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The CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoir are 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 integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir(s) is (are) used to store blood during extra-corporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). 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 reservoir may also be used for Post-Operative Chest Drainage Procedures.
The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs can be used in procedures lasting up to 6 hours.
The CAPIOX® RX15 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® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

The modified and predicate Capiox® RX device oxygenator utilizes a 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 wound 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 and predicate Capiox® RX device 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 blood, the modified and predicate Capiox® RX Reservoir relies 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 modified and predicate Capiox® RX devices both utilize an integrated oxygenator/heat exchanger module that provides for temperature control of blood as it enters the oxygenation phase. Each of the devices also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The reservoirs each provide filtration of venous and cardiotomy blood as it enters the reservoir.

The document describes a 510(k) premarket notification for a medical device called the "Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir." This particular submission is a "Special 510(k)" due to modifications made to the hardshell reservoir and a change in the plasticizer used in certain PVC tubing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: This 510(k) submission is for modifications to an existing device (Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir, previously cleared under K130333). Therefore, the "acceptance criteria" discussed are primarily focused on demonstrating that the modified device is substantially equivalent to the predicate device and that the changes do not raise new issues of safety or effectiveness. Clinical studies involving patients were explicitly deemed not necessary for this particular submission.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that substantial equivalence is demonstrated with several in-vitro performance evaluations. While it doesn't present a table with specific pass/fail criteria and exact numerical results, it does list the types of performance evaluations conducted to ensure the modified device performs comparably to the predicate.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not specify exact sample sizes for each in-vitro test. It only lists the types of tests conducted. Since these are in-vitro performance evaluations, the "data provenance" would refer to the testing conditions and the specific samples of the device (modified vs. predicate) used in the lab tests. There is no mention of country of origin for data as it's not a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable as the document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the modified Capiox® RX device to the predicate Capiox® RX device." The testing described is in-vitro performance evaluation, not expert-adjudicated clinical or image-based ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3.

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:

This information is not applicable. The device is an oxygenator and reservoir system, not an AI-assisted diagnostic or therapeutic tool for human readers. No MRMC study was conducted.

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

This information is not applicable. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for the in-vitro performance evaluations would be:

• Engineering specifications and regulatory standards: The tests are designed to demonstrate that the device meets predefined engineering requirements and applicable regulatory standards for blood oxygenators and reservoirs.
• Performance of the predicate device: The modified device's performance is compared against the established performance of the previously cleared predicate device, aiming for substantial equivalence rather than an absolute ground truth in the sense of a disease diagnosis.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/machine learning device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as this is not an AI/machine learning device.

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