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The device is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication.

The GiEntriport with Universal Single Lumen Adaptor is a multiport Device Description. The GiEnthport with Offirstal Surges or to a single lumen feeding tube.

The provided text contains information about a 510(k) Premarket Notification for the GiEntriport Single Lumen Adaptor. However, it does not describe a study involving acceptance criteria, reported device performance, sample sizes for test/training sets, expert involvement, or comparative effectiveness studies of AI. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a performance study with detailed metrics.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states that "Engineering evaluation, and testing were conducted to demonstrate that the design of the proposed device was equivalent to the predicate devices, and/or met the requirements for gastric decompression and delivery of fluids as such devices, as defined in EN1615:2000." This indicates that some testing was done to meet standards (EN1615:2000) and demonstrate equivalence, but the specific acceptance criteria and detailed reported performance metrics are not provided in this 510(k) summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document mentions "Engineering evaluation, and testing" but does not detail sample sizes, types of tests performed, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a medical tube/adaptor, not a diagnostic imaging AI system. The concept of "ground truth" established by experts for a test set, as typically applied to AI/Machine Learning in diagnostics, does not apply here. The "ground truth" for this device would relate to its physical performance and safety characteristics.

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

• Not applicable. See point 3.

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 is a physical medical device, not an AI system. No MRMC studies or AI assistance are mentioned or relevant to this type of device.

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

• Not applicable. This is a physical medical device.

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

• Cannot be directly answered in the AI/ML context. For this device, the "truth" would be its adherence to established engineering standards (EN1615:2000) for safety and performance, and functional equivalence to predicate devices for its intended use (gastric decompression, fluid/nutritional delivery).

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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