(153 days)
Meridian is a direct filling material for restoration of Class I to V cavities and for restoration of deciduous teeth.
Meridian is a light curing universal dental composite material of the latest nanohybrid type having an optimized chemical composition.
The provided text describes a 510(k) submission for a dental composite material named Meridian. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance against specific acceptance criteria using clinical studies with complex statistical methodologies often seen for other types of medical devices.
Therefore, many of the requested sections are not applicable to this type of device and submission. Based on the provided information, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are defined by the performance standards outlined in ISO 4049:2009 for polymer-based dental restorative materials, and the "reported device performance" demonstrates that Meridian meets these standards and is substantially equivalent to the predicate device (Tetric EvoCeram, K042819).
| Acceptance Criteria (ISO 4049:2009 Performance Parameters) | Reported Device Performance (Meridian) | Study Proving Acceptance |
|---|---|---|
| Water Absorption | Meets ISO 4049:2009 standards | Testing Summary states: "The device was tested in accordance with ISO 4049:2009 for Polymer based dental restorative materials for Water Absorption, Water solubility, Radiopacity, Flexural Strength, Depth of Cure. Modulus of Elasticity, and Compressive Strength and the results from testing demonstrates that Meridian is substantially equivalent to the predicate device." |
| Water Solubility | Meets ISO 4049:2009 standards | |
| Radiopacity | Meets ISO 4049:2009 standards | |
| Flexural Strength | Meets ISO 4049:2009 standards | |
| Depth of Cure | Meets ISO 4049:2009 standards | |
| Modulus of Elasticity | Meets ISO 4049:2009 standards | |
| Compressive Strength | Meets ISO 4049:2009 standards | |
| Biocompatibility | Meets ISO 10993 standards | Testing Summary states: "Biocompatibility testing and evaluation was also carried out according to ISO 10993." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the in vitro tests conducted according to ISO 4049:2009 and ISO 10993. These are laboratory-based material tests, not clinical studies involving patient data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is based on standardized laboratory testing protocols (ISO 4049:2009, ISO 10993), not on expert consensus or clinical interpretation.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results, typically involving human readers. This device underwent in vitro material testing.
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
Not applicable. This is a dental composite material, not an AI-powered diagnostic device. No MRMC studies were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material, not an algorithm.
7. The type of ground truth used
The ground truth used for this device is the physical and chemical properties of the material as measured by standardized, objective laboratory tests defined by international standards (ISO 4049:2009 for performance, ISO 10993 for biocompatibility). The comparison is against the predicate device, showing "substantial equivalence" based on these measurements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device involved meeting established material standards.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 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.