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510(k) Data Aggregation
(282 days)
Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.
The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance. They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3). The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth. The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials. The Dental Zirconia Blocks are provided as non-sterile.
The provided text describes the 510(k) summary for the "Dental Zirconia Blocks" device (K192262). This document focuses on demonstrating substantial equivalence to a predicate device, rather than performing a clinical study with acceptance criteria for a novel AI/software medical device.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details for an AI/software device cannot be extracted from this document.
This document describes a traditional medical device (dental zirconia blocks) and the testing performed is for physical and chemical properties, as well as biocompatibility, against established international standards.
For completeness, here's a summary of the testing performed and conclusions drawn from the provided text, adapted as much as possible to the prompt's structure, but it's important to reiterate that this is not an AI/software device study.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against various ISO standards. The document states that the proposed device "met all design specifications" and "complies with" these standards. The "acceptance criteria" are implied by the requirements of these standards.
| Acceptance Criteria (from referenced ISO standards) | Reported Device Performance (from text) |
|---|---|
| ISO 6872:2015/Amd1:2018 Dentistry - Ceramic Materials | Complies with ISO 6872 |
| Flexural strength > 800MPa | > 800MPa |
| Solubility < 100 µg/cm² | < 100 µg/cm² |
| Radioactive uranium-238 active concentration ≤ 1.0 Bq/g | ≤ 1.0 Bq/g |
| ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Complies with ISO 10993-1:2018, FDA Guidance, tests included genotoxicity etc. |
| ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | Complies with ISO 10993-1:2018, FDA Guidance, tests included cytotoxicity |
| ISO 10993-6 Biological evaluation of the medical devices - Part 6: Tests for Local Effects after Implantation | Complies with ISO 10993-1:2018, FDA Guidance, tests included implantation effect |
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Complies with ISO 10993-1:2018, FDA Guidance, tests included oral mucosa irritation, skin sensitization |
| ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity | Complies with ISO 10993-1:2018, FDA Guidance, tests included acute systemic toxicity, subacute toxicity, subchronic systemic toxicity, pyrogenicity |
| Density (pre sintering) | ≥ 3.0 g / cm³ |
| Density (post sintering) | ≥ 6.02 g / cm³ |
| Sintering Temperature | 1400-1600 °C |
| Appearance Test | Performed, results not detailed but implied compliance |
| Dimension Test | Performed, results not detailed but implied compliance |
| Product composition | Performed, results not detailed but implied compliance (conforms to ISO 13356:2015) |
| Linear thermal expansion-coefficient | Performed, results not detailed but implied compliance |
| Fracture toughness | Performed, results not detailed but implied compliance |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each non-clinical test. The tests are for material properties and biocompatibility, not for evaluating an algorithm on a dataset of patient cases. Thus, "data provenance" in the sense of country of origin of patient data or retrospective/prospective is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert labels on medical images) is not relevant for the non-clinical testing of zirconia blocks, which involves laboratory measurements and chemical/biological assays.
4. Adjudication method for the test set
Not applicable. This is not a study involving expert readers or diagnostic classifications.
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 is not an AI/software medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software medical device. The "standalone" performance here refers to the physical, chemical, and biological properties of the material itself.
7. The type of ground truth used
The "ground truth" for this device's evaluation is defined by the validated methods and specifications within the referenced ISO standards (e.g., methods for measuring flexural strength, solubility, density, and biocompatibility assays). Pathology or outcomes data are not mentioned.
8. The sample size for the training set
Not applicable. The concept of a "training set" is relevant for AI or machine learning models, which are not present in this submission.
9. How the ground truth for the training set was established
Not applicable. As above, there is no AI/ML training set.
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