(204 days)
everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.
everX Posterior is a light-cured, fiber-reinforced, universal type composite resin packaged in a unitip and available in one universal shade.
Here's an analysis of the provided text regarding the acceptance criteria and study for the everX Posterior dental device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that bench testing was performed in accordance with ISO 4049:2009 Dentistry - Polymer based restorative materials, and that the "testing results indicate that the device conforms to the required specifications."
Based on the information provided, the key performance criteria for everX Posterior are:
| Acceptance Criteria (from ISO 4049:2009) | Reported Device Performance (as stated in the document) |
|---|---|
| Sensitivity to ambient light | Conforms to required specifications |
| Depth of cure | Conforms to required specifications |
| Flexural strength | Conforms to required specifications |
| Water sorption | Conforms to required specifications |
| Solubility | Conforms to required specifications |
| Color stability after irradiation and water sorption | Conforms to required specifications |
For biocompatibility, the criteria are defined by ISO 10993-1, with specific tests:
| Acceptance Criteria (from ISO 10993-1) | Reported Device Performance (as stated in the document) |
|---|---|
| Cytotoxicity (ISO 10993-5) | Testing performed |
| Sensitization (ISO 10993-10) | Testing performed |
| Irritation (ISO 10993-10) | Testing performed |
| The document states these tests were performed and implies successful completion to ensure biocompatibility for the intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the bench tests.
The data provenance is not explicitly stated in terms of country of origin, but it is from non-clinical laboratory bench testing. The study is retrospective in the sense that the results are being presented as completed tests rather than a prospective study setup.
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 studies described are non-clinical bench tests (physical and chemical properties, biocompatibility) of a material, not diagnostic or clinical interpretation studies requiring human expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Bench tests follow standardized procedures, and the results are typically measured objectively by instruments or established laboratory methods, not through 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
An MRMC comparative effectiveness study was not done. This device is a dental restorative material, not an AI-powered diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical dental material, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the physical and chemical properties (e.g., flexural strength, depth of cure, water sorption, solubility, color stability), the "ground truth" is established by the defined specifications and test methods outlined in ISO 4049:2009. The device's performance is measured against these objective standards.
For biocompatibility, the "ground truth" is established by the scientific consensus and methodologies defined in ISO 10993-1, ISO 10993-5, and ISO 10993-10 for evaluating biological responses to medical devices.
8. The Sample Size for the Training Set
This information is not applicable. The testing described is for a physical material's properties and biocompatibility, not for training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.