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510(k) Data Aggregation
(90 days)
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD
no a lami i [ fuinsi no in icadores ties during examinations or minimal invasive surgical procedures
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I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Dual LED Lite Engine with Illumination LED Cable Coupled to a LED Lite Head), which signifies that the device is substantially equivalent to a predicate device. This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, or ground truth establishment.
The letter focuses on regulatory clearance, not the technical and clinical performance data that would typically be found in a study report or a summary of safety and effectiveness.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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