(84 days)
Dental Ceramic Blocks are indicated for fabrication of inlays onlays, aminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.
Dental Ceramic Blocks consist of methacrylate, benzoyl peroxide, barium glass powder and pigmen to form a solid block of material. The unique marriage of the materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use. Dental Ceramic Blocks is provided as non-sterile.
The provided text is a 510(k) Premarket Notification for a dental device, "Dental Ceramic Blocks." This document does not include information about AI/ML device performance or a study demonstrating the device meets acceptance criteria related to AI/ML.
The device described is a physical material (dental ceramic blocks) used to fabricate dental restorations. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance testing of these physical blocks, not an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies because the provided document does not pertain to an AI/ML device.
However, I can extract the information related to the physical device's performance acceptance criteria and proof if that is what you are looking for.
For the physical device (Dental Ceramic Blocks), here's what the document states regarding acceptance criteria and performance:
1. Table of acceptance criteria and reported device performance:
| Item | Acceptance Criteria (Implied / Contextual) | Reported Device Performance (Proposed Device) | Predicate Device Performance |
|---|---|---|---|
| Biocompatibility | Conforms with ISO 10993-1, FDA Guidance | Conforms with ISO 10993-1, FDA Guidance | Conforms with ISO 10993-1, FDA Guidance |
| Performance | Conforms with ISO 4049 | Conforms with ISO 4049 | Conforms with ISO 4049 |
| Flexural Strength | Sufficient to meet SE (implied > 191 MPa, but "slightly difference" and meets "acceptance criteria") | 207 MPa | 191 MPa |
| Radioactive (Radiopacity) | Sufficient to meet SE (implied > 1.8mm Al, but "slightly difference" and meets "acceptance criteria") | 2.3mm Al | 1.8mm Al |
Note: The document explicitly states "Although the results have slightly difference, they meet the acceptance criteria. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate devices" for Flexural Strength and Radioactive properties.
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for non-clinical performance and biocompatibility tests. It only lists the standards followed (e.g., ISO 4049, ISO 10993 series).
- Data provenance: Not explicitly stated, but implies lab testing. No information on country of origin of data. These are non-clinical / bench tests, not patient data trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is for a physical device, not an AI/ML diagnostic or measurement device. Ground truth is established by laboratory measurement standards (e.g., ISO standards).
4. Adjudication method for the test set:
- Not applicable. This is for a physical device, not an AI/ML diagnostic or measurement device.
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 document is not about an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is not about an AI/ML device.
7. The type of ground truth used:
- For the physical properties (Flexural Strength, Radiopacity), ground truth is established by standardized laboratory measurement methods outlined in ISO 4049 and ISO 7491.
- For Biocompatibility, ground truth is established by adherence to ISO 10993 series standards test methods (e.g., cytotoxicity, irritation, systemic toxicity, genotoxicity).
8. The sample size for the training set:
- Not applicable. This document is not about an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This document is not about an AI/ML device.
§ 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.