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Found 2 results
510(k) Data Aggregation
(42 days)
Direct bonding of light-cured composite and compomer materials, dentin sealing, direct bonding of light-cured composite to ceramics, composite, metals and amalgam.
Not Found
This is a letter from the FDA to a medical device manufacturer, indicating that their device, "Adhesive 1," has been found substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance for marketing the device.
Therefore, I cannot extract the requested information regarding the acceptance criteria and the study that proves the device meets them from the provided text.
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(77 days)
ADHESIVE 14 is to be used as a bonding agent for light curing composites and compomers to dentine tooth structure.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Adhesive 14. It does not contain any information regarding acceptance criteria or a study demonstrating the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance requirements. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Information about MRMC studies, standalone algorithm performance, or ground truth types.
- Details about training set size or how its ground truth was established.
Therefore, I cannot fulfill the request using the provided text.
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