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510(k) Data Aggregation
(90 days)
Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
Dental Glass Ceramics is composed of SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides. The block is intended to be processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method. The block is a single-use device and provided non-sterile.
The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
The provided document is a 510(k) Premarket Notification from the FDA for a dental material (Dental Glass Ceramics), not an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and study details for an AI-powered device.
Specifically, the document focuses on demonstrating substantial equivalence of the Dental Glass Ceramics to a predicate device based on material properties, intended use, and biocompatibility, as per ISO 6872 and ISO 10993 standards. It includes:
- A comparison table (Table 1) showing the proposed device and predicate device are "Same" across numerous characteristics like product code, classification regulation, indications for use, materials, crystallization state, device design, shades, single use, principle of operation, sterility, type/class per ISO 6872, mechanical properties (flexural strength, chemical solubility, radioactivity, linear thermal expansion, glass transition temperature) and biocompatibility.
- Biocompatibility testing results (Table 2) demonstrating that the material passed cytotoxicity, oral mucosa irritation, skin sensitization, subacute systemic toxicity, acute systemic toxicity, in vitro mammalian cell gene mutation, bacterial reverse mutation, and muscle implant tests. These tests are standard for evaluating the safety of implantable or device-contacting materials.
- A statement that no clinical study was included in the submission.
Therefore, it is impossible to extract the requested information about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details from this document. The nature of the device (dental material) and its regulatory pathway (510(k) for substantial equivalence to a material predicate) do not necessitate or include such information.
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(59 days)
Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Zirconia Dental Ceramics is composed of yttria-stabilized zirconia. It contains ZrQz+HfO2+Y2O3 and additional Al2O3 and other oxides. It offers various shapes and dimensions suitable for different milling systems. The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The proposed device is a single-use device, and provided non-sterile.
This document describes the premarket notification (510(k)) for "Zirconia Dental Ceramics." The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove clinical performance or a specific diagnostic accuracy. Therefore, the questions related to AI/ML device performance (e.g., acceptance criteria for accuracy, MRMC studies, ground truth establishment for training/test sets, expert adjudication) are largely not applicable to this type of medical device submission (dental ceramics).
The acceptance criteria and "study" described in this document are focused on non-clinical performance testing to demonstrate that the physical, chemical, and biological properties of the Zirconia Dental Ceramics conform to established standards for dental ceramic materials.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:
Acceptance Criteria and Device Performance for Zirconia Dental Ceramics
The acceptance criteria for this device are based on demonstrating compliance with the international standard ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 7405:2018 "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry" for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (ISO 6872:2015, etc.) | Reported Device Performance (Zirconia Dental Ceramics) | Judgment |
|---|---|---|---|
| Uniformity | Uniform (Expected for ceramic materials) | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials (Expected) | Free from extraneous materials | Pass |
| Radioactivity | ≤ 1.0 Bq.g⁻¹ | <0.017 Bq.g⁻¹ | Pass |
| Flexural strength | ≥ 800 MPa | 1076.4 MPa | Pass |
| Linear thermal expansion coefficient | (10.5 ± 0.5) × 10⁻⁶ K⁻¹ (as per predicate/reference) | 10.7 × 10⁻⁶ K⁻¹ | Pass |
| Chemical solubility | < 100 µg/cm² | 54.2 µg/cm² | Pass |
| Shrinkage factor | 1.253 ± 0.002 (as per reference device value) | 1.254 | Pass |
| Fracture Toughness | ≥ 5.0 MPa·m¹/² | 16.32 MPa·m¹/² | Pass |
| Biocompatibility Testing | Acceptance Criteria (ISO 7405:2018, ISO 10993 series) | Reported Test Results | |
| Cytotoxicity (ISO 10993-5:2009, 6.2/6.3 of ISO 7405:2018) | No cytotoxicity | No cytotoxicity under the conditions of the study | Pass |
| Skin Sensitization (ISO 10993-10:2010) | No skin sensitization | No skin sensitization under the conditions of the study | Pass |
| Oral Mucosa Irritation (ISO 10993-10:2010) | No oral mucosa irritation | No oral mucosa irritation under the conditions of the study | Pass |
| Acute Systemic Toxicity (ISO 10993-11:2017) | No acute systemic toxicity | No acute systemic toxicity under the conditions of the study | Pass |
| Subchronic Systemic Toxicity (ISO 10993-11:2017) | No subchronic systemic toxicity | No subchronic systemic toxicity under the conditions of the study | Pass |
| Genotoxicity (ISO 10993-3:2014) | No genotoxicity | No genotoxicity under the conditions of the study | Pass |
| Implantation (ISO 10993-6:2016) | No local effects | No local effects under the conditions of the study | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of test pieces for flexural strength, number of animals for biocompatibility tests). It relies on the methods outlined in the referenced ISO standards.
- Data Provenance: The tests were conducted to demonstrate conformity with international standards (ISO). The location of the testing laboratories or the origin of the data (e.g., country) is not explicitly stated, but the applicant and consultant are based in Shenzhen, China. The data is retrospective in the sense that it was collected prior to this submission for regulatory review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is a material science and biocompatibility study, not an AI/ML diagnostic study. The "ground truth" is defined by the physical/chemical/biological properties and the standards they are measured against, not by human expert interpretation of images or clinical outcomes in the context of diagnostic algorithms. The "experts" are the scientists and technicians performing the standardized tests.
4. Adjudication Method for the Test Set
- Not Applicable. There is no human interpretation or subjective assessment that requires adjudication in these physical, chemical, and biological tests. The results are quantitative measurements or qualitative observations (e.g., presence/absence of cytotoxicity) based on standardized protocols.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device. Performance is measured against material specifications.
7. The Type of Ground Truth Used
- The "ground truth" for this device is defined by:
- International Standards: Primarily ISO 6872:2015 for physical/chemical properties and ISO 7405:2018 (and related ISO 10993 series) for biocompatibility.
- Material Science Principles: The inherent properties of the zirconia material.
- Laboratory Measurements: Quantitative and qualitative results from standardized test methods.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
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(59 days)
Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products are categorized into class 4 according to ISO 6872.
The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
Dental Zirconia Pre-shaded Block is composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Mn2O3). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Pre-shaded Block has two color representations (i.e. monolayer and multilayer), corresponding to the categories of Color and Multilayer. The Multilayer also divided into two subcategories (Multilayer-SHT and Multilayer-3D) according to the consistency of the translucency across the zirconium block. And it offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.
This document is a 510(k) summary for a medical device called "Dental Zirconia Pre-shaded Block". The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process does not involve the type of acceptance criteria and study design typically associated with AI/ML-driven diagnostic devices that assess patient conditions or make clinical recommendations.
Because this document is about a material used in dentistry (zirconia blocks for crowns and bridges), the "acceptance criteria" and "study" are related to material properties and biocompatibility as per relevant international standards (ISO), rather than diagnostic performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.
Therefore, many of the requested elements for describing AI/ML device acceptance criteria and studies (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
However, I can extract information related to the performance testing of the material, which serves as its "acceptance criteria" in the context of material science.
Acceptance Criteria and Device Performance for "Dental Zirconia Pre-shaded Block"
The acceptance criteria for this dental material are based on the international standard ISO 6872:2015 Dentistry - Ceramic materials. The study proving the device meets these criteria involved non-clinical performance testing and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
The requirements are defined by ISO 6872:2015. The device's performance is reported for two categories: "Multilayer-3D" and "Color, Multilayer-SHT".
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (Multilayer-3D) | Reported Device Performance (Color, Multilayer-SHT) | Judgment |
|---|---|---|---|---|
| Physical Properties | ||||
| Uniformity | Uniform (as per standard) | Uniform | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials | Free from extraneous materials | Pass |
| Radioactivity | ≤ 1.0 Bq·g⁻¹ | 0.019 Bq·g⁻¹ | 0.019 Bq·g⁻¹ | Pass |
| Flexural strength | Multilayer-3D: ≥ 500 MPa | 1172.2 MPa | 1110.9 MPa | Pass |
| Color, Multilayer-SHT: ≥ 800 MPa | (N/A for Multilayer-3D) | (N/A for Color, Multilayer-SHT) | ||
| Linear thermal expansion coefficient | (10.5 ± 0.5) × 10⁻⁶ K⁻¹ (as per standard) | 10.8 × 10⁻⁶ K⁻¹ | 10.9 × 10⁻⁶ K⁻¹ | Pass |
| Chemical solubility | < 100 µg/cm² | 53.4 µg/cm² | 52.6 µg/cm² | Pass |
| Shrinkage factor | Not explicitly defined numerically in comparison, but inherent to material processing | 1.255 | 1.259 | Pass |
| Fracture Toughness | Multilayer-3D: ≥ 3.5 MPa·m¹/² | 18.24 MPa·m¹/² | 17.88 MPa·m¹/² | Pass |
| Color, Multilayer-SHT: ≥ 5.0 MPa·m¹/² | (N/A For Multilayer-3D) | (N/A for Color, Multilayer-SHT) | ||
| Biocompatibility | ||||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | No cytotoxicity | Pass |
| Skin Sensitization | No skin sensitization | No skin sensitization | No skin sensitization | Pass |
| Oral Mucosa Irritation | No oral mucosa irritation | No oral mucosa irritation | No oral mucosa irritation | Pass |
| Acute Systemic Toxicity | No acute systemic toxicity | No acute systemic toxicity | No acute systemic toxicity | Pass |
| Subchronic Systemic Toxicity | No subchronic systemic toxicity | No subchronic systemic toxicity | No subchronic systemic toxicity | Pass |
| Genotoxicity | No genotoxicity | No genotoxicity | No genotoxicity | Pass |
| Implantation | No local effects | No local effects | No local effects | Pass |
(Note: "N/A" indicates that the specific performance metric threshold applies to a different product category/class within the device, or the value is directly given without a specific numeric range from the predicate comparison, but judged against the ISO standard.)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of material samples, or human subjects for biocompatibility) used for each individual test. The tests were performed "according to ISO 6872:2015" and "ISO 7405:2018", which would imply the use of sample sizes consistent with these material science standards.
- Data Provenance: The tests are non-clinical (laboratory-based material testing) and performed by the manufacturer, Shenzhen Yurucheng Dental Materials Co., Ltd. The country of origin of the data is implicitly China, where the manufacturer is located. The nature of the data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For material testing, "ground truth" is established by the physical and chemical properties measured according to standardized methods (e.g., universal testing machines for flexural strength, chemical analysis for composition, standardized biological assays for biocompatibility). It does not involve human expert consensus or clinical interpretation typical of imaging or diagnostic AI. The "experts" are likely the qualified laboratory personnel conducting the tests.
4. Adjudication Method for the Test Set
- Not Applicable. Material property measurements do not typically involve adjudication in the clinical sense. Results are quantitative values obtained via standardized test methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done
- No. This type of study (MRMC) is relevant for AI/ML diagnostic interpretation where human readers' performance with and without AI assistance is evaluated. This is a material science device, so MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental material; there is no "algorithm" to evaluate in a standalone manner. The performance refers to the intrinsic properties of the material itself.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on standardized laboratory measurements of physical, chemical, and biological properties as defined by the ISO 6872:2015 (Dental Ceramic Materials) and ISO 7405:2018 (Biological Evaluation of Medical Devices Used in Dentistry) series of standards. This includes mechanical properties (flexural strength, fracture toughness), chemical properties (solubility, composition), physical properties (radioactivity, uniformity, thermal expansion, shrinkage factor), and biocompatibility endpoints (cytotoxicity, sensitization, systemic toxicity).
8. The Sample Size for the Training Set
- Not Applicable. This is a manufactured material, not an AI/ML model that undergoes "training" on a dataset. The consistent manufacturing process and material formulation are what ensure its properties.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no "training set," there is no ground truth established in this context. The manufacturing process of the zirconia block is controlled to meet the desired material specifications.
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