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510(k) Data Aggregation
(49 days)
The Obsidian™ Milling Blocks is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM methods.
The Obsidian™ Milling Blocks are a lithium silicate ceramic to be supplied with or without an attached mandrel to be milled using CAD/CAM methods. The product can produce a variety of monolithic restorations with great esthetics, lifelike translucency, and high strength including full-contour crowns, inlays, onlays, veneers partial crowns and substructures due to its excellent machining properties. The milling blocks will be available in the commonly used VITA Classical and Chromascop Bleach shades.
Here's a breakdown of the acceptance criteria and study information for the Obsidian™ Milling Blocks, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) | Substantial Equivalence |
|---|---|---|
| Indications for Use: Fabricate ceramic dental prostheses (crowns and bridges) for posterior and anterior applications using CAD/CAM or hot-press methods. | Indications for Use: Fabricate ceramic dental prostheses (crowns and bridges) for posterior and anterior applications using CAD/CAM methods. | Same (Proposed explicitly states CAD/CAM, but overall use is consistent) |
| Composition: Provided in Section 011 (though not detailed in the comparison table) | Composition: Provided in Section 011. Additional materials were added (details in section 011). | Difference (Additional materials were added, but deemed not to introduce new safety/effectiveness issues) |
| Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, C3, D2, D3, BL1, BL4 | Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, D2, D3, BL1, BL4 | Same |
| Flexural Strength: >300 MPa (meeting ISO 6872 requirements) | Flexural Strength: >300 MPa (meeting ISO 6872 requirements) | Same |
| Chemical Solubility: < 100µg/cm² (meeting ISO 6872 requirements) | Chemical Solubility: < 100µg/cm² (meeting ISO 6872 requirements) | Same |
| Freedom from Extraneous Material: Shall be free from extraneous materials when assessed by visual inspection (meeting ISO 6872 requirements) | Freedom from Extraneous Material: Shall be free from extraneous materials when assessed by visual inspection (meeting ISO 6872 requirements) | Same |
| Radioactivity: Activity concentration of uranium238 less than 1.0Bq g-1 (meeting ISO 6872 requirements) | Radioactivity: Activity concentration of uranium238 less than 1.0Bq g-1 (meeting ISO 6872 requirements) | Same |
| Coefficient of Thermal Expansion (25-500°C): 12.2+/-0.5 x10-6 °C (meeting ISO 6872 requirements) | Coefficient of Thermal Expansion (25-500°C): 12.2+/-0.5 x 10-6 °C (meeting ISO 6872 requirements) | Same |
| Packaging: Boxes of 5 blocks for Milling Blocks | Packaging: Boxes of 5 blocks for Milling Blocks | Same |
| Biocompatibility: Non-toxic and biocompatible (Meeting ISO 10993-5 and 10993-10 Requirements) - No reaction on cells (Cytotoxicity) - No reaction on tested subject (Sensitization) - No erythema or edema on test subject (Irritation) | Biocompatibility: Non-toxic and biocompatible (Meeting ISO 10993-5 and 10993-10 Requirements) - Cytotoxicity Study: Pass - ISO Intracutaneous Study: Pass - Irritation and Skin Sensitization Study: Pass | Same (Passes all tests) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of blocks for flexural strength, number of samples for chemical solubility, etc.). It generally refers to "test results" meeting ISO requirements.
For biocompatibility, it mentions "tested subject" for sensitization and irritation reports, implying animal testing, but the number of subjects and their origin are not provided.
The provenance of data is not explicitly stated. The tests were performed "in accordance with the Design Verification Plan," suggesting internal testing or testing by contract labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The tests performed are objective, quantitative measurements against established ISO standards and do not involve expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method for the test set
This information is not applicable and not provided. The tests are based on objective measurements and comparison to predefined acceptance criteria within ISO standards.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a dental material, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" used for device acceptance is based on:
- Established ISO Standards: Specifically ISO 6872 for flexural strength, chemical solubility, freedom from extraneous material, radioactivity, and coefficient of thermal expansion.
- Biocompatibility Standards: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation).
- Comparison to Predicate Device: The performance of the proposed device is compared directly to the cleared predicate device, Obsidian™ Ceramic Blocks (K100781), demonstrating "essentially the same" performance for the relevant physical and chemical properties and biocompatibility.
8. The sample size for the training set
This is not applicable. This document describes a medical device (milling blocks), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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