(16 days)
Fillings of class I-V Reconstruction of traumatically affected anteriors Facetting of discolored anteriors l acetting of disociered antine-Locking, splinting of loose anteriors Repair of veneers Filling of deciduous teeth Core build-up under crowns Composite inlays
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Here's an analysis of the provided text regarding the acceptance criteria and study information for the Grandio device:
This document is a 510(k) clearance letter from the FDA for a dental resin material. It does not contain specific acceptance criteria or study results in the format requested, as it's a regulatory clearance document, not a clinical study report.
The letter states that the device, Grandio, is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was on the market before May 28, 1976, or to a device that has been reclassified. The substantial equivalence determination is based on the information provided in the 510(k) submission by the manufacturer.
Therefore, the requested information elements cannot be fully extracted from this document. I will fill in what can be inferred or explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (for indications for use) | Determined to be "substantially equivalent" |
Explanation: The FDA clearance process for a 510(k) device like Grandio primarily relies on demonstrating substantial equivalence to a predicate device. This means the new device has the same intended use as the predicate and either has the same technological characteristics or has different technological characteristics but can be shown to be as safe and effective as the predicate and does not raise different questions of safety and effectiveness. The specific performance metrics (e.g., bond strength, wear resistance, color stability) that would have been submitted to demonstrate substantial equivalence are not detailed in this letter.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this document. Information on test set size would be in the manufacturer's 510(k) submission.
- Data Provenance: Not specified in this document. It would typically be from in-vitro studies, some in-vivo animal studies, or limited clinical data if required to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as this is a regulatory clearance letter, not a clinical study with expert ground truth establishment for a test set. The FDA typically relies on the manufacturer's scientific data and internal review by FDA experts.
- Qualifications of Experts: Not applicable in this context. The FDA's internal review team for dental devices (Division of Anesthesiology, General Hospital, Infection Control and Dental Devices), including professionals like Chiu S. Lin, PhD (Director), are the "experts" who reviewed the submission.
4. Adjudication method for the test set
- Adjudication method: Not applicable. This document does not describe a clinical study requiring an adjudication process for a test set. The FDA's review process is an internal regulatory determination based on the submitted evidence.
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
- MRMC Study: No. This device is a dental resin material, not an AI-powered diagnostic or assistive device. MRMC studies are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This device is a dental resin material, not an algorithm or AI system.
7. The type of ground truth used
- Type of Ground Truth: For a dental restorative material like Grandio, "ground truth" in the context of substantial equivalence generally refers to established performance benchmarks of the predicate device, recognized international standards (e.g., ISO for dental materials), and scientific principles related to material properties (e.g., mechanical properties, biocompatibility, esthetics). The manufacturer would submit data comparing Grandio's properties to these established benchmarks.
8. The sample size for the training set
- Sample Size: Not applicable. This is a material, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable. This is a material, not a machine learning algorithm with a "training set" and associated ground truth.
In summary, this document is an FDA clearance letter based on the concept of "substantial equivalence" to a predicate device. It does not provide the detailed study results, acceptance criteria for performance metrics, or specific methodologies of clinical trials or AI model development that would typically be found in a study report. Such information would have been part of VOCO GmbH's 510(k) submission to the FDA.
§ 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.