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The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.

The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.

The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min, when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.

The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.

The CAPIOX® FX15 and FX25 Hollow Fiber Oxygenator/Arterial Filter/Reservoir contains an integrated heat exchanger system and an integrated Arterial Filter. The device may also be used in conjunction with an optional hardshell reservoir. The design provides an integrated system for ease of use - as well as independent use of the oxygenator and the hardshell reservoir when desired by the user (perfusionist).

The CAPIOX® FX15 and FX25 Oxygenator/Arterial Filter/Reservoir device is a membraile-type oxygenator that consists of micro-porous hollow polypropylene fibers. When in use, blood flows around the outside of fibers while gas flows through the inside of the fibers. As the fibers are micro-porous, gas exchange can occur through the fiber walls by way of diffusion. The FX Oxygenator module is comprised of a wound fiber design whereby continuous strands of fiber are wound around a core support structure. The total amount of fiber that is exposed to blood and gas is approximately 1.5 m2 for the FX15 and 2.5 m2 for the FX25 model.

The screen mesh material that comprises the Arterial Filter is made of polyethylene terephthalate (PET) -and is wrapped around the outside of the hollow fiber membrane. This 32 micron mesh is responsible for the filtration of particulates from the blood stream, and also facilitates air removal from the blood.

The integrated heat exchanger contains a stainless steel bellows that facilitates the transfer of heat. The heat exchanger has a water inlet port and a water outlet port to allow water (from an external water bath) to enter and flow to the inside of steel bellows to effectively control the temperature of the blood that flows on the outside of the steel bellows.

The CAPIOX® FX15 Oxygenator may be used with a 3-liter hardshell blood reservoir. The CAPIOX® FX25 Oxygenator may be used with a 4-liter hardshell reservoir. The hardshell reservoir includes a positive pressure relief valve that is incorporated into the lid of the reservoir. The relief valve permits the release of positive pressure within the reservoir.

The information primarily focuses on establishing "substantial equivalence" to predicate devices, rather than defining and meeting specific quantitative acceptance criteria for device performance. The submission asserts that the new device is "identical" or performs "equivalently" to previously cleared devices. Therefore, the concept of acceptance criteria and proven performance against those criteria as would be typical for a novel AI/software device is not explicitly present in the provided text.

However, I can extract the types of performance evaluations conducted and what "equivalence" implies in this context.

Here's an attempt to structure the information based on your request, with the understanding that this is a 510(k) for a physical medical device, not an AI/software product, so some sections will not be directly applicable or will have "N/A":

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" and quantitative performance metrics are not explicitly stated in the document as they would be for an AI/software device. Instead, the performance evaluations compared the new device to predicate devices, concluding "equivalent performance." The implicit acceptance criterion is that the new device performs as well as or identically to the predicate devices for each tested parameter.

2. Sample size used for the test set and the data provenance

The document details "in-vitro performance evaluations" but does not specify the sample size for these tests. The data provenance is implied to be controlled laboratory testing conducted by Terumo. There is no mention of country of origin for data or if it was retrospective or prospective, as these are typically considerations for human data, not in-vitro device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is a physical medical device with in-vitro performance testing, not a system that requires expert-established ground truth from clinical data.

4. Adjudication method for the test set

N/A. This is a physical medical device with in-vitro performance testing.

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

N/A. This is a physical medical device. No human readers or AI assistance are involved in its operation or evaluation in the context described.

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

N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluations (Gas Transfer, Pressure Drop, Air Handling, Hemolysis, etc.) would be the established scientific and engineering principles for measuring these parameters in oxygenators and filters, and the performance characteristics of the predicate devices based on their own testing and clearance. The aim was to demonstrate that the new device performs identically to these established benchmarks.

8. The sample size for the training set

N/A. This is a physical medical device, not a machine learning model. There is no "training set."

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

N/A. As there is no training set for a physical device, this is not applicable.

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