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The iPulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle.

Indications for Use:

Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from:

Unstable refractory angina .
Impending infarction ●
Post Infarction Angina or Threatening Extension of Myocardial Infarction .
Refractory ventricular failure .
Mechanical complications because of myocardial infarction ●
Cardiogenic shock .
Support and stabilization of high risk patients undergoing diagnostic and non-surgical ● procedures
Ischemic related intractable ventricular arrhythmias .
Septic shock .
Interoperative pulsatile flow generation
Weaning from cardiopulmonary bypass .
Cardiac support for high risk surgical patients and coronary angiography and angioplasty ● patients
Prophylactic support in preparation for cardiac surgery .
. Post-surgical myocardial dysfunction
Cardiac Contusion .
Mechanical bridge to other assist devices ●
Cardiac support following correction of anatomical defects ●
Support for failed angioplasty and valvuloplasty

Device Description

The iPulse Intra-Aortic Balloon Pump (IABP) Console is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. The iPulse IABP Console is designed to work in conditions which are unique to the operating room, catheterization laboratory, critical care unit and during transport. The iPulse IABP Console has two operation modes; auto and manual. The auto operation mode provides simplicity and minimizes operator intervention. The manual operation mode provides operators with flexibility for difficult clinical cases.

The iPulse IABP Console is an electro-mechanical system used to inflate and deflate 8 French, 40 cc intra-aortic balloon catheters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

Acceptance Criteria and Device Performance Study

The iPulse Intra-Aortic Balloon Pump Console's acceptance criteria primarily revolved around demonstrating equivalence to two legally marketed predicate devices: the Datascope CS100 Intra-Aortic Balloon Pump (K031636) and the Arrow AutoCAT2 Intra-Aortic Balloon Pump (K002256).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Derived from Predicate Equivalence)	Reported Device Performance (iPulse Console)	Relevant Section for Performance
Intended Duration of Use: Temporary use, approx. ≤ 30 days	Temporary use, Approx. ≤ 30 days	Table 1
IAB Catheter Tested: 8F, 40 cc	8F, 40 cc	Table 1
IABP Drive System: Electro-pneumatic with replaceable helium cylinder	Electro-pneumatic with replaceable helium cylinder	Table 1
User Interface/Display Type: Laptop	Laptop	Table 1
Maximum Beat Rate: ≥ 185 BPM (based on lower predicate)	200 BPM	Table 1
Trigger Signals Accepted: ECG, Aortic pressure	ECG, Aortic pressure	Table 1
Console Size (on Cart): Comparable dimensions to predicates	30"Hx23"Wx11"D	Table 1
Console Weight: Comparable weight to predicates	126 lbs	Table 1
Voltage Requirement: 120/240 Vac	120/240 Vac	Table 1
Battery Type: Sealed Lead Acid	Sealed Lead Acid	Table 1
Battery Runtime (minimum): ≥ 2.0 hours (based on lower predicate)	2.5 hours	Table 1
Safety and Effectiveness: Equivalent to predicates	Safe and effective	Section g & h
Performance and Reliability: In accordance with FDA guidance	Demonstrated equivalence to 2 predicate IABP consoles	Section g
Software Verification: Compliance with applicable standards	Demonstrated compliance	Section g
Electrical Standards (EMI, EMC, Electrical Safety): Compliance with applicable standards	Demonstrated compliance	Section g

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

The document does not explicitly state a "test set" in terms of patient data or a specific number of devices tested for comparative performance. The pre-clinical testing mentioned involves "laboratory tests" which are typically in-house engineering and performance evaluations.

Sample Size: Not specified in terms of number of devices or clinical cases. The testing was conducted on the iPulse IABP Console itself.
Data Provenance: The testing was "pre-clinical laboratory testing" conducted by ABIOMED, Inc. (manufacturer). There is no mention of country of origin for any external data, and it is entirely retrospective in the sense that it's a report of completed internal testing.

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

Not applicable. The ground truth for this device's performance relies on engineering specifications, adherence to functional requirements, and comparison to the published specifications and performance characteristics of predicate devices. There is no mention of human expert evaluation in establishing a "ground truth" for the device's technical performance in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable, as there was no "test set" requiring adjudication by human experts in a clinical context. The "adjudication" for the device's performance was an assessment against established engineering and regulatory standards and comparison to predicate device specifications.

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 device is an Intra-Aortic Balloon Pump Console, not an AI-powered diagnostic tool requiring a MRMC study for human reader performance. Its effectiveness is measured by its mechanical and electrical performance in assisting the heart, not by improving human interpretation of medical images or data.

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

Not applicable. This is a medical device (hardware and embedded software) that operates in conjunction with human operation (human-in-the-loop is inherent to its use in a clinical setting). It is not solely an "algorithm" in the sense of an AI model being evaluated for standalone diagnostic performance. The pre-clinical testing did evaluate its standalone technical performance against specifications.

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

The ground truth for evaluating the iPulse IABP Console's performance was:

Engineering specifications and functional requirements: The device was tested against its design specifications for parameters like maximum beat rate, battery runtime, drive system, etc.
Regulatory standards: Compliance with applicable electrical standards (EMI, EMC, Electrical Safety) and software verification methods.
Predicate device performance: The performance of the iPulse console was specifically compared to the Datascope CS100 and Arrow AutoCAT2, aiming for "equivalence" in performance and reliability. FDA guidance for IABP catheters and consoles was also referenced.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model that requires a training set.

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

Not applicable. This document describes a medical device, not a machine learning model that requires a training set and corresponding ground truth.

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