(268 days)
The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.
The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide.
The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.
The provided text is a 510(k) summary for the Standard Bougie device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.
The "Performance Data" section (VII) lists several types of verification and testing, such as "Drainage Flow Rate Verification," "Balloon Strength Verification," and "Device Usability." These tests are likely related to the physical and functional performance of the bougie itself, not to an AI system's diagnostic accuracy or a human-AI team's effectiveness.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them from the provided text. The document describes a medical device (a bougie) used in bariatric surgery, not an AI or imaging diagnostic device.
To answer your request, I would need a different document that details the development, validation, and performance studies of an AI-powered medical device.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.