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For transection, resection, and/or creation of anatomoses. The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.

The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter devices deliver two double-staggered or two triple-staggered rows of staples while simultaneously dividing the tissue between the rows. A "no-knife" version may also be provided. The instrument's safety lock-out feature is designed to prevent a spent reload from being refired. Both the standard and the vascular/thin instruments have a staple line that is 20-60mm long and a cut line of 18-58mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. An articulation lever on the ETS-FLEX Endoscopic Articulating Linear Cutter enables bilateral movement of the instrument jaws. The instrument is reloadable with either a standard, blue reload for tissue that is compressible to 1.5mm in thickness, a thick, green reload for tissue that is compressible to 2.0mm in thickness, or a vascular/thin, white reload for tissue that is compressible to 1.0mm in thickness. Do not reload the instrument more than seven times for a maximum of eight firings per instrument.

This document does not contain information about an AI/ML device or its performance characteristics. The provided text is a 510(k) summary for a surgical stapling device, the ENDOPATH® ETS Endoscopic Linear Cutter.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (in the context of AI/ML).
• Sample size used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study or effect size.
• Standalone performance.
• Type of ground truth used (in the context of AI/ML).
• Sample size for the training set.
• How ground truth for the training set was established.

The "Performance data" section only states that "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance in transecting, resecting, and/or creation of anastomoses." This is a general statement about the physical device's function, not a detailed breakdown of specific performance metrics or acceptance criteria as would be found for an AI/ML device.

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