(34 days)
AQUARIUS™ Gastrostomy Replacement Tube is intended for use in a well-established gastrostomy tract for feeding and/or administration of medications. May be used for gastric decompression.
Aquariusi Gastrostomy Replacement Tube is a silicone feeding tube comprised of a double lumen tube with external proximal specific ENFit safety access port/s, external retention disk, balloon, and distal open flow-through tip. The tube is with external graduations (cm) and radiopaque marker at the distal end. The tube size and balloon capacity are clearly indicated on the shaft and pouch of each device. The tube is made without use of natural latex, BPA, or phthalates plasticizers.
The provided document is a 510(k) premarket notification for a medical device called the AQUARIUS™ Gastrostomy Replacement Tube. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device, demonstrating substantial equivalence to a legally marketed predicate device.
This document does not describe a study related to the performance of an AI/ML (Artificial Intelligence/Machine Learning) device or a study involving human readers. Therefore, I cannot extract information related to acceptance criteria and studies in the context of AI/ML or human performance improvement.
Instead, the document details the non-clinical summary for the AQUARIUS™ Gastrostomy Replacement Tube, which focuses on device functionality and safety. Here's an analysis of the "acceptance criteria" and "study" in that context:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various performance functionality tests conducted on the Gastrostomy Replacement Tube. While specific quantitative acceptance criteria are not explicitly stated in this summary, the completion of these tests implies that the device met pre-defined acceptable limits for each. The "reported device performance" is essentially the successful completion of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Positive pressure liquid leak (within limits) | Test conducted and passed |
| Stress Cracking (within limits) | Test conducted and passed |
| Resistance to separation from axial load (within limits) | Test conducted and passed |
| Resistance to separation from unscrewing (within limits) | Test conducted and passed |
| Resistance to overriding (within limits) | Test conducted and passed |
| Disconnection by unscrewing (within limits) | Test conducted and passed |
| Flow rate (within specifications) | Test conducted and passed |
| Dimension verification (within specifications) | Test conducted and passed |
| Tensile strength (within specifications) | Test conducted and passed |
| Tensile strength of connections (10Fr) (within specifications) | Test conducted and passed |
| Leak Test for G-tube 10F (within limits) | Test conducted and passed |
| Simulated Gastric fluids for G-tube 10Fr (no adverse effects) | Test conducted and passed |
| Balloon burst volume for G-tube 10Fr (within specifications) | Test conducted and passed |
| Biocompatibility (acceptable) | Evaluation conducted and passed |
| Shelf life (3 years) (met) | Test conducted and passed for 3 years shelf life |
2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not a dataset. The "test set" would be the specific physical samples of the device used for each test. The provenance is the manufacturer (Degania Silicone, Ltd. in Israel).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is for physical device testing, not expert-adjudicated data.
4. Adjudication method for the test set: Not applicable. This refers to physical device testing, not expert-adjudicated data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a medical device (gastrostomy tube), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a medical device (gastrostomy tube), not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these non-clinical tests is established by industry standards, international standards (like ISO 14971:2012 for risk management), and internal engineering specifications for the device's physical and functional performance. It's based on objective, measurable parameters and established engineering principles, not expert consensus or clinical outcomes data in the usual sense.
8. The sample size for the training set: Not applicable. This document is for a medical device (gastrostomy tube), not an AI/ML system. There is no concept of a "training set" for physical device testing.
9. How the ground truth for the training set was established: Not applicable. As there's no training set, there's no ground truth to establish for it in this context.
§ 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.