(328 days)
- fabrication of temporary crowns and bridges.
PMMA CAD/CAM discs are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians. They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in A1, A2, A3, B1, B2, B3, BL3 and clear shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).
Here's an analysis of the provided text regarding the PMMA CAD/CAM disc, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) premarket notification summary. This type of submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical trials. Therefore, the "acceptance criteria" discussed here are primarily related to material properties and safety tests, demonstrating equivalence to the predicate, rather than clinical performance metrics typically found in efficacy studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Property/Test) | Reported Device Performance (PMMA CAD/CAM disc) | Comparison to Predicate (ZENO PMMA disc) |
|---|---|---|
| Composition | Hot cured polymethyl methacrylate (PMMA) and pigments | Both composed of polymethyl methacrylate hot cured polymer |
| Indications for Use | Fabrication of temporary crowns and bridges | Similar indications for use |
| Physical Properties | Similar | Similar |
| Chemical Properties | Similar | Similar |
| E-modulus | Comparable | Comparable |
| Flexural Strength | Comparable | Comparable |
| Deflection | Comparable | Comparable |
| Polymerization Grade | High | High |
| Aesthetic Function | Same aesthetic function | Same aesthetic function |
| Biocompatibility: | ||
| - Cytotoxicity | Testing conducted | Not explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence. |
| - Sensitization | Testing conducted | Not explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence. |
| - Irritation | Testing conducted | Not explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" in the context of a clinical performance study. The equivalence is primarily based on material characterization and bench testing.
- Sample Size: Not applicable in the context of a clinical test set. The material testing would have involved specific sample sizes for each physical/chemical property test, but these details are not provided in this summary.
- Data Provenance: Not applicable for a clinical test set. The data would be derived from laboratory tests conducted on the PMMA CAD/CAM disc itself. No country of origin for clinical or retrospective/prospective data is mentioned as such studies were not performed for this submission.
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 submission is for substantial equivalence based on material properties and bench testing, not on clinical performance requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set requiring expert 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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a dental material (PMMA disc), not an AI-assisted diagnostic or therapeutic device. Therefore, no "human readers" or "AI assistance" are involved in its primary function for evaluating its effectiveness in the context of this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating substantial equivalence relied on:
- Material Science Benchmarks: Comparing the physical and chemical properties of the PMMA CAD/CAM disc to those of the predicate device.
- Biocompatibility Standards: Results from cytotoxicity, sensitization, and irritation testing, presumably against recognized standards or established safety profiles.
- Predicate Device Characteristics: The established and legally marketed characteristics of the ZENO PMMA disc served as the primary "ground truth" for comparison.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device (dental material), not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device type.
§ 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.