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The (X-Coated) Capiox® SX25 and SX18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs are used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours. The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both 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 Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. (The X-Coating™ is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.)

The Capiox® Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line. And the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device. The device may be used for procedures lasting up to 6 hours.

The modified and predicate Capiox SX Oxygenator utilizes 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. 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 and predicate Capiox SX Oxygenator has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as 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 Hardshell Reservoir relies upon mechanical entrapment of particulates and emboli within the filter media as a means to remove those particulates from the blood. The design of the modified Capiox SX oxygenator device is unaffected by the changes being incorporated at this time. The subject of this Special 510(k) is a modification being made to the Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with (K961000, K962667, K993772, and K013526) except that a positive pressure relief valve will be included in the lid of the reservoir. The intent of the relief valve is to eliminate excessive pressure that could accumulate in a reservoir during bypass procedures. The materials that are used in the construction of the CAPIOX® SX Oxygenator/Hardshell Reservoir may include, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene, and X-Coating™.

The provided text describes a 510(k) summary for a modified medical device, the Capiox® SX Oxygenator and Hardshell Reservoir. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device's efficacy through extensive clinical studies against specific performance criteria.

Therefore, many of the requested categories for acceptance criteria and studies (like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or not provided in this type of regulatory submission. This document describes in-vitro performance evaluations for substantial equivalence, not a study to establish clinical efficacy or AI performance.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria and corresponding reported performance metrics in the format of a typical efficacy study. Instead, it lists performance evaluations conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is implied to meet the expectations established by the predicate devices.

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

• Sample Size: Not specified. The evaluations mentioned are primarily in-vitro tests and assessments, not typically described with "test set" sample sizes in the context of clinical data or AI model evaluation.
• Data Provenance: In-vitro performance evaluations. No information on country of origin or whether it's retrospective/prospective in a clinical sense. These are laboratory-based engineering tests.

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

• Not Applicable. This is a 510(k) submission for a modified medical device, not a study evaluating an AI algorithm's diagnostic performance requiring expert-established ground truth. The "ground truth" here is the expected physical and functional performance of the device based on engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication method described, as this is not a study requiring expert consensus on clinical findings or AI outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance for diagnostic tasks. This document describes the substantial equivalence of a physical medical device (oxygenator/reservoir), not a diagnostic AI system.

6. Standalone (Algorithm Only) Performance

• No. This is not an AI algorithm. It's a physical medical device.

7. Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance. The "ground truth" for these performance evaluations is the established engineering design specifications for the modified device and the known, acceptable performance characteristics of the predicate devices. The goal is to show the modified device performs equivalently or within acceptable parameters.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of AI for this type of device modification. The device design and materials are based on existing engineering knowledge and the predicate device's design.

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

• Not Applicable. As there is no training set mentioned in an AI context, there's no ground truth established for it. The design of the modified device is based on internal engineering processes, regulatory requirements, and the characteristics of the predicate devices.

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