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510(k) Data Aggregation
(74 days)
Classic and Speed Sintering: Fully anatomic crowns and bridges in the posterior and anterior tooth region. Bridges with max. two pontics.
Super Speed Sintering: Fully anatomic crowns.
The inCoris TZI are blocks of various sizes from which custom made dental restorations are grinded using Sirona CAD/CAM system. inCoris TZI ceramics constitute blocks comprised of zirconia ceramics (Zr)2). The blocks are initially manufactured in a partially sintered state; then, they are individually processed to specification, and finally, densely sintered. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. Grinded restorations are colored by dipping the restoration in color liquid prior final sintering.
The provided document describes the Sirona Dental Systems inCoris TZI device, which is a block of zirconia ceramics used for dental restorations. The document is a 510(k) summary for premarket notification to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested items related to clinical study design, acceptance criteria, and performance metrics are not explicitly available in the provided text.
Here is an attempt to address your request based only on the provided information, noting where information is not present:
Acceptance Criteria and Device Performance for Sirona Dental Systems inCoris TZI
1. A table of acceptance criteria and the reported device performance
Based on the provided document, the acceptance criteria are primarily related to meeting material standards and demonstrating physical and chemical properties similar to a predicate device. The performance is reported in terms of these material properties.
| Acceptance Criteria (based on ISO standards and predicate device characteristics) | Reported Device Performance (inCoris TZI) |
|---|---|
| Material Composition Standards: - Complies with ISO 6872: 2008, "Dentistry -- Ceramic materials" - Complies with ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)" - Biocompatibility according to ISO 10993-1: 2009 | - The document states: "Both devices [inCoris TZI and predicate] meet ISO 6872: 2008... and ISO 13356: 2008..." - "The material is biocompatible according to ISO 10993-1: 2009..." |
| Physical Properties (Final technical data of densely sintered inCoris TZI): - Density - Fracture toughness KIC - Thermal expansion coefficient (20 - 500 °C) - Bending strength | - Density: 6.08 g cm-3 - Fracture toughness KIC: 6.4 MPa m1/2 - Thermal expansion coefficient: 10.4 x 10-6 K-1 - Bending strength: > 900 MPa |
| Chemical Properties: - ZrO2+HfO2+Y2O3 content - Y2O3 content - Al2O3 content - Fe2O3 content - Other oxides content | - ZrO2+HfO2+Y2O3: ≥ 99.9% - Y2O3: 5.4% - Al2O3: ≤ 0.35% - Fe2O3: ≤0.01% - Other oxides: ≤ 0.2% |
| Mechanical properties (appropriate for indications for use) | - Sintering tests performed show appropriate mechanical properties. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical tests have not been performed." (Section 10).
The testing mentioned (sintering tests, physical/chemical property measurements) are laboratory-based material characterization tests. The document does not specify a "test set" in the context of clinical or human subject data, nor does it provide details on the sample size for these material tests or their provenance.
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)
This is not applicable as no clinical tests were performed, and therefore no human observers or experts were used to establish ground truth for a test set. The "ground truth" for the material properties was established by standard laboratory measurement methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical tests or human subject evaluations requiring adjudication were performed.
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 device is a dental material (zirconia blocks) and not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental material, not an algorithm or software. Its performance is intrinsic to its physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the material properties, the "ground truth" was established by standardized laboratory measurement techniques and adherence to ISO standards for dental ceramic materials (ISO 6872:2008 and ISO 13356:2008).
8. The sample size for the training set
Not applicable. This is a material product, not a machine learning algorithm, so there is no concept of a "training set" in the context of AI development.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
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