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The GI Windows Flexagon Plus OTOLoc System is intended for use in the creation of side-to-side jejunum-jejunum and ileum-ileum 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 SFM Plus OTOLoc is intended for use in adult patients > 21 years.

The Flexagon SFM Plus OTOLoc 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 self-forming magnets and includes the delivery system. The OTOLoc component provides enterotomy preservation for immediate fluidic flow upon implant, while the alternating dipoles of the Flexagon magnet drives magnetic self-alignment to prevent apposition. The anastomosis formation occurs over time once the remodeling of the targeted tissues is complete. The Flexagon magnets compress the opposing tissues which allows the body to dictate the time required for re-epithelialization. Compression and necrosis of tissue is achieved between magnet devices and is created by the 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.

The provided text does not contain acceptance criteria or study details for an AI/software device. The document is an FDA 510(k) clearance letter for a physical medical device, the "Flexagon Plus OTOLoc System," which is a magnetic compression anastomosis system.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI device meets them, as the input document is not about an AI device.

The document discusses:

• Acceptance criteria (implicitly met through "Pass" results) for various non-clinical performance tests (biocompatibility, sterilization, packaging, shelf-life, magnetic properties, etc.) and animal studies.
• Clinical performance data for the physical device based on patient outcomes, but not related to an AI's diagnostic or assistive capabilities.

To answer your request, I would need a document detailing the clearance of an AI-powered medical device.

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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