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510(k) Data Aggregation
(319 days)
To fabricate veneers, inlays, onlays, crowns in the anterior region, 3-unit bridges in the anterior region, 3 unit bridges in the premolar region up to the second premolar as the terminal abutment, implant superstructures for single tooth restorations (anterior and posterior region).
Initial LiSi Block is a block system consisting of a glass ceramic block cemented to a milling machine specific mandrel. This block is designed to be milled in a CAD/CAM milling machine that is programmed to fabricate indirect restorations such as veneers, inlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal abutment, and implant superstructures for single-tooth restorations.
Initial LiSi Block is intended to fabricate the tertiary element/exostructure of the implant superstructure, such as a crown. This structure sits on top of an abutment to achieve esthetic and generate compatible occlusal forces. The implant superstructure is classified as a fixed prosthesis.
After milling, the restoration can be customized by use of porcelain stain. The composition and manufacturing process of this product allows for milling without the need to fire (sintering) in a porcelain furnace.
All raw materials are melted at very high temperatures and the melting process prior to distribution eliminates all volatile substances. Final product is provided as complex oxide ceramics.
The device is available in a range of shades, including high, medium, and low translucency, as well as medium and high opacity:
- (High Translucency); HT-BLE, HT-E0P, HT-E57, HT-E58, HT-E59, HT-E60, HT-NTL, HT-AMB, HT HT-B00, HT-B0, HT-A0, HT-A1, HT-A2, HT-A3, HT-A3, HT-A4, HT-B1, HT-B2, HT-B3, HT-B4, HT-C1, HT-C2, HT-C3, HT-C4, HT-D2, HT-D3, HT-D3, HT-D4 (27)
- MT (Medium Translucency): MT-B00, MT-A0, MT-A0, MT-A2, MT-A3, MT-A3.5, MT-A4, MT-B1, MT-B2, MT-B4, MT-C1, MT-C2, MT-C2, MT-C3, MT-C4, MT-D2, MT-D3, MT-D4, MT-0, MT-A, MT-B, MT-C, MT-D (24)
- LT (Low Translucency): LT-B00, LT-A0, LT-A1, LT-A2, LT-A3, LT-A3.5, LT-A4, LT-B1, LT-B2, LT-B3, LT-C1, LT-C1, LT-C2, LT-C3, LT-C4, LT-D2, LT-D3, LT-D4, LT-0, LT-A, LT-B, LT-C, LT-D (24)
- MO (Medium Opacity): MO-0, MO-1, MO-2, MO-3, MO-4 (5)
- HO (High Opacity): HO-0, HO-1, HO-2, HO-3, HO-4 (5)
- Shelf Life: 10 years from the date of manufacture -
- Storage: Recommended for optimal performance, store at room temperature (4-25°C/39.2-77.0°F) away from direct sunlight and high humidity.
The provided document describes the "Initial LiSi Block," a CAD/CAM machineable glass ceramic block for dental restorations. The study described focuses on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating device performance in humans.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is reported against the requirements of ISO 6872:2008 - Dentistry - Ceramic Materials, and additional physical and chemical properties.
| Property | Acceptance Criteria (from ISO 6872:2008 or manufacturer's requirements) | Reported Device Performance (Implied by "complies with all the requirements" or "acceptable") |
|---|---|---|
| Uniformity | Uniformly dispersed throughout the dental ceramic material. | Complies |
| Freedom from extraneous materials | Free from extraneous materials. | Complies |
| Radioactivity | Not more than 1.0 Bq ⋅ g⁻¹ of uranium 238 (gamma spectroscopy technique) | Complies |
| Flexural strength (Biaxial flexure test) | Greater than 300 MPa | Complies (and "higher flexural strength" than reference predicate MSCB) |
| Chemical solubility | Less than 100µg ⋅ cm⁻² | Complies |
| Glass transition temperature | Not deviate by more than 20°C from the value stated by the manufacturer. | Complies |
| Thermal expansion coefficient | Not deviated by more than 0.5 X 10⁻⁶ K⁻¹ from the value stated by the manufacturer. | Complies |
| Shade | Equivalent to the standard product. | Complies |
| Fracture toughness | No specific requirement (calculated using Vickers-hardness). | Reported (value not specified, but calculation was performed). |
| Bulk density | No specific requirement (calculated). | Reported (value not specified, but calculation was performed). |
| Biocompatibility | Acceptable according to ISO 10993-1:2009. | Acceptable |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of human data or a model evaluation with a defined sample size. The testing described is primarily non-clinical, involving material property evaluation.
- Sample Size: Not applicable in the context of a "test set" for performance evaluation from patient data. The tests are performed on material samples, but specific sample numbers for each test (e.g., number of blocks for flexural strength) are not provided.
- Data Provenance: The data provenance is from laboratory testing of the device material. It is retrospective in the sense that the material is manufactured and then tested. There are no mentions of country of origin for the data other than the manufacturing company being GC America Inc. (Illinois, USA) and GC Corporation (presumably Japan, given the company names in the predicate table).
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 as the described study is a non-clinical evaluation of material properties, not a study involving expert assessment of diagnostic or clinical outcomes. Ground truth for material properties is established through adherence to international standards and validated laboratory test methods.
4. Adjudication method for the test set
This information is not applicable as there is no test set requiring adjudication by experts or human readers.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a dental material (ceramic block), not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a physical material for dental restorations.
7. The type of ground truth used
The ground truth used for this device's evaluation is primarily based on:
- International Standards: Specifically, ISO 6872:2008 (Dentistry - Ceramic Materials) for physical and chemical properties, and ISO 10993-1:2009 for biocompatibility. These standards define the acceptable range or threshold for material characteristics.
- Manufacturer Specifications: For properties like glass transition temperature and thermal expansion coefficient where the requirement is "Not deviate by more than [X] from the value stated by the manufacturer."
- Visual Inspection: For properties such as uniformity, freedom from extraneous materials, and shade.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" for this type of device submission.
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