(93 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 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
| Acceptance Criteria (ASTM Standard) | Reported Device Performance (Summary) |
|---|---|
| ASTM F2182 "RF Heating" | Device met standards for MRI safety |
| ASTM F2052 "Force" | Device met standards for MRI safety |
| ASTM F2213 "Torque" | Device met standards for MRI safety |
| ASTM F2119 "Image Artifact" | Device met standards for MRI safety |
| ASTM F2503 "Marking Medical Devices" | Device met standards for MRI safety |
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.
§ 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.