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

The AEON Endoscopic Powered Stapler system is composed of the AEON Endoscopic Powered Stapler Handle ("Powered Handle") and AEON Endoscopic Stapler Reloads ("Reloads"). 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 Powered Handle may be reloaded and fired up to 20 times in a single procedure. The Powered Handle is available in three different lengths (60mm, 160mm and 260mm) and the Reloads are available in multiple staple sizes to accommodate various tissue thicknesses.

The AEON Endoscopic Powered Stapler uses software to control the operation of the stapler and is AC powered. The device is sterile packaged and is labeled for single use.

The provided FDA 510(k) clearance letter and summary for the AEON™ Endoscopic Powered Stapler focuses on demonstrating substantial equivalence to predicate devices, primarily for an expanded indication to include thoracic applications. However, it does not contain the detailed information typically found in a study report proving a device meets specific acceptance criteria, especially for AI/ML-driven devices.

Based on the provided text, here's an analysis of the acceptance criteria and the study that supports it, with the caveat that many details commonly sought for AI/ML device evaluations are not present in this document.

Acceptance Criteria and Study for AEON™ Endoscopic Powered Stapler (Thoracic Applications)

The core "acceptance criteria" discussed in this document revolve around demonstrating substantial equivalence for the expanded indication of "thoracic surgery." This implies that the device, when used for this new application, performs safely and effectively without raising new questions of safety or efficacy. Since the device itself is a mechanical surgical stapler with software control, the criteria are likely related to the mechanical performance and clinical outcomes.

The document explicitly states that the expanded Indications for Use for thoracic applications are supported by real-world evidence data.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a mechanical device with software control, the "acceptance criteria" are implied by the claim of substantial equivalence and the successful real-world evidence for thoracic applications. Specific quantitative performance metrics typical for AI/ML (e.g., sensitivity, specificity, AUC) are not directly stated. Instead, the acceptance criteria are implicitly that the device is "safe and effective for use for thoracic applications" without adverse events or performance issues that would preclude clearance.

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

• Sample Size: The document does not specify the sample size (number of patients, procedures, or stapler uses) used in the real-world evidence data.
• Data Provenance: The data is described as "Real-world evidence data." The document does not specify the country of origin of this data or whether it was retrospective or prospective.

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

This information is not provided in the document. For a surgical stapler's clinical performance, "ground truth" would typically relate to clinical outcomes assessed by surgeons or other medical professionals.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described. This type of study is typically relevant for diagnostic imaging AI systems where human readers interpret images with or without AI assistance. The AEON™ Endoscopic Powered Stapler is a surgical instrument, not a diagnostic AI. The document states "human factors testing is not applicable to support the expanded Indications for Use," further indicating that comparative studies with human action are not central to this particular clearance process.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

The device is a powered surgical stapler that uses software to control its operation. While the software itself might have undergone standalone validation, the performance described (safety and effectiveness for thoracic applications) would inherently involve the device operating with a human surgeon in the loop. A standalone "algorithm only" performance in the context of surgical stapling would be largely meaningless without the mechanical components and user interaction. The document implies that the device's overall performance, including its software-driven functions, was evaluated in real-world use for thoracic applications.

7. The Type of Ground Truth Used

For "real-world evidence data" supporting the safety and effectiveness of a surgical stapler for thoracic applications, the ground truth would most likely be derived from:

• Clinical Outcomes Data: This would include metrics like incidence of staple line failure, leaks, bleeding, tissue trauma, successful resection/transection, complication rates, and patient recovery within a thoracic surgical context.
• Surgeon Assessments: Evaluations by operating surgeons regarding ease of use, stapler performance, and observed tissue response.

The document does not explicitly state the specific type of ground truth, but these are the most probable types for this device and its application.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of the expanded indications or real-world evidence. This is expected given that the clearance is for a mechanical device with software control, not an AI/ML diagnostic algorithm that typically relies on extensive training data. The software within the stapler likely has deterministic control logic rather than learning algorithms that require large training datasets in the typical AI sense.

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

Since a "training set" is not mentioned or described in the context of the device's software learning or the expanded indications, the method for establishing its ground truth is not applicable here. The software control functions were likely verified and validated through a design control process, not machine learning model training.

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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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AEONTM Laparoscopic Instruments is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of monopolar electrosurgical cutting and/or coagulation.

The AEON Laparoscopic Instruments are sterile, disposable, single-use, individuallypackaged surgical instruments that are designed to cut, grasp, dissect, and coagulate selected tissue in laparoscopic surgery. The instruments are designed to be used with an electrosurgical generator (to be purchased separately).

There are 10 different instrument tip configuration variants. The only difference between the 10 variants is the geometry of the tip scissors/graspers in three shaft working lengths 22cm, 33cm, and 45cm.

Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.

The proposed device is provided Ethylene Oxide (ETO) sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided text is a 510(k) summary for a medical device called "AEON Laparoscopic Instruments." It details the device's purpose, design, intended use, and a comparison to a predicate device to demonstrate substantial equivalence for FDA clearance.

Upon reviewing the document, it's clear that the information you're requesting regarding acceptance criteria and the study that proves the device meets them (specifically related to AI/ML or diagnostic performance) is not present in this submission.

Here's why, and what information is available:

• Device Type: The AEON Laparoscopic Instruments are surgical tools (forceps, scissors, probes) used in laparoscopic procedures for cutting, grasping, dissecting, and monopolar electrosurgical coagulation. They are not an AI/ML device, a diagnostic device, or a device that generates or analyzes medical images for interpretation.
• Performance Data: The "Performance Data" section (Section 9) focuses exclusively on:
  • Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601 series standards.
  • Biocompatibility: Compliance with ISO 10993 series standards.
  • Sterilization and Shelf Life: Compliance with ISO 11607, ASTM F1980, ASTM F1929, and ISO 11135 standards.
• Substantial Equivalence: The filing establishes substantial equivalence primarily based on the device's intended use, design, and technological characteristics being similar to an existing predicate device (Unimax Laparoscopic Instrument K103508). This is typical for Class II surgical instruments.

Therefore, since this device is not an AI/ML-driven diagnostic tool, the following information you requested is not applicable or cannot be extracted from this document:

1. Table of acceptance criteria and reported device performance (for AI/diagnostic performance): Not applicable. The "performance" here relates to safety and functional specifications for a surgical instrument.
2. Sample size for the test set and data provenance: No "test set" in the context of diagnostic performance or AI model evaluation. Sample sizes would refer to the number of instruments tested for physical performance, biocompatibility, sterility, etc.
3. Number of experts and qualifications for ground truth: No expert human interpretation or "ground truth" establishment in the context of diagnostic performance.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device does not involve human readers interpreting AI-generated output.
6. Standalone (algorithm only) performance: Not applicable. There is no algorithm.
7. Type of ground truth used: Not applicable. Ground truth for diagnostic performance is not relevant.
8. Sample size for the training set: Not applicable. No AI model involved.
9. How ground truth for the training set was established: Not applicable. No AI model involved.

In summary, the provided document describes a 510(k) submission for conventional surgical instruments, not an AI/ML-enabled medical device. As such, the requested information regarding AI/ML performance acceptance criteria and study details is irrelevant to this specific filing.

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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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