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The AutoCAT®2 Intra-Aortic Balloon Pump (IABP) and AC3™ Series Intra-Aortic Balloon Pump (IABP) arc clinically indicated for use for the following conditions:

1. Acute Coronary Syndrome

2. Cardiac and Non-Cardiac Surgery

3. Complications of Heart Failure

The AutoCAT Series IABP System, including the AutoCAT®2 and AC3™ Series IABP's, provide counter-pulsation therapy to adult patients with impaired left ventricular (LV) function. They provide hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta.

The IABP delivers helium (He) into the IAB catheter 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 catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore 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 AutoCAT Series IABP Systems consists of two main components:

• The pump control/display module which incorporates a touch screen and keypad for . system operation, and
• . The pneumatic drive module which is incorporated into the body of the device

The AutoCAT Series IABP are designed to be used with 30, 40 and 50cc IAB catheters with the appropriate connectors. The primary difference between the AutoCAT®2 IABP and AC3TM series IABP is the user interface, where the display is a touchscreen.

This document describes the FDA's 510(k) clearance for the AutoCAT®2 and AC3™ Series Intra-Aortic Balloon Pump (IABP) systems. The clearance is based on the substantial equivalence to predicate devices, and the document primarily focuses on design modifications and verification testing rather than an AI-driven diagnostic or prognositc device.

Therefore, many of the requested categories related to medical AI applications, such as expert consensus, ground truth establishment, sample sizes for training sets, multi-reader multi-case studies, and specific performance metrics like sensitivity, specificity, and AUC, are not applicable to this document. This document describes a medical device (an intra-aortic balloon pump) and its mechanical/electrical performance, not an AI/ML algorithm.

However, I can extract information related to the acceptance criteria and study that proves the device meets the criteria based on the provided text, focusing on the device's functional integrity as a medical pump.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document states:

• "The proposed modification to the IABP systems were verified through design verification testing as outlined on the following page."
• "The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device."

While specific numerical acceptance criteria (e.g., pressure ranges, flow rates) and the exact reported performance values are not detailed within this document, the statement confirms that such criteria existed and were met. The "performance" is implicitly stated as "similar to the predicate device."

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified. Given it's a device modification verification for a US-based manufacturer, it's highly likely the testing was conducted internally or with US-based facilities. The document describes "design verification testing" which implies lab or bench testing, not clinical studies with patient data.
• Retrospective or Prospective: Not applicable as this refers to a device's performance verification, not analysis of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a medical device (pump) clearance, not an AI/ML algorithm requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" for a pump is its physical and electrical reliability and performance metrics, which would be established by engineering specifications and testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for human interpretation of medical data (e.g., radiologists reviewing images). For device verification, engineers perform tests against predefined 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 IABP, a mechanical pump, not an AI product designed to assist human readers in tasks like image interpretation.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance validation is derived from engineering specifications and established performance characteristics of the predicate devices. The testing verifies that the modified device performs according to these engineering and functional standards, similar to the predicate device. It's about meeting designed-for-purpose operational parameters, not diagnostic accuracy against a clinical reference.

8. The sample size for the training set

Not applicable. This is not an AI/ML driven device that requires a training set.

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

Not applicable. This is not an AI/ML driven device.

Summary relevant to the document:

The device clearance relies on the "design verification testing" performed on the modified IABP systems. The document states that "The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device." The primary "study" proving the device met acceptance criteria was this internal engineering and performance testing against established technical and functional specifications. The acceptance criteria themselves are implicitly the functional and safety requirements for an intra-aortic balloon pump, ensuring the modified parts do not introduce new safety concerns or degrade performance compared to the previously cleared predicate devices.

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The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically indicated for use in any of the following conditions:

1. Acute Coronary Syndrome
2. Cardiac and Non-Cardiac Surgery
3. Complications of Heart Failure

The FiberOptix® Intra-Aortic Balloon (IAB) Catheter consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) is utilized to regulate the inflation and deflation of the balloon.
The FiberOptix® IAB Catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface.
The FiberOptix® IAB Catheter has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.

The provided text is a 510(k) summary for the FiberOptix® Intra-Aortic Balloon Catheter Kit. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information necessary to answer all parts of your request, especially regarding a clinical study proving the device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies.

Here's an analysis of what information is available and what is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified.
• Data provenance: Not specified. The study described is "bench tests", implying laboratory testing rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not applicable. The study was bench testing of the device's physical performance, not an evaluation of diagnostic or clinical interpretation requiring expert consensus.
• Qualifications of experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication method: Not applicable. This was bench testing, not a study involving human adjudication of clinical data.

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

• MRMC study: No, an MRMC study was not done. The document describes a medical device (an intra-aortic balloon catheter) and its physical performance, not an AI or imaging diagnostic tool.

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

• Standalone performance: Not applicable. This is for a medical device (catheter), not an algorithm.

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

• Type of ground truth: Not explicitly stated as "ground truth" in the context of clinical data. For the bench tests, the "ground truth" would be the engineering specifications and performance standards for the device and its predicate, verified through physical measurements and observations during the tests.

8. The sample size for the training set

• Sample size for training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described focuses on verifying the modified design's performance against the predicate.

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

• How ground truth for training set was established: Not applicable, as there is no training set for this type of device and study.

Summary of the Study:

The study described is a series of bench tests (laboratory testing) to provide evidence that the modified FiberOptix® IAB Catheter is substantially equivalent to predicate devices. The technological differences relate to a modified fiber optic sensor configuration for improved robustness.

The specific tests performed were:

• Insertion, Durability Test & (FOS) Static Pressure Test
• Simulated Misuse Test & (FOS) Static Pressure Test

The reported conclusion is that "The results of the verification test met the specified acceptance criteria and performed similar to the predicate device." This demonstrates that the subject device is substantially equivalent based on its physical and functional performance characteristics.

The document does not provide information on clinical trials, human subject data, or AI algorithm performance, as it pertains to a mechanical medical device that is being cleared based on substantial equivalence to a predicate through bench testing.

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