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The GI Windows FLEXAGON System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows FLEXAGON is intended for use in adult patients > 21 years.

The FLEXAGON device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive surgery in the gastrointestinal tract. The system is comprised of magnets and includes the delivery systems. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with subsequent healing of tissue around the devices. Once the anastomosis is formed the magnet device is expelled naturally in approximately 3-6 weeks.

I am sorry, but the provided text is an FDA 510(k) clearance letter for a medical device (Self-Forming Magnet - Flexagon). While it discusses device performance and testing, it does not contain the specific details required to answer your full request about acceptance criteria and a study proving the device meets them, especially in the context of an AI/algorithm-based device.

The information you are asking for, such as:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample size and data provenance for a test set.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

These are all critical components of a regulatory submission for AI/Machine Learning-enabled medical devices. The provided document describes a physical medical device (magnetic compression anastomosis system) and its non-clinical and clinical testing, which focuses on aspects like biocompatibility, sterilization, mechanical properties, and animal/cadaver/human clinical use for a surgical procedure.

The document explicitly states on page 10:
"Software
The Flexagon System does not contain software"

Therefore, there is no AI/algorithm component to this device, and thus no data on AI acceptance criteria, training sets, test sets, expert adjudication, or MRMC studies for AI performance will be found in this document.

Ask a specific question about this device