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510(k) Data Aggregation
(124 days)
1Derful™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges) in the anterior applications and not used solely as an implant. 1Derful™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use.
1Derful™ Zirconia are disc 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 dentures, crowns or bridges. 1Derful™ Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttria- stabilized tetragonal zirconia (Y-TZP). Shading oxide will also be used to create the need shade in the disc. These three oxide materials are Fe2O3, ErO3, Co3O4 & Er2O3.
The provided text describes the non-clinical testing performed for the 1DERFUL™ HS & 1DERFUL™ HT Zirconia blanks. It does not mention any clinical studies, multi-reader multi-case studies, or human-in-the-loop performance. Therefore, information regarding those aspects cannot be extracted.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Property | Acceptance Criteria (Standard Requirement) | Reported Device Performance (1DERFUL™ HS & 1DERFUL™ HT) | Outcome |
|---|---|---|---|
| Flexural Strength Test per ISO 6872:2015 Section 7.3 | Minimum (mean) 800 MPa for class 6 fixed prostheses, lowest value | > 1000 MPa | Pass |
| Freedom from extraneous materials per ISO 6872:2015 Section 5.2 active conc. of not more than 1.0 Bq g-1 of Uranium238 | < 1.0 Bq g-1 of Uranium238 | < 0.03 | Pass |
| Chemical solubility per ISO 6872:2015 Section 7.6 | Maximum 100 µg/cm² | 5.257 µg/cm² (from table on page 5) AND 18.1 µg/cm² (from table on page 8) | Pass |
| Fracture Toughness per ISO 6872:2015 Section Annex A | 5.0 MPa m^0.5 (min.) for Class 5 | 5.0 MPa m^0.5 | Pass |
| Sintered density (in-house calculated d=m/v) | ≥ 6.09 g/cm³ (from page 6) | 6.08 g/cm³ (from table on page 5) AND 6.08 g/cm³ (from table on page 6) | Pass |
| Grain Size determined per ISO 13356:2008 | (Not explicitly stated in "Acceptance Criteria" column, but the standard mandates the determination) | 0.41 µm | Pass |
| Amount of monoclinic phase (X-ray diffraction, ASTM F1873-98) | (Not explicitly stated in "Acceptance Criteria" column, but the standard mandates the determination, and the predicate has Tetragonal 98.5%, Monoclinic 1.5% max) | ZrO2– Zirconium Oxide Tetragonal P42/mmc 98.5%ZrO2– Baddeleyite Monoclinic P21/a 1.5% (max) | Pass |
| Linear Thermal Expansion Coefficient per ISO 6872:2015 | (Not explicitly stated as a minimum/maximum, but the standard requires the test) | 10.1 µm/m°C | Pass |
| Fe2O3 content | (Not explicitly stated in "Acceptance Criteria" column, but is tested as a component with a limit of ≤0.01%) | ≤0.01 | Pass |
Note: There are two different "Chemical solubility" values reported for the 1DERFUL™ device. One is 5.257 µg/cm² in the comparison table on page 5, and another is 18.1 µg/cm² in the detailed testing results table on page 8. Both are below the 100 µg/cm² limit.
Also, the Sintered Density acceptance criteria on page 6 states "≥ 6.09 g cm3", while the reported performance is 6.08 g/cm³ on both page 5 and 6, and it's marked as "Pass". This might indicate a slight discrepancy or that the "≥" means "at least" and 6.08 is considered acceptable based on the standard.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for individual tests. The text only says "1Derful, Inc performed a series of tests".
- Data Provenance: Not explicitly stated. The tests were performed by "1Derful, Inc" and are non-clinical, likely internal laboratory testing rather than data from a country of origin or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was non-clinical laboratory testing, not a study involving experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set
Not applicable. See point 3.
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. The document explicitly states: "Clinical tests have not been performed." Therefore, no MRMC study (which typically involves human readers assessing cases) was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical material (zirconia blanks) for dental prostheses, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical testing was established by adherence to recognized international standards and guidance documents, such as ISO 6872:2015 and ISO 13356:2008. The performance metrics (e.g., flexural strength, chemical solubility, fracture toughness) were measured and compared against the limits specified in these standards.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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