Search Results

The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.

The GastriSail™ Gastric Positioning System is a 40FR flexible, non-sterile, single-use, dual lumen gastric tube designed to be inserted into the esophagus by an anesthesiologist for use in gastric and bariatric surgical procedures, such as sleeve gastrectomy.

The GastriSail™ Gastric Positioning System consists of a dual lumen flexible tube. One lumen houses the Sail feature and integrated LED guidelights, and the other lumen has rows of distal holes which, when connected to suction provides vacuum to the stomach for evacuation of stomach contents and suction fixation along the lesser curvature of the stomach. This lumen is also used to perform leak testing at the end of the procedure.

This document is a 510(k) premarket notification for a medical device, the GastriSail™ Gastric Positioning System. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics for a novel AI algorithm.

Therefore, many of the requested categories relating to AI algorithm performance and clinical study design are not applicable or cannot be extracted from this document.

Here's an analysis of the provided text in relation to your request:

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

The document does not present a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for a device's performance in the way an AI algorithm study would. Instead, it details non-clinical and in-vivo testing to demonstrate that the modified device's characteristics are comparable to the predicate device.

The "acceptance criteria" are implied by the types of tests conducted and their successful completion, indicating that the device performs as expected and is substantially equivalent to the predicate.

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

The document does not provide specific sample sizes for the "test set" in terms of number of patients or cases. The non-clinical and in-vivo tests likely used a predetermined number of devices/specimens for each test, but these are not explicitly stated.

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, but the in-vivo testing was conducted in "porcine," indicating animal model data, not human patient data. These studies are typically prospective laboratory/animal model studies.

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)

This is not applicable. This device is a physical surgical tool, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the performance tests would be objective measurements and observations determined by engineers and researchers during the testing.

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

Not applicable. This concept applies to human expert review and consensus, typically for establishing ground truth in diagnostic studies, which is not the nature of this submission.

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 not an AI-powered diagnostic device, and no MRMC study was conducted. The device is a physical surgical instrument.

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

Not applicable. This device is a physical instrument, not an algorithm.

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

The ground truth for the non-clinical and in-vivo testing would be based on:

• Objective Measurements: For dimensional measurements, vacuum pressure, tensile strength, battery performance.
• Engineering Specifications: Whether the device meets predefined criteria for its physical and functional attributes.
• Observation/Evaluation by Trained Personnel: For visual inspection and the esophageal insertion test in porcine models, assessing proper function and absence of adverse events.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. See point 8.

Ask a specific question about this device