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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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The Capiox® Advance 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 Capiox® Advance Hardshell Reservoir device and the predicate Capiox® RX Hardshell Reservoir device are both used as a blood storage devices during and after cardiopulmonary bypass procedures. Venous blood enters the reservoir via gravity, or by way of external vacuum that may be applied to the reservoir.

Venous blood that is drawn from the patient enters the device via the venous blood inlet port. The blood passes through a defoamer to remove air bubbles from the blood and through a filter to remove particulates from the blood.

Blood may also be suctioned into the reservoir from the cardiotomy field. This blood enters the device through the cardiotomy blood suction ports. The blood passes through a defoamer to remove air bubbles from the blood and through a filter to remove particulates from the blood.

Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.

The design of the Capiox® Advance Hardshell Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. It contains a rotatable venous blood inlet port. The total capacity of the reservoir is 4000mL.

The venous section of the reservoir contains a filter for particulate matter removal and a defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter for particulate matter removal and a defoamer to facilitate air bubble removal.

The provided text describes a 510(k) premarket notification for the Capiox® Advance Hardshell Reservoir (K153143). This is an administrative document for a medical device and, as such, it does not contain the detailed data from clinical studies with acceptance criteria, sample sizes, or ground truth establishment that would be present in a research paper.

However, I can extract the relevant information that is available about the performance evaluations and what they aim to show for the device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Performance Evaluations" that were conducted to establish substantial equivalence to a predicate device (Capiox® RX Hardshell Reservoir; K130359). However, it does not provide specific numerical acceptance criteria or the reported device performance for each evaluation. It simply lists the types of tests performed.

The document states that "Clinical studies involving patients are not necessary to demonstrate substantial equivalence... Substantial equivalence is demonstrated with the following in-vitro performance evaluations." This indicates that the evaluations listed above are the studies that demonstrate the device meets the necessary criteria for substantial equivalence, implying their results were favorable and met internal company-defined specifications, even if those are not explicitly detailed here.

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

The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the Capiox® Advance Hardshell Reservoir to the predicate device." Therefore, there was no test set with human patient data used for this 510(k) submission.

The provenance of the data for the in-vitro performance evaluations is not specified, but it would typically be internal laboratory testing conducted by Terumo Cardiovascular Systems Corporation.

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

Not applicable, as no clinical studies with human patient data were conducted that would require expert-established ground truth. The evaluations were in-vitro tests, likely with predefined physical or chemical standards.

4. Adjudication method for the test set

Not applicable, as no test set with human patient data was used.

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 device is a cardiopulmonary bypass hard-shell reservoir, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This device is a physical medical device, not a software algorithm.

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

The "ground truth" for the in-vitro performance evaluations would be the established scientific and engineering standards and specifications for devices of this type, as well as the performance of the predicate device. For example:

• Air Handling Performance: Likely measured against predefined thresholds for air bubble removal efficiency.
• Hemolysis: Measured against acceptable levels of blood cell damage according to ISO standards or industry best practices.
• Venous Filter Dynamic Hold Up and/or Pressure Drop: Measured against specifications ensuring adequate blood flow and minimal retention.
• Product Integrity/Seal, Burst, Leak, Circulation, Pull Testing: Measured against engineering specifications for mechanical strength and leak resistance.
• Pre-Connect Evaluation: Likely assessed for ease of connection and secure fit.
• Package Testing: Assessed against standards for maintaining sterility and integrity during shipping and storage.

These "ground truths" are based on engineering principles, industry standards (e.g., ISO), and the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable.

Summary:

The provided document describes a 510(k) premarket notification for a Class II medical device, the Capiox® Advance Hardshell Reservoir. The submission relies on demonstrating "substantial equivalence" to a predicate device through in-vitro performance evaluations rather than clinical studies with human patients. As such, information typically found in detailed studies evaluating diagnostic algorithms (like acceptance criteria, sample sizes for human readers/patients, ground truth establishment by experts, or AI-specific studies) is not present. The "studies" in this context are a series of laboratory-based engineering and performance tests designed to confirm that the modified device functions comparably and safely to its predicate.

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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

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