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FIBEROPTIX® IAB with the Intra-Aortic Balloon Pump as a control system is 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 IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as the Intra-Aortic Balloon Pump (IABP) is utilized to requlate the inflation and deflation of the balloon.
The FIBEROPTIX IAB 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 has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.

The provided text describes the 510(k) submission for the FIBEROPTIX IAB, focusing on its substantial equivalence to a predicate device. The information details various tests performed to demonstrate this equivalence.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The provided text lists several design verification tests performed. While it explicitly states that the results "met the specified acceptance criteria and performed similar to the predicate device," it does not provide a specific table detailing the acceptance criteria values for each test or the exact performance metrics observed.

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

The text mentions "bench tests" for design verification. However, it does not specify the sample size used for any of these tests. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective nature), as these are bench tests and not human clinical studies.

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)

This type of information is usually relevant for studies involving subjective human interpretation (e.g., image analysis). For the described bench tests, no experts were used to establish ground truth in this manner. The ground truth for these engineering tests would be established by objective measurements against predefined engineering specifications.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the described tests are bench tests, no such adjudication method was applicable or employed.

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

The provided information focuses on the substantial equivalence of an intra-aortic balloon catheter, a physical medical device, through a series of engineering bench tests. It does not describe an AI-powered device or an MRMC comparative effectiveness study involving human readers or AI assistance. Therefore, there is no mention of effect size for human readers with or without AI.

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

Similar to the point above, the FIBEROPTIX IAB is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study was not conducted or is not applicable in this context.

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

For the bench tests described, the ground truth would be established by engineering specifications and objective measurements. For example:

• Dimensional Analysis: Ground truth is the specified dimensions (e.g., diameter, length).
• Tensile Testing: Ground truth is the specified material strength or bond strength.
• Volume Test: Ground truth is the specified balloon inflation volume.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these specific tests.

8. The sample size for the training set

The provided text only discusses pre-market submission via a 510(k) pathway, focusing on substantial equivalence to a predicate device through bench testing. It does not mention any training set size, as it does not describe the development or evaluation of a machine learning or AI algorithm.

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

As there is no mention of a training set (because it's not an AI/ML device), this information is not applicable and therefore not provided in the text.

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