(46 days)
Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.
Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have esthetic qualities that mimic natural tooth appearance.
The provided text describes a 510(k) submission for a medical device, a Temporary Crown and Bridge Resin. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving new performance against acceptance criteria through a clinical study of the type usually associated with AI/software devices. Therefore, many of the requested points related to AI/software performance studies are not applicable to this document.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" in this context are the physical and mechanical properties of the predicate device (Luxatemp) that the applicant device (Cosmedent TEMPORARY C&B Filling Material) aims to be substantially equivalent to. The reported performance is the measured properties of the Cosmedent device.
| Property | Acceptance Criteria (Predicate: LUXATEMP) | Reported Device Performance (Cosmedent TEMPORARY C & B Filling Material) |
|---|---|---|
| Compressive strength | 220 MPa | 225 MPa |
| Flexural strength | 92 MPa | 82 MPa |
| Percent filler by weight | 44 | 46 |
| Radiopaque | Yes | Yes |
2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to material properties testing, not a clinical study with a "test set" in the context of AI/software or diagnostic performance. The testing would have been conducted in a laboratory setting. No information on the number of samples tested for the material properties is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties like compressive strength is established through standardized laboratory testing methods, not expert consensus.
4. Adjudication method for the test set: Not applicable. Material properties are measured objectively.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/software device.
7. The type of ground truth used: For the material properties (compressive strength, flexural strength, percent filler by weight, radiopacity), the ground truth is established through objective laboratory measurements following established standards for dental materials.
8. The sample size for the training set: Not applicable. This is not an AI/software device with a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.
§ 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.