(228 days)
GenesisZr® 4Y+(ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
GenesisZr® 4Y+ (ST1100) Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown, bridge or coping.
The provided text is a 510(k) Premarket Notification for a dental device, GenesisZr® 4Y+(ST1100) Zirconia. This document focuses on demonstrating substantial equivalence to a predicate device based on physical, chemical, and performance characteristics, rather than clinical efficacy studies. Therefore, it does not describe an acceptance criteria table, a study proving device performance in a clinical setting, or details related to AI/human-in-the-loop studies.
Instead, the document details nonclinical testing to demonstrate the device meets established specifications and international standards for dental ceramic materials.
Here's an analysis of the provided text based on your request, highlighting what is present and what is absent:
Device: GenesisZr® 4Y+(ST1100) Zirconia
The provided document describes a premarket notification (510(k)) for a dental material, specifically zirconia blanks used for dental restorations. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through nonclinical testing, material characterization, and adherence to recognized standards. It typically does not involve clinical studies or human-in-the-loop performance evaluations as would be expected for a diagnostic AI device.
Therefore, the requested information regarding acceptance criteria for clinical performance, sample size for test sets/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance for an AI device is not applicable to this document.
However, I can extract information related to the device's physical and performance characteristics, which serve as its "acceptance criteria" in the context of this 510(k) submission, and how its performance against these criteria was "proven" through nonclinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are its physical and chemical properties, as measured through laboratory testing, and its compliance with relevant ISO standards.
| Characteristic | Acceptance Criteria (from ISO standards / industry norms) | Reported Device Performance (GenesisZr® 4Y+(ST1100) Zirconia) | Predicate Device Information (ArgenZ HT+) |
|---|---|---|---|
| Physical Properties: | |||
| Sintered Density | ≥ 6.0 g/cm³ (ISO 13356:2015 Section 4.1 Req't.) | ≥ 6.07 g/cm³ (Reported: 6.07 g/cm³) | 6.08 g/cm³ |
| Thermal Expansion Coefficient (20-500°C) | No specific requirement stated in table (ISO 6872:2015) | 10.2 µm/m °C | 10.3 µm/m °C |
| Bending Strength (average flexural strength) | > 800 MPa (ISO 6872:2015 Limit) | 1,100 MPa | 1,348 MPa |
| Grain size | Not explicitly stated as acceptance criteria | 0.66 µm | Not supplied |
| Fracture Toughness (KIC) | ≥ 5.0 MPa m^(0.5) (ISO 6872:2015 Annex A; minimum for class 5) | > 5.0 MPa m^(0.5) | Not supplied |
| Chemical Properties: | |||
| Material Composition (ZrO2 + HfO2 + Y2O3 + Al2O3) | > 99.0% | > 99.0% | ZrO2+HfO2+Y2O3: > 99 wt% |
| Al2O3 | ≤ 0.05% | ≤ 0.05% | Not specified |
| SiO2 | ≤ 0.01% | ≤ 0.01% | Not specified |
| Fe2O3 | ≤ 0.01% | ≤ 0.01% | Not specified |
| Chemical Solubility |
§ 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.