(198 days)
NextDent Ortho Flex is a 3D print resin intended for the manufacturing of 3D printed dental splints and retainers. To retain the regulated dentition.
NextDent Ortho Flex is intended exclusively for professional dental work.
Light-Cure Resin, provided in a container.
NextDent Ortho Flex is a dimethacrylic based light-cure resin with pigments, polymerized via photo initiators in a 3D printer setting for fabrication of splints and retainers for long term repeated use.
Fabrication of splints and retainers with NextDent Ortho Flex requires a computer-aided and manufacturing (CAD/CAM) system that includes the following additive printer and post-cure unit:
Printer: Brand: 3D Systems, Type: NextDent 5100 Figure 4, Software: 3D Sprint
Post-cure unit: Brand: NextDent, Type: LC-3DPrint Box, Software: n.a.
Printer and resin must be optimized to each other in order to get complete and precise printed parts.
Both the NextDent™5100 Figure4® 3D printer and the post-curing lightbox NextDent™ LC-3DPrint Box make use of a UV light source to polymerize the NextDent Ortho Flex resin.
NextDent™5100 Figure4® 3D printer or NextDent™ LC-3DPrint Box is not included with the device.
Cured parts are finished using conventional dental methods and instruments. NextDent 3D printed cured parts should be cleaned with nonchemical products.
Materials of Use: dimethacrylate-based resins with photo-initiator and pigments.
The provided text is a 510(k) summary for a dental resin product, NextDent Ortho Flex, and primarily discusses its substantial equivalence to a predicate device based on material characteristics and performance in specific laboratory tests. It does not contain information related to an AI/ML-enabled medical device, diagnostic performance, or studies involving human readers or ground truth established by experts/pathology/outcomes data.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/ML device. The document focuses on the physical and chemical properties of a 3D printable dental resin.
To illustrate, here's what the document does discuss regarding "acceptance criteria" and "study" for NextDent Ortho Flex, which is very different from an AI/ML device:
Acceptance Criteria and Study for NextDent Ortho Flex (Dental Resin)
The "acceptance criteria" for this device are based on its compliance with established industry standards for dental materials, specifically ISO 20795-2:2013 and ISO 10993 series for biocompatibility. The "study" involves a series of bench tests to verify these properties.
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported values. Instead, it states compliance with standards.
| Acceptance Criteria (Standard / Property) | Reported Device Performance |
|---|---|
| Material Properties: | |
| ISO 20795-2:2013 Dentistry – Base polymers - Part 2: Orthodontic base polymers (Type 2 light-activated material) | "NextDent Ortho Flex is compliant to the applicable requirements defined in ISO 20795-2:2013 for Type 2 light-activated material." |
| Curing | Tested and deemed compliant |
| Color | Tested and deemed compliant |
| Porosity | Tested and deemed compliant |
| Ultimate flexural strength | Tested and deemed compliant |
| Flexural modulus | Tested and deemed compliant |
| Maximum stress intensity factor | Tested and deemed compliant |
| Fracture work | Tested and deemed compliant |
| Charpy impact strength | Tested and deemed compliant |
| Sorption | Tested and deemed compliant |
| Solubility | Tested and deemed compliant |
| Biocompatibility: | |
| ISO 10993-1:2018 (Surface device, not in contact with oral mucosa / mucosal membrane, permanent (>30 days), repeated use) | "NextDent Ortho Flex is compliant to the applicable requirements defined in ISO 10993 including parts 1, 3, 5, 10, 11, 12, 17 and 18 and ISO/TS 21726 for permanent medical devices and therefore biocompatible." |
| Biocompatibility tests (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Subacute/sub chronic systemic toxicity, Genotoxicity) | Deemed compliant to applicable requirements. |
| Shelf-Life: | |
| Stability for 18 months | "NextDent Ortho Flex has a shelf life of 18 months." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the bench tests (e.g., how many specimens for flexural strength). It also does not mention data provenance in terms of country of origin or whether the data was retrospective or prospective, as this is typically irrelevant for material property bench 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)
Not applicable. Ground truth as typically understood for AI/ML devices (e.g., expert consensus on image interpretation, pathology reports) is not relevant for the bench testing of a dental resin's physical and chemical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no expert review or adjudication process described, as the tests are objective laboratory measurements against predefined 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 device is a material for manufacturing dental products, not an AI/ML diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As above, this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established international standards for dental materials (e.g., ISO 20795-2:2013 for mechanical properties and the ISO 10993 series for biocompatibility) as demonstrated through objective laboratory testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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