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The Arrow Intra-Aortic Balloon (IAB) Catheter With a Fiber Optic Sensor and a Measurement System is clinically indicated for the following conditions:

• a. Acute Coronary Syndrome
• b. Cardiac and Non-Cardiac Surgery
• c. Complications of Heart Failure

IAB's are designed to provide cardiac assist therapy. In cardiac assist therapy a standard electronic pressure transducer can be connected externally to the central lumen of an IAB as a means of monitoring arterial pressure.

The purpose of the IAB device modification is to provide an alternative means for obtaining arterial pressure readings directly from the tip of an IAB catheter, as opposed to a standard electronic pressure transducer that is connected externally to the central lumen of an IAB.

A pressure sensor is attached to a flexible optical fiber in the IAB catheter. The sensor is positioned within the tip of the IAB catheter and the fiber runs the length of the inner lumen, exiting at the trifurcation and attaches to an optical connector. The sensor in the IAB catheter optically transmits light to a sensor measurement system. The sensor measurement system displays and outputs an arterial pressure.

Because the fiber optic sensor is positioned directly in the aorta, an arterial pressure can be directly obtained as opposed to obtaining arterial pressure readings through the end of a fluid-filled column and transducer. Additionally the fiber optical not electrical, therefore, the pressure signal is immune to any electrical noiselinterference that can affect a standard electronic pressure transducer. The fiber optic measurement system outputs the pressure via a digital or analog signal. The output signal can be input into a patient monitoring system or Intra-Aortic Balloon Pump (IABP).

This FDA 510(k) premarket notification describes the Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System. However, it does not contain the detailed study information required to fully answer your request regarding acceptance criteria and device performance.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway that often relies on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than requiring extensive de novo clinical trials or detailed performance studies with acceptance criteria.

Here's what information can be extracted and what is missing based on your request:

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

• Missing. The document states, "The results of the laboratory tests demonstrate that the device is substantially equivalent," but it does not provide a table of specific acceptance criteria or the quantitative reported performance of the device against those criteria (e.g., accuracy, precision, bias of the fiber optic sensor pressure readings).

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

• Missing. No information on the sample size of any test sets, the type of study (retrospective or prospective), or the data provenance is provided. The evaluation seems to be based on "laboratory tests" rather than clinical or extensive animal studies detailed in this summary.

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)

• Missing. There is no mention of experts or ground truth establishment for a test set.

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

• Missing. No information on adjudication methods is present.

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 / Missing. This device is an IAB catheter with a fiber optic pressure sensor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or AI assistance effect size is not relevant to this specific device.

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

• Partially Applicable / Missing Details. The device's primary function is to measure arterial pressure via a fiber optic sensor. The description implies it acts as a standalone measurement system, outputting pressure via a digital or analog signal to a patient monitoring system or IABP. However, the document does not contain details of specific standalone performance studies (e.g., detailed accuracy studies comparing its readings to a gold standard, independent of an IABP or human interpretation). It only states "laboratory tests" were performed.

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

• Missing. The document does not specify the ground truth used for validating the "laboratory tests." For a pressure sensor, a typical ground truth would involve comparison to a highly accurate calibrated reference pressure transducer.

8. The sample size for the training set

• Not Applicable / Missing. This device does not appear to involve a machine learning algorithm that would require a "training set" in the conventional sense. If there were any statistical models involved in the sensor's calibration or processing, details are not provided.

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

• Not Applicable / Missing. See point 8.

Summary of available information:

• Device Name: Arrow Intra-Aortic Balloon (IAB) Catheter With A Fiber Optic Sensor And A Measurement System
• Intended Use: Clinically indicated for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, and Complications of Heart Failure.
• Technological Characteristics: The device provides an alternative means for obtaining arterial pressure readings directly from the tip of an IAB catheter using a fiber optic sensor. It is described as "technologically equivalent" to previously cleared pressure sensors and the Camino Ventrix Subdural Tunneling Pressure Monitoring Kit (K982702) for its fiber optic aspect.
• Testing: "Laboratory tests" were performed, and the results "demonstrate that the device is substantially equivalent." No details of these tests, specific acceptance criteria, or quantitative results are provided in this summary.
• Regulatory Pathway: 510(k) "Substantial Equivalence" to predicate devices.

To obtain the detailed information requested, one would typically need to review the full 510(k) submission and supporting documentation, which is generally much more extensive than this summary letter.

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