(158 days)
Fabrication of orthodontic and dental appliances such as mouthguards, splints and positioners.
The product is for use with DLP / SLA printers that work at wavelengths of 385 nm or 405 nm.
LuxaPrint Ortho Plus is a (meth)acrylate-based photocurable polymer resin indicated for use for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and positioners, using a 3D printing process. LuxaPrint Ortho Plus material is used in a dental laboratory to fabricate a removable custom dental appliance. LuxaPrint Ortho Plus will be available in two variants matched to the operating wavelength of the 3D printer (385 nm and 405 nm). LuxaPrint Ortho Plus is used in conjunction with a compatible dental scanner, 3D printer, and curing equipment. Typical medical indications include bruxism and teeth grinding, or stabilization of the tooth's position after active orthodontic treatment.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for a dental material (LuxaPrint Ortho Plus), not an AI/ML medical device. Therefore, the information typically required to answer questions about acceptance criteria and studies proving an AI/ML device meets them (such as validation of an algorithm's performance, human-in-the-loop studies, details of training/test sets, expert adjudication methods, etc.) is not present in this document.
The document discusses the substantial equivalence of the LuxaPrint Ortho Plus (a photocurable polymer resin for 3D printing dental appliances) to a predicate device (EnvisionTEC GmbH E-Guard). The "acceptance criteria" here refer to the physical and chemical properties of the material, not the performance of an AI algorithm.
However, I can extract the information related to the material's acceptance criteria and the non-clinical performance testing detailed in the document, even though it doesn't align with the typical AI/ML device validation questions.
Here's a breakdown based on the provided text, interpreting the questions in the context of a dental material if direct AI/ML answers aren't available:
Acceptance Criteria and Study for LuxaPrint Ortho Plus (Dental Material)
1. Table of Acceptance Criteria and Reported Device Performance
For this dental material, the "acceptance criteria" are based on physical and chemical properties, often aligning with ISO standards for dental materials. The study proves that the material meets these properties, demonstrating its comparability to the predicate device.
| Attribute | Acceptance Criteria (Predicate Device K201173) | Reported Device Performance (LuxaPrint Ortho Plus) | Similarity/Difference & Compliance |
|---|---|---|---|
| Water Solubility | 0.5 µg/mm³ | 1.5 – 3.6 µg/mm³ (385 nm) | |
| 0.7 - 2.1 µg/mm³ (405 nm) | Equivalent; both meet ISO 4049 & ISO 20795-2 requirements | ||
| Water Sorption | 37 µg/mm³ | 18.6 – 20.3 µg/mm³ (385 nm) | |
| 17.1 – 17.7 µg/mm³ (405 nm) | Equivalent; both meet ISO 4049 & ISO 20795-2 requirements | ||
| Flexural Strength | 79 – 85 MPa | 80 – 93 MPa (385 nm) | |
| 77 - 90 MPa (405 nm) | Equivalent; both meet ISO 4049 & ISO 20795-2 requirements | ||
| Flexural Modulus | 2052 - 2130 MPa | 1.9 - 2.4 GPa (385 nm) | |
| 2.1 - 2.5 GPa (405 nm) | Equivalent; both meet ISO 4049 & ISO 20795-2 requirements (Note: GPa vs MPa, 1 GPa = 1000 MPa, so values are comparable). | ||
| Biocompatibility | ISO 10993-1, -5, -10, -3 | ISO 10993 | Equivalent (LuxaPrint Ortho Plus tested under ISO 10993, implicitly meeting relevant parts). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Performance data demonstrated that finished devices manufactured using the LuxaPrint Ortho Plus material meet all predetermined acceptance criteria..." and "3D printed devices fabricated using LuxaPrint Ortho Plus have been tested for and found to have comparable physical properties..." However, specific numerical sample sizes for each test (e.g., how many specimens for flexural strength) are not provided in this summary.
- Data Provenance: The tests were "Non-clinical Performance Testing." The "Owner's Name" and address for DMG Dental Enterprises SE is Hamburg, Germany. This suggests the testing likely occurred in Germany or under the oversight of the German manufacturer. The document doesn't specify if the testing was retrospective or prospective in the sense of a clinical trial; these are physical material property tests.
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 dental material submission. "Ground truth" for an AI/ML device typically refers to expert-labeled data for an algorithm's output. For a physical material like LuxaPrint Ortho Plus, the "ground truth" is established by direct physical and chemical measurements (e.g., using calibrated lab equipment) and adherence to international standards (ISO). No human experts are used to "label" or "adjudicate" the material's physical properties.
4. Adjudication Method for the Test Set
This question is not applicable. No human adjudication is involved in determining the physical properties of a material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This question is not applicable. An MRMC study is relevant for evaluating the performance of medical imaging devices or AI algorithms that assist human readers. This submission is for a dental material with no reading component.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm or software component described for this device. The device itself is the material.
7. The Type of Ground Truth Used
For this dental material, the "ground truth" used for testing was based on:
- Standardized Physical and Chemical Measurements: This includes properties like water solubility, water sorption, flexural strength, and flexural modulus, measured according to established international standards (ISO 4049, ISO 20795-2).
- Biocompatibility Standards: Compliance with ISO 10993.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is a physical resin material, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. See point 8.
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