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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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Cementation of all-ceramic, composite and metal restorations
Post cementation

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental cement called "BeautiLink SA." It discusses regulatory aspects, general controls, and indications for use.

It does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the nature of test sets (retrospective/prospective, country of origin).
• Information on experts, ground truth establishment, or adjudication methods for any test or training sets.
• Any mention of a Multi-Reader Multi-Case (MRMC) study or the effect size of AI assistance.
• Details about standalone algorithm performance.
• Information on the training set size or how its ground truth was established.

This document is a regulatory clearance, not a study report or technical specification outlining performance metrics and supporting validation studies.

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• Restoration of deciduous teeth
• Non-load bearing Class I and Class II restorations in permanent teeth
• Restoration of Class III and Class V cavities and wedge shaped defects
• Core build-up

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a dental cement called "GlasIonomer FX ULTRA". It does not contain any information about acceptance criteria, study details, or performance of an AI/ML powered medical device. Therefore, I cannot generate the requested response.

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Fabrication of all ceramic restorations except for four- or more unit bridges including molars.

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I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a dental product called "Vintage Prime Press," which is a porcelain powder for clinical use. It outlines the regulatory clearance process and the indications for use of this device.

The document does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria. It discusses the regulatory path, product classification, and general controls applicable to the device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, information about sample sizes or data provenance for a test set, details on expert roles for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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• Direct restorations with light-cured composite resin
• Repair of fractured restorations with light-cured composite resin
• Post cementation and core build-up
• Cementation of indirect restorations with light-cured/dual-cured resin cement
• Treatment of hypersensitive teeth or exposed root surface
• Sealing of tooth preparation (cavity or abutment) for indirect restorations

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving the device meets those criteria.

The document is an FDA 510(k) clearance letter for a dental bonding agent named "BeautiBond Xtreme." It primarily

• Confirms the FDA's review and determination of substantial equivalence for the device.
• Outlines the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device.
• Lists the indications for use of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them based on the provided text.

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For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations and implant supported restorations, using a dental CAD / CAM system.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental material (Shofu Block HC Hard), not an AI/ML device. Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly concerning AI/ML performance metrics, ground truth, sample sizes, and expert adjudication, is not applicable to this document.

The document discusses the regulatory clearance process for a tooth shade resin material under the name "Shofu Block HC Hard" and confirms its substantial equivalence to predicate devices. It outlines general regulatory requirements for medical devices but does not include any performance data or study details that would typically be associated with AI/ML device evaluations.

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Shade adjustment of ceramic restorations

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I am sorry, but the provided text from the FDA letter (K191794) for "Vintage Art Universal" does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) clearance letter for a dental porcelain powder, classifying it as a Class II device. It primarily discusses:

• The FDA's determination of substantial equivalence to predicate devices.
• Regulatory requirements and general controls (registration, listing, GMP, labeling, adverse event reporting).
• The intended use of the device: "Shade adjustment of ceramic restorations."

There is no mention of:

• Specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device).
• Details of a clinical study or performance study, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Any information regarding AI/human reader performance or MRMC studies.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the provided text. This type of information is typically found in the 510(k) summary or the full submission, not in the clearance letter itself unless specifically highlighted for a novel device or testing paradigm.

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• Class III and Class V restorations
• Small Class I restoration
• Base/Liner

Not Found

The provided text from the FDA 510(k) clearance letter for the Shofu Dental Corporation's "FIT SA" device does not contain the detailed information necessary to fully answer all the questions about acceptance criteria and a study proving the device meets them. This document is a clearance letter, which means the FDA has reviewed the manufacturer's submission and found the device substantially equivalent to a legally marketed predicate. However, it typically does not include the specifics of the performance studies themselves.

The information provided only states the indications for use and general regulatory information. It does not describe any specific acceptance criteria for a performance study, nor does it detail a study that proves the device meets those criteria.

Therefore, for almost all of the requested information, the answer is "Information not provided in the input text."

Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

• Information not provided in the input text. The clearance letter does not list specific performance metrics or acceptance criteria for the FIT SA device. It only states the device's indications for use.

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

• Information not provided in the input text. The letter does not mention any sample sizes, types of data (retrospective/prospective), or data provenance for any testing.

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)

• Information not provided in the input text. This detail would typically be part of a clinical or performance study report, which is not included in the FDA clearance letter.

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

• Information not provided in the input text. Adjudication methods are specific to how discrepancies in ground truth establishment are resolved, which is not mentioned here.

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

• Information not provided in the input text. This type of study is typically for AI-assisted diagnostic devices. FIT SA is a dental restorative material, so an MRMC study related to AI assistance would not be applicable. The letter does not mention any MRMC studies.

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

• Information not provided in the input text. Similar to point 5, this is not applicable to a restorative dental material. The device itself is not an algorithm.

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

• Information not provided in the input text. As there's no mention of a performance study with a test set, there's no information on how ground truth would have been established. For dental restorative materials, performance is typically assessed through physical, mechanical, and biocompatibility testing, potentially in vitro or in vivo studies, but not in the way an AI diagnostic device uses "ground truth."

8. The sample size for the training set

• Information not provided in the input text. As the device is a material and not an AI algorithm, the concept of a "training set" in this context is not applicable.

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

• Information not provided in the input text. (Not applicable for this type of device.)

Summary regarding the provided text:

The provided FDA 510(k) clearance letter for the Shofu Dental Corporation's FIT SA device is a regulatory document confirming clearance based on substantial equivalence. It does not contain the detailed technical or clinical study results, acceptance criteria, or ground truth establishment methods that would be typically found in a clinical study report or the technical sections of a 510(k) submission. Therefore, the specific information requested in the questions cannot be extracted from this document.

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Build-up porcelain for fabrication of metal bonded ceramic restorations

Not Found

I am sorry, but the provided text is an FDA 510(k) clearance letter for a dental product called "Vintage Pro." It describes the regulatory classification, product code, and indications for use of this porcelain powder for clinical use.

This document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies related to an AI/device performance evaluation. Therefore, I cannot extract the requested information to fill in your table and answer your questions.

To help you, I would need a document that describes the clinical performance study of a device, particularly an AI-powered one, detailing its validation process.

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