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The ACAT 2 Intra-Aortic Balloon Pump is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure

The ACAT 2 IABP is the next generation of the Arrow ACAT 1 IABP manufactured by Arrow International.

The purpose of the new ACAT 2 is to convert the original ACAT 1, which is a manual adjustment system, into a one button automatic or manual IABP system. This will be accomplished through the development of new software algorithms. The existing ACAT 1 hardware, electronics, pump assembly and packaging designs are the same for the ACAT 2 IABP.

NOTE: This is a software update to the existing ACAT 1 IABP only.

This software has been developed to meet customer requirements and/or preferences. The software is identical to the ACAT 11 software, with the addition of an "Optimized" mode. The Optimized mode employs greater device involvement in detecting the patient's heartbeat and timing the inflation and deflation of the Intra-Aortic Balloon (IAB), thus reducing the requirements for intense monitoring by a qualified Cardiologist or Perfusionist.

The provided text is related to a 510(k) premarket notification for the Arrow ACAT 2 Intra-Aortic Balloon Pump. This document is a regulatory submission to the FDA, not a study report. It states that the K002256 submission was not re-reviewed by the FDA for the administrative change described, and the original 510(k) determination was made in 2001.

Crucially, this type of regulatory submission (510(k)) for a Class II device like the Arrow ACAT 2 IABP typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting explicit acceptance criteria and a human clinical study to "prove" meeting those criteria in the way you've described for an AI/ML device. While performance data may be submitted to support substantial equivalence, it's not usually presented as a standalone study with the detailed elements you've requested for an AI/ML device's acceptance criteria.

The document explicitly states regarding the ACAT 2: "NOTE: This is a software update to the existing ACAT 1 IABP only. This software has been developed to meet customer requirements and/or preferences. The software is identical to the ACAT 11 software, with the addition of an 'Optimized' mode. The Optimized mode employs greater device involvement in detecting the patient's heartbeat and timing the inflation and deflation of the Intra-Aortic Balloon (IAB), thus reducing the requirements for intense monitoring by a qualified Cardiologist or Perfusionist."

Given this, the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, particularly in the context of an AI/ML device's performance study, is not present in the provided text. The document focuses on regulatory classification, indications for use, and a comparison to predicate devices, especially noting a software update.

Therefore, I cannot populate the table or answer the specific questions based on the provided text, as it does not contain the detailed study information typically found in an AI/ML or diagnostic device performance evaluation.

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