(169 days)
Whip Mix VeriSplint 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 guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
The VeriSplint ®OS system is a combination of a scanner, resin, 3D printer, and curing unit. The system components work together to manufacture a splint/bite guard. The additive manufactured appliance is part of a photo-cured product family that is a combination of methacrylate resins. In general, the products in this family are composed of a 3-component methacrylic system, polymerized via photo initiators in a 3D printer setting. The material is an alternative to traditional heat cured and auto polymerizing resins.
The provided text describes the Whip Mix VeriSplint device and its performance testing to demonstrate substantial equivalence to predicate devices, primarily for its physical and chemical properties as a dental material. It does not describe a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or MRMC studies, as would be common for AI/ML-based medical devices.
Therefore, many of the requested elements for the acceptance criteria and study proving device performance (specifically those related to AI/ML and human reading studies) are not applicable to the information provided in this document.
Here's the information that can be extracted from the provided text, focusing on the material characteristics and the regulatory review process for VeriSplint:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on the requirements of ISO 20795-2:2013, Dentistry – Base Polymers – Part 2: Orthodontic base polymers, and comparison to predicate devices.
| Requirement | Acceptance Criteria (from ISO 20795-2:2013 or inferred from predicate) | Reported VeriSplint Performance | Primary Predicate Performance (K150432) | Reference Predicate Performance (K162572) |
|---|---|---|---|---|
| Flexural Strength | ≥ 50 MPa | > 100 MPa | 90 MPa | Not provided |
| Flexural Modulus | ≥ 1500 MPa | > 2500 MPa | Not provided | Not provided |
| Water Solubility | ≤ 5µg/mm³ |
N/A