Search Results

Cementation of: - metal-based inlays, onlays, crowns and bridges - high-strength (zirconia-based) all-ceramic crowns and bridges - metal, ceramic and fiber posts - high strength all ceramic inlays i - । resin inlays, onlays, crowns and bridges

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for "Meron Plus OM" does not contain any information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The document is a standard clearance letter for a dental cement, outlining its classification, predicate device, and intended uses. It primarily addresses regulatory aspects, not performance studies of an AI/ML system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance using the provided text.

To answer your question, I would need a document related to the clearance of an AI/ML-driven medical device, which would typically include details about:

• Performance metrics: Specific thresholds for accuracy, sensitivity, specificity, AUC, F1-score, etc.
• Study design: Prospective/retrospective, sample size, data source.
• Ground truth establishment: How the "truth" was determined for the test cases (e.g., expert consensus, pathology, clinical outcomes).
• Expert qualifications and adjudication: Details about the radiologists/clinicians involved.
• Human-in-the-loop studies (MRMC): If applicable, how AI assistance improved human performance.
• Stand-alone performance: Algorithm-only results.
• Training data details: Size and ground truth establishment for the training set.

Ask a specific question about this device

Meron Plus is intended for permanent cementation of porcelain-fused-to metal crowns, bridges on hard dental tissue and cores rebuilt with amalgam, composite or glass ionoms, cements. Meron Plus is further intended for the permanent cementation of metal inlays, onlays, crowns and bridges, posts, crowns manufactured from alumina-only or zirkonia-only cores and orthodontic appliances.

Meron Plus is a resin reinforced chemically curing glass ionomer cement for permanent cementation. It is delivered in bottles for mixing by the dentist as well as in capsules (so called application capsules "AC") for the better handling and ease of use. The device is characterized by high adhesion to tooth structure.

The provided text is a 510(k) summary for Meron Plus, a dental cement. It focuses on demonstrating substantial equivalence to a predicate device based on material composition and prior use of components, rather than providing a detailed study proving device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and expert involvement is not present in this document.

However, based on the information provided, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

This information is not available in the provided 510(k) document. The document primarily focuses on the substantial equivalence of components to legally marketed devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not available in the provided 510(k) document. The submission states: "The prior use of all of the components Meron Plus in legally marketed devices support our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary." This indicates that the 510(k) did not rely on
new performance testing of the final device but rather on the established performance of its components and predicate devices.

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):

This information is not available in the provided 510(k) document. Since new performance studies were deemed unnecessary, there would not have been a need for experts to establish ground truth for a test set of the final device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not available in the provided 510(k) document. See point 3.

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:

This information is not applicable and not available in the provided 510(k) document. Meron Plus is a dental cement, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable and not available in the provided 510(k) document. Meron Plus is a dental cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not available in the provided 510(k) document. The submission relies on the established safety and effectiveness of the components and predicate devices through their prior use in legally marketed products.

8. The sample size for the training set:

This information is not available in the provided 510(k) document. This type of information would be relevant for devices that undergo a training phase (e.g., AI algorithms), which is not the case for this dental cement based on the provided document.

9. How the ground truth for the training set was established:

This information is not available in the provided 510(k) document. See point 8.

Ask a specific question about this device