(223 days)
The Pre-Loaded Replacement G-Tube Device is to be used as a percutaneous replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The Pre-Loaded Replacement G-Tube Device can also deliver medication and allow for decompression of the stomach.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "AMT Pre-Loaded Replacement Gastrostomy Tube." This document is a regulatory approval letter and an "Indications for Use Statement."
Unfortunately, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.
The letter from the FDA (Pages {0} and {1}) is primarily concerned with:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory classification (Class II).
- Mentioning general controls provisions, manufacturing practice requirements, and other Federal Laws or Regulations.
- Granting permission to market the device.
The "Indications for Use Statement" (Page {2}) describes what the device is intended for (e.g., replacement gastrostomy tube for nutrition, medication delivery, stomach decompression) but does not provide any performance metrics or study details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (Table of acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, and ground truth establishment for training set) is not present in this regulatory correspondence.
§ 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.