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510(k) Data Aggregation
(60 days)
HT, HT-C, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML: used to make the crown, bridge, inlay, veneer of the all-porcelain restoration.
UT, UT-C, UT-ML and 3D-PRO: used to make the crown, maximum 3-unit bridge, inlay, veneer of the all-porcelain restoration.
Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.
The provided document is a 510(k) Premarket Notification from the FDA for a Zirconia Block used in dental restorations. This document does not describe an AI medical device or a study proving its performance against acceptance criteria.
Therefore, I cannot extract the information required to answer your questions about acceptance criteria and a study proving a device meets them. The document pertains to a dental material, not an AI or software-based medical device.
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(107 days)
Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, for jacket facing, veneers. All Blocks are processed through dental laboratories or by dental professionals.
Zirconia ceramic block is made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental appliance/prosthesis (e.g., removable dentures, for jacket facing, veneers) for patient use. It is used to removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
The provided document, K233125, is a 510(k) premarket notification for a medical device called "Zirconia Block." This device is a ceramic material intended for use in manufacturing dental prosthetics. The document primarily focuses on demonstrating the substantial equivalence of the Zirconia Block to a legally marketed predicate device (K192262, "Dental Zirconia Blocks") through non-clinical testing.
However, the provided text does not describe any study that proves an AI/ML-driven device meets acceptance criteria. The described tests are for a physical material (Zirconia Block) and assess its physical, chemical, and biological properties, not the performance of a software or AI/ML algorithm.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/ML device. The table provided is for a physical material.
- Sample size used for the test set and data provenance for an AI/ML device.
- Number of experts used to establish ground truth or their qualifications for an AI/ML device.
- Adjudication method for an AI/ML device.
- MRMC comparative effectiveness study or human reader improvement with AI assistance.
- Stand-alone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set for an AI/ML device.
- How the ground truth for the training set was established for an AI/ML device.
The provided document is about a material, not an AI/ML medical device.
If you are interested in the acceptance criteria and performance for the Zirconia Block material itself based on the provided document, here is the information:
Acceptance Criteria and Device Performance for Zirconia Block (a physical material):
1. Table of Acceptance Criteria and the Reported Device Performance:
| ID# | Test | Acceptance Criteria (Method) | Reported Device Performance (Conclusion) |
|---|---|---|---|
| 1.1 | Chemical Composition | Y2O3+Zr(Hf)O2 > 99.5% | 99.9% for all 10 samples |
| 1.2 | Flexural Strength | ≥ 800 Mpa (as per Table VI, but not explicitly stated as acceptance criteria in Table VII-1 for this row, instead it seems the number shown is the result of another chemical composition test row) | 912Mpa, 914Mpa, 910Mpa, 912Mpa, 915Mpa, 916Mpa, 906Mpa, 913Mpa, 913Mpa, 916Mpa (These values are presented as results for "Chemical Composition" in the table, which seems to be a mislabeling in the original document, these are typical flexural strength results) |
| 1.3 | Pre-sintering Density (first row) | ≥ 2.75 g/cm³ (Product technical requirements) | 3.1 g/cm³ for all 10 samples (e.g., 3.1 and 6.07g/cm³ indicates both pre- and post-sintering results for one sample) |
| 1.3 | Post-sintering Density (second row) | ≥ 6.00 g/cm³ (Product technical requirements) | 6.06 g/cm³ or 6.07 g/cm³ for all 10 samples |
| 1.4 | Sintering Shrinkage Rate | 19% - 22% | 20.46% - 20.55% for all 10 samples |
| 1.5 | Pre-sintering Solubility (first row) | ≤ 2000 µg/cm² | 0 µg/cm² for all 10 samples |
| 1.5 | Post-sintering Solubility (second row) | ≤ 100 µg/cm² | 0 µg/cm² for all 10 samples |
| 1.6 | Linear thermal expansion-coefficient | (10.5 ± 0.5) × 10⁻⁶ K⁻¹ | 10.3 to 10.6 × 10⁻⁶ K⁻¹ for all 10 samples |
| 1.7 & 1.8 | Scale out rate | The scaling factor falls within the range in between 1.210 and 1.260, and the deviation of the actual value from the nominal value should not be greater than 0.005. | 1.238 to 1.250 for all 10 samples (as listed) |
| 1.9 | Appearance (Surface) | Surface should be smooth and pore-free. | Yes (indicating compliance) for all 10 samples |
| 1.9 | Appearance (Color) | The color of zirconia porcelain block used for chip processing (initial sintering state) should be uniform, there should be no local pigment separation phenomenon, there should be no foreign body attached. | Yes (indicating compliance) for all 10 samples |
| 1.9 | Appearance (Size) | The size error should be less than ± 0.2mm. | +0.02mm to +0.03mm (indicating compliance) for all 10 samples |
| 1.10 | Packaging | The packing identification should be distinct, and the packing material should not have obvious changes. | No obvious changes (indicating compliance) for all 10 samples |
| 2.1 | Cytotoxicity | Non-Cytotoxicity (ISO 10993-5:2009) | Pass |
| 2.2 | Sensitization | Non-Sensitization (ISO 10993-10:2021) | Pass |
| 2.3 | Irritation or intracutaneous reactivity | Non-Irritation or intracutaneous reactivity (ISO 10993-23:2021) | Pass |
| 2.4 | Acute systemic toxicity | Non-Acute systemic toxicity (ISO 10993-11:2017) | Pass |
| 2.5 | Subacute toxicity | Non-Subacute toxicity (ISO 10993-11:2017) | Pass |
| 2.6 | Sub chronic toxicity | Non-Sub chronic toxicity (ISO 10993-11:2017) | Pass |
| 2.7 | Genotoxicity | Non-Genotoxicity (ISO 10993-3:2014) | Pass |
2. Sample Size for the Test Set and Data Provenance:
- For physical tests (1.1 to 1.10), 10 samples of the Zirconia Block were tested.
- The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is Hangzhou IVISTA Medical Devices Co., Ltd. from China. The tests are non-clinical (bench testing) and thus are not retrospective or prospective in the same way clinical data would be.
3. Number of Experts used to establish the ground truth for the test set and their qualifications:
- This is not applicable as the tests performed are bench tests on a physical material (Zirconia Block). Ground truth is established by complying with specified ISO standards and technical requirements for material properties, not by expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable as these are bench tests for material properties following established measurement methods in laboratory settings, not diagnostic interpretations 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:
- No, this study was for a physical dental material, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this study was for a physical dental material, not a standalone algorithm.
7. The type of ground truth used:
- For physical testing, the ground truth is based on objective measurements of the material's properties (e.g., chemical composition, density, flexural strength) as defined by recognized consensus standards (e.g., ISO 6872 mentioned in Table VI, although specific ISO standards are not fully detailed for each physical test in Table VII-1 beyond biocompatibility) and product technical requirements.
- For biocompatibility testing, ground truth is established by complying with the outcomes specified by relevant ISO 10993 series standards (e.g., Non-Cytotoxicity, Non-Sensitization).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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(87 days)
Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. All blocks are processed by dental laboratories or by dental professionals.
Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.
The provided text is an FDA 510(k) Premarket Notification for a dental product called "Zirconia Block." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device for regulatory clearance. It does not present acceptance criteria for an AI/ML-based device or a study proving that an AI/ML device meets such criteria.
The document describes a physical product (Zirconia Block) used for dental restorations and details its composition, intended use, and physical/chemical properties, comparing them to a predicate device. The "Clinical Performance Data" section explicitly states "Not applicable. Clinical performance testing has not been performed for the subject device." This further confirms that no study was conducted to demonstrate clinical performance, and by extension, no study to prove an AI/ML device meets acceptance criteria.
Therefore, I cannot provide the requested information because the provided text pertains to a traditional medical device (Zirconia Block) and not an AI/ML-based device.
To answer your request, I would need a document describing an AI/ML-based medical device.
Ask a specific question about this device
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