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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 AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses

The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples and staple line length are based on the selection of the Stapler Reload open staple height and staple line length. The AEON™ Endoscopic Stapler handle and reload are sterile, single use devices.

The modification presented in this 510(k) is to remove the "MR Unsafe" from the MRI Safety Information section of the Instructions for Use (IFU).

This document describes the AEON Endoscopic Stapler and a 510(k) submission (K201882) to remove the "MR Unsafe" designation from its Instructions for Use (IFU). The information provided does not pertain to an AI/ML device or its performance study; rather, it details the testing conducted for MRI safety of a physical medical device. Therefore, I cannot extract information related to AI/ML device acceptance criteria, human reader improvement with AI assistance, or related aspects.

However, I can provide the acceptance criteria and study information that is present in the document regarding the MRI compatibility testing of the AEON Endoscopic Stapler.

Acceptance Criteria and Study for MRI Compatibility of AEON Endoscopic Stapler

The provided document describes the modification to the AEON Endoscopic Stapler to remove the "MR Unsafe" designation from its IFU. The study conducted was to demonstrate MRI safety, not the performance of an AI/ML diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing showed "all stapler reload sizes meet the ASTM standards for removal of the 'MR Unsafe' designation," implying successful adherence to the acceptance criteria for each standard.

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

• Sample Size: The document mentions "worst-case staple line size" was tested, implying a representative sample of the device was used for the physical testing. However, a specific numerical sample size (e.g., number of stapler units tested) is not explicitly stated in the provided text.
• Data Provenance: The data is generated from nonclinical, laboratory-based performance tests conducted in a controlled environment as part of a 510(k) submission. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA by a company located in Massachusetts, USA. The study design is prospective in nature, as new testing was performed to support the change in MRI safety labeling.

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

This question is not applicable as the study did not involve human interpretation or subjective assessment by experts to establish ground truth. The ground truth for MRI safety is established by adherence to quantitative and qualitative criteria defined within the specified ASTM standards.

4. Adjudication Method for the Test Set

This question is not applicable. The assessment was based on physical performance of the device against predefined engineering standards (ASTM), not on expert consensus or human reading.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This study concerns the physical MRI safety of a surgical stapler, not the performance of an AI-assisted diagnostic system.

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

This question is not applicable. This study pertains to a physical medical device.

7. The Type of Ground Truth Used

The ground truth used for this study was defined by established engineering standards (ASTM) for MRI safety of medical devices. Performance was measured against the acceptance criteria outlined within these standards (e.g., specific thresholds for RF heating, image artifact levels, force, and torque).

8. The Sample Size for the Training Set

This question is not applicable. This study involves physical device testing, not an AI/ML model that requires a training set.

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

This question is not applicable. No training set was used.

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The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.

The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples and staple line length are based on the selection of the Stapler Reload open staple height and staple line length. The AEON™ Endoscopic Stapler handle and reload are sterile, single use devices.

The modification presented in this 510(k) is a change in the product Instructions for Use (IFU) labeling to add the following two (2) contraindications:

• 1. "The AEON™ Endoscopic Stapler is contraindicated for use on the heart, central circulatory system, or central nervous system."
• 2. "Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta, any tissue that compresses to less than 0.75 mm in thickness, or any tissue that does not comfortably compress to 0.75 mm."
     This second contraindication is associated with the addition of an AEON Endoscopic Stapler reload staple height of 2.0mm and the compressed tissue thickness contraindication associated with this staple height.

The provided text describes a 510(k) premarket notification for a modified AEON™ Endoscopic Stapler. The modification involves adding a 2.0mm open staple height reload and an associated contraindication. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K173443), rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML device.

However, based on the provided text, I can infer the "acceptance criteria" relate to the performance of the stapler itself, and the "study" is the nonclinical performance testing conducted.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with pass/fail values. It states that the device "meets all performance specification requirements" and "shows that all stapler reload sizes meet all performance specification requirements."

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

The document does not specify the exact sample sizes (e.g., number of stapler firings, number of tissue samples) for the nonclinical tests.

• Test Set Sample Size: Not explicitly stated. The text mentions "Testing consisted of the following performance tests for each stapler reload size," implying tests were conducted across the range of available reload sizes, but the quantity within each test is not given.
• Data Provenance: The tests were "nonclinical tests" conducted to verify design specifications. This implies laboratory or bench-top testing, not human or animal clinical data in this submission. There is no mention of country of origin for any data related to these specific tests.

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

Not applicable. This device is a mechanical stapler, and the "tests" were performance evaluations against engineering specifications. There is no mention of human expert-established ground truth in the context of diagnostic interpretation or similar, as would be common for AI/ML devices.

4. Adjudication Method for the Test Set

Not applicable. There was no need for adjudication as the data was from objective performance measurements rather than subjective assessments.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This submission does not include data from Clinical Studies."

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

Yes, in a conceptual sense. The "performance data" presented is for the device itself ("algorithm only" if the device's function is considered its 'algorithm'), without human-in-the-loop performance measurement. The testing "verified that the proposed device is as safe and as effective as the predicate device, performs as intended, and meets all design specifications."

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical performance tests would be the pre-defined design specifications and engineering requirements for a surgical stapler. These specifications dictate acceptable ranges for firing force, staple formation, burst pressure, and tensile strength.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI/ML system that undergoes a "training set" process.

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

Not applicable. As this is not an AI/ML device, the concept of a "training set" and associated ground truth establishment does not apply. The device's design and manufacturing processes are based on established engineering principles and material science.

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The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.

The AEON™ Endoscopic Stapler places two. triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples is determined by the selection of the appropriate reload.

This 510(k) reports reloads with two staple sizes (gray - 2.25mm and black - 5.0mm) and in two lengths (45mm and 60mm).

The provided document is a 510(k) premarket notification summary for the AEON™ Endoscopic Stapler. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about an AI/ML-driven medical device, nor does it detail a study involving human readers, ground truth establishment by experts, or any of the criteria typically associated with the evaluation of AI systems in medical imaging.

Therefore, I cannot provide a response filling out the requested table and details because the document is about a surgical stapler and its mechanical/physical performance, not an AI software.

The document explicitly states: "This submission does not include data from Clinical Studies." and the performance data section lists purely mechanical and material tests (e.g., Firing Force, Staple Formation, Burst Evaluation, Biocompatibility).

To clarify, a medical device like the AEON™ Endoscopic Stapler (a physical surgical tool) would not typically have acceptance criteria, performance metrics, or study methodologies that involve:

• A "test set" or "training set" of data points in the sense of AI/ML.
• "Experts" establishing "ground truth" for image interpretation.
• "Adjudication methods" for discrepant reads.
• "Multi-reader multi-case (MRMC) comparative effectiveness studies" for human readers improving with AI assistance.
• "Standalone (algorithm only without human-in-the-loop performance)" studies.

The document's purpose is to show the stapler performs its mechanical function safely and effectively, similar to an existing predicate device.

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The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.

The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples is determined by the selection of the appropriate reload that is available in two staple sizes (tan - 3.25mm, purple - 4.0mm) and in one length (60mm).

The provided 510(k) summary for the AEON Endoscopic Stapler (K171589) does not describe an AI or software-based medical device. Therefore, the information requested regarding acceptance criteria and a study proving device meeting acceptance criteria in the context of AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment, training/test set sizes) is not applicable to this submission.

The 510(k) pertains to a physical medical device, an endoscopic stapler, and the performance data presented is focused on the device's mechanical, biological, and functional attributes.

However, I can extract information related to the device's performance testing for its physical characteristics, as detailed in the "Performance Data" section.

Here's a summary based on the provided document, addressing the closest relevant points:

1. Acceptance Criteria and Reported Device Performance (Focusing on physical/mechanical attributes):

The document lists "Performance Data" which includes various tests. While explicit acceptance criteria values are not provided in this summary, the tests themselves imply certain performance standards that the device met. The conclusion states the device "meets all design specifications."

2. Sample Size and Data Provenance:

• Sample Size: The document does not specify the sample sizes used for each of the listed in-vitro and in-vivo tests. It only lists the types of tests performed.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be nonclinical and are likely internal company testing or conducted by contract research organizations. These are "nonclinical tests" as stated in the document.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. This is a physical device, not an AI/software for diagnostic or image interpretation, so "ground truth" established by experts in the typical AI sense is not relevant. The "ground truth" here would be objective measurements and observations of the stapler's performance against its design specifications and safety standards.

4. Adjudication Method:

• Not Applicable. As this is a physical device, there is no adjudication method in the context of interpretation or diagnosis that would apply to AI/software. Test results for mechanical and biological performance would be fact-based.

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

• Not Applicable. This type of study is relevant for AI-powered diagnostic or interpretive tools; it does not apply to a surgical stapler. The document explicitly states: "This submission does not include data from Clinical Studies."

6. Standalone Performance Study:

• Partially Applicable (in a different context). The provided performance data (in-vitro and in-vivo) represents the "standalone" performance of the AEON Endoscopic Stapler itself, without human-in-the-loop performance in the sense of AI assistance. The tests focused on the device's inherent functional, mechanical, and biological properties.

7. Type of Ground Truth Used:

• The "ground truth" for the nonclinical tests would be:
  • Objective Measurements: E.g., measured firing force, staple length, cut line length, pressure resistance, tensile strength.
  • Validated Test Methods: Adherence to established test protocols for biocompatibility (ISO-10993-1).
  • Visual Inspection/Observation: For staple formation, articulation, safety mechanism function.
  • Predetermined Specifications: The device's performance was compared against its design specifications that define acceptable ranges for these parameters.

8. Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is a physical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. There is no "training set" or corresponding ground truth establishment process in the context of AI for this type of device.

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