(74 days)
SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards and splints.
The SmileGuard™ system combines the light-curable resin, for use with a scanner with design software, validated 3D printer and a curing unit. These components are used together during the additive manufacture of dental appliance splints/mouth guards. The light-curing resin is a proprietary composition 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 filled in lightproof 1 kg PE bottles labeled and offered together with a programmed RFID chip (referred to as TAG), which is required for use with the validated EnvisionTEC 3D printers. The TAG contains information identifying the resin: material, name and amount. The SmileGuard™ resin is an alternative material to heat-curing and auto-polymerizing resins.
The provided text describes the 510(k) premarket notification for a device named "SmileGuard™", a light-curable resin for fabricating orthodontic and dental appliances. The document is primarily focused on demonstrating substantial equivalence to a predicate device (KeyPrint® KeySplint Soft™) through comparative testing of material properties, rather than an AI-driven medical device requiring clinical performance studies directly involving AI.
Therefore, many of the requested fields regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI models are not applicable to this specific device and the information provided. The document focuses on the physical and chemical properties of the resin, its biocompatibility, and manufacturing process.
Here's a breakdown of the provided information relevant to your request, with an explanation of why other aspects are not present:
Device Description:
SmileGuard™ is a light-curable resin used with a scanner, design software, validated 3D printer, and curing unit for the additive manufacture of dental appliance splints/mouth guards.
Intended Use:
Fabrication of orthodontic and dental appliances such as mouthguards, nightguards, and splints.
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are not performance metrics in the sense of diagnostic accuracy (like sensitivity/specificity for AI), but rather material property specifications and biocompatibility requirements for the resin. The acceptance criteria are based on established ISO and ASTM standards for dental polymers and biocompatibility.
| Characteristic | Acceptance Criteria (Predicate / Standard Requirement) | Reported Device Performance (SmileGuard™) | Unit | Test Standard |
|---|---|---|---|---|
| Tensile Strength | Unknown (but acceptable for predicate) | 19.1 +/- 2.5 | MPa | ISO 527 |
| Tensile Modulus | Unknown (but acceptable for predicate) | 319 +/- 48 | MPa | ISO 527 |
| Elongation at Break | >110% [Ref ASTM D638; pass, per design requirements] | 138 +/- 16% | % | ISO 527 |
| Ultimate Flexural Strength | 44-47 MPa [Ref ASTM D790; pass, per design requirements] | 37.3 +/- MPa (Note: reported as 37.3 +/- MPa) | MPa | ASTM D790 |
| Ultimate Flexural Modulus | 1,100-1,400 MPa [Ref ASTM D790; pass, per design requirements] | 1,107 +/- 37 | MPa | ASTM D790 |
| IZOD Impact (notched) | 45-48 J/m [Ref ASTM D256; pass, per design requirements] | 70.7 +/- 12.1 | J/m | ASTM D256, method A |
| Shore D Hardness | 80-85 MPa [Ref ASTM D2240; pass per design requirements] | 76 +/- 2% (Note: reported as 76 +/- 2%) | % (or Shore D) | ASTM D2240 |
| Biocompatibility | Meets requirements for mucosal membrane contact >30 days (ISO 10993) | Biocompatible and non-toxic | N/A | ISO 10993 (Parts 5 & 10) |
| Shelf Life | Stability for 18 months at 5°-30°C (viscosity, photoreactivity, visual inspection) | Validated real time for 18 months | N/A | Internal Validation (real-time stability) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a laboratory testing program as outlined in Section VII of the 510(k) Summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of samples (e.g., number of test specimens) used for each physical property test (Tensile, Flexural, Impact, Hardness). It provides mean values and standard deviations, implying multiple samples were tested for each property.
- Data Provenance: The testing was conducted in a laboratory setting. No information about country of origin of data is provided beyond the manufacturer and regulatory consultant being based in Germany and the US respectively. The tests performed are prospective bench tests (physical property measurements and biocompatibility testing on newly manufactured resin samples).
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. This is not a study involving human interpretation of data for "ground truth" (e.g., medical image reading). The "ground truth" for material properties is established by the results of standardized physical and chemical tests performed in a laboratory, and for biocompatibility by the results of in vitro and in vivo biological tests according to ISO standards. No human expert "adjudication" of these test results in the sense of diagnostic interpretation is mentioned or required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is relevant for human expert consensus in diagnostic studies (e.g., radiology reads), not for laboratory material testing or biocompatibility assessments.
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 fabricating dental appliances, not an AI-driven diagnostic or assistive tool for human interpretation. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no standalone AI algorithm in the context of this device. The device is a material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is derived from objective, quantitative measurements obtained through standardized laboratory tests (e.g., ISO, ASTM standards for material properties) and biological test results for biocompatibility (ISO 10993 series). It is not based on expert consensus, pathology, or outcomes data in the usual clinical sense.
8. The sample size for the training set:
- Not applicable. This is not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
N/A