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The ESSeX Aspiration/Irrigation and Positioning Guide is intended for use by surgeons during endoscopic abdominal and thoracic surgical procedures to deliver and remove irrigation fluid to and from the operative site, localizing and removal of irrigation, feeding, drainage, and chest tubes.

The ESSeX Aspiration/Irrigation Instrument with Positioning Guide is a reusable stainless steel irrigation/aspiration instrument with a positioning guide. The instrument is designed to for use during endoscopic surgical procedures. ESSeX Aspiration/Irrigation Instrument with Positioning Guide is The manufactured from surgical grade stainless steel. The instrument has an overall operating length of 35.6cm and an outer diameter of 7.5 mm. The instrument functions as a standard suction/irrigator and provides for the localization and removal of a variety of irrigation, feeding, drainage, and chest tubes. The positioning quide component of the instrument is attached in such a manner that allows for the delivery or capture of irrigation or drainage tubes.

The provided document focuses on the 510(k) submission for the ESSeX Aspiration/Irrigation Instrument with Positioning Guide, demonstrating its substantial equivalence to a predicate device. It primarily discusses the device description, intended use, and substantial equivalence, but does not contain information about specific acceptance criteria or a study that proves the device meets such criteria.

The document states: "All necessary testing will be performed on the ESSeX Aspiration/Irrigation Instrument with Positioning Guide and packaging to ensure that the product is substantially equivalent to the predicate devices and to ensure the safety and effectiveness of the device." However, it does not elaborate on what these tests entailed, what the acceptance criteria were, or what the results of those tests were.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This 510(k) summary is focused on establishing substantial equivalence based on comparative characteristics to a predicate device rather than presenting detailed performance study results against specific criteria.

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