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MAXIMA FORTÉ" Hollow Fiber Oxygenator with Plasma Resistant Fiber is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from blood and is designed to operate at blood flow rates between 1 and 7 liters per minute for periods up to six hours.

The Medtronic MAXIMA FORTE™ Hollow Fiber Oxygenator with Plasma Resistant Fiber is a single use, disposable, sterile, nonpyrogenic, gas exchange device with a self contained, venous side heat exchanger for regulating blood temperature. The MAXIMA FORTE" oxygenator consists of a polycarbonate outer case which incorporates an oxygenator fiber bundle and a self contained heat exchanger. The fiber bundle is separated from the self contained heat exchanger by a polycarbonate housing. The static priming volume of the oxygenator blood path is approximately 295 ml. The oxygenator is designed to operate at blood flow rates between 1 - 7 liters per minute for periods up to 6 hours.

The provided text is a summary of safety and effectiveness for a medical device called the MAXIMA FORTÉ™ Hollow Fiber Oxygenator. It does not describe a study involving "acceptance criteria" and "device performance" in the typical sense of a clinical trial or a study assessing an AI algorithm's diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable to this document. I will extract the relevant information and explain why other sections cannot be filled based on the provided text.

Here's the information derived from the provided document:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the MAXIMA FORTÉ™ device itself. Instead, it refers to "accepted scientific methods" from oxygenator standards (ISO/DIS 7199 and BG7199-1996) for assessing new technological characteristics. The "performance data" is used to demonstrate substantial equivalence to the predicate devices, rather than meeting specific, numerical acceptance criteria for the new device as a standalone.

The in-vitro bench testing aimed to show that the MAXIMA FORTÉ™ does not significantly affect safety and effectiveness when compared to predicate devices. The listed tests are the performance aspects evaluated.

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

The document describes in-vitro bench testing. This means the testing was performed in a laboratory setting, not on human patients or live animal models, for the purpose of demonstrating substantial equivalence to predicate devices.

• Sample size: Not specified. Typical bench testing for devices like this involves a certain number of units tested to ensure repeatability and consistency, but the exact number of MAXIMA FORTÉ™ units or predicate units tested is not stated.
• Data provenance: In-vitro bench testing data. No country of origin is specified, and it is inherently prospective for the device under review, but comparative to existing predicate devices.

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 concept of "experts establishing ground truth" is not applicable to the described in-vitro bench testing of an oxygenator. The "ground truth" here is determined by physical measurements and engineering assessments according to established standards.

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

Not applicable. Adjudication methods are relevant for subjective assessments, often in clinical or diagnostic scenarios. In-vitro bench testing relies on 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 not an AI or diagnostic imaging device.

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

Not applicable. This is not an AI or algorithm-based device.

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

For the in-vitro bench testing, the "ground truth" would be established by:

• Engineering measurements and performance specifications as defined by the oxygenator standards (ISO/DIS 7199 and BG7199-1996).
• Comparative performance data from the predicate devices.
  The goal was to demonstrate that the MAXIMA FORTÉ™ performs similarly and safely according to these objective measures, not that it aligns with a subjective expert judgment.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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The CAPIOX® SX25 Hollow Fiber Oxygenator is 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 the blood or perfusion fluid flowing through the device.

The CAPIOX SX25 Hardshell Reservoir (detachable) is 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.

CAPIOX® SX25 Hollow Fiber Oxygenator contains an integrated heat exchanger and a detachable Hardshell Reservoir. This design permits an integrated system for ease of use as well as independent use of the oxyegnator and of the Hardshell reservoir to accommodate a variety of circuit configurations.

The SX25 oxygenator is a membrane oxygenator consisting of microporous hollow fibers with an integrated heat exchanger, consisting of stainless steel tubes.

The detachable Hardshell reservoir has a rotatable connection with the oxygenator which permits optimum positioning for connections in the circuit. The venous blood inlet port is also rotatable to permit minimizing tubing lengths which could result in lower circuit priming volumes.

The Hardshell reservoir contains a defoamer and a screen filter in the venous blood inlet section. The total capacity of the reservoir is 4,000 mL.

The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal and the removal of particulates/emboli from suctioned blood entering the reservoir.

A detachable sampling system is positioned at the top of the hardshell reservoir which contains 3 three-way stopcocks. These stopcocks can be used for sampling. The sampling system contains a one-way valve permitting withdrawal of liquid samples but prohibiting entry of air into the blood exiting the oxygenator.

Here's a breakdown of the acceptance criteria and study information for the CAPIOX® SX25 Hollow Fiber Oxygenator, based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission demonstrates substantial equivalence primarily through comparison to the predicate device, the CAPIOX SX18. The acceptance criteria are largely implied by demonstrating that the SX25 meets or exceeds the performance of the SX18 for critical functions, or that differences do not raise new safety or effectiveness concerns.

Study Information

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

   • The document does not specify explicit sample sizes for the performance tests (Gas Transfer, Effect on Blood Components, Pressure Drop). It states "Comparison of the SX25 and SX18 performance was conducted."
   • Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, Terumo Medical Corporation. There is no indication of retrospective or prospective clinical data.

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

   • This submission is a premarket notification (510(k)) primarily focused on bench testing and substantial equivalence to a predicate device. There is no mention of human-expert-established ground truth in the context of clinical observations or interpretations, which is typical for device performance assessments like gas transfer or blood compatibility. The "ground truth" here is the performance of the predicate device (SX18) as established in its own clearance, and the known physiological principles of oxygenation.

3. Adjudication method for the test set:

   • Not applicable as this is bench testing comparing objective performance parameters, not subjective expert assessment of medical images or conditions.

4. 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:

   • No. This is not an AI/software device. It's a medical device for cardiopulmonary bypass.

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

   • Not applicable as this is not an AI/software device. The performance data presented are "standalone" in the sense that they are intrinsic device performance metrics (gas transfer, pressure drop, effect on blood components) determined through laboratory testing.

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

   • The "ground truth" for the performance characteristics (gas transfer, pressure drop, effect on blood components) is established by validated laboratory testing methods and engineering principles. The performance of the predicate device (SX18) serves as the primary reference point. For sterilization and materials, the ground truth is adherence to established regulatory standards (SAL, EO residuals, ISO-10993).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device, so there is no concept of a "training set."

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

   • Not applicable for the same reason as above.

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