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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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