(115 days)
Calcium Bridge is a resin-based composite recommended for use as a liner or initial layer beneath all composite resins, or as flowable composite in preventive resin restorations. For Use only by a Licensed Dentist. Rx Use Only.
Calcium Bridge is a resin-based, flowable polymerizable composite paste recommended as a lining material beneath composite resins or as a preventive resin restoration (PRR) material (a minimally invasive procedure to protect a tooth). A PRR restoration is not intended to prevent caries but intended to be used in the treatment of caries. Because Calcium Bridge is highly radio-opaque this allows for easy radio-graphic observation compared to enamel, dentin, and possible secondary caries.
This document is a 510(k) summary for a dental device called "Calcium Bridge." It compares the device to a predicate device, "Tetric EvoCeram," to demonstrate substantial equivalence. It does not contain information about a study proving the device meets acceptance criteria related to AI or digital image analysis. Therefore, it's not possible to provide the requested information.
The document discusses the following properties, which could be considered acceptance criteria for a dental material:
Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided test values):
| Property | Acceptance Criteria (Predicate) | Reported Device Performance (Calcium Bridge) |
|---|---|---|
| Light Curing Capability | Cures Less Than 20 seconds | Cures Less Than 20 seconds |
| Radiopacity (Aluminum Equivalent) | Equal to 2.0 mm Aluminum | 3.5 mm Aluminum |
| Fluorescence | Visible Blue Glow Detected | Visible Blue Glow Detected |
| Compressive Strength | 250 MPa | Greater Than 250 MPa |
| Depth of Cure | Greater Than 1.5 mm | Greater Than 1.5 mm |
| Biocompatibility (ISO 10993-5, Cytotoxicity) | (N/A - Not Available for Predicate) | Zone of Inhibition 0.25 cm |
Missing Information (based on your request, but not present in the document):
The document does not describe a study involving human readers, AI, or ground truth establishment in the context of diagnostic performance. Therefore, I cannot answer the following parts of your request:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
§ 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.