(141 days)
For restoration of permanent teeth best restored with a single unit full crown (e.g. as an alternative to a complex multi-surface direct restoration)
3M TM ESPE™ Adult Crown is a tooth colored single unit crown for use as a durable restoration for permanent teeth. This preformed composite crown, manufactured by 3M ESPE, is initially malleable and can be easily customized to the crown preparation by trimming and reshaping. The crown is then light-cured to obtain its high strength and subsequently cemented in place with permanent cement. The entire crown procedure is accomplished in one visit.
The provided document is limited in detail regarding the acceptance criteria and study proving the device meets them. It appears to be a 510(k) summary for the "3M™ ESPE™ Adult Crown" which focuses on demonstrating substantial equivalence to predicate devices through bench testing.
Here's a breakdown of the available information and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists the properties evaluated for the 3M™ ESPE™ Adult Crown in comparison to predicate devices, but it does not explicitly state specific acceptance criteria (thresholds or limits) for each property. Instead, it implies that the device's performance should be "substantially equivalent" to the predicate devices.
| Property Evaluated | Reported Device Performance (Relative to Predicate Devices) | Acceptance Criteria (Explicitly Stated) |
|---|---|---|
| Compressive Strength | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Flexural Strength | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Flexural Modulus | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Depth of Cure | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Surface Hardness (Barcol) | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Radiopacity | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Water Sorption | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Water Solubility | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Diametral Tensile Strength | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| Sensitivity to Ambient Light | Evaluated in comparison to predicate devices Paradigm™ MZ100 Block for CEREC® and Sinfony™ Indirect Lab Composite. | Not explicitly stated (implied substantial equivalence) |
| In Vitro Chewing Simulation | Compared to Paradigm™ MZ100 Block for CEREC®. | Not explicitly stated (implied substantial equivalence) |
The document states: "Based on bench testing conducted, the clinical performance of 3M ™ ESPETM Adult Crown is expected to be substantially equivalent to crowns produced using Paradigm™ MZ100 Block for CEREC® and Sinfony TM Indirect Lab Composite."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for the bench testing of each property.
- Data Provenance: The studies are described as "bench testing" and "In Vitro Chewing Simulation study." This implies laboratory-based testing, not human subject data. Therefore, questions of country of origin or retrospective/prospective do not directly apply in the human data sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable as the studies are described as "bench testing" and "In Vitro Chewing Simulation," which do not involve expert interpretation or ground truth establishment in the manner of medical image analysis or clinical trials. The "ground truth" here would be the physical measurements themselves.
4. Adjudication Method
- This is not applicable for bench testing. Adjudication methods are typically used when multiple human experts provide interpretations that need to be reconciled.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document describes bench testing and an in vitro simulation, not a study involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance
- No, this refers to a medical device, not an AI algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used
- For the bench tests, the "ground truth" would be the objective physical and chemical measurements obtained from the material samples themselves, based on standardized testing methodologies for dental materials.
- For the "In Vitro Chewing Simulation," the ground truth would be the results of the simulation based on established testing protocols designed to mimic chewing forces.
8. Sample Size for the Training Set
- This device is a physical product (a preformed composite crown), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The product's development would likely involve material science research and development, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set was Established
- As there is no "training set" for an AI algorithm, this question is not applicable. The "ground truth" in the product's development would refer to the characteristics and performance of the materials measured during its formulation and testing.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.