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510(k) Data Aggregation
(115 days)
The Obsidian™ Press ceramic is used to fabricate Press Over Metal dental prostheses in the nature of crowns and bridges as well as monolithic dental prostheses in the nature of crowns, veneers, inlays, and onlays for posterior and anterior applications, as well as 3-unit anterior bridges (including pre-molar region as terminal abutment) using pressing methods.
Obsidian™ Press is a lithium silicate ceramic to be supplied in the form of ingots to be pressed to temperature in various furnaces. The increased Obsidian™ Press CTE value is intended to allow the Obsidian™ Press ceramic to be used in Press Over Metal applications, using various approved dental alloys, in addition to the all ceramic applications. The ingots are designed to be pressed into a variety of restorations including Press Over Metal (POM) such as full contour crowns and bridges, as well as monolithic all-ceramic restorations such as full contour crowns, up to 3-unit anterior bridges (including pre-molar region as terminal abutment), inlays, onlays, partial crowns, and veneers with esthetics, translucency, and strength. The ingots will be available in the commonly used VITA Classical and Chromascop Bleach shades.
Here's an analysis of the provided text to extract information regarding acceptance criteria and the supporting study, formatted as requested:
Device Name: Obsidian™ Press (All-Ceramic and POM)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate Devices & Proposed Device) | Reported Device Performance (Obsidian™ Press) |
|---|---|
| Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, C3, D2, D3, BL1 and BL4 (for Obsidian™ Ceramic Blocks and IPS 99 One/Ceram) Or High and low translucencies: 16 A-D and 4 Bleach BL shades (for IPS e.max Press) | A1, A2, A3, A35, B1, B2, B3, C1, C2, D2, D3, BL1 and BL4 |
| Flexural Strength: >300 MPa (meeting ISO 6872 requirements) | >300 MPa (meeting ISO 6872 requirements) |
| Chemical Solubility: < 100µg/cm² (meeting ISO 6872 requirements) | < 100µg/cm² (meeting ISO 6872 requirements) |
| Freedom from Extraneous Material: Shall be free from extraneous materials when assessed by visual inspection (meeting ISO 6872 requirements) | Shall be free from extraneous materials when assessed by visual inspection (meeting ISO 6872 requirements) |
| Radioactivity: Activity concentration of uranium238 less than 1.0Bq g-1 (meeting ISO 6872 requirements) | Activity concentration of uranium238 less than 1.0Bq g-1 (meeting ISO 6872 requirements) |
| Coefficient of Thermal Expansion (25-500°C): 12.2+/-0.5 x10-6 °C (meeting ISO 6872 requirements) | 12.2+/-0.5 x 10-6 °C (meeting ISO 6872 requirements) |
| Biocompatibility: Non-toxic and biocompatible (Meeting the ISO 10993-5 and 10993-10 Requirements) | Non-toxic and biocompatible (Meeting the ISO 10993-5 and 10993-10 Requirements) |
| Cytotoxicity Study: Pass (using the IX MEM extraction method at 37°C) | Pass (no reaction on any of the cells) |
| ISO Intracutaneous Study: Pass (Extract 0.9% sodium chloride USP solution and sesame oil, NF) | Pass (no reaction on the tested subject) |
| Irritation and Skin Sensitization Study: Pass (Extract 0.9% sodium chloride USP and sesame oil, NF) | Pass (no erythema or edema on the test subject) |
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 mentions "various non-clinical and applicable tests were performed" and then lists specific performance and biocompatibility tests. However, it does not specify the sample sizes used for these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The information implies these were lab-based tests conducted to meet ISO standards.
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 report focuses on non-clinical, material science, and biocompatibility testing. Therefore, it does not involve experts establishing ground truth in the context of diagnostic performance (e.g., radiologists). The "ground truth" for these tests would be defined by the standardized testing methodologies themselves (e.g., ISO 6872 requirements for flexural strength, ISO 10993 for biocompatibility) and the results obtained from those methodologies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for studies where human interpretation or consensus is required to establish ground truth, often in diagnostic imaging or clinical trials. This submission involves laboratory-based material testing and biocompatibility studies, where the results are quantitative or based on defined pass/fail criteria according to international 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
Not applicable. This device is a dental material (lithium silicate ceramic), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This product is a physical dental material, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance criteria listed (Flexural Strength, Chemical Solubility, Freedom from Extraneous Material, Radioactivity, Coefficient of Thermal Expansion) is established by conformance to established international standards (ISO 6872).
For biocompatibility (Cytotoxicity, Sensitization, Irritation), the ground truth is established by conformance to ISO 10993 standards and the observed biological responses (e.g., no reaction on cells, no erythema/edema).
8. The sample size for the training set
Not applicable. This submission is for a physical device (dental ceramic), not a machine learning model that requires a training set. The "testing" involves physical and biological assessment of the material itself.
9. How the ground truth for the training set was established
Not applicable. As the device is not an AI/ML product, there is no training set or associated ground truth for such a purpose.
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