(266 days)
Remedial Blanks for the Fabrication of Dental Restoration
Neo Denta Zirconia is a partially sintered zirconia disc, which is vttrium oxide stabilized zirconium dioxide. The disc can be milled into various shapes of prostheses. A CAD/CAM system can be used to produce the prostheses needed from the blank. Neo Denta Zirconia provides an alternate to the gold, porcelain, ceramics and other types of material used in the dental laboratories for dental restoration.
This document describes a 510(k) submission for "Neo Denta Zirconia," which is a relabeled product of "Sagemax Z-Blank." The submission asserts substantial equivalence to the predicate device due to identical technological characteristics.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Study Details for Neo Denta Zirconia
Based on the provided document, the Neo Denta Zirconia is a relabeled product, and its acceptance criteria and performance are established through equivalence to a predicate device, Sagemax Z-Blank. No independent clinical "study" as you might typically envision for a new device was performed for Neo Denta Zirconia itself. Instead, its safety and effectiveness are established by demonstrating that it is identical in all material aspects to a device already cleared by the FDA.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this device is a relabeled predicate, the acceptance criteria and performance are inherently tied to the predicate device, Sagemax Z-Blank. The document states "The dimensions, the material, the chemical composition and all other properties of Neo Denta Zirconia are the same compared to Sagemax Z-Blank."
| Acceptance Criteria Category | Reported Device Performance (Neo Denta Zirconia) |
|---|---|
| Dimensions | Same as Sagemax Z-Blank |
| Material | Same as Sagemax Z-Blank |
| Chemical Composition | Same as Sagemax Z-Blank |
| Other Properties | Same as Sagemax Z-Blank |
| Particle Size | Measured by laser scanning (No specific value stated, implies conformity to Sagemax Z-Blank's established performance) |
| Microstructure | Measured (No specific value stated, implies conformity to Sagemax Z-Blank's established performance) |
| Surface Condition | Measured (No specific value stated, implies conformity to Sagemax Z-Blank's established performance) |
| 1-CR value (Color) | Determined using Xrite Color i7 and UV Spectrophotometer (No specific value stated, implies conformity to Sagemax Z-Blank's established performance) |
| Flexural Strength & Toughness | Determined using an Autograph strength test machine (No specific value stated, implies conformity to Sagemax Z-Blank's established performance) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an independent clinical study for Neo Denta Zirconia. The "test set" for Neo Denta Zirconia's submission was essentially a comparison to the specifications and performance of the Sagemax Z-Blank.
- Data Provenance: The data provenance for Neo Denta Zirconia's submission is derived from the predicate device (Sagemax Z-Blank) and non-clinical laboratory testing performed on Neo Denta Zirconia to confirm its identical nature to the predicate. The document does not specify the origin of Sagemax Z-Blank's data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no independent clinical study with a test set requiring expert ground truth establishment was conducted for Neo Denta Zirconia. The "ground truth" for Neo Denta Zirconia is its direct equivalence to Sagemax Z-Blank.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.
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
- No MRMC comparative effectiveness study was done. This device is a dental material, not an AI-assisted diagnostic tool or imaging device. Therefore, questions regarding human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone (algorithm only) performance study was done. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the substantial equivalence claim is the demonstrated identical technological characteristics (dimensions, material, chemical composition, and other properties) of Neo Denta Zirconia to the predicate device, Sagemax Z-Blank, which was previously cleared by the FDA (510(k) number Z062695). Non-clinical testing (particle size, EDS & X-ray EV, microstructure, surface condition, 1-CR value, flexural strength/toughness) was performed on Neo Denta Zirconia to verify these characteristics match the predicate.
8. The sample size for the training set
- Not applicable. As this is a dental material submission based on substantial equivalence to a predicate, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of submission.
§ 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.