Search Results

Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, using the hot press technique or CAD/CAM system.

Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Dental Glass Ceramics Blocks". This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a study involving a diagnostic algorithm or AI.

The information requested in your prompt (acceptance criteria for device performance, ground truth establishment, sample sizes for AI training/testing, MRMC studies, etc.) is typically found in submissions for devices that employ diagnostic algorithms, machine learning, or AI, particularly those where the device's output is an interpretative result that a human uses for diagnosis or patient management.

The "Dental Glass Ceramics Blocks" are a material used for dental restorations. The "study" referenced in the document is primarily non-clinical bench testing to ensure the physical and chemical properties of the material meet established standards (like ISO 6872:2015) and biocompatibility.

Therefore, I cannot provide all the requested information as it is not present in this document. I will fill in what can be extracted and explain why other parts are not applicable.

Device Name: Dental Glass Ceramics Blocks (HT, LT, MT)
Regulation Number: 21 CFR 872.6660
Regulation Name: Porcelain Powder For Clinical Use
Regulatory Class: Class II
Product Code: EIH

Acceptance Criteria and Device Performance (Material)

Explanation for Not Applicable (N/A) or Not Provided fields:

1. Sample size used for the test set and the data provenance:

   • N/A. This device is a material, not a diagnostic algorithm. The "test set" for performance evaluation refers to samples of the material used in bench tests (e.g., test pieces for flexural strength, chemical samples for biocompatibility). The document does not specify the number of material samples tested, but it states "Bench testing was performed per ISO 6872:2015 and internal procedures."
   • Data provenance (country of origin, retrospective/prospective) is relevant for patient data used in AI/diagnostic device studies, not for material testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. Ground truth, in the context of diagnostic algorithms, refers to a definitive disease status or interpretation established by medical experts or pathology. For material performance, the "ground truth" is defined by the technical specifications in standards like ISO 6872:2015 and biocompatibility guidelines, and measured by laboratory instruments and protocols. There are no "experts" establishing "ground truth" in the diagnostic sense for this type of device.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. Adjudication methods are used in diagnostic studies to resolve discordant interpretations among readers/experts. This is not applicable to
     material testing where measurements are objective and performed according to standardized protocols.

4. 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:

   • N/A. This device is a dental material, not an AI or imaging device with human-in-the-loop interaction for diagnosis. Therefore, MRMC studies are not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • N/A. This is a material, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Technical Specifications/Standards and Bench Testing Results. For this device, the "ground truth" for its performance is defined by the established technical requirements and test methods outlined in ISO 6872:2015 (for physical/chemical properties) and ISO 10993 series (for biocompatibility). The device performance is then measured against these standards through laboratory bench tests.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not a machine learning or AI device.

8. How the ground truth for the training set was established:

   • N/A. Not an AI/ML device.

Ask a specific question about this device

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Vsmilehappyzir Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

Vsmilehappyzir Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry -- Ceramic materials.

The provided document is a 510(k) summary for Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, intended use, and non-clinical performance testing. It does not describe a study involving a device that provides AI/algorithm-based diagnostic or clinical assistance, nor does it involve human readers or image analysis.

Therefore, many of the requested categories are not applicable to the information contained in this document.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states that "Bench testing was performed per ISO 6872:2015 and internal procedures... All tests were verified to meet acceptance criteria." It then lists several tests and their 'Pass' results, indicating acceptance. However, it does not explicitly state the numerical acceptance criteria for each test.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing" and "Biocompatibility testing." For biocompatibility, it indicates specific animal models where applicable (e.g., Syrian hamsters for oral mucosa irritation, guinea pig for dermal sensitization, rats for subacute/subchronic toxicity, ICR mice for acute systemic toxicity/genotoxicity, rabbits for muscle implant). However, it does not specify the number of samples or animals used for each test. The results are reported as "Pass," implying sufficient sample sizes were used to meet the standard's requirements.

Data provenance: The testing was performed according to international ISO standards (e.g., ISO 6872:2015, ISO 10993 series). The submitter is a Chinese company (Hunan Vsmile Biotechnology Co., Ltd.). This is non-clinical lab testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving expert assessment of images or clinical cases to establish ground truth. The "ground truth" for these tests is defined by the objective measurement of physical and biological properties against established ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no adjudication method described as this is not a study involving human interpretation or consensus.

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 document describes material science testing for dental zirconia blanks, not an AI-assisted diagnostic or clinical effectiveness study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This document describes material science testing for dental zirconia blanks, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device performance is the adherence to specifications derived from international standards (ISO 6872:2015 for ceramic materials, ISO 10993 series for biocompatibility). These are objective, measurable physical and biological properties.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this type of device.

Ask a specific question about this device