(75 days)
Grandio SO is intended for use as:
- class I to V fillings
- reconstruction of traumatically affected anteriors
- facetting of discolored anteriors
- correction of shape and shade for improved aesthetic appearance
- locking, splinting of loose anteriors
- repairing veneers
- restoration of deciduous teeth
- core-build-up under crowns
- composite inlays
Grandio SO is a condensable, methacrylate based dental filling composite for all cavity Classes with excellent physical properties e.g. Wear resistance, compressive strength, color stability and durability in the mouth. Grandio SO has optimal opacity and can be easily polished. It is therefore highly qualified for long lasting, esthetic restorations.
The provided document is a 510(k) summary for a dental filling composite named "Grandio SO." It establishes substantial equivalence to a predicate device based on shared intended uses and improved physical features. However, this document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes, expert involvement, or ground truth establishment.
The 510(k) summary focuses on the device description, its intended uses, and technological characteristics in comparison to a predicate device. It states that the device has "improved physical features" and that "performance data and results... support the safety and effectiveness of Grandio SO for the intended use" but does not elaborate on what that performance data entails, what specific acceptance criteria were used, or how those criteria were met through a study.
Therefore, I cannot provide the requested table and study details based on the given text.
Here's what I can extract and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: The document vaguely mentions "improved physical features" and that "performance data and results... support the safety and effectiveness." No specific performance metrics or values are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned. The manufacturer is VOCO GmbH, located in Cuxhaven, Germany, but this doesn't specify the origin of any test data.
- Retrospective/Prospective: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not mentioned.
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 device is a dental filling material, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not mentioned. Given it's a dental material, "ground truth" would likely refer to engineering and biocompatibility testing standards rather than medical image interpretation.
8. The sample size for the training set:
- Not applicable. This is a material, not a machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This is a material, not a machine learning algorithm.
In summary, the provided 510(k) document is a regulatory submission for a dental composite material. It does not include the detailed study information typically found for diagnostic or AI-driven medical devices that require extensive clinical performance evaluation against specific acceptance criteria. The claim of "improved physical features" and supporting "performance data" is made without presenting the specific data or the methodology of how it was generated or evaluated against acceptance criteria.
§ 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.