(255 days)
PMMA Block is a device 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.
This product is a kind of homogeneous high polymer material made from quality polymethylmethacrylate added with cross-linking agents to improve the network structure through a unique polymerization molding technology. It is mainly used for the fabrication of multi-unit, fully or partially anatomical long-term temporary bridge restorations with up to two pontics by CAD/CAM systems. Both anterior and posterior crown & bridge are recommended.
This document describes the premarket notification (510(k)) for the PMMA Block, a device used for fabricating temporary crowns and bridges. The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving the device meets specific acceptance criteria based on human-in-the-loop performance or clinical outcomes.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by ISO standards and comparison to a predicate device.
| Acceptance Criterion (Set by Standards/Predicate) | Reported Device Performance (PMMA Block) |
|---|---|
| Intended Use (Same as predicate) | A device made from PMMA 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 restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology. |
| Material of Construction (Same as predicate) | PMMA |
| Shades (Comparable to predicate) | 20 Vita Shades |
| Processing Method (Same as predicate) | Variable Thickness Milling Blank and machined using any milling system |
| Flexural Strength (According to ISO 10477, implied) | ≥50 MPA (Predicate: 113 MPA) |
| Shelf-life (For information, not a direct acceptance criterion for equivalence) | Five Years |
| Performance Effectiveness (Tested according to ISO 10477) | Tested according to ISO 10477. "Its results show that the subject device fully meets the requirement..." (Specific numerical results beyond flexural strength not detailed in this summary). |
| Performance Safety (Tested according to ISO 10993 standards) | Tested according to ISO 10993 standards. |
| Biocompatibility (According to AAMI / ANSI / ISO 10993 standards) | Tested according to AAMI / ANSI / ISO 10993-3, 10993-5, 10993-10, and 10993-11. |
| Physical Property Testing (Includes flexural strength, surface polishing performance, bond strength, water sorption, solubility, shade consistency, color stability as per ISO 10477) | "The test results... show that the subject device fully meets the requirement..." (Specific values beyond flexural strength not provided in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of clinical studies with patient data. The testing was non-clinical, primarily physical property and biocompatibility tests. The sample size for these non-clinical tests is not provided in this summary.
- Data Provenance: The data is from non-clinical laboratory testing (physical, chemical, and biological) conducted by Rizhao Huge Dental Industry Co., Ltd. The country of origin for the data generation would be China, where the manufacturer is located. The nature of these tests is not "retrospective" or "prospective" in the typical clinical sense, but rather laboratory evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome. For this device, the "ground truth" for non-clinical testing is adherence to established international standards (ISO, AAMI/ANSI/ISO). Expert consensus for ground truth is not relevant for this type of submission.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1) are used in clinical studies to resolve discrepancies among expert readers. Since this submission relies on non-clinical testing against standards and comparison to a predicate, such methods are not relevant.
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
This information is not applicable. The PMMA Block is a material for dental restorations, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The PMMA Block is a physical product (material) and not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is adherence to international standards for dental materials (ISO 10477) and biocompatibility (ISO 10993 series), and demonstration of comparable characteristics to a legally marketed predicate device. There is no clinical "ground truth" data (like pathology or outcomes data) presented in this 510(k) summary.
8. The Sample Size for the Training Set
This information is not applicable. There is no AI component involved, and thus no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for an AI algorithm.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.