(60 days)
SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.
SprintRay Apex Flex is a photo-polymeric methacrylate/acrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to fabricate partial dentures by 3D printing layer upon layer of the composite material. The product is available in two shades: Light Pink and Standard Pink.
SprintRay Apex Flex resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Apex Flex resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Apex Flex file created in an optical impression system, 3D printer, and curing light equipment.
Apex Flex resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.
The provided document is an FDA 510(k) clearance letter and supporting summary for a dental resin product, SprintRay Apex Flex. This document does not describe an AI/ML-enabled medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the substantial equivalence of a new dental material (resin) to existing predicate devices based on physical, chemical, and biocompatibility properties.
Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., test set data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the material properties of the SprintRay Apex Flex device as presented in the document.
Analysis of Acceptance Criteria and Device Performance for SprintRay Apex Flex
The "acceptance criteria" for this device are implicitly derived from the performance of the predicate and reference devices, and conformance to industry consensus standards like ISO 20795-1. The SprintRay Apex Flex is demonstrated to be substantially equivalent to these devices by meeting comparable performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison of the SprintRay Apex Flex (Subject Device) against its primary predicate (Flex-Star V), secondary predicate (TCS® Unbreakable), and a reference device (SprintRay NightGuard Flex). The "acceptance criteria" are not explicitly stated as numerical thresholds but are implied by the measured values of the predicate devices, particularly the Flex-Star V as the primary predicate. The subject device must show comparable or improved performance without raising new safety or effectiveness concerns.
| Performance Metric | Implied Acceptance Criteria (Predicate/Reference Range or Pass) | Reported SprintRay Apex Flex Performance |
|---|---|---|
| Material Type | Thermoplastic nylon resin (predicates), Light-curable polymerizable resin (reference) | Light-curable polymerizable resin |
| Biocompatibility | Tested to ISO-10993-1 and ISO 7405 (for NightGuard Flex) | Tested to ISO-10993-1 and ISO 7405; Considered tissue contacting > 30 days. |
| Flexural Strength | ~26.9 MPa (Flex-Star V), Similar (TCS Unbreakable), 10.4-11.2 MPa (NightGuard Flex) | 26.5 ± 0.8 MPa |
| Flexural Modulus | ~612 MPa (Flex-Star V), 353 ± 4.2 MPa (TCS Unbreakable), 169 ± 1.6 MPa (NightGuard Flex) | 748 ± 21 MPa |
| Water Sorption | Pass (Flex-Star V), 14.8 ± 0.4 µg/mm³ (TCS Unbreakable), 19.5 ± 1.6 µg/mm³ (NightGuard Flex) | 8.9 ± 0.3 µg/mm³ |
| Water Solubility | Pass (Flex-Star V), 2.5 ± 0.7 µg/mm³ (TCS Unbreakable), 1.6 ± 0.7 µg/mm³ (NightGuard Flex) | 3.3 ± 0.2 µg/mm³ |
| Residual Monomer (Methyl Methacrylate) | Not detectable | Not detectable |
| Other Bench Tests (Pass/Fail) | Conformity with ISO 20795-1 (implied pass/acceptable range) for: Total Fracture Work, Maximum Stress Intensity Factor, Tolerance, Depth of Cure, Accuracy Fitting, Shade, Freedom from Porosity, Homogeneity, Viscosity. | "Functioned as intended and the outcomes were as expected" (indicates pass/acceptable). |
Summary of Device Performance: SprintRay Apex Flex demonstrates comparable or in some cases superior physical properties (e.g., flexural modulus, lower water sorption) compared to the predicate and reference devices, while meeting biocompatibility and other standard requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/ML model for diagnostic performance. The "testing" refers to bench testing of material properties.
- Sample Size: The exact number of samples tested for each material property (e.g., flexural strength, sorption) is not provided. The results are reported with mean values and standard deviations, implying multiple samples were tested for each property as per ISO standards.
- Data Provenance: The data is generated from bench testing of the manufactured SprintRay Apex Flex resin. The "country of origin" for this data would be the location where these laboratory tests were conducted, which is not specified in the document but is typically part of the manufacturer's internal testing process. The nature of the data is prospective in the sense that the manufacturer specifically produced and tested samples of the Apex Flex resin for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the document describes a material and its physical properties, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for material properties is established by standardized test methods (e.g., ISO 20795-1) and measurement equipment, not by human experts.
4. Adjudication Method for the Test Set
Not applicable. As the "test set" refers to material samples undergoing physical and chemical tests, there is no need for adjudicating human interpretations.
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 document pertains to a dental material, not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This question refers to AI algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on standardized laboratory measurements of physical, mechanical, and chemical properties (e.g., flexural strength, water sorption) as defined by ISO consensus standards (specifically ISO 20795-1 and ISO 10993-1/7405 for biocompatibility). There is no "expert consensus" or "pathology" in the context of a diagnostic outcome.
8. The Sample Size for the Training Set
Not applicable. As this is a material, there is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are measured.
9. How the Ground Truth for the Training Set Was Established
Not applicable. 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.