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The pREBOA-PRO™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The pREBOA-PRO™ Catheter balloon is designed with flow channels to enable the clinician precise, smooth control during inflation and deflation. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use. The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a quidewire. In addition, the catheter is compatible with guidewires up to 0.025" that can be used to facilitate subsequent vascular procedures affer a REBOA procedure. A peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line Pressure Relief (safety) Valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The peel-away sheath can be separated from the catheter shaft affer insertion if needed. The device is a single-use, sterile device.

The pREBOA-PRO Catheter is a medical device intended for temporary occlusion of large vessels and blood pressure monitoring, particularly in patients requiring emergency control of hemorrhage. The provided document is a 510(k) summary, which indicates that the device is seeking substantial equivalence to a legally marketed predicate device (ER-REBOA™ Catheter, K172790).

The document details performance data including various bench and in vivo animal tests to demonstrate the safety and effectiveness of the modifications made to the pREBOA-PRO Catheter compared to its predicate. Additionally, a retrospective clinical study using the predicate device is summarized to support the concept of partial REBOA, which the pREBOA-PRO Catheter is designed to facilitate with improved control.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance values for the pREBOA-PRO Catheter in a pass/fail format. Instead, it lists various "in vitro bench tests" and "in vivo animal tests" that were performed to demonstrate that the device "meets applicable design and performance requirements."

However, based on the types of tests mentioned, we can infer some of the performance aspects that were evaluated. For a medical device submission seeking substantial equivalence, "acceptance criteria" are often implicitly linked to demonstrating performance comparable to the predicate device and meeting recognized standards.

Here's a generalized table reflecting the types of performance assessed, acknowledging that specific numerical criteria are not provided in this summary:

It's crucial to note that the specific numerical targets or thresholds for "meets requirements" are not detailed in this summary. These would typically be found in the full submission to the FDA.

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

The document describes two main categories of studies:

• Bench and Animal Tests (for pREBOA-PRO Catheter itself):

  • Sample Size: Not explicitly stated for individual bench tests (e.g., how many catheters were tested for burst strength, fatigue, etc.).
  • Data Provenance: Not explicitly stated for the bench tests. For the in vivo animal tests, they were conducted using porcine and ovine models. These are prospective animal studies designed to evaluate the new device.

• Clinical Study (Retrospective, using the predicate ER-REBOA™ Catheter):

  • Sample Size: 46 patients were included in the retrospective clinical study.
  • Provenance: This was a retrospective analysis of data collected from a local prospectively collected database at a major US trauma center. The data was collected between January 2016 and May 2019. The information indicates the data is from the United States.

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

This information is not provided in the document.

For the retrospective clinical study, the "ground truth" would generally be established by clinical outcomes and diagnoses within the patient medical records. The study refers to "electronic data and local REBOA registry", implying that medical professionals (e.g., trauma surgeons, intensivists) made the clinical decisions and recorded outcomes. However, the exact number and qualifications of experts involved in data abstraction, adjudication, or "ground truth" determination for the study are not specified.

For the animal studies, the "ground truth" is measured physiological responses and observations, typically assessed by veterinarians and research personnel. Their specific qualifications are not mentioned.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

For the retrospective clinical study, it's unclear if any formal adjudication process was used to resolve discrepancies in patient data or outcomes. For bench and animal studies, "adjudication" in the sense of expert consensus on outcomes is less common; results are typically based on objective measurements and observations by the study team.

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:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device (pREBOA-PRO Catheter) is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human "readers" interpreting cases with or without AI assistance. Therefore, the concept of "effect size of how much human readers improve with AI" is not applicable here.

The document discusses the clinical effectiveness of a technique (REBOA, specifically partial REBOA) and the device's role in facilitating that technique, but not cognitive assistance.

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

No, this refers to a physical medical device, not a standalone algorithm. The "performance data" section details the device's mechanical, functional, and biological performance characteristics, evaluated through bench and animal testing. These are assessments of the device itself, akin to "standalone" performance for a physical product.

7. The Type of Ground Truth Used:

• For Bench Tests: The "ground truth" for bench tests is based on engineering specifications, recognized standards, and objective measurements of the device's physical and functional properties. For example, "balloon burst" would have an objective standard for acceptable pressure.
• For Animal Studies: The "ground truth" is based on physiological measurements (e.g., blood pressure, blood flow), observed performance (e.g., occlusion success, ease of deployment), and pathological findings from the animal models. This is considered outcomes data from an experimental setting.
• For Retrospective Clinical Study (using predicate device): The "ground truth" was derived from patient medical records, clinical outcomes data (e.g., mortality, organ failure, ventilator days, dialysis, vasopressor requirements), and the local REBOA registry. This is essentially retrospective clinical outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable in the conventional sense for this type of device submission.

• The pREBOA-PRO Catheter is a physical medical device. It does not employ machine learning algorithms that require a "training set" of data.
• The "Performance Data" describes validation and verification testing, not a training process.
• The "Real World Evidence" clinical study using the predicate device is an observational study of clinical outcomes, not a dataset used for "training" an algorithm.

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

This information is not applicable as there is no "training set" in the context of an AI algorithm described for this device. The "ground truth" for the device's design and testing (as described in point 7) was established through engineering principles, adherence to standards, and direct measurement in laboratory and animal settings, and for the retrospective study, through recorded clinical outcomes.

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