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has applications in open and endoscopic surgery. It is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremies, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting.

The Origin Ligator Device is a single-use endoscopic device with dual functions of ligation and transection of isolated vessels and other structures. It consists of a tube, handle assembly, and located at the distal end of the tube is the cutting blade, grasping jaws, and a clip delivery system. The cutting blade is activated independently from the grasping jaws and the clip delivery system. The Origin Ligator Device will allow both clipping and cutting operations to be performed multiple times without removing the device

The provided text is a 510(k) summary for the "ORIGIN Ligator Device," a Class I (later reclassified to Class II by the FDA letter) manual surgical instrument. This submission focuses on establishing substantial equivalence to a predicate device (ORIGIN AcuClip® Endoscopic Multiple Clip Applier, K920599) and does not contain information about the device's technical acceptance criteria or a dedicated study proving performance against those criteria.

The 510(k) summary describes the device's function and intended use, and the FDA letter confirms substantial equivalence without detailing specific performance data. Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given information.

Similarly, the other requested details (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study results, standalone performance, and training set information) are not included in this type of regulatory submission, which primarily focuses on justifying substantial equivalence based on existing predicate devices.

Summary of what cannot be provided from the given text:

• Table of acceptance criteria and reported device performance: This information is not present in the 510(k) summary or the FDA letter.
• Sample sizes (test, training): Not provided.
• Data provenance: Not provided.
• Number and qualifications of experts: Not provided.
• Adjudication method: Not provided.
• MRMC comparative effectiveness study results: Not mentioned.
• Standalone performance study results: Not mentioned.
• Type of ground truth used: Not discussed.
• How ground truth for training set was established: Not discussed.

Information that can be extracted (though not directly related to performance metrics):

• Device Name: Origin Ligator Device
• Regulatory Class: Initially Class I, then reclassified to Class II by the FDA.
• Intended Use: "It is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremities, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting."
• Predicate Device: ORIGIN AcuClip® Endoscopic Multiple Clip Applier, (K920599; 7/15/92).

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