(85 days)
Evadyne® is a light cured single-component material for the temporary restoration of crowns, bridges, or similar dental prostheses. Evadyne is intended for the general dental patient population.
NeoDental Chemical Products, Inc, (NeoDental) wishes to submit their Evadyne® Temporary Crown and Bridge Resin for 510(k) clearance. Evadyne®, (shown in Figure 1) is a yellowish translucent, light-cured temporary restoration material for direct filling. After curing, Evadyne can be removed in one piece when the permanent restoration is to be placed. Evadyne® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.
The provided document is a 510(k) Summary for a dental device called "Evadyne Temporary Crown and Bridge Resin". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or AUC).
Instead, the document focuses on:
- Device Description and Intended Use: Explaining what the Evadyne resin is and how it's used.
- Substantial Equivalence to a Predicate Device: Comparing Evadyne to Fermit-N (K934978) based on intended use, indications, and technological characteristics. The argument for substantial equivalence relies on them having similar applications, mechanisms of polymerization, and general properties, while acknowledging some differences in composition, flow, and flexural strength.
- Non-Clinical Test Data (Biocompatibility): This section details the biocompatibility evaluation, primarily through referencing recognized consensus standards (ISO 10993-1) and listing specific biological tests conducted (Cytotoxicity, Sensitization, Genotoxicity, Irritation) in 2001-2002 by Covance Lab. It also mentions that the main ingredient (UDMA) and filler (fluoroaluminosilicate glass) are widely used and have a history of safe use, and that 76,000 units have been sold since 2005 without reported incidents.
- Claims of Equivalence, not Performance Targets: The document concludes that Evadyne is "substantially equivalent" to the predicate device, not that it meets specific quantitative performance targets or acceptance criteria in a comparative study against a pre-defined threshold.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary information (acceptance criteria, device performance metrics, study design for accuracy, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance data) is not present in the provided text.
The closest information related to "acceptance criteria" is the device's conformance to biocompatibility requirements according to ISO 10993-1 and the fact that "Results were found to conform to requirements (see section 15)," but the specific numerical acceptance criteria for these biological tests are not detailed here. The "reported device performance" is simply the claim of being "substantially equivalent" and having an uneventful safety record over several years.
Summary of what cannot be provided from the text:
- Table of acceptance criteria and reported device performance: Not available. The document discusses "substantially equivalent" to a predicate, and conformance to biocompatibility standards, but no quantitative performance metrics or specific acceptance criteria are listed.
- Sample size for the test set and data provenance: Not applicable as it's not a performance study measuring accuracy. Biocompatibility tests would have their own sample sizes (e.g., guinea pigs for sensitization), but these are not for device performance against a diagnostic target.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted or reported.
- Standalone performance study: No such study described or reported.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no AI/ML involved).
- How ground truth for the training set was established: Not applicable.
§ 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.