(89 days)
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:
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- "The AEON™ Endoscopic Stapler is contraindicated for use on the heart, central circulatory system, or central nervous system."
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- "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.
- "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."
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."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance: | All reload sizes met design specifications. |
| - Firing force within limits | Satisfactory |
| - Retraction force within limits | Satisfactory |
| - Proper formed staple shape | Satisfactory |
| Tissue Sealing Performance: | All reload sizes met design specifications. |
| - Suture line burst pressure (porcine intestine) meets specifications | Satisfactory |
| - Tensile strength of staple line meets specifications | Satisfactory |
| Substantial Equivalence: | The modified device performs as intended and is as safe and effective as the predicate device. |
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.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.