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The Neurescue device is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The NEURESCUE device is a large vessel occlusion catheter comprised of two main components: The NEURESCUE Catheter and the NEURESCUE Assistant.

The Catheter is an occlusion balloon catheter and the Assistant is a hub for interfacing with the operation of the Catheter. During normal use the device can be operated automatically. Alternatively, the device can be operated manually.

For manual use the interface consists of two Luer lock ports for:

• Manual inflation and deflation of the balloon with saline -
• -Flushing of the arterial FLUSH port with saline

Inflation and deflation of the balloon can be accomplished by an automatic filling and deflation function (automatic operation with a peristaltic pump) or manually.

Whether the filling is performed manually or automatically, the user is informed of the pressure at the tip of the Catheter. The device has a built-in alarms system.

The provided text describes the 510(k) summary for the Neurescue device, which is a vascular clamp. It outlines performance testing (bench and in vivo) to support its safety and effectiveness and its substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria or reported device performance in the format of a table, nor does it detail a clinical study with human subjects (multi-reader multi-case, standalone, etc.) that would prove the device meets acceptance criteria related to diagnostic or assistive performance with AI.

The document focuses on engineering and animal model testing to demonstrate the device's technical specifications and physical performance (e.g., balloon inflation, pressure sensing, material integrity) and its intended use for temporary occlusion of large vessels and blood pressure monitoring.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and type of ground truth used for AI-related performance, are not applicable or not available in this FDA 510(k) summary because the device is a physical medical device (vascular clamp), not an AI-driven diagnostic or assistive software.

However, I can extract the information related to the acceptance criteria and performance testing that is mentioned, recognizing that it pertains to the device's physical and functional attributes rather than AI performance.

Acceptance Criteria and Device Performance (Based on Provided Text)

Given the nature of the device (a physical vascular clamp, not an AI software), the "acceptance criteria" discussed in the document are primarily related to its mechanical performance, functionality, and safety in in vitro (bench) and in vivo (animal) testing, rather than diagnostic accuracy or human reader improvement. The document summarizes categories of tests and states that the device "meets applicable design and performance requirements" or "demonstrate[s] that the NEURESCUE device has been designed for and tested to conform to its intended use," implying these were the acceptance criteria for each test.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bench Testing: The specific sample sizes for each in vitro (bench) test are not provided in this summary. The tests are described as being "carried out" or "verified," implying sufficient samples were used to meet internal validation requirements.
• In Vivo Testing: One "GLP Study to Evaluate the Performance of the NEURESCUE Catheter in the Aorta of an Acute Naïve Porcine Model" was conducted. The exact number of porcine models (sample size) is not specified.
• Data Provenance: The tests are part of the premarket notification (510k) submission by Neurescue Aps, located in Copenhagen, Denmark. The data would thus originate from their internal testing or contracted testing facilities. All testing described is of a prospective nature (designed and conducted specifically for this submission). No reference to retrospective data is made.

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

• For the technical and performance testing (bench and in vivo), "ground truth" is established by engineering specifications, physical measurements, and observed functional performance rather than expert (e.g., radiologist) interpretation.
• The radiopacity test mentions "real users" with human cadavers; however, the number or qualifications of these users/experts are not specified. Their role seemed to be to confirm visibility, not to establish a diagnostic ground truth.

4. Adjudication Method for the Test Set

• Not applicable as the testing involves objective measurements, mechanical performance, and animal studies, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic or assistive devices where human reader performance is a key outcome. The Neurescue device is a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone study (in the context of AI performance) was not done. The device's "automatic inflation and deflation function" and "built-in alarm system" are functionalities of the device itself, not an AI algorithm that makes diagnostic predictions. Performance of these automated functions would be part of the bench and software testing, but not a standalone AI performance study.

7. The Type of Ground Truth Used

• Engineering Specifications and Physical Measurements: For bench tests (e.g., dimensions, tensile strength, burst volume, pressure accuracy, inflation time, battery life).
• Observed Functional Performance: For tests like kink resistance, deployment, occlusion, and alarm functions.
• Biocompatibility Standards: For biocompatibility tests.
• Animal Physiological Response/Survival: For the in vivo GLP study in porcine models, performance would be assessed against physiological parameters and outcomes in the animal model.
• User Observation/Feedback: For radiopacity testing ("real users with human cadavers").

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI-driven system that requires a "training set" in the context of machine learning. The software testing mentioned refers to traditional software development and validation (unit testing, system testing, software validation) for controlling the device's functions, not for training a predictive model.

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

• Not applicable. See point 8.

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