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510(k) Data Aggregation
(137 days)
To construct cosmetic prosthetic dental restoratives for use in fixed restorations with or without metal frameworks to include:
- single crowns,
- telescope crowns,
- conus crowns,
- bridges,
- Maryland bridges,
- bridges on implants,
- inlays,
- onlays
- facettes (laminate veneers), and
- restorations.
CRISTOBAL consists of a series of layered composite restorative glass strength materials, combining the benefit of porcelain, composite and dental alloys, whose combined properties of wear resistance, flexural strength, maximum compressive strength and bulk modulus, make it suitable for all types of fixed cosmetic prosthetic restorations. CRISTOBAL offers the patient a tooth colored occlusal surface with the feeling of natural teeth.
CRISTOBAL is subject to complete polymerization for optimal reactions of the various materials. Due to the fact that the light curing material of CRISTOBAL is radioand its matrix has a very high content in inorganic particles (barium opaque. borosilicate), it allows for the production of fixed prostheses with functional, mechanical, and cosmetic longevity.
CRISTOBAL is composed of silanized barium borosilicate particles, a non-fracturable filler material, which are closely packed (74.2 weight percent) providing optimal silanization and cohesion of glass thereby ensuring protection against fracture together, with strong resistance to damage. With the matrix of Bis-GMA, TEDMA and UDDMA, these elastic memory properties also ensure damage resistance.
Despite the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, the provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific performance thresholds.
Instead, the document is a 510(k) Pre-market Notification Summary for a dental restorative material called CRISTOBAL. The primary purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to present a standalone performance study against pre-defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an attempt to address the points based on the available information, highlighting where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, the document does not define specific "acceptance criteria" against which CRISTOBAL was tested in a dedicated study. Instead, it compares CRISTOBAL's properties to those of two predicate devices to demonstrate substantial equivalence.
| Property | Predicate Device 1 (Kulzer DENTACOLOR) | Predicate Device 2 (Heraeus Kulzer ARTGLASS) | CRISTOBAL (Reported Performance) |
|---|---|---|---|
| Bending/Flexural (MPa) | 70-75 | 120 | 155 |
| Modulus Flexibility (MPa) | 3300 - 3500 | 9 000 | 8 500 |
| Comprehensive (MPa) | 350 | Not Available | 350 |
| Vickers-Hardness (N/mm²) | 400 | 590 | 670 |
| Fracture Damage during Vickers Hardness Tests (mm²) | Not Available | Not Available | 0.245 |
| Abrasion (µm/year) | Not Available | Good | < 8 |
| Bulk Modulus NFT 51101 (MPa) | Not Available | Not Available | 4 084 |
| Water Solubility (ug/mm²) | 1 | 0.5 | -10-2 (0.01) |
| Type of Filler Material | Pyrogenic Silicon Dioxide | Microfine Glass Particles | Barium Borosilicate |
| Total Mineral Filler Content by Weight (%) | 51 | 72 | 77 |
| Glazing Technique | Mechanical Polishing | Mechanical Polishing | Mechanical Polishing |
| Polymerization Shrinkage (%) | 0.16 | Negligible | 0.12 |
| Shade Stability (ΔE) | ~3 | 2 | High |
Note: The comparison in the document aims to show CRISTOBAL is "substantially equivalent" in properties, often performing comparably or better than the predicates. There are no explicit "acceptance criteria" values provided in this table.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document does not describe a clinical or lab "test set" in the traditional sense of a study designed to meet acceptance criteria. The data presented are material property values, likely derived from standard material testing methods, but the sample sizes for these tests are not provided.
- Data Provenance: Not specified. There is no information regarding the country of origin of the data or whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This document does not describe a study involving expert assessment or "ground truth" establishment in the context of clinical or image-based diagnostics. The data are material properties, not interpretations requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as no expert-based "test set" requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a material science submission, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. No algorithm or AI component is described in the context of this dental material.
7. Type of Ground Truth Used
Not applicable in the conventional sense. The "ground truth" for the reported material properties would be the physical measurements obtained through standardized material testing methods. No "expert consensus," "pathology," or "outcomes data" is mentioned as a ground truth for the material properties.
8. Sample Size for the Training Set
Not applicable. This document is about a physical dental material; there is no "training set" as it would apply to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved.
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