(58 days)
The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure
The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provides temporary support to patients with impaired left ventricular function through the therapeutic method referred to as counterpulsation increases coronary and systemic profusion, decreasing after load (myocardial work) and decreasing preload.
The AutoCAT Series IABP System utilizes computer technology to select and maintain precise IAB inflation and deflation timing and triggering based on current physiological data from the patient. The system offers two modes of operation, the Autopilot mode, where functions are automatically selected and controlled by the IABP and the Operator mode where the user has control over settings and selections.
The provided documents are a 510(k) summary and FDA clearance letters for the Arrow AutoCAT Intra-Aortic Balloon Pump Series. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI/ML device.
However, based on the information provided, I can infer and reconstruct some aspects relevant to your request, especially regarding performance data and regulatory compliance.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported numerical device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that the device, with modified software, "meets all the same performance standards of the unmodified device." It then lists the regulatory and guidance documents it complies with, implying that performance is evaluated against these standards.
Inferred Acceptance Criteria / Performance:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Functional Equivalence | The AutoCAT Series IABP System (with V2.22 software) is substantially equivalent in Intended Use and Fundamental Scientific Technology to the predicate devices (AutoCAT K983866, ACAT 1 K965209, ACAT 2 K002256, FOS / FOMS IAB Black Box K021462). | This is the primary "acceptance criterion" for a 510(k) submission. The new device must perform comparably to a legally marketed predicate device. The performance is assessed through various tests to show the modifications (software V2.22) do not raise new questions of safety and effectiveness. |
| Performance Standards | "The AutoCAT IABP Series with modified software meets all the same performance standards of the unmodified device." | This is a general statement. Specific numerical performance data is not provided in a table. It implicitly means the device performs its intended therapeutic function (counterpulsation, increasing coronary/systemic perfusion, decreasing afterload/preload) at a level comparable to the predicate devices. |
| Software Validation | Complies with "FDA Guidance: 'General Principles of Software Validation - Final Guidance' January 11, 2002" and "FDA Guidance: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Final Guidance' May 11, 2005". | This ensures that the software modifications (V2.22) were developed and tested according to FDA's standards for medical device software, implying safety and reliability. |
| Electrical Safety/EMC | Complies with IEC 60601-1-4:1997 (Medical Electrical Equipment- General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems), EN 55024:1998 (Information Technology Equipment-Immunity Characteristics), and EN 55022:1998 (Information Technology Equipment- Radio Disturbance Characteristics Limits and Methods of Measurement). | These are international standards for electrical safety and electromagnetic compatibility (EMC) in medical devices, ensuring the device operates safely and without interference in a medical environment. |
| Clinical Indications | Cleared for: a. Acute Coronary Syndrome, b. Cardiac and Non-Cardiac Surgery, c. Complications of Heart Failure. | The device's performance must be sufficient to support these clinical indications for use, as demonstrated by equivalence to predicate devices and adherence to relevant standards. |
2. Sample size used for the test set and the data provenance
The document does not provide specific details on the sample size for a test set (e.g., number of patients, number of cases) or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for studies involving clinical data, which is not the primary focus of this 510(k) summary for a software update to an established device. The assessment here is centered on the software modifications and adherence to engineering/safety standards rather than a new clinical trial with a "test set" of patient data in the AI/ML sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is a 510(k) for an Intra-Aortic Balloon Pump software update, the "ground truth" concept as applied to AI/ML devices for diagnostic or interpretive tasks (e.g., imaging diagnosis) is not relevant here. The "ground truth" for IABP function would be physiological parameters and the device's ability to accurately sense and provide counterpulsation based on those parameters according to established medical principles. These are assessed through engineering tests and simulations rather than expert consensus on diagnostic images.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method, as it does not appear that a "test set" requiring expert adjudication (common in AI/ML diagnostic studies) was used. Testing would involve engineering verification and validation.
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 is not an AI-assisted diagnostic or interpretive device for human readers. It's an automated therapeutic device (an Intra-Aortic Balloon Pump) with software for controlling its operation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device, an Intra-Aortic Balloon Pump, operates in both "Autopilot mode, where functions are automatically selected and controlled by the IABP" and "Operator mode where the user has control over settings and selections." While the Autopilot mode represents a form of "standalone" algorithm operation, the context is the device's performance of its therapeutic function, not an algorithm's diagnostic performance. The 510(k) submission assesses the safety and effectiveness of this standalone capability (Autopilot) as part of the overall device. The performance is assessed against engineering standards and comparison to predicate devices, not typically through metrics like sensitivity/specificity derived from a clinical dataset (unless a significant change warranted a new clinical study, which is not indicated here).
7. The type of ground truth used
For an IABP, the "ground truth" would be the actual physiological state of the patient (e.g., continuous arterial pressure waveforms, ECG signals) and the correct physiological response the device should generate (e.g., precise timing of balloon inflation/deflation relative to the cardiac cycle for optimal counterpulsation).
This "ground truth" is typically established through:
- Physiological models and simulations: Using calibrated simulators that mimic human cardiovascular dynamics.
- Animal studies: If novel physiological interactions are being investigated (less likely for a software update to an established device).
- Bench testing: Verifying that sensors accurately detect physiological signals and that the pump mechanism correctly inflates/deflates the balloon according to software commands.
- Clinical experience and medical consensus: The fundamental principles of counterpulsation and the desired physiological outcomes are well-established in cardiology.
The document implicitly refers to this type of ground truth by stating it meets "performance standards" and is "substantially equivalent" to predicate devices, which have already clinically demonstrated their ability to achieve these physiological goals.
8. The sample size for the training set
Not applicable. This is not an AI/ML device in the sense of requiring a "training set" of data for a machine learning model. The software update (V2.22) involves modifications to pre-set start-up settings, autopilot timing, calibration, signal switching, triggering, purge cycle, noise recognition, arrhythmia timing, alarm handling, and help text. These are likely based on engineering design, refinement, and bug fixes rather than a machine learning training paradigm.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the AI/ML context for this type of software update. The "ground truth" for the software's logic and parameters would be derived from:
- Engineering specifications and requirements: Defining how the device should operate.
- Physiological data and models: Understanding cardiovascular mechanics and optimal counterpulsation strategies.
- Clinical feedback and empirical data: Data from previous device versions and clinical practice informing improvements and error correction.
§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.