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The ETHICON™ 4000 and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, single-patient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.

ETHICON™ 4000 60mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.

The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.

Based on the provided FDA 510(k) clearance letter for the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads (K250835), here's an analysis of the acceptance criteria and the study proving the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which summarizes the FDA's decision based on the applicant's submission. It does not contain the full details of the studies conducted. Therefore, some information requested (e.g., specific acceptance criteria values, sample sizes for training sets, adjudication methods, details of expert qualifications, and MRMC study effect sizes) is not explicitly stated in this public document. The answers below are derived directly from the content provided and identify where information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The primary purpose of this 510(k) submission was to expand the indications for use of an already cleared device to include transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. The acceptance criteria would therefore revolve around demonstrating safe and effective performance of the stapling system in these specific organ tissues.

Based on the document, the general "acceptance criteria" can be inferred from the types of performance tests conducted and the conclusion statement that the "subject devices passed the functional requirements of the device features" and "have been demonstrated to be safe and effective for the expanded indications for use."

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria (e.g., minimum burst pressure, maximum staple height deviation) are not provided in this summary document, we can only infer the categories of performance that were evaluated and determined to be acceptable.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the document. The general descriptions refer to "nonclinical (bench) tests" and "pre-clinical (animal) testing," implying a test set was used, but no specific numbers of samples, instances, or animal subjects are provided.
• Data Provenance:
  • Country of Origin: Not specified. Standard practice for such studies would likely involve labs in the US or collaborating international facilities, but the document does not state this.
  • Retrospective or Prospective: These were prospective studies, as they were conducted specifically to gather data for this 510(k) submission to support the expanded indications for use.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as this submission is for a mechanical surgical stapler and reload system, not an AI or image-based diagnostic device where "ground truth" would be established by human experts in image interpretation. The "truth" in this context is the physical performance and biological outcome (e.g., successful staple formation, hemostasis) confirmed through engineered testing and animal models.

4. Adjudication Method for the Test Set

This information is not applicable as this submission is for a mechanical device. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be inter-reader variability. The "adjudication" in this context would be the rigorous adherence to testing protocols and criteria, verified by engineers and potentially DVMs for animal models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or CAD (Computer-Aied Detection/Diagnosis) systems where the performance of human readers (e.g., radiologists) is compared with and without AI assistance. This submission is for a mechanical surgical stapler.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as this is not an AI/algorithm-based device. The "standalone performance" of the device is its mechanical function (stapling, cutting) which was assessed through bench and animal testing.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance was established through:

• Bench Test Results: Direct measurement and evaluation of physical characteristics and functional performance (e.g., formed staple height, staple form quality, vessel sealing, staple line integrity) under controlled laboratory conditions. These are objective engineering measurements.
• Animal Model Outcomes: Direct observation and measurement of biological outcomes in live animal tissues (porcine model for liver, spleen, pancreas, isolated vessels, lung, uterine tissues). "Hemostasis performance" implies direct assessment of whether the stapling achieved effective cessation of bleeding. These are physiological and anatomical "truths."

8. The Sample Size for the Training Set

This information is not applicable as this is a mechanical device, not an AI/machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above (not an AI/ML device).

In summary, the 510(k) clearance for the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads for expanded indications was based on a combination of rigorous nonclinical (bench) testing to verify mechanical performance and engineering specifications, and pre-clinical (animal) testing to demonstrate in vivo safety and effectiveness, particularly hemostasis performance in the newly indicated solid organs (liver, pancreas, kidney, spleen) and associated vasculature. The acceptance criteria were implicitly met by the successful completion and positive outcomes of these tests, demonstrating substantial equivalence to predicates and no new questions of safety and effectiveness for the expanded uses.

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