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GastroFlush is indicated for use in clearing occlusions/clogs from enteral feeding tubes placed for nutrition and/or decompression in adult or adolescent patients that have tube size 8Fr-24Fr and tube length no longer than 42 inches.

It is intended to be used by or under the direction of a licensed physician.

The GastroFlush device uses a pulsatile stream of pressurized water to gently dislodge and flush clogs from obstructed G-tubes, NG tubes and other tubes placed for the purposes of enteral nutrition and/or gastrointestinal decompression in the clinical or home setting. A series of connected one-way valves is used to ensure that the pressurized water flows in only the correct direction. Pressure relief valves with specified "cracking pressure" are used to ensure that overpressure of the system is avoided. Lastly, specialty connectors including the use of the new ENFit enteral feeding tube connectors conforming to ISO 80369-3 ensure against the inadvertent misconnection of the GastroFlush device to the clogged enteral tube, or the use of Luer syringes and/or similar devices in the attempt to unclog the enteral tube.

The provided text describes the "GastroFlush" device and its performance testing, specifically "Bench Testing" which includes "Tube Clearance Testing", "Leak-Free Pressure Testing", and "Overpressure Valve Testing". There is no multi-reader multi-case (MRMC) comparative effectiveness study, nor a standalone algorithm performance study, as this is a physical medical device, not an AI/software device. Similarly, there is no mention of training sets or ground truth establishment relevant to machine learning.

Here's the information extracted from the provided document, formatted to answer the questions:

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Tube Clearance Testing: 30 enteral feeding tubes from each "worst case" group (smallest diameter/longest tubes and largest diameter/longest tubes), for a total of 60 tubes.
   • Leak-Free Pressure Testing: 30 enteral feeding tubes from each group (unspecified if the same "worst case" tubes or different), so at least 30 samples.
   • Overpressure Valve Testing: 15 sample valves from the production lot.
   • Data Provenance: The tests are described as "in-vitro" and "bench testing," meaning they were conducted in a laboratory setting. No specific country of origin for the data is mentioned, but the company (Bionix Development Corporation) is based in Toledo, Ohio, USA. The testing is retrospective in the sense that it was completed prior to the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is a physical device testing its mechanical properties and performance against established specifications ("in-vitro occlusion," "leak-free performance," "valve opening pressure"). There's no subjective "ground truth" derived from expert consensus as would be the case for image interpretation in AI. The "worst case" examples for tube clearance were defined through "discussions with FDA reviewers," implying regulatory and technical expert input during the protocol definition phase, but not for establishing individual ground truth labels for the test set itself.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as the testing involves objective measurement of device performance, not human interpretation or a need for adjudication.

4. 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:

   • No. This is not an AI/software device. No MRMC study was conducted.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical mechanical device designed to be used by a medical professional. Its performance is inherent to the device itself (e.g., its ability to clear a clog or resist leaks).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for these tests relates to the physical and functional parameters of the device.
     • For Tube Clearance Testing, the ground truth was whether the device successfully cleared an "in-vitro occlusion." The occlusions themselves were "defined through discussions with FDA reviewers" to represent "worst case" scenarios.
     • For Leak-Free Pressure Testing, the ground truth was the absence of leakage at specified pressures.
     • For Overpressure Valve Testing, the ground truth was the measured opening pressure of the valve against a specified range.
   • These are engineering/performance specifications, not clinical or diagnostic ground truth.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable. This is not a machine learning device.

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