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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.

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.

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