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• 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.

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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.

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• 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.

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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.

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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.

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