiopaque restorative material.

This document is a 510(k) clearance letter from the FDA for a dental restorative material, not an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies typically associated with AI/ML device evaluations.

The document mainly focuses on:

• Device Name: Beautifil II Enamel
• Regulation Number: 21 CFR 872.3690
• Regulation Name: Tooth shade resin material
• Regulatory Class: II
• Product Code: EBF
• Indications for Use: Direct anterior and posterior restorations (except for tooth root), and repair of restorations and prostheses.
• FDA Determination: Substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information for acceptance criteria and study data because this document pertains to a traditional medical device (dental filling material) and does not involve AI/ML technology or associated performance studies in the context of diagnostic or prognostic capabilities.

Ask a specific question about this device

BEAUTIFIL e Posterior / BEAUTIFIL Bulk comes in 28 shades, among which Universal and A shade (given the trade name BEAUTIFIL Bulk) provide high transparency and greater depth of cure by reducing pigment content compared to other shades. Universal and A shade (BEAUTIFIL Bulk) are intended only for direct posterior restorations.

BEAUTIFIL e Posterior
(Indications)

• Direct posterior restorations .
• Repair of restorations and prostheses ●

BEAUTIFIL Bulk
(Indications)
Direct posterior restorations using a light-curing resin paste to be used for masking the substructure color of dental restorations.

Not Found

I am sorry, but the provided text is a correspondence from the FDA regarding the 510(k) clearance of the "BEAUTIFIL e Posterior / BEAUTIFIL Bulk" dental device. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

The document primarily focuses on the FDA's "substantial equivalence" determination to legally marketed predicate devices, meaning it allows the device to be marketed. It does not include the detailed technical study information you are asking for.

Ask a specific question about this device

• . Base in Class I and II direct restorations
• . Liner under direct restorative materials
• . Restorations of small posterior cavities (including occlusal restorations)

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a dental resin material (Beautifil Bulk Flowable). This document outlines the FDA's marketing clearance for the device based on its substantial equivalence to a predicate device.

This document does NOT contain information about acceptance criteria, detailed device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

Therefore, I cannot extract the information necessary to fulfill your request. The document discusses regulatory aspects, product classification, and indications for use, but not the specific technical study details you are looking for.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity, which is used for various restorations. It is suitable for filling and repairing for anterior and posterior, such as class I through V restorations, wedge shaped defects and root caries. It can be also applied to core build-up and repair of fractured laminate veneer, porcelain, composite resin and C&B materials.

BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity.

The provided document is a 510(k) clearance letter from the FDA for a dental filling composite resin named "Beautifil II" (K071742). It indicates that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

The letter focuses on regulatory approval based on demonstrating substantial equivalence, not on providing detailed performance data from a specific study against pre-defined acceptance criteria. The indications for use are mentioned, but no performance metrics are listed.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sizes used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present.
6. If a standalone study was done: Not explicitly detailed with performance metrics. The letter implies comparison to a predicate, not standalone performance against acceptance criteria.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The document's purpose is to grant marketing clearance, not to publish detailed study results. Such study details would typically be found in the 510(k) submission itself, which is not publicly available in this format, or in associated clinical publications.

Ask a specific question about this device