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510(k) Data Aggregation
(90 days)
PMMA Blocks for Dental Use
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
The PMMA Blocks for Dental Use is a homogeneous high polymer material made from PMMA (polymethylmethacrylate) added with cross-linking agents to improve the network structure through a unique polymerization molding technology. The device is for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six months while awaiting a permanent restorations are designed and manufactured by a dental professional (such as a dentist) using CAD technology.
The proposed device contains two models with different shape: Cylinder and Cuboid. There are 39 specifications for Cylinder model (variation in different diameters and heights), and 44 specifications for Cuboid model (variation in different lengths, widths, and heights).
There are 20 various shades of the proposed device: 1 is transparent (without color added), the other 19 shades are colored (with different coloring matters added). The 19 shades created based on 19 Vita Shades contain A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 and OM1,OM2,OM3.
The PMMA Blocks for Dental Use would be produced on the 39 specifications of Cylinder model or 44 specifications of Cuboid model, with a shade chosen from the 20 various shades.
The PMMA Blocks for Dental Use is provided as non-sterile.
This document describes acceptance criteria and provides results from non-clinical testing of "PMMA Blocks for Dental Use". The document does not contain information about a study that proves the device meets the acceptance criteria, nor does it contain information about clinical studies with human readers or AI.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance values against those criteria. Instead, it refers to compliance with international standards for performance and biocompatibility.
Performance Test Standards:
| Test Category | Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical/Mechanical | ISO 10477: 2018 (Dentistry-Polymer-based crown and bridge materials) | Compliance with all requirements of ISO 10477: 2018 | "The test results shown the subject device is fully complied with the requirements of the above standard." |
| "Tested according to ISO 10477" | |||
| Color Stability | ISO 7491: 2000 (Dental materials-Determination of color stability) | Compliance with all requirements of ISO 7491: 2000 | Test conducted, results implied to meet standard. |
| Shelf Life Validation | ASTM F 1980 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) | Maintenance of performance and safety characteristics after accelerated aging for 5 years | "The shelf life validation test of the proposed devices was conducted after accelerated aging for 5 years (ASTM F 1980)" |
| Biocompatibility | ISO 10993-5: 2009 (Cytotoxicity) | Non-cytotoxic | Test performed, implied to meet standard. |
| ISO 10993-10: 2010 (Irritation and Skin Sensitization) | Non-irritating, non-sensitizing | Test performed, implied to meet standard. | |
| ISO 10993-11: 2017 (Systemic Toxicity) | No systemic toxic effects | Test performed, implied to meet standard. | |
| ISO 10993-6: 2016 (Local Effects after Implantation) | No adverse local effects | Test performed, implied to meet standard. | |
| ISO 10993-3 (Genotoxicity, Carcinogenicity and Reproductive Toxicity) | Non-genotoxic, non-carcinogenic, no reproductive toxicity | Test performed, implied to meet standard. | |
| ISO 10993-1:2018, FDA Guidance (General Biocompatibility) | Compliance with general biocompatibility requirements | "Comply with ISO 10993-1:2018, FDA Guidance, tests included cytotoxicity, oral mucosa irritation, skin sensitization, Subchronic systemic toxicity, genotoxicity, Acute Systemic Toxicity and Pyrogens." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing of a dental material. Information regarding "sample size used for the test set" typically refers to the number of individual test specimens or batches tested for each specific test mentioned (e.g., number of specimens for flexural strength, number of samples for cytotoxicity assay). However, this specific detail (the exact number of specimens per test) is not provided in the document.
Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this non-clinical, in-vitro/materials testing. The tests are laboratory-based and performed on the device material itself, not on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical material testing, not human-reviewed data where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes non-clinical material testing, not a study involving human interpretation or adjudication.
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
An MRMC comparative effectiveness study was not done. The document focuses on the non-clinical performance and biocompatibility of a dental material, not on the effectiveness of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done. The device is a material, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as the document pertains to non-clinical material testing, where "ground truth" is typically defined by scientific measurement against established standards (e.g., specific chemical composition, physical properties, or biological reactions measured in a lab setting), rather than clinical interpretation or outcomes.
8. The sample size for the training set
This information is not applicable. The document describes the testing of a physical medical device (PMMA Blocks), not an AI algorithm that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable. As in point 8, there is no training set mentioned or implied in this document.
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