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PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

The proposed device. PANTHER Endo Linear Cutter Staplers with Single Use Loading Units (SULU) is sterile (ETO), single-patient-use surgical instruments, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two triple-staggered rows. The Endo Linear Cutter Stapler will accommodate any of the reloading unit with staple cartridge lengths of 30mm, 45mm, and 60mm and come in long or compact shaft lengths, and they may be reloaded and fired up to 25 times in a single procedure. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 3.5 mm, 4.0 mm or 4.8mm SULU.

The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.

The provided document is a 510(k) summary for a medical device called "PANTHER Endo Linear Cutter Staplers with Single Use Loading Units." This document's purpose is to demonstrate substantial equivalence to a predicate device, not to present a study proving a device meets specific acceptance criteria for performance as would typically be seen in the context of an AI/ML medical device.

Therefore, the information requested in the prompt, such as acceptance criteria tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document. This document focuses on non-clinical tests to establish substantial equivalence of a physical medical device.

Here's an explanation of what is present and why the requested information isn't:

• Acceptance Criteria and Reported Performance: The document doesn't outline specific, quantifiable acceptance criteria for a "performance study" in the way one might expect for diagnostic accuracy or algorithmic performance. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It then lists the types of non-clinical tests: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing. The success of these tests implies meeting design specifications for mechanical and material integrity rather than meeting a clinical performance metric.
• Sample Size and Data Provenance for Test Set: Not applicable. The "tests" mentioned are non-clinical, likely involving a number of units of the device for physical, sterility, and integrity evaluations, not patient data.
• Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth for non-clinical physical tests typically involves validated reference standards or established laboratory methods, not expert consensus on clinical data.
• Adjudication Method: Not applicable for non-clinical testing.
• MRMC Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to a physical stapler device.
• Standalone Performance: Not applicable. This refers to the performance of an algorithm without human intervention, which is not relevant to a physical stapler device.
• Type of Ground Truth Used: For the non-clinical tests, the ground truth would be based on established engineering and materials science standards, chemical analysis (for endotoxin), and physical integrity assessments, not clinical pathology or outcomes data.
• Sample Size for Training Set: Not applicable. This device is a physical stapler, not an AI/ML algorithm that requires a training set.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of available information related to "testing" as presented:

• Device Tested: PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
• Purpose of Testing: To verify the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device (Autosuture ™ ENDO GIA™ Staplers with ENDO GIA ™ Single Use Loading Units).
• Types of Non-Clinical Tests Conducted:
  • Physical Performance Testing
  • Endotoxin Testing
  • Package Integrity Testing
  • Shelf Life Testing
  • Biocompatibility (Cytotoxicity, Irritation, Sensitization) - Compliance with ISO 10993-5 and ISO 10993-10
• Conclusion: The tests led to the conclusion that the device is Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.

This document describes the regulatory pathway for a surgical stapler, which primarily involves demonstrating equivalence to a previously approved device through non-clinical performance and a comparison of design and materials. It does not contain the kind of detailed clinical study performance data or AI/ML specific criteria requested.

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