(154 days)
The SprintRay High Impact Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Fabrication of dental prosthetics with High Impact Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
The High Impact Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
High Impact Denture Base Resin is intended exclusively for professional dental work. SprintRay High Impact Denture Base Resin is offered in following shades/colors:
- Light Pink .
- Original Pink ●
- . Light Meharry
- Original Meharry .
- . Dark Meharry
High Impact Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, 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 text describes the regulatory clearance for a dental resin, not an AI/ML powered device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI/ML device.
However, based on the information provided for the SprintRay High Impact Denture Base, I can extract information related to its performance and equivalence to a predicate device. This information pertains to the physical and biocompatibility characteristics of the resin, not AI/ML performance.
Here's a summary of the performance data and equivalence to predicate devices, as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the industry consensus standard ISO 20795-1 and the biocompatibility testing standards. The reported device performance indicates that the SprintRay High Impact Denture Base functioned as intended and the outcomes were as expected against these standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Biocompatibility Testing: | |
| ISO 10993-1, ISO 7405 | Considered tissue contacting for >30 days. All tests indicated the device is safe. |
| - Genotoxicity | Outcomes as expected |
| - Cytotoxicity | Outcomes as expected |
| - Acute Systematic Toxicity | Outcomes as expected |
| - Sensitization | Outcomes as expected |
| - Irritation | Outcomes as expected |
| Bench Testing (ISO 20795-1): | |
| - Flexural Strength and Modulus | Outcomes as expected |
| - Water Sorption and Solubility | Outcomes as expected |
| - Stability | Outcomes as expected |
| - Residual Methyl Methacrylate Monomers | Outcomes as expected |
| - Homogeneity | Outcomes as expected |
| - Surface Characteristics | Outcomes as expected |
| - Shape Capability, Translucency, and Polishability | Outcomes as expected |
| - Freedom from Porosity | Outcomes as expected |
| - Color Stability | Outcomes as expected |
| Additive Manufacturing (FDA Guidance): | Testing performed, results provided in 510(k), covering relevant properties and orientation during manufacturing details. |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state sample sizes for each specific test (e.g., number of samples for flexural strength). It broadly states that "High Impact Denture Base was tested for conformity with the industry consensus standard ISO 20795-1." These standards typically specify sample sizes for their respective tests.
- Data provenance is not provided (e.g., country of origin, retrospective or prospective). The tests are laboratory-based bench and biocompatibility tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this device is based on established scientific and engineering standards (ISO standards) and laboratory test results, not expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation or clinical data, which is not the case here.
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 is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is defined by the performance specifications and methodologies outlined in recognized international standards for dental materials (e.g., ISO 20795-1 for physical properties, ISO 10993 for biocompatibility).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML powered device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.