(79 days)
The AMT Button Replacement Gastrostomy Device is to be used as a 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 AMT Button Replacement Gastrostomy Device can also deliver medication and allow for decompression of the stomach.
AMT Button is injection molded of Silicone. The Dome is injected molded from Silicone and Barium mixed for radiopaic detection if desired and is glued (with silicone) to the body of the Button. The Anti-Reflux Valve is injected molded from Silicone and Barium mixed for radiopaic detection if desired and is glued (with silicone) to the body of the Button. The device is sold in various sizes. Size is determined by the Physician or Professional Health Giver (dependant on length of existing stoma tract). The AMT Button is packaged in a kit which includes Directions For Use, Obturator Rod, Patient Care Kit, Stoma Measuring Device. The AMT Button Replacement Gastrostomy Device is sterile, single user, and disposable. The Patient Care Kit and Stoma Measuring Device are Non-Sterile and packaged for single user, disposable.
This submission describes a medical device, the AMT Button, and makes a claim of substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and performance data for a new, novel device. Therefore, much of the requested information regarding experimental design, ground truth, and statistical analysis is not applicable.
Here's an analysis of the provided text in relation to your request:
Analysis of the Provided Text:
The document is a 510(k) submission for the "AMT Button" device. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a predicate device already on the market, not to prove safety and effectiveness through clinical trials with defined acceptance criteria for novel performance.
Key Findings from the Document:
- Device Type: AMT Button Gastrostomy Feeding Device (a replacement gastrostomy device).
- Claim of Substantial Equivalence: The submitter claims the AMT Button is "as safe and effective as other predicate devices cited above" and is "identical in design and manufacture, using the same materials and processes used in 510(k) K843392 of Applied Medical Technology, Inc."
- Predicate Devices: K843392 (AMT Button), Microvasive/Boston Scientific Corp. Button, C.R. Bard Button.
- FDA Response: The FDA letter confirms the device is substantially equivalent for the stated indications for use.
Given this context, most of the requested points ("acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," "how ground truth for training set was established") are not applicable to this type of submission. This document does not describe the kind of performance study one would typically find for a new diagnostic or AI-driven device with quantifiable acceptance criteria.
Information from the Text (formatted where applicable):
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission does not present specific quantitative acceptance criteria or performance metrics for this device as it is a claim of substantial equivalence based on material and design similarity to existing devices. There are no performance results (e.g., sensitivity, specificity, accuracy) provided that would be compared against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No test set is described. The submission relies on demonstrating similarity to legally marketed predicate devices, not on a performance study with a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
Not applicable. No experts or ground truth establishment are described in this type of submission.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. No test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. An MRMC study was not done, nor would it typically be required for a 510(k) submission based on substantial equivalence to predicate devices for this product type. There is no mention of human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
No. This is a physical medical device (gastrostomy button), not an AI algorithm. Therefore, no "standalone" algorithm performance study was conducted.
7. The Type of Ground Truth Used
Not applicable. Ground truth is not a concept applied in this substantial equivalence submission. The basis for safety and effectiveness is the long-standing use and FDA approval of the predicate devices, and the demonstrated similarity of the new device to those predicates in terms of materials and design.
8. The Sample Size for the Training Set
Not applicable. This submission does not involve a training set as it is not an AI/algorithm device requiring machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
In summary, the provided text is a 510(k) premarket notification for a medical device seeking substantial equivalence, not a scientific study describing performance metrics against pre-defined acceptance criteria for a novel device or AI.
§ 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.