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The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.

The REALIZETM Gastric Calibration Tube is a non-sterile, single patient use instrument consisting of a 745 mm long silicone tube with an approximate 38 F (12.7mm) rounded, closed tip. At the proximal end, the tube is equipped with a check valve which mates with a syringe used to fill a balloon located approximately 6.8 cm from the distal tip. At the distal end, the tube has two suction/irrigation holes that allow the removal of fluids and/ or irrigation during the procedure, if necessary. Reference markings are provided on the tube shaft, with the zero reference located approximately 39.6 cm from the proximal end of the balloon.

The provided text describes a 510(k) submission for the REALIZE™ Gastric Calibration Tube. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt (acceptance criteria, specific study details like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth methodologies) is generally not part of a 510(k) summary for a device like this.

A 510(k) summary for a relatively low-risk device like a gastric calibration tube primarily relies on:

• Comparison to predicate devices: Showing similar intended use, technological characteristics, and materials.
• Bench testing: To confirm the new device performs as intended and is equivalent to the predicate.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

• Gastric calibration
• Visible and tactile delineation of the antrum
• Decompression of the stomach
• Drainage and removal of gastric fluid
• Sizing of a gastric pouch
• Maintenance of integrity (e.g., balloon inflation, tube strength)
• Material compatibility and biocompatibility (implied by material similarity) | "Bench testing was performed to evaluate the performance of the intended use of the new device. The performance testing shows that the REALIZE™ Gastric Calibration Tube is equivalent to the BioEnterics® Gastric Balloon Suction Catheter."

Specifics:

• Non-sterile, single patient use.
• 745 mm long silicone tube.
• Approximate 38 F (12.7mm) rounded, closed tip.
• Proximal end: check valve for syringe.
• Balloon: 6.8 cm from distal tip.
• Distal end: two suction/irrigation holes.
• Reference markings on tube shaft. |

Missing Information/Not Applicable to 510(k) Summary:

• Quantified acceptance criteria (e.g., "balloon must inflate to X pressure without leakage for Y duration"). The summary only states "equivalent."
• Specific numerical performance metrics for the REALIZE™ device.
• Detailed comparison results showing how the REALIZE™ device met each implied criterion against the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified. "Bench testing" generally refers to laboratory testing of physical samples, not human subjects or patient data.
• Data Provenance: Not specified, but implied to be laboratory-generated (bench testing) and not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable. For bench testing of a physical device like this, "ground truth" as it relates to expert review of medical images or patient outcomes is not relevant. The "truth" is established by engineering specifications and direct physical measurements.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods are typically used for subjective assessments (e.g., image interpretation) or clinical endpoints in human studies. Bench testing results are typically objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases. This device's performance was evaluated through bench testing, not an MRMC study.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this device does not involve AI or image interpretation by human readers.

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

• No. This device is a physical medical instrument, not an algorithm. Standalone performance refers to the performance of a software algorithm without human intervention.

7. The Type of Ground Truth Used

• For this type of device and testing, the "ground truth" would be established by engineering specifications, direct physical measurements and observations during bench testing, and potentially comparison to the known performance of the predicate devices. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As above, no training set for an AI/ML algorithm was used.

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