(90 days)
SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.
SprintRay Digital Temp is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer of the composite material. SprintRay Digital Temp resin is offered in various shades such as Bleach, A1, A2 and B1. Digital Temp is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.
SprintRay Digital Temp resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Digital Temp resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Digital Temp file created in an optical impression system, 3D printer, and curing light equipment.
Digital Temp 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 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 text is a 510(k) summary for SprintRay Digital Temp, a light-curable resin used for fabricating temporary dental restorations. It does not contain information on acceptance criteria or studies proving that a device meets such criteria for an AI/ML-based medical device.
Instead, it focuses on the substantial equivalence of the Digital Temp resin to a predicate device based on:
- Intended Use/Indications for Use: Both are for temporary dental restorations.
- Technological Characteristics: Both are light-cured acrylate resins used with 3D printers and scanned 3D images.
- Performance Data: Biocompatibility testing and bench testing based on ISO 10477 were performed, and the resin "functioned as intended."
Therefore, I cannot extract the requested information about acceptance criteria and the study proving an AI/ML device's performance, as the document describes a material (resin) and not an AI/ML algorithm.
The questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies) are highly relevant to AI/ML device evaluations but are not addressed in this material-focused 510(k) summary.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.