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The Avantgarde Faecal Management System (FMS) is intended for faecal management by the collection of semi liquid or liquid faecal matter in bedridden adults.

The Avantgarde Faecal Management System (catheter) is an invasive medical device to be used inside the body. It consists of a silicone catheter tube with inflation cuff and irrigation port, a 1,500ml collection bag, mounting plate with an attachment strap and 45ml syringe. This tray of devices, is supplied as a Convenience Kit. In addition, other related medical devices to enable the Avantgarde work effectively, include the Avantgarde Faecal Management System Replacement Pouches which are to be supplied on a bundle basis.

This non-sterile device is for single use only.

The FMS catheter tube is constructed of a silicone material. The balloon once inflated retains the device in the rectum. The liquid or semi-liquid stool is diverted into the drainage tube, which provides a route for the liquid or semi-liquid faecal matter to pass into the collection bag.

Along the tube are two lumens with individual access ports. One port to inflate and deflate the balloon and the other to add water to flush and irrigate the catheter tube.

Its shelf life is 5 years from the date of production.

This device is a fecal management system, not an AI device, so the requested information about acceptance criteria and study proving it meets them, including details about AI, human readers, training and test data, and ground truth, is not applicable.

The provided text describes a 510(k) premarket notification for the "Avantgarde Faecal Management System" and "Avantgarde Faecal Management System Replacement Pouches." This is a medical device for collecting semi-liquid or liquid fecal matter in bedridden adults, and it is not an AI/ML device.

Therefore, the requested information, which is specifically designed for evaluating AI/ML devices, is not applicable to this submission. Questions about a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, sample sizes for training/test sets, and ground truth establishment for AI models do not pertain to this device.

The 510(k) summary provides non-clinical performance data and states that the device was found to be substantially equivalent to a predicate device (ConvaTec Flexi-Seal Signal) based on functional and structural characteristics and various industry standards (e.g., F1980, F88, F1929, ASTM D4169, W-ZK-08-65, ISO8669-2, ISO 10993).

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