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For use in a variety of open procedures, such as abdominal, pediatric, thoracic, gynecologic, etc. and for use in endoscopic and laparoscopic the assol gynocelling hemostatic transection of vessels and other tissue structures.

Richard-Allan's Reflex AEC 35, with shorter shaft length is substantially equivalent to our currently marketed Reflex AEC 35. These instruments have the same component materials, method of manufacturing, and method of sterilization. These instruments have similar instructions for use.

The provided document is a 510(k) premarket notification for a medical device (Reflex AEC Linear Stapler/Cutter). It states that the device is "substantially equivalent" to an already marketed device and does not involve a study with acceptance criteria and a reported device performance as typically seen for AI/ML-based medical devices or novel technologies requiring extensive clinical trials.

The document does not contain any information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, or data provenance.
• Number of experts or their qualifications, or adjudication methods for ground truth.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Ground truth types for test or training sets.

This is because the submission is for a modification (shorter shaft length and expanded indications) of an existing device, and the primary focus is on establishing "substantial equivalence" to predicate devices, rather than proving performance against specific acceptance criteria through a formal study as would be done for a new device requiring performance validation.

The key points from the provided text related to safety and effectiveness are:

• Substantial Equivalence: The Reflex AEC 35 with a shorter shaft length is substantially equivalent to the currently marketed Reflex AEC 35. This determination is based on having the "same component materials, method of manufacturing, and method of sterilization" and "similar instructions for use."
• Safety and Effectiveness: The document explicitly states that the difference in shaft lengths "will not affect safety or effectiveness of our device, overall function or application intended for the use of this type of device."
• Intended Use: The modified device has the same intended use as the current Reflex AEC 35, Multifire GIA, and Endo GIA 30: "hemostatic transection of vessels and other tissue structures."
• Expanded Indications: The expanded indication for use (general open procedures like abdominal, thoracic, pediatric, gynecologic) is also stated "will not affect safety or effectiveness of our device, or overall function of this type of device."

Therefore, based on the provided text, a table of acceptance criteria and a study with detailed performance metrics, sample sizes, and ground truth information cannot be extracted because this type of information is not part of a 510(k) submission focused on substantial equivalence for a mechanical device modification.

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