(53 days)
Imagine Reflex is a dental ceramic that can be used by dental technicians to fabricate porcelain-fused-to-metal restorations. It is suitable for veneering dental alloys with a coefficient of thermal expansion [CTE(25 -500°C): 13.8 – 15.1 x 10*K¹] and a solidus temperature that has to exceed 1000°C (1830°F) as well as electroformed galvanogold.
Imagine Reflex can be used for veneering inlays, partial crowns, single crowns, and bridges.
Not Found
The provided text is a 510(k) summary for a dental ceramic product, Imagine® Reflex®. It primarily focuses on regulatory information, specifically demonstrating substantial equivalence to a predicate device. This type of submission does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be relevant to software or AI-based medical devices.
Therefore, based on the provided text, I cannot extract the information required to populate the requested table and answer the specific questions about acceptance criteria and study details. The document relates to a material science product (dental porcelain), not a diagnostic device or a device with an AI component.
Here's a breakdown of why the information is not present in the provided text:
- No "device performance" in the AI/Software sense: Dental ceramic performance is typically evaluated by material properties (e.g., strength, thermal expansion, compatibility with alloys), not by diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI/software devices.
- No "acceptance criteria" related to diagnostic accuracy: The criteria for a dental ceramic would involve material standards and biocompatibility, not statistical thresholds for diagnostic performance.
- No "test set," "training set," "ground truth," or "experts" for diagnostic evaluation: These concepts are central to validating AI and diagnostic devices. For a dental ceramic, the "ground truth" might be defined by chemical composition or mechanical testing results, not by expert consensus on images.
- No "MRMC study" or "standalone performance": These are specific to evaluating how well an algorithm (with or without human assistance) performs a diagnostic task.
Conclusion: The provided regulatory document for K031326, Imagine® Reflex®, is for a dental material and does not contain the type of study information (acceptance criteria, performance metrics, sample sizes, expert ground truth, or MRMC studies) typically found in submissions for AI or software-driven medical devices. Therefore, I cannot generate the requested table or answer the specific questions based on this document.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.