(105 days)
SprintRay Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
SprintRay Digital Crown resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.
Fabrication of dental prosthetics with SprintRay Digital Crown resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital crown file created in an optical impression system, 3D printer, and curing light equipment. SprintRay Digital Crown Resin is intended exclusively for professional dental work. Digital Crown Resin is offered in following shades/colors: Bleach, A1, B1.
The device is manufactured via additive manufacturing process using a 3D printer with 405 nm wavelength, 50 m print layer thickness, and light energy of 28.8 mW/cm².
Digital Crown resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
The provided document is a 510(k) Summary for the SprintRay Digital Crown resin. It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values. Instead, it states that "In all instances, Digital Crown resin functioned as intended and the outcomes were as expected" for the various bench tests. It also indicates that the device met ISO standards.
However, the "Comparison of Technology Characteristics" table implicitly conveys acceptance criteria by listing the standards that both the predicate and the subject device adhere to, and then stating "Similar" for the reported performance.
Here's a reconstructed table based on the provided information, focusing on the standards and the conclusion of compliance:
| Feature/Test | Acceptance Criteria (Implied by Standard Adherence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, ISO 7405 | Tested and considered compliant. |
| Genotoxicity | ISO 10993-3 | Tested, outcomes as expected. |
| Cytotoxicity | ISO 10993-5 | Tested, outcomes as expected. |
| Acute Systemic Toxicity | ISO 10993-11 | Tested, outcomes as expected. |
| Sensitization | ISO 10993-10 | Tested, outcomes as expected. |
| Irritation | ISO 10993-10 | Tested, outcomes as expected. |
| Bench Testing | ISO 10477, ISO 4049 | Functioned as intended, outcomes as expected. |
| Flexural Strength and Modulus | ISO 10477, ISO 4049 | Functioned as intended, outcomes as expected. |
| Water Sorption and Solubility | ISO 10477, ISO 4049 | Functioned as intended, outcomes as expected. |
| Radio-opacity | ISO 10477, ISO 4049 (Likely subsumed) | Functioned as intended, outcomes as expected. |
| Print Accuracy and Dimensional Stability | ISO 10477, ISO 4049 (Likely subsumed) | Functioned as intended, outcomes as expected. |
| Shape Capability, Translucency, Polishability | ISO 10477, ISO 4049 (Likely subsumed) | Functioned as intended, outcomes as expected. |
| Freedom from Porosity | ISO 10477, ISO 4049 | Functioned as intended, outcomes as expected. |
| Color Stability and Shade Consistency | ISO 10477, ISO 4049 | Functioned as intended, outcomes as expected. |
| Residual Methyl Methacrylate Monomers | ISO 10477, ISO 4049 | Functioned as intended, outcomes as expected. |
| Stability | ISO 10477, ISO 4049 | Functioned as intended, outcomes as expected. |
| Additive Manufacturing Properties | FDA Guidance: Technical Considerations for AM Medical Devices | Performed, results provided in 510(k). |
| Shelf life | >1.5 years (from Predicate) | 1.5 years |
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 explicitly state the sample size used for the test set or the data provenance for any of the performance studies (biocompatibility or bench testing). It only refers to "a battery of testing" and "additional 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)
This information is not applicable and therefore not provided in the document. The device is a material (resin) for fabricating dental prosthetics, and its performance is evaluated through objective physical, chemical, and biological tests, not through expert assessment of diagnostic accuracy or interpretation of images. Therefore, there's no "ground truth" to be established by experts in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data (e.g., radiology reads) where discrepancies between assessors need to be resolved to establish ground truth. As this document describes the bench testing of a material, clinical adjudication is irrelevant.
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
This type of study is not applicable to this device. An MRMC study is relevant for AI-powered diagnostic devices that influence human interpretation. The SprintRay Digital Crown is a material for manufacturing dental prosthetics, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a material, not an algorithm. The performance tests described (biocompatibility and bench testing) evaluate the intrinsic properties of the material and the fabricated dental appliance, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility and bench testing, the "ground truth" is established by adherence to internationally recognized standards (ISO standards) and scientific test methodologies. For example, flexural strength is measured according to specific protocols outlined in ISO 10477 and ISO 4049, and the result is compared against the requirements specified in those standards. The outcomes of these tests inherently serve as their own "ground truth" concerning the material's properties according to those standards.
8. The sample size for the training set
This information is not applicable as the device is a material and not a machine learning model. There is no concept of a "training set" for the material itself.
9. How the ground truth for the training set was established
This information is not applicable (see point 8).
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.