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The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, and/or creation of anastomoses. The instruments have application 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 of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The ECHELONTM 3000 45 mm and 60 mm Staplers 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.

The ECHELON™ 3000 45 mm Staplers have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long.

The ECHELON™ 3000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm 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 instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section.

The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.

The provided text is a 510(k) summary for the ECHELON™ 3000 Surgical Stapler. It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria and the specifics of a study proving the device meets those criteria for an AI/algorithm-based medical device.

The document discusses performance data for a surgical stapler, which is a mechanical device, not an AI/algorithm-based diagnostic or therapeutic tool. Therefore, the types of "acceptance criteria" and "studies" will differ significantly from those for an AI system.

Here's how the information provided relates to your request, and where there are gaps due to the nature of the device:

Regarding the Surgical Stapler (as described in the document):

• Acceptance Criteria and Reported Performance: The document lists various bench testing criteria (Formed Staple Height (FSH), Staple Line Integrity (SLI), Force to Close, Staple Line Visual Analysis, Staple Line Strength) and animal testing (Acute Hemostasis evaluation, Tissue Healing response, Survival Study). For a 510(k), the "acceptance criteria" are generally that the device performs comparably to a predicate device and does not raise new questions of safety or effectiveness. The reported performance is that these tests "demonstrate that the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness." However, specific numerical acceptance criteria (e.g., FSH must be within X range) and the exact numerical performance results are not provided in this summary. This level of detail is typically found in the full 510(k) submission, not the public summary.

  Given that this is a mechanical device, not an AI, a table like you requested would list mechanical properties and their measured values against predefined acceptable ranges derived from the predicate device or engineering specifications.

• Sample Size: The document mentions "bench testing" and "animal testing" but does not specify the sample sizes used for these tests.

• Data Provenance: Not specified for the bench or animal testing.

• Number of Experts/Qualifications/Adjudication Method for Test Set: Not applicable in the context of this device's testing. These are relevant for AI systems relying on expert ground truth.

• MRMC Comparative Effectiveness Study: Not applicable. This is a study design for evaluating the impact of AI on human reader performance. This device is a mechanical stapler.

• Standalone Performance: The "bench testing" and "animal testing" can be considered "standalone" performance testing for a mechanical device, as it evaluates the device's physical properties and function without human intervention beyond operation.

• Type of Ground Truth: For a mechanical device like a stapler, "ground truth" equates to established engineering specifications, mechanical properties (e.g., staple height, tensile strength), and biological outcomes (e.g., hemostasis, healing) validated through standard scientific and engineering practices. It's not "expert consensus" on an image, but rather measurable physical and biological parameters.

• Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that undergoes a "training set" process.

• How Ground Truth for Training Set was Established: Not applicable for the same reason.

If the request was hypothetically for an AI-based medical device, and we were to invent the details based on common FDA expectations for AI/ML:

Let's imagine this document was for an AI-powered diagnostic tool. Here's what such a response would include, creating hypothetical details where the provided document has gaps:

Hypothetical Acceptance Criteria and Study for an AI-Powered Diagnostic Device (e.g., for detecting a specific condition in medical images):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 500 cases (e.g., 250 positive, 250 negative for the condition).
• Data Provenance:
  • Country of Origin: Multi-site, primarily from hospitals in the United States and Europe.
  • Retrospective/Prospective: Primarily retrospective data collected from institutional archives. A small subset (50 cases) was prospectively collected to ensure generalizability.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: 3 independent expert readers.
• Qualifications: All were board-certified radiologists with at least 10 years of experience in diagnosing the target condition. Two had fellowship training in the relevant sub-specialty.

4. Adjudication Method for the Test Set

• Method: 2+1 adjudication. Initial reads by two independent expert radiologists. In cases of disagreement, a third, senior-level radiologist (the "tie-breaker") reviewed the case and the initial reads to make a final ground truth determination.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Yes, an MRMC study was performed.
• Effect Size: The study demonstrated a statistically significant improvement in human reader performance when assisted by the AI.
  • Sensitivity: Human readers' sensitivity improved by an average of 6.1 percentage points (e.g., from 82% unaided to 88.1% AI-assisted, p

Ask a specific question about this device

ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads 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 FLEX™ Powered Plus Articulating Endoscopic Linear Cutters 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. The ECHELON FLEX™ 45 Powered Plus instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The ECHELON FLEX™ 60 Powered Plus instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm 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 instruments are packaged with a primary lithium battery pack that must be installed prior to use. The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.

I am sorry, but based on the provided text, there is no information about a study that proves a device meets acceptance criteria related to AI or image analysis. The document is a 510(k) premarket notification for surgical staplers and only mentions bench testing to demonstrate performance and substantial equivalence to predicate devices. It explicitly states:

• "Clinical studies were not required to demonstrate substantial equivalence."
• "All verification requirements met criteria for success. The determination of substantial equivalence relied on testing including bench studies that evaluated consistent staple formation."

Therefore, I cannot provide the requested details regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided document. The document describes a traditional medical device (surgical stapler) and its regulatory clearance process, not an AI-powered diagnostic or image analysis device.

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