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Intended for making dental plates, bite plates, frame-works, clasps,personal trays, appliances, occlusal splints and night guards.

Flexible Block is a circular solid (disc) or rectangular solid (block) made from polyamide through high-temperature injection molding, and is used in a CAD/CAM milling machine for production of dental plates, bite plates, frame-works, clasps, personal trays, appliances, occlusal night guards. These blocks are available in a variety of shapes and sizes for different milling systems and in a variety of dental shades.

Here's a breakdown of the acceptance criteria and study information for the Flexible Block device, based on the provided FDA 510(k) summary:

This device is a material (dental polymer blanks) used in a CAD/CAM milling machine to create dental restorations, not a diagnostic AI device. Therefore, many of the typical AI acceptance criteria and study components (like expert ground truth, adjudication, MRMC studies, standalone algorithm performance, and training set details) are not applicable. The "acceptance criteria" here refer to the product's physical, chemical, and biological properties meeting established standards for similar dental materials.

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

• Non genotoxicity (ISO 10993-3)
• Non cytotoxicity (ISO 10993-5)
• Non sensitization or irritation (ISO 10993-10)
• Non systemic toxicity (ISO 10993-11) | Met (Biocompatibility tests performed and "satisfy the ISO 10993 standards," including systemic toxicity, skin irritation, skin sensitization, in vitro cytotoxicity, in vitro mammalian cell TK gene mutation test, in vitro mammalian chromosome aberration test, and bacterial reverse mutation study) | NA (Predicate "Flexible Block" stated as "NA" for specific 10993 tests in the comparison table, but overall assumed biocompatible as a marketed device.) |
  | Regulatory Classifications | Class II | Class II |
  | Indications for Use | Similar (Intended for making dental plates, bite plates, frame-works, clasps, personal trays, appliances, occlusal splints and night guards.) | Similar (for making dental plates, bite plates, frame-works, clasps, personal trays, appliances, occlusal splints and night guards) |
  | Contraindications | Same | Same |
  | Labeling | Similar | Similar |
  | Target Population | Dental patients | Dental patients |
  | Anatomical Site | On teeth | On teeth |
  | Where Used | Hospital, dental clinic, and relevant places | Hospital, dental clinic, and relevant places |
  | Human Factors | Dental professional | Dental professional |
  | Design | Circular solid (disc) or rectangular solid (block) of polyamide. | Circular solid (disc) or rectangular solid (block) of super polyamide and thermoplastic compound. |
  | Cautions | Similar | Similar |
  | Standards Met | Same (implicitly, by meeting specific ASTM and ISO standards) | Same (implicitly, by meeting specific ASTM and ISO standards) |
  | Sterility | Non-sterile | Non-sterile |
  | Chemical Safety | Similar | Similar |

Study to prove acceptance criteria:

The study performed was a series of bench tests to evaluate the physical, chemical, and biological properties of the Flexible Block device.

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

• Sample Size: Not explicitly stated in terms of number of blocks tested for each physical property. However, it mentions "We selected our Flexible Block (Model: monolayer; Specification: 98×20mm; Shade: Clear) as the representative in biocompatibility tests," implying a single representative model was used for biocompatibility.
• Data Provenance: The tests were conducted by the manufacturer, Shandong Huge Dental Material Corporation, based in China ("No. 68 Shanhai Road, Donggang District Rizhao City, Shandong 276800 China"). This is a retrospective evaluation of a newly manufactured material against established standards.

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

• Not Applicable. For a material device, "ground truth" is established by adherence to physical, chemical, and biological standards (e.g., ASTM, ISO). There are no human "experts" establishing ground truth in the context of diagnostic performance here. The "experts" would be the personnel in the testing laboratories who perform the tests according to the specified standards.

4. Adjudication method for the test set

• Not Applicable. There is no adjudication method in the context of evaluating a material against objective physical and chemical standards.

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 is a material device, not an AI-enabled diagnostic tool. No MRMC study was performed.

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

• Not Applicable. This is a material device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device is based on established material science standards (e.g., ASTM D638, ASTM D570, ASTM D256, ASTM D790) for physical properties, and international biocompatibility standards (ISO 10993 series) for biological safety.

8. The sample size for the training set

• Not Applicable. This is a material device, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing process of the material could be seen as analogous to a "training set" in a very abstract sense (optimizing the material's properties), but it does not use a data-driven training set like AI models.

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

• Not Applicable. As there is no training set for an AI model, there is no ground truth established for it. The development of the material's properties would be based on material science principles and iterative testing against target performance specifications.

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