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The AC3TM Series IABP (Intra-Aortic Balloon Pump) System is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure

Device Description

The AC3 Series Intra-Aortic Balloon Pump (IABP) System, which is the subject of this submission, is substantially equivalent to the previously cleared Arrow AutoCAT®2 IABP System which was previously cleared via K060309.
The AC3 Series IABP System is the next generation platform which is based on the existing AutoCAT2 IABP System; cleared Device via K060309 on 6 April 2006.
The AC3 Series IABP System (AutoCAT3) includes a new Graphical User Interface. The primary algorithms that control the therapeutic function of the device have not been altered from the AutoCAT2.
The AC3 Series IABP system provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an IAB (Intra-aortic Balloon) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta.
The IABP delivers Helium (HE) into the IAB during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes HE from the IAB just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the pressure the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand.
The AC3 Series IABP System consists of two main components:
The pump control / display module which incorporates a touch screen and keypad for system operation
The pneumatic drive module which is incorporated into the body of the device.
The AC3 is designed to be used with 30, 35, 40, and 50cc Intra-Aortic Balloons with the appropriate connectors. (UltraFlex™, Ultra 80, NarrowFlex®, and RediGuard® Catheters).
The system offers two modes of operation:
Autopilot Mode, where most functions are automatically selected and controlled by the IABP
Operator mode, where an operator can control most settings and selections.

AI/ML Overview

This is a 510(k) premarket notification for an Intra-Aortic Balloon Pump (IABP) system called AC3 Series IABP. It argues for substantial equivalence to a previously cleared predicate device, the AutoCAT2 IABP System.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics in a pass/fail format for clinical performance. Instead, it details various types of performance testing and states that the device "meets all requirements," "is in compliance with the standards," and "meets all acceptance criteria and specifications." The comparison table (Table 5.2) focuses on demonstrating that the new AC3 Series IABP is either "No change," "Same as AutoCAT2," or has "Greater range" or "Improved" features compared to the predicate device.

However, based on the descriptions of the tests, we can infer some implicit acceptance criteria and the device's reported performance:

Aspect of Performance	Implicit Acceptance Criteria	Reported Device Performance and Study Summary
Electrical Safety & EMC	Compliance with IEC 60601-1 (3rd ed.), 60601-1-2 (3rd ed.), 60601-1-6 (3rd ed.), 60601-1-8 (2nd ed.), 60601-2-27 (3rd ed.), 60601-2-34 (3rd ed.), 60601-2-49 (2nd ed.), and RTCA DO-160 Section 20 Category R.	"Test reports provided confirm that the AC3 is in compliance with the standards as noted in Table 5.1." (Performed by an outside test house).
Software Verification	Compliance with IEC 62304:2006 (Medical device software-Software lifecycle processes) and FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software requirements must be met.	"Software Verification testing has been completed to demonstrate that the software requirements have been met. Documentation has been supplied to also comply with FDA's guidance document, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'."
Human Factors / Usability	Changes to the user interface should not negatively impact device performance. Compliance with FDA's "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366:2007. No use errors observed during testing, and a high percentage of successful task completion (e.g., >95% successful completion with no operational difficulty).	33 users participated in the evaluation, performing 22 use cases based on critical tasks and potential risk areas. "There were no use errors observed during testing and 96% of the use cases were completed successfully with no operational difficulty (on the first attempt) whereas 4% of the use cases were completed with only minor operational difficulty."
Cleaning & Disinfection	Effectiveness of recommended cleaning methods (AAMI TIR12:2010, AAMI TIR30:2011). Disinfection method must result in a six log10 reduction in colony forming units (CFU) of selected organisms (AAMI TIR12:2010, ANSI/AAMI ST58:2013).	"Testing was completed to verify the effectiveness of the recommended cleaning methods." Components representing worst-case material/use profile were selected. "Testing was also completed to demonstrate the recommended method of disinfection would result in a six log10 reduction in colony forming units (CFU) of selected organisms." "Testing demonstrated the AC3 Series IABP system could effectively be cleaned and disinfected using the recommended methods." (Performed by an outside test house).
Environmental / Mechanical Testing	Device meets all requirements for operational parameters and reliability. Device is substantially equivalent to the predicate (AutoCAT2 IABP).	"The result of this testing confirms that the device meets all acceptance criteria and specifications as required." This testing confirmed that the AC3 is substantially equivalent to AutoCAT2. (No specific numerical results provided).
ECG Trigger Validation	ECG triggering of the AC3 Series IABP system is equivalent to the AutoCAT2 ECG Triggering.	"Testing was conducted using recordings of real Electro-Cardiogram (ECG) waveforms from the American Heart Association (AHA) database." An AutoCAT2 and AC3 Series IABP system were simultaneously assessed using the same ECG input. "The data confirmed that the devices are substantially equivalent with regard to their triggering reliability."
Reliability Testing	Device can run continuously and perform as intended. All acceptance criteria for continuous operation are met.	AC3 pumps were run continuously for 9 days (216 to 218 hours). "All pumps successfully inflated and deflated the attached IAB catheter and met all acceptance criteria for this test."
Rate Limit Testing (Balloon Inflation/Deflation)	System successfully inflates and deflates various size IAB catheters (30cc, 35cc, 40cc, 50cc). Inflation and deflation meet all requirements.	"Testing confirmed that the inflation and deflation of connected balloons met all requirements."

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

Human Factors / Usability Testing: 33 users participated. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but given it's a usability test for a medical device seeking FDA clearance, it's highly likely to be prospective data collected in a controlled environment.
ECG Trigger Validation: "Recordings of real Electro-Cardiogram (ECG) waveforms from the American Heart Association (AHA) database." This suggests a retrospective dataset of real patient ECGs. The specific sample size (number of ECG waveforms or patients) is not provided.
Reliability Testing: The "sample" here refers to the number of AC3 pumps. "AC3 pumps were run continuously for 9 days." The exact number of pumps is not specified, but it implies multiple units were used for the continuous run test.
Cleaning/Disinfection & Electrical Safety/EMC: Sample sizes are not specified, but these are typically tested on a limited number of device units or components.

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

Human Factors / Usability Testing: There is no mention of "experts" establishing ground truth in the context of clinical outcomes or diagnoses. The "ground truth" for this test is successful task completion and absence of use errors, which is assessed by the participants' performance and observations by the test administrators.
ECG Trigger Validation: The "ground truth" for ECG triggering would be the accurate detection and timing of specific cardiac events within the AHA ECG waveforms. While the AHA database provides these waveforms, the process for establishing the "truth" of these events (e.g., expert cardiologists annotating them) is inherent to the database itself and not detailed here as part of the AC3 study. The study compares the AC3's detection accuracy against the already established and accepted timing in the database, and against the predicate device.
For other tests (Electrical Safety, Software, Cleaning, Mechanical), ground truth is established by adherence to recognized standards and specifications, not typically by expert consensus of individual cases.

4. Adjudication Method for the Test Set

Human Factors / Usability Testing: Not explicitly an adjudication method in the sense of reconciling clinical interpretations. The observed "minor operational difficulty" for 4% of use cases was likely directly observed and categorized by the test administrators, rather than requiring formal adjudication among multiple reviewers.
ECG Trigger Validation: The comparison seems to be direct against the AHA database and the predicate device. There is no mention of an adjudication panel.
For other tests, adjudication methods are not applicable as they involve objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not Applicable: This document describes a traditional 510(k) submission for an Intra-Aortic Balloon Pump system, which is a hardware device with embedded software. It is not an AI-driven diagnostic or interpretative software device. Therefore, MRMC studies and the concept of "human readers improving with AI vs without AI assistance" are not relevant to this submission. The "AI" mentioned ("primary algorithms that control the therapeutic function") in this context refers to the device's control logic, not AI in the sense of machine learning for interpretation or diagnostic aid.

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

Yes, implicitly for some aspects: The "algorithm" here refers to the embedded control software.
- Software Verification Testing: This is effectively a standalone test of the software's functionality and adherence to requirements.
- ECG Trigger Validation: The comparison of the AC3 system's (algorithm's) ECG triggering against the AHA database and the predicate device is a standalone performance assessment of a key algorithmic function.
- Reliability Testing: The pumps running continuously and performing as intended is a standalone assessment of the device's overall function, which includes its internal algorithms determining inflation/deflation.

7. The Type of Ground Truth Used

Industry Standards and Specifications: For Electrical Safety & EMC, Software Verification, Cleaning & Disinfection, and Environmental/Mechanical Testing, the ground truth is established by the requirements of the cited international standards (IEC, AAMI, ANSI/AAMI, RTCA DO-160) and the device's own design specifications.
AHA Database ECG Waveforms: For ECG Trigger Validation, the "ground truth" for cardiac event timing is derived from the established and validated waveforms within the American Heart Association (AHA) database.
Observed Performance / Absence of Errors: For Human Factors/Usability Testing, the "ground truth" for usability is based on direct observation of user interaction and successful task completion, as defined by the study protocol.
Predicate Device Performance: In many instances, the "ground truth" or benchmark for demonstrating substantial equivalence is the performance of the legally marketed predicate device (AutoCAT2), particularly for aspects like ECG triggering where direct simultaneous comparison was performed.

8. The Sample Size for the Training Set

Not Applicable in the traditional ML sense: Since this is not an AI/Machine Learning diagnostic device, there isn't a "training set" in the conventional meaning. The "primary algorithms that control the therapeutic function" are described as largely unchanged from the predicate device (AutoCAT2 IABP System). These are likely deterministic control algorithms developed through engineering design, rather than machine learning models trained on data.

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

Not Applicable: As there is no traditional ML training set described, the concept of establishing ground truth for it is not relevant to this submission. The "ground truth" that guided the development of the device's core algorithms would have been established through physiological understanding, engineering principles, and clinical/pre-clinical testing over the development cycles of this device and its predicate.

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