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The AEON Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

The AEON Endoscopic Powered Stapler system is an endoscopic linear cutter and reload system that simultaneously cut and staple tissue. The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The AEON Endoscopic Powered Stapler system is composed of an AEON Endoscopic Powered Stapler Handle and the AEON Endoscopic Stapler Reloads. Multiple staple handle lengths and multiple staple sizes are available to accommodate various tissue thicknesses. The AEON Endoscopic Powered Stapler uses software to control operation of the stapler and is AC powered. The device is sterile packaged (Ethylene Oxide) and single use. The AEON Endoscopic Powered Stapler Handle may be reloaded and fired up to 20 times in a single procedure.

The provided text describes the AEON Endoscopic Powered Stapler and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria and study results in the format requested.

Specifically, the document lists various performance tests conducted (e.g., staple height and formation, staple line strength, ex-vivo leak-burst pressure testing, software verification and validation, animal testing for hemostasis, human factors testing, electrical safety, EMC, biocompatibility, sterilization, packaging, and shelf-life validations). However, it does not provide a table of specific acceptance criteria or reported device performance against those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them with the specified details. The document states that "The results of testing and evaluation listed above demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to the predicate device," but it does not expand on the quantitative results or specific conditions.

Here's what I can extract from the provided text, and what is missing:

What is (partially) available in the text:

• 1. A table of acceptance criteria and the reported device performance: This is not provided in the text. The document lists types of tests performed but not the specific criteria or quantitative results.
• 2. Sample size used for the test set and the data provenance:
  • Test Set Sample Size: Not explicitly stated for any of the listed tests.
  • Data Provenance:
    • "Animal testing was performed to assess In vivo confirmation of staple line hemostasis..." (Implies animal data).
    • "Human Factors testing was executed..." (Implies human user data).
    • Other tests are non-clinical (e.g., bench testing, software V&V).
    • Country of origin for data is not mentioned.
    • Retrospective or prospective nature of data is not specified.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not mentioned in the provided text for any test.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• 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, as this device is a surgical stapler, not an AI-assisted diagnostic tool for "human readers." Human factors testing was performed but not in an MRMC comparative effectiveness study context.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is an "Endoscopic Powered Stapler" which is a physical surgical tool controlled by software. Software verification and validation testing was done for the algorithm, but this isn't a standalone diagnostic algorithm in the typical sense of this question. Its performance is integrated into the device's function.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
  • For "Staple line hemostasis," the ground truth was assessed in vivo in animal testing, implying direct observation of physiological outcomes.
  • For other non-clinical tests (e.g., staple height, strength, leak-burst), the ground truth would be physical measurements and engineering specifications.
• 8. The sample size for the training set: Not applicable, as this is hardware with integrated software, not a machine learning model that requires a "training set" in the common understanding. Software verification and validation primarily involve testing against requirements rather than training on data.
• 9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

In summary, the provided FDA 510(k) clearance letter and summary discuss the device and the types of non-clinical, software, animal, and human factors testing performed to demonstrate substantial equivalence, but it does not elaborate on the specific acceptance criteria, quantitative performance results, or detailed methodologies of these studies as requested. These details would typically be found in the manufacturer's full 510(k) submission, which is more comprehensive than the publicly available summary.

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The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, thoracic and urologic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload.

This 510(k) revises the labeling, including indications, contraindications, and warnings, for the AEON Endoscopic Stapler.

The provided text describes a 510(k) premarket notification for the AEON™ Endoscopic Stapler. The submission aims to revise the labeling of the existing device, specifically expanding its indications for use.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria for the AEON™ Endoscopic Stapler in the context of expanding its indications. Instead, the performance data section focuses on "safety and effectiveness" as the overarching goal for the revised labeling.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify an exact numerical sample size for the retrospective clinical studies. It vaguely refers to "the results of the retrospective clinical studies."
• Data Provenance: The studies are described as "retrospective clinical studies." There is no mention of the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information about the number or qualifications of experts used to establish ground truth for the retrospective clinical studies.

4. Adjudication method for the test set:

The document does not mention any adjudication method for the retrospective clinical studies.

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:

This is not applicable as the device is a mechanical stapler, not an AI-assisted diagnostic tool or an imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is mentioned or relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is a mechanical stapler.

7. The type of ground truth used:

For the retrospective clinical studies, the ground truth appears to be outcomes data in terms of observed complications or lack thereof during real-world surgical use. The statement "no complications associated with the AEON™ Endoscopic Stapler" suggests that the absence of adverse events served as the evidence for safety and effectiveness in the expanded indications.

8. The sample size for the training set:

This is not applicable as a training set is typically associated with machine learning or AI models. The studies described are retrospective clinical studies of a mechanical device.

9. How the ground truth for the training set was established:

This is not applicable for the reasons mentioned in point 8.

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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

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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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