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The Medtronic AFFINITY® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance™ Biocompatible Surface is intended for use in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The Medtronic AFFINITY Oxygenator with Balance" Biocompatible Surface is a single-use, disposable, sterile, nonpyrogenic fluid path, gas exchange device with a self contained, venous-side heat exchanger for regulating blood temperature. The microporous polypropylene hollow fibers are wound around a core and encased in a plastic outer shell. Oxygen flows through the hollow fibers and blood flows from the stainless steel heat exchanger around the hollow fibers. Gas exchange occurs by diffusion across the hollow fiber membrane. A gas outlet is provided for scavenging, and a gas vent prevents over pressurization. The modification to the currently marketed AFFINITY® Hollow Fiber Oxygenator is to coat the primary blood contact surfaces with a non-leaching, biocompatible coating (Balance™).

The provided text is a 510(k) submission for a medical device, specifically an oxygenator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of quantitative acceptance criteria through a standalone clinical study. Therefore, general acceptance criteria and performance data are discussed in the context of comparison to the predicate devices.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly based on demonstrating that the new device, the AFFINITY®NT Oxygenator with Balance™ Biocompatible Surface, does not raise new safety or effectiveness concerns compared to its predicate devices and performs comparably. The "reported device performance" refers to the results of in vitro bench testing and biocompatibility testing.

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

The document does not specify a "test set" in the sense of a clinical trial patient cohort. The evaluation was done through in vitro bench testing and biocompatibility testing.

• Sample Size: Not explicitly stated for each test. The testing would involve a certain number of device units or components subjected to standardized laboratory tests.
• Data Provenance: The testing was conducted by Medtronic Perfusion Systems. The provenance is internal company testing, likely done in a lab setting, rather than from a specific country of origin or being retrospective/prospective clinical data. It is retrospective in the sense that the data was collected for the purpose of this 510(k) submission.

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 to this type of submission. Ground truth, in the context of expert review, is typically associated with diagnostic devices where expert interpretation of images or other data is compared against device output. Here, the "ground truth" for the bench tests would be the established scientific methods and engineering specifications.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. Adjudication methods are used in clinical trials or studies involving expert consensus, which are not described here. The "adjudication" for the bench testing would be the interpretation of the test results against predefined engineering and performance standards by qualified engineers and scientists.

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

No, an MRMC comparative effectiveness study was not done. This type of study investigates how human readers' performance (e.g., diagnostic accuracy) changes with or without the assistance of an AI algorithm. The device in question is an oxygenator, which is a therapeutic device, not a diagnostic one that would typically involve human "readers" interpreting output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is a medical apparatus (oxygenator), not an AI algorithm. It functions autonomously in terms of gas exchange and heat regulation within the extracorporeal circuit.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the performance evaluation was established through:

• Established scientific methods and engineering standards: Referenced standards include ISO/DIS 7199, BG7199-1996, and ISO 10993-1. These standards define the acceptable performance and safety parameters for blood-gas exchangers and biocompatibility.
• Comparison to predicate devices: The "ground truth" for demonstrating substantial equivalence is the known safety and effectiveness of the legally marketed predicate devices (AFFINITY® Hollow Fiber Oxygenator and MAXIMA FORTÉ® Hollow Fiber Oxygenator with Balance™ Biocompatible Surface). The new device's performance data was compared against the expected performance of these predicates.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data. The device's design and manufacturing are based on engineering principles and established medical device development processes.

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

This is not applicable as there is no training set mentioned or implied for this device.

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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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