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The Echelon families of endoscopic linear cutters (articulating and straight) are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The Echelon Endoscopic Linear Cutters (Articulating and Straight) Device Description are sterile, single patient use instruments that simultaneously cut and staple tissue. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact, regular and long. The shafts for both the articulating and straight instruments can rotate freely in either direction. In addition, the Echelon Articulating Endoscopic Linear Cutters incorporate an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are shipped without a cartridge and must be loaded prior to use. The instruments' lock-out feature is designed to prevent a used cartridge from being refired.

The provided text describes the Ethicon Endo-Surgery Echelon Endoscopic Linear Cutters (Articulating and Straight). However, it does not contain acceptance criteria or detailed results from a scientific study proving the device meets specific criteria. The document is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and outcome metrics.

Here's a breakdown of what the document does provide concerning performance, and what it lacks based on your request:

What is provided:

• Performance Data: "Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the devices will perform as intended."

What is NOT provided in the document concerning a study:

1. A table of acceptance criteria and the reported device performance: This is absent. The document only generically states "perform as intended" without defining specific quantitative or qualitative criteria for success.
2. Sample size used for the test set and the data provenance: Not mentioned for any specific test. The phrase "preclinical laboratory evaluation in an animal model" is too vague to extract this information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such expert-driven ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical instrument, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. The "preclinical laboratory evaluation in an animal model" implies physiological outcomes or observations, but details are missing.
8. The sample size for the training set: Not applicable, as this is not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document states that "Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the devices will perform as intended." However, it does not specify:

• Acceptance Criteria: No specific numerical or qualitative targets for performance are listed (e.g., staple line integrity, burst pressure, number of misfires, tissue damage thresholds).
• Reported Device Performance: No specific numerical or qualitative results from the tests are reported against any criteria.
• Details of the Study: Missing are details about the methodology, sample sizes, animal model specifics, or the exact endpoints measured in the "preclinical laboratory evaluation" or "bench testing."

Therefore, based solely on the provided 510(k) summary, it's not possible to complete the requested table or answer most of the questions about detailed study design and acceptance criteria. The regulatory filing focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and the broad statement that testing confirmed intended performance, rather than providing a detailed scientific publication of performance metrics against predefined acceptance criteria.

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