(210 days)
EnvisionTEC's E-Guard is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations, i.e. bite guards/splints and occlusal night guard/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
The E-Guard system combines a scanner with design software, the light-cured resin, a 3D printer and a curing unit. These components are used together during the manufacture of the dental appliance splint/bite guard. The light-curing resin is composed of acrylate/methacrylate, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make customized bite splints, using the 3D-printer. The resin is offered in lightproof 1 kg PE bottles along with a programmed chip (referred to as TAG), which is required for use with the 3D printer. The TAG contains information identifying the resin material, name and amount. The E-Guard resin is an alternative material to heat-cured and auto-polymerizing resins.
The provided text describes the acceptance criteria and a study proving the substantial equivalence of the E-Guard device to a predicate device, VeriSplint.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from DIN EN ISO 20795-2:2013 for Orthodontic base polymers) | Reported E-Guard Device Performance (based on testing of 2 samples from the same lot) | Predicate Device (VeriSplint) Performance |
|---|---|---|
| Water Solubility | 0.5 ug/mm³ | 100 MPa |
| Bending Modulus | (1) 2130 MPa; (2) 2052 MPa | > 2500 MPa |
| Biocompatibility | Biocompatible, according to ISO 10993 testing (meets requirements for device in contact with mucosal membrane for >30 days) | Biocompatible, according to ISO 10993 testing |
| Sterility | Non-sterile | Non-sterile |
| Shelf Life | Validated real-time for 1 year (viscosity, reactivity, homogeneity, color change tested) | Not explicitly detailed but implied |
| Additive Manufacturing Considerations | Evaluated according to FDA's guidance, including relevant properties and orientation during manufacturing | Not explicitly detailed but implied |
Note: The document states that "The requirements for flexural strength, flexural modulus, water solubility and water sorption content were met" by the E-Guard device, even though some reported values are quantitatively different from the predicate or general acceptance criteria. This suggests the criteria itself may have a range or different specific thresholds that were met. For instance, the predicate's bending strength is stated as "> 100 MPa", and the E-Guard's values (85.1 MPa, 79.4 MPa) are lower. However, the conclusion still states the requirements were met, implying that the specific ISO standard allows for this difference or the context of the comparison focuses on overall substantial equivalence rather than identical performance values in every aspect.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For explicit physical properties like Bending Strength and Bending Modulus, the document mentions "Testing of 2 samples, same lot". The overall number of manufactured bite splints used for the performance evaluation according to DIN EN ISO 20795-2:2013 is not explicitly stated, beyond stating "Testing was conducted to evaluate the performance of a manufactured bite splint."
- Data Provenance: Not explicitly stated, but likely from internal laboratory testing conducted by EnvisionTEC GmbH, a German company ("D-45968 Gladbeck Germany"). The tests were performed according to ISO standards, which are international. It is a retrospective study in the context of this 510(k) submission, as the data was collected prior to the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The ground truth for the physical and biocompatibility testing is based on established international standards (DIN EN ISO 20795-2:2013 and ISO 10993) rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable as the 'ground truth' is determined by quantitative measurements against ISO standards for material properties and biocompatibility, not by expert review of individual cases requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a dental material, and the evaluation focuses on its physical and biological properties, not a diagnostic or interventional imaging tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. The device is a light-cured resin used in an Additive Manufacturing process for dental appliances. It is a material, not a software algorithm, so "standalone" performance in the context of AI algorithms is not relevant. The performance evaluation is of the material itself and the manufacturing process.
7. The Type of Ground Truth Used
The ground truth used for performance validation is based on established international standards for dental materials:
- DIN EN ISO 20795-2:2013, Dentistry - Base Polymers - Part 2: Orthodontic base polymers: For flexural strength, flexural modulus, water solubility, and water sorption content.
- ISO 10993: For biocompatibility.
8. The Sample Size for the Training Set
Not Applicable. As a physical material evaluated against defined standards, there is no "training set" in the context of machine learning or AI models. The material's properties are inherent to its composition and manufacturing process, not learned from data in a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. (Refer to point 8).
N/A