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G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

G-BLOCK is a compact block made of graphene-doped polymer suitable for the manufacture of dental prostheses using CAD/CAM technology. The polymer is based on polymethyl methacrylate (PMMA) doped with graphene (an allotrope of carbon).

G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

G-BLOCK, compounded of polymethyl methacrylate (PMMA) doped with Graphene, is manufactured using the heat-curing method.

G-BLOCK presents high modulus and elastic limit to ensure that the tensions generated during biting and chewing do not cause permanent deformations, and it is possible to manufacture prosthesis of smaller sections.

G-BLOCK presents high deformation resistance and stress limit, thus avoiding the formation of cracks and fractures.

G-BLOCK is low density making the prosthesis lightweight.

G-BLOCK increases the material hardness comparing with acrylic resins used in dentistry.

G-BLOCK has colour stability.

G-BLOCK has wide chromatic range, even within the same piece, making it look extremely natural.

G-BLOCK is chemically inert.

G-BLOCK water absorption is 4 μg/mm³ and a solubility of 0.5 μg/mm². The release of residual monomer is minimum, with a percentage of 0.004% of residual monomer. Thanks to these physical properties G-BLOCK offers a durable and safety treatment.

G-BLOCK is available in different formats, sizes and colors, having all variations the same physicochemical characteristics.

The device is presented in the form of a polymer block glued to an aluminum pin that allows the device to be fixed on the milling machine so that the block can be milled to obtain dental prostheses with the use of specific CAD/CAM equipment.

G-BLOCK is available in 2 different formats: MONOCHROMA and MULTICHROMA. Monochrome and Multichroma blocks may be both used for anatomical monolithic restorations.

When machined, Monochroma and Multichroma present a different visual effect:

• Monochroma, is made of a pure colour matching the dentin.

• Multichroma, has a chromatic spectrum based on the natural colour imitating the optical effects of the natural dentition.

Both variants are presented in two sizes: 14 and 40.

G-BLOCK device is available in the following colours, A1, A2, A3, A3.5, B1, B2, BL1, BL2, C2 (according to G-CAM shade guide).

G-BLOCK are provided non-sterile and as a single use device.

G-BLOCK must be used only by professionals as dental lab technicians and / or dentist.

G-BLOCK should be stored at room temperature in its original packaging, in dry storage and avoid exposure to direct sunlight. PMMA polymer from which the G-BLOCK is made is stable and can be stored for an extended period of 5-year shelf life.

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G-CAM discs are intended to be used for the manufacture of full and partial removable dentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, veneers, copings and substructures.

G-CAM is a thermoplastic acrylic disc made by a principal base of polymethyl methacrylate (PMMA) resin doped with graphene (allotropic form of carbon), suitable for the creation of dental prostheses using CAD/CAM technology.

G-CAM discs are intended to be used for the manufacture of full and partial removable dentures, implant overdentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, onlays, veneers, copings and substructures.

The provided text describes a 510(k) premarket notification for a dental device called G-CAM. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive human studies. Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" will largely relate to non-clinical performance testing against recognized standards and comparison with predicate devices, as clinical human-in-the-loop studies were explicitly not performed.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for G-CAM

The acceptance criteria for G-CAM are primarily based on demonstrating substantial equivalence to predicate devices through conformity with recognized international standards for dental materials.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in a traditional sense with numerical targets before the results. Instead, it provides a comparison table (Table 1) that lists the G-CAM's characteristics and its measured performance against the relevant ISO standards, alongside the characteristics of the predicate devices. The "acceptance" is implied by meeting or exceeding the minimum requirements of the specified ISO standards, and by showing substantial equivalence to the predicate devices.

Table.1 Comparison of G-CAM with Predicate and Reference Devices (with performance data)

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the number of physical samples (e.g., discs, test specimens) used for each specific non-clinical test (e.g., flexural strength, water absorption). The testing was performed according to recognized standards (e.g., ISO 20795-1, ISO 10477), which would dictate the appropriate sample sizes for each test.
• Data Provenance: The tests were conducted by Graphenano Dental S.L. in Spain. The data is from non-clinical bench testing. The document does not specify if the testing was retrospective or prospective in terms of a specific study design as it's a premarket submission focusing on material properties.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for material properties is established by the specifications and methodologies of the international ISO standards themselves, not by human expert consensus or interpretation of images. The tests measure physical and chemical properties directly.
• The tests were performed by laboratories or personnel competent in conducting tests according to the specified ISO standards for dental materials.

4. Adjudication Method for the Test Set

• Not applicable. This concept typically applies to clinical studies where subjective human assessments (e.g., image interpretation) need to be resolved. For objective bench testing of material properties, results are quantitative and do not require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing is not required to demonstrate substantial equivalence as the indications for use are like legally marketed devices and the designs previously cleared under a premarket notification." and "No clinical studies are submitted."
• Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance, as this is a dental material and not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a dental material (G-CAM discs) intended for the manufacture of dental prostheses using CAD/CAM technology. It is not an algorithm or an AI-based system. Its performance relates to its material properties and manufacturing quality, not autonomous algorithmic outputs.

7. Type of Ground Truth Used for Performance Testing

• Non-clinical material properties: The "ground truth" or reference for the performance testing of the G-CAM device are the specifications and minimum requirements outlined in recognized international standards such as ISO 20795-1 (Dentistry — Base polymers — Part 1: Denture base polymers), ISO 10477 (Dentistry — Polymer-based crown and veneering materials), ISO 4049 (Dentistry — Polymer-based restorative materials), ISO 48-4 (Plastics — Determination of hardness — Part 4: Durometer method), ASTM E384 (Standard Test Method for Knoop and Vickers Hardness of Materials), ISO 13320 (Particle size analysis — Laser diffraction methods), ISO 7405 (Dentistry — Evaluation of biocompatibility of medical devices used in dentistry), and ISO 10993 (Biological evaluation of medical devices).
• For biocompatibility, specific tests (Cytotoxicity, Sensitization, Acute Systemic Toxicity, Subchronic Toxicity by Subcutaneous Implantation, Material-Mediated Pyrogenicity, Genotoxicity, Carcinogenicity) were performed to establish the ground truth of biological safety.

8. Sample Size for the Training Set

• Not applicable. This device is a physical dental material, not an AI or machine learning model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As stated above, there is no training set for this type of medical device submission.

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