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510(k) Data Aggregation
(149 days)
-Occlusal bite registration
-Fixing of face bow registrations
- Location material for intraoral pin tracing templates
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the device "Registrado Scan" does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance.
The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This type of detailed performance data is typically found in the 510(k) submission itself, which is a much larger document not provided here. The clearance letter only confirms the regulatory decision based on that submission.
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