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510(k) Data Aggregation
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Luminesse Shaded Zirconia SZ
Luminesse Shaded Zirconia SZ blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic patient specific dental restorations - full contour crowns and bridges for anterior and posterior location - as prescribed by a dentist.
Luminesse Shaded Zirconia SZ are used for full contour zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Shaded Zirconia SZ will undergo sintering. The shaded zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Shaded Zirconia SZ will exhibit maximum strength for posterior and anterior dental restorations.
The provided text is a 510(k) Pre-market Notification for a dental device, Luminesse Shaded Zirconia SZ. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new AI/CADeX device. Therefore, much of the requested information regarding AI/CADeX studies is not available in the document.
However, I can extract the acceptance criteria and performance data for the physical properties of the dental material as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Tests | Acceptance Criteria (ISO 6872 Requirements for dental ceramic) | Luminesse Shaded Zirconia SZ (Reported Device Performance) | Predicate Device (BruzXir™ Shaded) | Similarities and Differences |
|---|---|---|---|---|
| Flexural Strength | > 800 MPa | Average: > 1,000 MPa | Average: 1000 - 1200 MPa Max: 1465 MPa | Both devices meet minimum ISO 6872 requirement by over 30%. Similarities in flexural strength indicate both devices perform the same. |
| Coefficient of Thermal Expansion (CTE) | Not explicitly stated in table, but relative comparison to predicate | Average ≈ 10.3 x 10-6/K | Average ≈ 11 x 10-6/K | Negligible difference, indicating similar behavior during CAD/CAM machining. |
| Vickers Hardness | Not explicitly stated in table, but relative comparison to predicate | Average ≈ 52 (H.V.) | Average ≈ 49 (H.V.) | Small difference of 3 (H.V.) reported between average values. This small difference does not impact performance. |
| Density (sintered) | Not explicitly stated in table, but relative comparison to predicate | >6.05 g/cm³ | 5.90 g/cm³ | Within experimental error, dimensions are similar. Minor difference in density does not impact performance compared to predicate. |
| Chemical Composition | Not explicitly stated in table, but relative comparison to predicate | ZRO2+HfO2+Y2O3+Al2O3 >90% | ZRO2+HfO2+Y2O3+Al2O3 >90% | Identical chemical composition for major chemical makeup. |
| Biocompatibility Assessment | Based on ISO 10993-1, predicate device results were accepted | Expected to meet requirement | PASS (Cytotoxicity, Sensitization, Irritation) | The proposed device is made of the same material as the predicate, with similar manufacturing and body contact. Given the predicate's successful biocompatibility tests, the proposed device's biocompatibility performance is considered similar. |
Regarding the study proving the device meets acceptance criteria:
The study conducted was a non-clinical performance testing and a comparison against a predicate device to establish substantial equivalence.
2. Sample size used for the test set and data provenance:
- Sample size: Not explicitly stated for each specific test (e.g., number of samples for flexural strength). The document mentions "performance testing (flexural strength, shading consistency and coefficient of thermal expansion – CTE) in accordance with ISO 6872:2008."
- Data provenance: Not explicitly stated (e.g., country of origin). The study was conducted by Talladium, Inc. in Valencia, CA, which implies the testing was likely done in the US, but this is not explicitly stated for the raw data. It is a retrospective comparison to the predicate device's data and ISO standards.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- This type of information is not applicable to this document as it concerns physical material properties and biocompatibility, not diagnostic image interpretation or clinical judgment requiring expert consensus on ground truth. The "ground truth" here is defined by international standards (ISO 6872:2008 for dental ceramic).
4. Adjudication method for the test set:
- Not applicable. See point 3. This is not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI/CADeX device or a device requiring human efficacy studies of this nature.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/CADeX device. The performance tests were done on the physical material itself.
7. The type of ground truth used:
- The "ground truth" for the physical properties (flexural strength, CTE, etc.) is established by international standards (ISO 6872:2008) for dental ceramic materials.
- For biocompatibility, the ground truth is established by ISO 10993-1: Biological evaluation of medical devices, with reference to the predicate device's successful biocompatibility testing.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/CADeX device that learns from data.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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