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510(k) Data Aggregation
(181 days)
ARENA Star, Galaxy Star
Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. All zirconia block are processed through dental laboratories or by dental professionals.
Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) used to produce dental restoration to support designing computer for dental use and to process cutting as a manufacture unit, on which CAD/CAM system is applied for processing and sintering. After application, this material cannot to be reused for fabrication.
The provided FDA 510(k) clearance letter pertains to a Non-Sterile Zirconia Block used for dental restorations. This document focuses on demonstrating the substantial equivalence of the new device (ARENA Star, Galaxy Star) to a predicate device (Non-Sterile Zirconia Block, K223253) based on its material properties and chemical composition, not on an AI or software-driven diagnostic or assistive system.
Therefore, the requested information about acceptance criteria, study design for AI performance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not apply to this submission. This is a material science and manufacturing equivalency clearance, not a performance study for AI.
However, I can extract the acceptance criteria related to the material properties and the type of non-clinical testing performed.
Updated Information based on the provided document:
Acceptance Criteria and Device Performance for ARENA Star, Galaxy Star (Non-Sterile Zirconia Block)
The acceptance criteria for this device are based on demonstrating mechanical and biological equivalence to a predicate device and adherence to international standards for dental ceramic materials.
- Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Standard (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Density (post sintering) | 6.00 g/cm³ | 6.00 g/cm³ |
| Flexural Strength | >800 MPa per ISO 6872:2015 Type II Class 5 | >800 MPa per ISO 6872:2015 Type II Class 5 |
| Sintering temperature | 1500 ± 50 ℃ | 1500 ± 50 ℃ |
| Biocompatibility | Meets ISO 10993 requirements | Meets ISO 10993 requirements |
| Chemical Composition | ZrO2 with others (Specific raw materials listed) | ZrO2 with others (Specific raw materials listed) |
| Non-Clinical Performance Tests | Conformance to specified tests including Visual, Dimensions, Packaging, Uniformity, Extraneous materials, Chemical Solubility, Linear Thermal Expansion (all per ISO 6872) | Conforms to all specified tests per ISO 6872 |
| Cytotoxicity | Conformance to ISO 10993-5:2009 | Conforms to ISO 10993-5:2009 |
| Intracutaneous Reactivity Test | Conformance to ISO 10993-10:2010 | Conforms to ISO 10993-10:2010 |
| Sensitization Test | Conformance to ISO 10993-10:2010 | Conforms to ISO 10993-10:2010 |
| Acute Systematic Toxicity | Conformance to ISO 10993-11:2017 | Conforms to ISO 10993-11:2017 |
The remaining information requested is typically relevant for AI/ML-based medical devices, which operate on analyzing data (e.g., images, signals) and often involve performance metrics like sensitivity, specificity, accuracy, and comparisons to human expert performance. This 510(k) submission is for a physical medical device (zirconia block), where the "study" demonstrating criteria fulfillment is primarily non-clinical bench testing and chemical analysis to confirm material properties and biocompatibility.
Therefore, for aspects like "Sample size for the test set," "Experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," "Training set sample size," and "Ground truth for the training set" – these points are not applicable to this specific device and the information provided in the 510(k) clearance letter. The "ground truth" here is established through standardized material testing methods and chemical analysis, not through expert interpretation of data.
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