(170 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 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."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical/Functional Performance: | |
| Rotation and Articulation Performance | Device performed as intended, meeting design specifications. |
| Safety Mechanism Performance | Device performed as intended, meeting design specifications. |
| Firing Force within specified range | Device performed as intended, meeting design specifications. |
| Retraction Force within specified range | Device performed as intended, meeting design specifications. |
| Proper Staple Formation | Device performed as intended, meeting design specifications. |
| Staple and Cut Line Length as specified | Device performed as intended, meeting design specifications. |
| Staple Line Pressure Test | Device performed as intended, meeting design specifications. |
| Staple Line Tensile Test | Device performed as intended, meeting design specifications. |
| Packaging & Sterility: | |
| Package Integrity maintained | Device performed as intended, meeting design specifications. |
| Shelf Life maintained | Device performed as intended, meeting design specifications. |
| Biological Performance (In Vivo): | |
| Burst Evaluation satisfactory | Device performed as intended, meeting design specifications. |
| Hemostasis Evaluation satisfactory | Device performed as intended, meeting design specifications. |
| Staple Formation satisfactory | Device performed as intended, meeting design specifications. |
| Biocompatibility (Cytotoxicity, Sensitization, | Compliant with ISO-10993-1:2009 for Biological evaluation of Medical Devices. |
| and Irritation/Intracutaneous Reactivity) pursuant | |
| to ISO-10993-1:2009 | |
| Endotoxin Limit met | Device performed as intended, meeting 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.
§ 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.