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• class I to V restorations
• reconstruction of traumatically damaged anteriors
• facetting of discolored anteriors
• correction of shape and shade for improved aesthetic appearance
• locking, splinting of loose teeth
• repairing veneers
• restoration of deciduous teeth
• core-build-up under crowns
• composite inlays

Not Found

The provided FDA 510(k) Clearance Letter for "GrandioSO Unlimited" indicates that the device has been cleared as a "Tooth Shade Resin Material" (Product Code: EBF). This means it is a dental filling material, and the information provided in the document pertains to its substantial equivalence to predicate devices, its intended uses, and regulatory compliance.

Crucially, this document is a regulatory clearance for a physical dental material, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/SaMD performance (e.g., accuracy, sensitivity, specificity for diagnostic or assistive AI) are not applicable to this specific dental material clearance letter.

The clearance for a dental material like GrandioSO Unlimited is based on demonstrating substantial equivalence to a legally marketed predicate device, typically through:

• Material properties testing: Demonstrating that the physical, chemical, and mechanical properties (e.g., flexural strength, wear resistance, color stability, biocompatibility) are comparable to the predicate device.
• Biocompatibility testing: Ensuring the material is safe for use in the body.
• Clinical use claims: Showing that the material can be used for the stated indications (e.g., Class I to V restorations) effectively and safely, often supported by existing literature or non-clinical data if the material formulation is similar to established products.

Therefore, I cannot extract the requested information (1-9) from the provided text because these elements are specific to the validation of AI/SaMD performance, not the regulatory clearance of a dental restorative material.

The document states:

• Device Name: GrandioSO Unlimited
• Regulation Name: Tooth Shade Resin Material
• Product Code: EBF
• Indications for Use: Class I to V restorations, reconstruction of traumatically damaged anteriors, facetting of discolored anteriors, correction of shape and shade for improved aesthetic appearance, locking, splinting of loose teeth, repairing veneers, restoration of deciduous teeth, core-build-up under crowns, composite inlays.

These are typical uses for a dental composite material. The "study" proving it meets "acceptance criteria" would be a battery of standard dental material tests and biocompatibility assessments, demonstrating its equivalence to existing, legally marketed tooth shade resin materials. This letter does not contain the specifics of those material tests or any AI/SaMD-related performance metrics.

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GrandioSO Light Flow is intended for use for:

• Filling/characterisation of small cavities
• Filling/characterisation of class III, IV, and V cavities
• Extended fissure sealing
• Blocking out undercuts
• Lining or coating cavities
• Repairing fillings, veneers and temporary restorations
• Luting translucent prosthetic pieces

Not Found

The provided text is an FDA 510(k) clearance letter for a dental material, "GrandioSO Light Flow." It does not contain any information about acceptance criteria or a study proving the device meets those criteria, specifically in the context of an AI/ML-driven medical device.

The document discusses:

• Device Name: GrandioSO Light Flow
• Regulation Number: 21 CFR 872.3690 (Tooth Shade Resin Material)
• Regulatory Class: Class II
• Product Code: EBF
• Indications for Use: Filling/characterization of small, Class III, IV, and V cavities; extended fissure sealing; blocking out undercuts; lining or coating cavities; repairing fillings, veneers, and temporary restorations; and luting translucent prosthetic pieces.
• General regulatory information: Such as annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration, and adverse event reporting.

Since the request is about acceptance criteria and a study for an AI/ML-driven medical device, and this document describes a dental resin material, it does not contain the information needed to fulfill the request. Therefore, I cannot construct the table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

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• Class I and II posterior restorations
• Base in class I and II cavities
• Class V restorations
• Locking, splinting of loose teeth
• Repairing veneers, enamel defects and temporary C&B-materials
• Extended fissure sealing
• Restoration of deciduous teeth
• Core build-up

Not Found

The provided document is an FDA 510(k) clearance letter for a dental resin material named "GrandioSO x-tra." It confirms the device's substantial equivalence to a predicate device for specific dental restoration indications.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment. These details are typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the input text.

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• Crowns, inlays, onlays, veneers
• Implant supported crowns

Not Found

The provided documents do not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for the Grandio blocs device.

The documents are a 510(k) clearance letter from the FDA for a dental resin material named "Grandio blocs." This letter primarily confirms that the device has been found substantially equivalent to predicate devices and outlines general regulatory requirements.

Specifically:

• There is no mention of a study proving the device meets acceptance criteria.
• No acceptance criteria or reported device performance are presented.
• No sample sizes for test or training sets are provided.
• No information on data provenance (country, retrospective/prospective) is given.
• No details on experts or ground truth establishment are available.
• No adjudication method is described.
• No MRMC comparative effectiveness study is mentioned.
• No standalone algorithm performance is discussed, as this device is a physical dental material, not an AI/software device.
• No type of ground truth is specified.

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Grandio Core Dual Cure:

• core build ups of vital and non-vital teeth
• Luting of root posts

Not Found

The provided text is an FDA 510(k) clearance letter for a dental device called "Grandio Core Dual Cure." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, clinical study design, or performance metrics.

Therefore, I cannot extract the requested information regarding:

• Acceptance Criteria and Reported Device Performance: This information is not present.
• Sample size used for the test set and data provenance: No test set or study data is described.
• Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described.
• Adjudication method for the test set: Not applicable as no test set is described.
• Multi reader multi case (MRMC) comparative effectiveness study: No such study is mentioned.
• Standalone (algorithm only without human-in-the-loop performance): This is a dental material, not an AI algorithm.
• Type of ground truth used: Not applicable as no study is described.
• Sample size for the training set: Not applicable as no training set for an AI algorithm is involved.
• How the ground truth for the training set was established: Not applicable.

The document discusses the regulatory review of a dental material's "substantial equivalence" to legally marketed predicate devices, based on its indications for use. It's a regulatory clearance, not a scientific study report.

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Grandio SO Flow is intended for use as:

• filling minimally invasive cavities of all classes -
• filling small class I cavities and extended fissure sealing -
• filling class II V cavities including V-shaped defects and cervical caries -
• blocking out undercuts -
• lining or coating cavities .
• repairing fillings and veneers -
• luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.)

Not Found

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a dental material (Grandio SO Flow), which is a physical device, not an AI/ML-driven device. As such, the document does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance. Therefore, I cannot fulfill your request based on the given input.

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filling minimally invasive cavities of all classes -

• filling small class I cavities and extended fissure sealing -
• filling class II - V cavities including V-shaped defects and cervical caries
• blocking out undercuts -
• lining or coating cavities
• repairing fillings and veneers
• luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.) -

Grandio SO Heavy Flow is a steady but shear thinning, methacrylate based dental filling composite for all cavity classes with increased inorganic filler content and excellent physical properties e.g. wear resistance, compressive strength, color stability in the mouth compared with other flow composites. Grandio SO Heavy Flow comes in different tooth like shades of optimal opacity and can be easily polished. It is therefore highly qualified for long lasting esthetic restorations.

Grandio SO Heavy Flow is processed according to current state of the art procedures for light curing flowable dental composites, thus, Grandio SO Heavy Flow can be applied by any dental professional who is familiar with this kind of materials. Like the predicate device Grandio Flow it can easily be placed and processed prior to curing and finishing.

Grandio SO Heavy Flow will be offered in the following presentations:

• , syringes of 2g
• -Caps of 0.25g

Here's an analysis of the provided text regarding the acceptance criteria and study for the Grandio SO Heavy Flow device:

Important Note: The provided document is a 510(k) summary for a dental filling composite. These summaries typically describe the device's equivalence to a predicate rather than detailed studies proving performance against formal acceptance criteria in the way one might see for, say, an AI-powered diagnostic system. As such, many of the requested fields regarding detailed study design, ground truth, and expert involvement are not applicable or not provided in this type of document. I will fill in what is available and indicate when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

• Filling small class I cavities and extended fissure sealing
• Filling class II - V cavities including V-shaped defects and cervical caries
• Blocking out undercuts
• Lining or coating cavities
• Repairing fillings and veneers
• Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.) | Same indications as predicate device Grandio Flow (K051868, K101213) |
  | Technological Characteristics | - Methacrylate based dental filling composite
• Nanohybrid technology (optimized mixing ratio of inorganic filler particles in different sizes)
• Increased inorganic filler content
• Excellent physical properties (e.g., wear resistance, compressive strength, color stability) | Based on nanohybrid technology, similar components to predicate device Grandio Flow |
  | Physical Properties | Optimized with regard to several physical parameters (e.g., wear resistance, compressive strength, color stability) | Improved compared with predicate Grandio Flow (K051868, K101213) |
  | Biocompatibility/Safety | Prior use of all components in legally marketed devices. | Prior use in legally marketed devices (supports decision that additional testing for cytotoxicity, mutagenicity, and biocompatibility studies are not necessary). |

Explanation of "Acceptance Criteria" for this device: For a 510(k) submission like this, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a previously legally marketed predicate device. This means the new device must have the same intended use as the predicate and either the same technological characteristics or, if different, those differences must not raise new questions of safety and effectiveness. The document highlights "improved physical features" which suggests meeting or exceeding predicate performance rather than specific numerical acceptance thresholds.

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided: This 510(k) summary does not describe a "test set" in the context of an algorithm or diagnostic study. The "testing" referred to is related to the physical properties of the dental material itself, likely performed in a lab setting rather than on patient data. There is no mention of "samples" in terms of patient cases or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided: This information is not relevant to a dental material 510(k) submission. There is no concept of "ground truth" established by experts in the context of materials' physical properties.

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

• Not Applicable / Not Provided: This is not relevant for this type of device and submission.

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

• Not Applicable / Not Provided: This document describes a dental filling material, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant.

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

• Not Applicable / Not Provided: This document describes a dental filling material, not an algorithm.

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

• Not Applicable / Not Provided: For a dental material, "ground truth" would refer to measured physical and chemical properties (e.g., compressive strength, wear resistance, color stability, biocompatibility). These are typically determined through standardized laboratory tests, not expert consensus or pathology in the diagnostic sense. The document states "performance data and results" and "improved physical features" but does not detail the specific methodology for establishing this "ground truth" beyond stating "optimized."

8. The sample size for the training set

• Not Applicable / Not Provided: This document describes a dental filling material, not an AI model.

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

• Not Applicable / Not Provided: This document describes a dental filling material, not an AI model.

Summary of the Study (as described in the 510(k) Summary):

The "study" in this context is a substantial equivalence demonstration based on comparing the Grandio SO Heavy Flow to predicate devices (Grandio Flow, K051868, K101213).

• Purpose: To demonstrate that Grandio SO Heavy Flow is as safe and effective as previously legally marketed devices for its intended use.
• Methodology:
  • Comparison of Intended Use: Grandio SO Heavy Flow has the same intended use as the predicate devices.
  • Comparison of Technological Characteristics: Grandio SO Heavy Flow is a nanohybrid composite, similar to the predicate. The components are also similar, allowing the manufacturer to leverage prior biocompatibility testing. The new device has "increased inorganic filler content and excellent physical properties" (e.g., wear resistance, compressive strength, color stability) which are explicitly stated as "improved physical features" compared to the predicate.
  • Performance Data: The document explicitly states "For details of product performance data please see section 9 (substantial equivalence comparison)" but this section is not provided in the extracted text. However, it mentions "performance data and results also provide support for the safety and effectiveness."
  • Biocompatibility: The prior use of all components in legally marketed devices is deemed sufficient to support the decision that additional cytotoxicity, mutagenicity, and biocompatibility studies with the final formulation are not necessary.

Conclusion from the document: The FDA found Grandio SO Heavy Flow to be substantially equivalent to the predicate devices, allowing it to be marketed. This decision is based on the information provided regarding intended use, technological characteristics, and performance data (though not detailed here) that demonstrate the new device is as safe and effective as its predicates.

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Grandio SO is intended for use as:

• class I to V fillings
• reconstruction of traumatically affected anteriors
• facetting of discolored anteriors
• correction of shape and shade for improved aesthetic appearance
• locking, splinting of loose anteriors
• repairing veneers
• restoration of deciduous teeth
• core-build-up under crowns
• composite inlays

Grandio SO is a condensable, methacrylate based dental filling composite for all cavity Classes with excellent physical properties e.g. Wear resistance, compressive strength, color stability and durability in the mouth. Grandio SO has optimal opacity and can be easily polished. It is therefore highly qualified for long lasting, esthetic restorations.

The provided document is a 510(k) summary for a dental filling composite named "Grandio SO." It establishes substantial equivalence to a predicate device based on shared intended uses and improved physical features. However, this document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes, expert involvement, or ground truth establishment.

The 510(k) summary focuses on the device description, its intended uses, and technological characteristics in comparison to a predicate device. It states that the device has "improved physical features" and that "performance data and results... support the safety and effectiveness of Grandio SO for the intended use" but does not elaborate on what that performance data entails, what specific acceptance criteria were used, or how those criteria were met through a study.

Therefore, I cannot provide the requested table and study details based on the given text.

Here's what I can extract and what is missing based on your request:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: The document vaguely mentions "improved physical features" and that "performance data and results... support the safety and effectiveness." No specific performance metrics or values are provided.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned. The manufacturer is VOCO GmbH, located in Cuxhaven, Germany, but this doesn't specify the origin of any test data.
• Retrospective/Prospective: Not mentioned.

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):

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Not mentioned.

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:

• Not applicable. This device is a dental filling material, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This is not an algorithmic device.

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

• Not mentioned. Given it's a dental material, "ground truth" would likely refer to engineering and biocompatibility testing standards rather than medical image interpretation.

8. The sample size for the training set:

• Not applicable. This is a material, not a machine learning algorithm.

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

• Not applicable. This is a material, not a machine learning algorithm.

In summary, the provided 510(k) document is a regulatory submission for a dental composite material. It does not include the detailed study information typically found for diagnostic or AI-driven medical devices that require extensive clinical performance evaluation against specific acceptance criteria. The claim of "improved physical features" and supporting "performance data" is made without presenting the specific data or the methodology of how it was generated or evaluated against acceptance criteria.

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Grandio Flow is intended for the following applications:

• filling minimally invasive cavities of all classes -
• filling small class I cavities and extended fissure sealing -
• filling class II-V cavities including V-shaped defects and cervical caries -
• blocking out undercuts -
• lining or coating cavities -
• repairing fillings and veneers -
• luting translucent prosthetic pieces (e.g. full ceramic crowns, etc.) -

Not Found

The provided document is an FDA 510(k) clearance letter for a dental resin material (Grandio Flow). It is not a study report or clinical trial documentation for an AI/CADe/CADx device. Therefore, it does not contain any of the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement for such studies.

The document indicates that the device Grandio Flow is a "Tooth Shade Resin Material" and is classified as "Regulatory Class: II" with product code "EBF". The 510(k) clearance states that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance for this product category does not typically involve the kind of performance studies with acceptance criteria, ground truth, and expert review that would be conducted for a diagnostic AI device.

Therefore, I cannot extract the requested information from this document.

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Grandio Flow Try-In assists the dentist in selecting the correct shade for cementing with Grandio Flow Try-In assists the dentist in oblocing the other watch the shades of polymerized Grandio Flow composites.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental material (Grandio Flow Try-In). It does not contain information about acceptance criteria or a study proving a device meets such criteria for an AI/ML powered device. The letter is for a physical dental product and not a software device that would typically have the kind of performance metrics you are asking about.

Therefore, I cannot provide the requested information based on the given document.

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