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510(k) Data Aggregation
(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 |
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(227 days)
GenesisZr® UHT700 Zirconia blanks are indicated for Monolitic-ceramic for single-unit anterior or posterior prostleses and for three-unit prostheses not involving molar restoration, adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration_adhesively, or non-adhesively cemented.
GenesisZr® UHT700 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.
The provided text describes the 510(k) Premarket Submission for GenesisZr® UHT700 Zirconia. This submission focuses on demonstrating substantial equivalence to a predicate device (CCRI, Inc., Pavati® Z40.2 (K160867)) primarily through non-clinical testing of physical, chemical, and material properties, and comparison of manufacturing processes and indications for use.
Crucially, no information about a study proving the device meets acceptance criteria for an AI or software algorithm is present in this document. The document pertains to a dental material (zirconia blanks) and its physical and chemical properties, not a software device requiring performance metrics like accuracy, sensitivity, or specificity.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for a test set or training set. This document does not describe such a study for this medical device.
The only "performance" discussed relates to the material's physical and chemical properties as measured against established dental material standards (ISO 6872:2015 and ISO 13356:2015).
Here's a breakdown of what is available in the document regarding the device's characteristics, which are the basis for its clearance, but not an AI/ML study:
The available document details the non-clinical testing performed to demonstrate substantial equivalence of the GenesisZr® UHT700 Zirconia blanks to the predicate device, Pavati® Z40.2 (K160867). This is a material science characterization, not a performance study of a diagnostic or therapeutic device with AI/ML components.
Here's the relevant information about the acceptance criteria and the "study" (non-clinical testing) that proves the device meets these criteria in the context of a dental material:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by international standards for dental ceramic materials (ISO 6872:2015 and ISO 13356:2015) and comparison to the predicate device's properties. The "performance" reported is the measured physical and chemical properties of the GenesisZr® UHT700 Zirconia.
| Property | Acceptance Criteria (from ISO standards / Predicate) | Reported GenesisZr® UHT700 Zirconia Performance |
|---|---|---|
| Sintered Density (g/cm³) | ≥ 6.0 (ISO 13356:2015, Sec. 4.1 Req't.) | 6.04 |
| Thermal Expansion Coefficient (20-500°C) | Comparable to predicate (10.3 µm/m °C) | 10.2 µm/m °C |
| Bending Strength (MPa) | > 600 MPa (and comparable to predicate) | 600 MPa |
| Chemical Solubility (µg/cm²) | 2.0 (and comparable to predicate) | 2.4 |
| ZrO2 + HfO2 + Y2O3+ Al2O3 (%) | > 99.9 | > 99.9 |
| Y2O3 (%) | 9.85% ±0.65 | 9.85% ±0.65 |
| Al2O3 (%) | ≤ 0.1 | ≤ 0.01 |
| SiO2 (%) | ≤ 0.02 | ≤ 0.02 |
| Fe2O3 (%) | ≤ 0.01 | ≤ 0.01 |
| HfO2 (%) | ≤ 5.0 | Not explicitly listed, but implied by total ZrO2+HfO2+Y2O3+Al2O3 > 99.9 |
| Freedom from extraneous materials (Uranium238 Bq g-1) |
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(123 days)
GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for:
- Full contour monolithic crowns and bridges in anterior and posterior regions.
- Anatomically reduced for veneering, crown and bridge frames.
- Bridge to be limited to 3 units with a maximum of 1 pontic.
GenesisZr™ 4Y Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in one color, white, and various sizes that are used in customized 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 customized rendered blank is milled the device is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
The provided document is a 510(k) Premarket Notification for a dental device, GenesisZr™ 4Y Zirconia. This document primarily focuses on establishing substantial equivalence to a predicate device based on material properties, indications for use, and standardized bench testing.
It explicitly states that "Clinical tests have not been performed." Therefore, the document does not contain information related to acceptance criteria for clinical performance, human reader studies (MRMC), or ground truth establishment based on expert consensus, pathology, or outcomes data as would be typically found for AI/imaging devices.
The "acceptance criteria" and "device performance" in this context refer to the results of non-clinical, bench testing against established ISO standards for dental materials.
Here's the information that can be extracted from the provided text, framed within your request:
1. A table of acceptance criteria and the reported device performance
| Test Parameter / Acceptance Criteria (Standard) | Reported Device Performance (GenesisZr™ 4Y Zirconia) | Predicate Device Performance (Prismatik™ CZ), if available |
|---|---|---|
| Material Composition % wt. | ||
| Zirconia Powder: ZrO2+HfO2+Y2O3: >99 | >99 | >99 |
| Y2O3: (Predicate: 5.2) | 6.9 | 5.2 |
| Al2O3: ≤ 0.05 | ≤ 0.05 | ≤ 0.05 |
| SiO2: ≤0.002 | ≤0.002 | N/A (Other oxides: 900MPa) |
| Chemical solubility per ISO 6872:2008 (Limit 100 µg/cm²) | 6.0 µg/cm² | N/A |
| Biocompatibility per ISO 10993-1: Part 1 | Biocompatibility risk management analysis conducted. | N/A |
| Blank sizes (mm) | Disc: 95-110mm x 10-30mm | Disc sizes: 98.5 x 10-30mm |
2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of test pieces, batches) used for each non-clinical test. The tests were performed on the GenesisZr™ 4Y Zirconia material itself. The data provenance is from internal testing performed by United Dental Resources Corporation. The document does not specify country of origin for the data or whether it's retrospective or prospective, as these terms are not applicable to the non-clinical material testing described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is based on compliance of material properties with established international standards (ISO standards) and not on expert clinical interpretation of data.
4. Adjudication method for the test set
Not applicable. There was no human interpretation or adjudication involved, as it was non-clinical material testing against pre-defined physical and chemical property limits.
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 device is a dental material, not an AI-assisted diagnostic or imaging device. Clinical tests as such were explicitly not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm. Performance was evaluated based on the physical and chemical properties of the material itself.
7. The type of ground truth used
The "ground truth" for this submission is compliance with the requirements specified in international standards such as ISO 6872:2008 ("Dentistry - Ceramic materials") and ISO 13356: 2008 ("Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). It also includes a biocompatibility risk management analysis per ISO 10993-1.
8. The sample size for the training set
Not applicable. This is a material, not a machine learning model. There is no concept of a "training set" for the type of testing described.
9. How the ground truth for the training set was established
Not applicable for the reason stated above.
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