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The Capiox® FX Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir 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 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir (both 3-liter and 4-liter) is for use with patients when the required blood flow rate will not exceed 5.0 L/min. The Capiox® FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

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

The modified Capiox® FX15 and FX25 Advance Oxygenators (with 4-liter Reservoir) utilize porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.

The modified Capiox® FX15 and FX25 Advance devices have an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.

With respect to the filtration of arterial blood, the modified Capiox® FX15 and FX25 Advance Oxygenators rely upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.

The design of the subject and predicate devices is nearly identical. No modifications are being made to the oxygenator or arterial filter components of the reservoir component of the devices remain identical to the design of the original reservoir that was cleared by FDA with K140774, except for the following:

• The geometry of the polycarbonate Venous Inlet Port is being modified from an angled design to a curved design. The curved design for the inlet port will facilitate enhanced air handling within the device.
• The venous port drop tube within the reservoir is being modified from a straight design at the lower end of the tube to a flared design, which is intended to improve flow dynamics through the reservoir.
• The polyvinyl chloride flexible tubing used in the Reservoir is being changed from PVC tubing with DEHP plasticizer to PVC tubing with TOTM plasticizer. This change will address growing market concerns with the use of DEHP and to meet pending regulatory requirements in the global market. The modified tubing affects the venous drop tubes, the sampling manifold tubing, the arterial quick disconnect and the arterial purge line tubing.
• The minimum operating level of the Reservoir will be reduced from 200mL to 150mL.
• The decal-type graduate scale label affixed to the outside surface of the Reservoir is being increased in length to offer convenience to the user-perfusionist.

The materials that are used in the construction of the Capiox® FX15 and FX25 Advance Oxygenators include nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.

The provided text describes a 510(k) premarket notification for the Terumo Capiox FX15 and FX25 Advance Oxygenators with Integrated Arterial Filter and Hardshell Reservoir. This is a medical device submission, and the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a novel AI device. Therefore, many of the requested elements for AI device studies (like sample size for test sets, data provenance, ground truth establishment, MRMC studies, training set size) are not applicable or not explicitly detailed in this type of document.

However, I can extract information related to the device's performance evaluation and acceptance criteria through the lens of device substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance (Demonstrated through Substantial Equivalence)

The core "acceptance criteria" in this context are tied to demonstrating substantial equivalence to a predicate device (Terumo® Capiox® FX Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir - K140774). The performance of the modified device (Capiox® FX15 and FX25 Advance Oxygenators with 4-liter Reservoir) must be equivalent to the predicate device, especially considering the changes made to the reservoir.

Since this is a Special 510(k) focusing on changes to the reservoir, the performance criteria are applied to the reservoir's functions. The main changes are:

• Geometry of the polycarbonate Venous Inlet Port (angled to curved)
• Venous port drop tube (straight to flared)
• Plasticizer in PVC tubing (DEHP to TOTM)
• Minimum operating level of the Reservoir (200mL to 150mL)
• Decal-type graduate scale label (increased length)

The document does not provide a table with specific numerical acceptance criteria (e.g., "hemolysis index < X") and corresponding reported performance values for each test. Instead, it broadly states that "Performance evaluations have demonstrated substantial equivalence" or "The subject Capiox® FX15 and FX25 Advance devices exhibit equivalent performance to the predicate devices."

Table of Performance Evaluations and Outcome Statements:

Since this is a medical device submission for substantial equivalence and not an AI device study, most of the remaining points are not directly applicable or explicitly stated in the document.

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

• Sample Size: Not explicitly stated for each performance test. The document refers to "simulated use testing of the reservoirs" and "performance evaluations."
• Data Provenance: The studies were conducted by Terumo Cardiovascular Systems Corporation. Location information is "Elkton, Maryland, USA." The studies are prospective in the sense that they were conducted specifically for this submission.

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

• Not applicable as this is not an expert-driven AI study. Performance tests generally rely on established engineering and physiological testing standards for medical devices.

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

• Not applicable as this is not an expert-driven AI study requiring adjudication of interpretations. The performance evaluations are objective measurements.

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 is a medical device (oxygenator, reservoir, filter) and not an AI or imaging diagnostic device.

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

• Not applicable. This device does not have an "algorithm" in the context of AI. Its performance is mechanical and physiological.

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

• The "ground truth" for the device's performance tests would be established by industry standards, engineering specifications, and physiological requirements for cardiopulmonary bypass devices, as determined by validated test methods (e.g., for hemolysis, gas exchange efficiency, pressure drop, air handling).

8. The sample size for the training set:

• Not applicable. This is not an AI device trained on a dataset.

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

• Not applicable.

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