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The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions.

SurgiQuest AirSeal™ Optical Trocar & Cannula System

This document is a 510(k) premarket notification from the FDA, primarily concerned with establishing substantial equivalence for the SurgiQuest AirSeal™ Optical Trocar & Cannula System to legally marketed predicate devices. It does not contain the detailed information required to answer your specific questions regarding acceptance criteria and study data.

My analysis of the provided text confirms that the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, nor data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect sizes.
6. Results from a standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any study.
8. The sample size for a training set.
9. Information on how ground truth for a training set was established.

This document is a regulatory approval letter based on substantial equivalence, not a detailed technical report of device performance studies. Therefore, it lacks the specific study design and results information you are looking for.

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