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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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The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units (SULUs) have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

The Autosuture™ ENDO GIA™ Staplers when used with the ENDO GIA™ Curved-Tip Single Use Loading Unit (SULUs) can be used to blunt dissect or separate target tissue from other certain tissue.

The Autosuture™ ENDO GIA™ Staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate Single Use Loading Unit (SULU). The staplers will accommodate any of the single use loading units that are available in 30 mm, 45 mm and 60 mm lengths.

This 510(k) reports a new version of our currently marketed Autosuture™ ENDO GIA™ Staplers (K061095). This new version is considered a modification of the currently marketed Autosuture™ ENDO GIA™ Staplers. The modifications are as follows:

• Ergonomic and performance enhancements to the ENDO GIA™ Stapler Instrument.
• Addition of ENDO GIA™ Single Use Loading Units (SULUs) with Tri-Staple™ technology. Tri-Staple™ technology means that each of the two triple-staggered rows has a stepped configuration whereby the staples in the outer row are a taller height then the staples in the middle row which in turn are a taller height than the staples in the inner row. The ENDO GIA™ SULUs with Tri-Staple™ technology are available in articulating 30 mm, 45 mm and 60 mm length cartridges.
• Addition of ENDO GIA™ Single Use Loading Units (SULUs) which have a curved-tip anvil configuration. The curved-tip can be used to dissect and manipulate tissue when locating target tissue for subsequent firing and placement of staples.

The provided document is a 510(k) summary for a surgical stapler. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding detailed acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set details.

The document states: "Bench and animal model performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with the new ENDO GIA™ Single Use Loading Units are safe and effective and perform as intended." This indicates that performance data was generated, but the specifics of what those performance evaluations entailed and what criteria were used for acceptance are not provided in this public summary.

Therefore, I cannot fulfill your request with the information given. The provided text is a regulatory submission summary, not a detailed study report.

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The Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection of liver lissue, hepatic vasculature and biliary structures.

SterilMed's reprocessed AutoSuture GIA Endoscopic Stapler places two triple staggered rows of titanium staples and the blade, contained in the reload, simultaneously divides the tissue between the two rows. These devices allow for a maximum of 8 reloads in a single surgical procedure. The OEM has specified that the subject staplers may be fired up to 25 times in a single surgical procedure. SterilMed has lowered the number of firings allowed to 8 based upon clinical input, the procedures these devices are used for and the maximum allowable firings for similar devices of other manufactures. Note: Only the stapler is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.

The provided document describes a 510(k) premarket notification for Reprocessed AutoSuture GIA Endoscopic Staplers. This is a submission for a reprocessed medical device, not a novel AI/software-as-a-medical-device (SaMD) product. Therefore, the information requested in the prompt, such as AI model performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment, is not applicable to this type of submission.

The acceptance criteria and supporting study for a reprocessed device primarily focus on demonstrating that the reprocessed device performs substantially equivalently to the original (predicate) device and that the reprocessing methods (cleaning, sterilization, functional testing) are validated and effective.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance for Reprocessed AutoSuture GIA Endoscopic Staplers

Regarding the AI/SaMD specific questions from the prompt:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, this is a reprocessed physical device. Testing would involve a sample of reprocessed devices from the production line, not a data test set.
2. 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 applicable. Clinical input informed the "8 firings" decision, but this isn't ground truth for an algorithm.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a reprocessed device, "ground truth" would relate to objective measurements of functionality, safety (e.g., sterility, cleanliness, burst strength for staple lines), and material integrity compared to the new device specifications and regulatory standards. It doesn't involve clinical "ground truth" in the diagnostic sense.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission demonstrates substantial equivalence for a reprocessed stapler through bench testing and process validation for cleaning, sterilization, packaging, and functional performance, rather than clinical studies or AI algorithm validation.

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