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The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of adult and small adult patients during cardiopulmonary bypass surgery.

The integrated arterial filter is intended to filter 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 4-liter reservoir may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is for use with patients when the required blood flow rate will not exceed 8.0 L/min.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology can be used in procedures lasting up to 6 hours.

The Capiox® NX19 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 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 Capiox® NX19 Oxygenator device has an integrated heat exchanger that is comprised of Polyethylene Terephthalate tubes arranged in a cylindrical shape. The circulating blood contacts the exterior surface of these tubes. Temperature-controlled water distributed from an external water bath fills the interior of the tubes. The heat exchanger material permits heat transfer to occur across the walls of the heat exchanger tubes to achieve the necessary temperature of the circulating blood.

The Capiox® NX19 Oxygenator device can be operated at flow rates up to 8 liters per minute (1/min) and at a minimum flow rate of 2.0 liters per minute (1/min) or 0.5 liters per minute (1/min) for up to 2 hours.

The integrated arterial filter of the Capiox® NX19 Oxygenator device relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.

The Capiox® NX19 Oxygenator device also includes a 4-liter hardshell reservoir used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section with a filter and defoamer and a cardiotomy section with a filter and defoamer.

This document describes the premarket notification (510(k)) for the Terumo Capiox NX19 Oxygenator with Integrated Arterial Filter and other components, seeking to demonstrate its substantial equivalence to a predicate device. This is NOT a study proving the device meets acceptance criteria in the context of an AI/ML medical device, but rather an FDA submission for a traditional medical device (oxygenator) based on non-clinical performance testing and comparison to a predicate device.

Therefore, I cannot fulfill the request to provide information regarding acceptance criteria and a study proving device performance as if it were an AI/ML medical device submission, as the provided text pertains to a traditional medical device submission. The concepts of "test set," "ground truth," "expert adjudication," "MRMC studies," "human readers improve with AI," and "standalone algorithm performance" are not applicable here.

However, I can extract the acceptance criteria and performance data for the physical medical device based on the provided text, reinterpreting "acceptance criteria" as the performance benchmarks established by comparison to predicate/reference devices.

Re-interpretation of Acceptance Criteria and Performance for the Terumo Capiox NX19 Oxygenator:

The document states that Terumo conducted in-vitro performance evaluations to demonstrate substantial equivalence to the predicate Capiox FX25 Advance Oxygenator. The acceptance criteria essentially infer that the performance of the NX19 must be "substantially equivalent" to or better than the predicate and reference devices for various functional parameters.

Here's a breakdown of what can be inferred, framed as closely as possible to the requested structure, though with caveats for the fundamental difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in the context of an AI test set. The document refers to "in-vitro performance evaluations" and "verification testing." The number of units tested for each in-vitro evaluation (e.g., how many oxygenators were subjected to gas transfer tests, hemolysis, etc.) is not detailed in this summary.
• Data Provenance: The studies were in-vitro performance evaluations conducted by Terumo Cardiovascular Systems. They are not clinical studies involving patients. The provenance is internal company testing to demonstrate substantial equivalence to legally marketed predicate devices. It is a prospective set of tests designed for this 510(k) submission.

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

• This is not applicable to this type of traditional medical device submission. Ground truth, in the AI/ML sense, is not established by human experts reviewing data for the device's performance. The "ground truth" for these physical tests is typically the measured physical performance against engineering specifications or established performance of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" in the sense of reconciling expert opinions for test set ground truth as would be found in an AI/ML study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This type of study is relevant for AI/ML diagnostic devices where human readers (clinicians) interact with the AI. This is a physical oxygenator. The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate device."

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This concept pertains directly to AI/ML algorithms, not a physical medical device like an oxygenator. The "standalone performance" is the device's measured in-vitro performance.

7. The Type of Ground Truth Used

• The "ground truth" for the performance comparison is the established performance characteristics of the legally marketed predicate device (Capiox FX25 Advance Oxygenator - K151791) and other reference devices (Sorin Inspire 8F Oxygenator - K121536, and Terumo Capiox NX19 - K172071).
• These are based on previously accepted engineering and performance specifications and in-vitro testing results for those devices.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that is "trained" on data. It is a manufactured physical product.

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

• Not applicable. There is no "training set" or "ground truth" establishment in the context of machine learning for this device. The design and materials are based on engineering principles and knowledge of the predicate device.

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The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of adult and small adult patients during cardiopulmonary bypass surgery.

The integrated arterial filter is intended to filter 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 4-liter reservoir may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is for use with patients when the required blood flow rate will not exceed 8.0 L/min.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology can be used in procedures lasting up to 6 hours.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is a device used during cardiopulmonary bypass surgery. It includes an oxygenator that utilizes porous fiber technology for gas exchange, an integrated heat exchanger made of Polyethylene Terephthalate tubes for warming or cooling blood, an integrated arterial filter for removing particles and emboli, and a hardshell reservoir for storing blood. The reservoir has sections for venous and cardiotomy blood, each with filters and defoamers. The device is designed for blood flow rates up to 8.0 L/min and procedures lasting up to 6 hours.

The provided text describes the Terumo Capiox NX19 Oxygenator with Integrated Arterial Filter and the study performed to demonstrate its substantial equivalence to a predicate device (Capiox FX25 Advance Oxygenator) and a reference device (Sorin Inspire 8F Oxygenator).

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a direct side-by-side table of acceptance criteria and reported device performance values. Instead, it describes various performance evaluations conducted and states that the NX19's performance features are "deemed substantially equivalent" to the predicate and reference devices. The text indicates that the acceptance criteria for performance testing for the NX19 were set using the Sorin Inspire 8F as a reference device. It implies that the NX19 met these criteria to be considered substantially equivalent.

However, based on the text, we can infer the categories of performance for which criteria exist and that the device met these criteria:

Note 1: These tests were conducted on the NX19 Oxygenator.
Note 2: These tests were conducted on the reservoir and cleared with the predicate FX25 in K151791. The NX19 uses the exact same reservoir.

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

The document does not explicitly state the numerical sample sizes for each in-vitro performance test. It refers to these as "in-vitro performance evaluations." The data provenance is in-vitro testing conducted by Terumo Cardiovascular Systems Corporation. There is no mention of country of origin of the data for these specific tests, but the company is based in the US (Elkton, Maryland). The nature of "in-vitro" implies a controlled laboratory environment rather than retrospective or prospective patient data for these performance evaluations.

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

This information is not provided in the document. The performance evaluations are in-vitro physical and functional tests, likely assessed against pre-defined engineering and performance specifications derived from the predicate and reference devices, rather than expert review of clinical data.

4. Adjudication method for the test set:

This information is not applicable/provided. For in-vitro performance tests, adjudication methods like 2+1 or 3+1 (typically used for clinical image review or diagnostic assessments) are not relevant. The assessment would involve comparing quantitative measurements against established criteria.

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/provided. The device is an oxygenator and integrated components for cardiopulmonary bypass surgery, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or evaluation of AI assistance for human readers is not relevant to this device.

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

This information is not applicable/provided. The device is a physical medical device (oxygenator, filter, heat exchanger, reservoir) and does not involve an algorithm or AI. The performance studies are for the device's physical functions.

7. The type of ground truth used:

The ground truth for the performance evaluations is based on established engineering and performance specifications derived from the legally marketed predicate device (Capiox FX25 Advance Oxygenator) and further informed by the reference device (Sorin Inspire 8F Oxygenator). The goal was to demonstrate "substantial equivalence" to these devices, meaning the NX19's performance met comparable levels.

8. The sample size for the training set:

This information is not applicable/provided. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The device's design and manufacturing are based on engineering principles and material science.

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

This information is not applicable/provided for the same reason as point 8.

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INSPIRE 8F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 8F M is intended to be used for 6 hours or less.

INSPIRE HVR DUAL is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR DUAL can be used post-operatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less.

The INSPIRE 8F DUAL is a high efficiency microporous hollow fiber membrane oxygenator integrated with an arterial filter and a heat exchanger (INSPIRE 8F M) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). A molded fitting joint connects the oxygenator to the reservoir.

The device can be operated at flow rates up to 8 liters per minute (I/min).

The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suction blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The integrated arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.

The INSPIRE 8F DUAL is a modified version of the currently marketed INSPIRE 8F integrated oxygenator/hardshell venous cardiotomy reservoir system.

The provided document is a 510(k) summary for a medical device, the INSPIRE 8F DUAL hollow fiber oxygenator. It details the device description, indications for use, technological characteristics, and non-clinical test results conducted to demonstrate substantial equivalence to a predicate device.

Based on the nature of this document (a 510(k) for a physical medical device, specifically an oxygenator used in cardiopulmonary bypass), the "study" referred to is a series of in vitro performance and physical/mechanical integrity tests, not a clinical study involving human patients or analysis of imaging data with expert readers. Therefore, many of the typical elements associated with AI/imaging device studies (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable in this context.

The document explicitly states that the "study" involved "in vitro testing" and lists various performance and physical/mechanical integrity tests.

Here's how the provided information maps to your request:

1. A table of acceptance criteria and the reported device performance

The document provides a list of tests conducted and states that "The INSPIRE 8F DUAL successfully met all acceptance criteria for each test." However, the specific numerical acceptance criteria for each test and the explicit numerical reported performance values are not detailed within this 510(k) summary. The table below lists the tests performed, and the performance is reported as meeting "all acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The sample sizes for each specific in vitro test are not provided in this summary. These are typically detailed in the full test reports, which are part of the detailed 510(k) submission, but not summarized here.
• Data Provenance: The tests were "in vitro," meaning they were conducted in a laboratory setting, not on patient data. The manufacturer is Sorin Group Italia S.r.I., located in Italy. The tests would have been performed in a controlled laboratory environment. The methods followed "relevant requirements of 'Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA' issued on November 29, 2000; ISO 15674, 'Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags'."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This is not applicable as the "ground truth" for in vitro physical/performance tests is established by adhering to widely accepted engineering, chemical, and biological testing standards and protocols (e.g., ISO standards, FDA guidance documents) and measurements obtained from calibrated equipment. There are no "experts" in the sense of clinical readers establishing ground truth for image interpretation.

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

• This is not applicable for in vitro performance testing. Performance is measured against predefined engineering specifications and standards.

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 is not applicable. This device is a physical medical device (an oxygenator), not an AI/imaging diagnostic tool. No human reader studies (MRMC or otherwise) were conducted or are relevant for its approval.

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

• This is not applicable. There is no AI algorithm involved with this device. The "standalone" performance here refers to the device's own physical and functional characteristics measured in a lab setting, which were indeed tested ("in vitro test results").

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

• The "ground truth" for this device's performance tests is based on engineering specifications, industry standards (e.g., ISO 15674), and regulatory guidance documents (e.g., FDA guidance for defoamer submissions). The device's measured performance during in vitro testing must fall within pre-defined acceptable ranges specified by these standards.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• This is not applicable for the same reason as above.

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