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The REBOA Balloon Occlusion Catheter is a coaxial catheter recommended for temporary occlusion of the aorta. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi-layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter, and will accept the passage of the appropriate guidewire. All catheter sizes will have radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. There are also markings on the catheter shaft to aid in placement. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.

AI/ML Overview

This document describes testing and acceptance criteria for the REBOA Catheter, a device intended for temporary occlusion of the aorta.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria	REBOA Results	Predicate Device - PTS-X Results
Visual Inspection	The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device.	All catheters were visually inspected without any anomalies.	All catheters were visually inspected without any anomalies.
Balloon Preparation Test	Each catheter shall be prepped per the procedure without functional difficulties or anomalies.	All catheters tested were without functional difficulties or anomalies.	All catheters tested were without functional difficulties or anomalies.
Diameter and Profile Test	The balloon diameter at rated burst pressure / volume shall be within +/- 10% of the labeled balloon diameter and the samples should fit through the selected introducer with no problems.	All catheters met the acceptance criteria.	All catheters met the acceptance criteria.
Balloon Distensibility	The results must demonstrate that the balloon diameter are within +/- 10% of the labeled diameter at the RBP / rated volume and will not be significantly increased at increasingly higher pressures.	All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the rated volume. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.	All data obtained demonstrates that the balloon diameter is within +/- 10% of the labeled diameter at the RBP. All data obtained demonstrates that the diameter of the balloons will not be significantly increased at increasingly higher pressures.
Balloon Minimum Burst Strength / Volume	The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure / volume.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Repeated Balloon Inflation (Balloon Fatigue) Test	No breaks allowed.	No Breaks.	No breaks.
Balloon Inflation/Deflation Test	Inflation achieved in less than 12 seconds and deflation achieved in less than 59 seconds.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Balloon Deflatability Test	There should be no interference with balloon deflation.	All catheters met the established acceptance criteria.	All catheters met the established acceptance criteria.
Tip Pull and Torque Test	Must withstand at least 8 turns without breaking.	No breaks.	No breaks.
Bond Strength Test	All bonds must withstand at least 8.9 Newtons / 2 lbs. of pull strength.	All bonds met the established acceptance criteria.	All bonds met the established acceptance criteria.
Catheter Body Maximum Pressure Test	All samples must withstand 700 psi.	All samples met the established acceptance criteria.	All samples met the established acceptance criteria.

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

The document does not explicitly state the specific sample sizes used for each in-vitro test. It mentions "All catheters" or "All samples" met the criteria, suggesting that a representative sample was tested for each evaluation.

The data provenance is from in-vitro testing, meaning the tests were conducted in a laboratory setting, not on human subjects. There is no information regarding country of origin, retrospective or prospective data.

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

This information is not applicable as the "ground truth" for the in-vitro tests conducted on the REBOA Catheter is based on objective, measurable physical and mechanical properties, not expert interpretation of diagnostic data.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are objective physical measurements, not requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

This information is not applicable as the REBOA Catheter is a medical device, not an AI diagnostic tool that would involve human readers.

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

This information is not applicable for the same reason as point 5.

7. The Type of Ground Truth Used:

The ground truth for the in-vitro tests is based on objective, measurable physical and mechanical properties (e.g., diameter, pressure resistance, burst strength, inflation/deflation times, pull strength).

8. The Sample Size for the Training Set:

This information is not applicable as there is no mention of a "training set" in the context of this device. The testing described is for performance verification of the final device, not for training a model or algorithm.

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

This information is not applicable for the same reason as point 8.

Summary of the Study:

The study detailed in the 510(k) Summary is an in-vitro performance verification study of the REBOA Catheter. It compares the performance of the REBOA Catheter against pre-defined acceptance criteria and, in some cases, against a predicate device (PTS-X PTV Catheter and Fogarty Occlusion Catheter). The study aims to demonstrate that the REBOA Catheter meets the necessary physical and mechanical specifications for its intended use, establishing substantial equivalence to legally marketed predicate devices. The "study" here refers to a series of laboratory tests, not a clinical trial or an AI algorithm validation.

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