(66 days)
The AMT Balloon Stoma Measuring Devices are to be used by medical professionals and home health givers in association with replacement gastrostomy feeding devices. The purpose of the AMT Balloon Stoma Measuring Devices is to aid in determining the depth (length) of an established stoma tract in order to assist in determining the proper length replacement gastrostomy feeding device to be used.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (AMT Balloon Stoma Measuring Devices). This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.
The letter explicitly states that the FDA has determined the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, not a detailed performance study as you've outlined.
Therefore, I cannot extract the requested information from the given text.
§ 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.