(142 days)
Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class I, III, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs.
Nexcomp is a light-cured, esthetic, resin-based dental restorative designed for direct placement in both anterior and posterior restorations. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra-fine filler and 40 nm silica particles. Nexcomp will be marketed in 19 shades which corresponded with the Vita Shade Guide.
The provided text describes the 510(k) premarket notification for a dental restorative material called Nexcomp. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI/device meets specific acceptance criteria for diagnostic performance.
Therefore, I cannot extract the detailed information requested regarding AI/device performance, reader studies, ground truth establishment, or sample sizes for training/test sets as these concepts are not applicable to the provided document. The document concerns a physical dental material, not an AI or diagnostic device.
However, I can extract the acceptance criteria and performance data for the physical properties of the Nexcomp dental material and present it in a table, as well as information about the testing performed.
Acceptance Criteria and Device Performance (for Physical Properties of Dental Material)
The document primarily focuses on demonstrating that the new Nexcomp device has similar physical properties to its predicate device, and that these properties meet relevant ISO standards for dental materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (ISO Standards/Predicate Similarity) | Reported Device Performance (Subject Device) | Reported Predicate Device Performance |
|---|---|---|---|
| Material Properties | |||
| Compressive strength | Should be more than 5MPa. | Average 232.76 MPa | Average 288.68 MPa |
| Flexural strength | > 80 MPa | Average 87 MPa | 91.82 MPa |
| Depth of cure | > 1.0 mm | 2.88 mm | 4.96 mm |
| Surface hardness (Vickers hardness) | Based on ISO 6507-1:2005 (no specific numerical criterion stated in table, but performance is compared) | Average 56 KHN | Average 39.36 KHN |
| Radio-opacity | > 1mm | More than 1mm | More than 1mm |
| Water sorption |
§ 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.