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510(k) Data Aggregation
(30 days)
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I am sorry, but the provided text is a set of FDA letters and does not contain the information required to answer your request. The document is a 510(k) clearance letter for a dental resin material, and it primarily focuses on regulatory approval rather than a detailed study description with acceptance criteria and performance metrics.
Therefore, I cannot extract the information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from this document.
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(30 days)
- filling minimally invasive cavities of all classes
- filling small class I cavities and extended fissure sealing
- filling class II-V cavities including V-shaped defects and cervical caries -
- blocking out undercuts -
- lining or coating cavities
- repairing fillings and veneers .
- luting translucent prosthetic pieces (e.g. full ceramic crowns, etc.) -
Not Found
The provided document is an FDA 510(k) clearance letter for a dental material (N-Hybrid-Composite LC Flow). It does not contain information about acceptance criteria, study details, or performance data in the context of an AI/ML device. Therefore, I cannot extract the requested information.
The document primarily focuses on:
- Confirming that the device is substantially equivalent to a predicate device.
- Listing the indications for use of the dental composite material.
- Emphasizing compliance with FDA regulations for medical devices.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission document that details the performance testing of an AI/ML device.
Ask a specific question about this device
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