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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 | < 100 µg/cm² (ISO 6872:2015 Limit) | 8.229 µg/cm² | 66.11 µg/cm² |
| Freedom from extraneous materials (Uranium238) | < 1.0 Bq g-1 (ISO 6872:2015 Section 5.2) | < 0.03 | Not supplied |
| Biocompatibility | Compliance with ISO 10993-1: Part 1 | Assured through use of same material composition and manufacturing process as predicate device. | Compliance with ISO 10993-1: Part 1 |
Note: The "acceptance criteria" here are largely derived from the requirements of the cited ISO standards (ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 13356:2015 "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). The device's reported performance data are directly compared against these standards to demonstrate compliance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of specimens tested) for each physical and chemical property test. It states that "United Dental Resources Corporation performed a series of tests" and that "sintered tests coupled with mechanical bench testing confirmed that the device meets specifications."
- Data Provenance: The data is generated from nonclinical bench testing conducted by the manufacturer, United Dental Resources Corporation. The provenance is internal to the company for the purpose of this regulatory submission. The document does not mention the country of origin of the raw data beyond the company's address (University Park, Illinois 60484, USA). The testing is retrospective in the sense that it was completed prior to the 510(k) submission, but it's not retrospective clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This submission is for a material device, not an AI diagnostic tool or a device requiring subjective interpretation by human experts to establish ground truth for performance. The "ground truth" for this device lies in its measurable physical and chemical properties and compliance with engineering standards.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human readers or subjective interpretations, there is no need for an adjudication method. Performance is determined by objective laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant for diagnostic imaging devices or AI tools where human reader performance is a key metric. For a dental ceramic material, MRMC studies are not applicable. The document states: "Clinical tests have not been performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This term is only relevant for software/AI devices. The GenesisZr® 4Y+(ST1100) Zirconia is a physical material blank.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on objective measurements of physical and chemical properties against established international standards (ISO 6872:2015 and ISO 13356:2015). This is a form of engineering/material specification compliance. It is not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device, so there is no "training set." The device is a manufactured product with defined material properties.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
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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) | < 100 (ISO 6872:2015) | Meets ISO Standard (< 100) |
| Grain size | Not specified as an explicit acceptance criteria comparison, but reported. | 0.66 µm |
| Fracture toughness (MPa m0.5) | > 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) | < 1.0 (ISO 6872:2015 Section 5.2) | < 0.03 |
2. Sample size used for the test set and the data provenance:
This document describes non-clinical bench testing of material properties, not testing on human subjects or clinical data. Therefore, the concept of "test set sample size" in the context of an AI/ML study is not applicable. The sample sizes for the material property tests (e.g., number of specimens for bending strength) are not specified in this summary, but would be standard for material characterization.
- Data Provenance: The data comes from "sintered tests coupled with mechanical bench testing" performed by United Dental Resources Corporation. The location/country of origin of this testing is not specified, nor is whether it was retrospective or prospective in conventional clinical study terms, as it's lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for material properties is established by physical and chemical measurements using validated laboratory methods and instruments, not by expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
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 therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No algorithm is involved.
7. The type of ground truth used:
The ground truth used for this device's non-clinical testing is measured physical and chemical properties validated against established international standards (ISO 6872:2015, ISO 13356:2015).
8. The sample size for the training set:
Not applicable. There is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML algorithm requiring a training set.
In summary, the provided document details a 510(k) submission for a dental material based on substantial equivalence through non-clinical laboratory testing and comparison to an existing predicate device, not through clinical studies of an AI-powered device.
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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: < 0.3) |
| Fe2O3: ≤0.002 | ≤0.002 | N/A (Other oxides: < 0.3) |
| HfO2: (Predicate: < 2) | Not explicitly stated (part of ZrO2+HfO2+Y2O3) | < 2 |
| Freedom from extraneous materials per ISO 6872:2008 Section 5.2 (active conc. of not more than 1.0 Bq g⁻¹ of Uranium²³⁸) | <0.03 | N/A |
| Sintered Density g/cm³ per ISO 13356: 2008 Section 4.1 (Req't. of ≥ 6.0) | 6.09 g/cm³ | N/A |
| Coefficient of thermal expansion (CTE) | 10.2 µm/m °C | N/A |
| Fracture toughness Kıc | 3.5 MPa m⁰.⁵ | N/A |
| Flexural strength per ISO 6872: 2008 (Limit >900MPa) | 1100 MPa | 1100MPa |
| 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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