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The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours. The oxygenator is suitable for the delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The Quadrox-i Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter. The Quadrox-i Adult may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136).

This document is a 510(k) Pre-market Notification for a medical device called the "Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating." This notification aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices, rather than performing a traditional clinical study with acceptance criteria in the manner of a diagnostic AI device.

Therefore, many of the typical acceptance criteria and study design elements you've requested (like sample sizes for test sets, ground truth establishment, MRMC studies, effect sizes, etc.) are not applicable in this context. This is because the submission is focused on demonstrating substantial equivalence through non-clinical testing, rather than proving a specific performance metric against a defined ground truth for a diagnostic output.

However, I can extract information related to the device's performance based on the non-clinical testing presented to demonstrate this substantial equivalence.

Here's a breakdown of the available information:

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

The document does not provide a table of quantitative acceptance criteria in the sense of specific thresholds for metrics like sensitivity, specificity, or AUC as one would expect for an AI diagnostic device. Instead, it states that the device "met the requirements of" specific ISO standards. These standards themselves contain the "acceptance criteria" through their methodologies and required performance levels for device functionality.

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

The document does not specify sample sizes for "test sets" or data provenance in the way one would for a clinical study on an AI diagnostic. The testing performed was non-clinical bench testing to evaluate the device against established international standards for medical devices. Therefore, these standards dictate the number of units or test replicates required for each specific test (e.g., how many devices are needed for a particular biocompatibility test or performance test). This is not a "data set" in the computational sense, but rather physical devices subjected to laboratory conditions.

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 is not applicable here. Ground truth, in the context of this 510(k) submission, is established by adherence to the methodologies and specifications within the referenced ISO standards. The "experts" involved are those who designed and conducted the tests according to these standards, and those who verified the results against the standard requirements. Their qualifications would be in biomedical engineering, materials science, toxicology, and other relevant fields required to perform and interpret the specified tests. There are no "experts" evaluating images or clinical data to establish a ground truth for a diagnostic outcome.

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

Not applicable. This is not a study involving human readers or interpretation requiring adjudication.

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 diagnostic device and no MRMC study was conducted.

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

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

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

The "ground truth" for this submission is adherence to the performance and safety specifications outlined in recognized international standards (ISO 10993-1, ISO 7199, ISO 15675) and demonstrated through non-clinical bench testing. This is a regulatory "ground truth" rather than a clinical one.

8. The sample size for the training set

Not applicable. No training set for an algorithm was used.

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

Not applicable. No training set for an algorithm was used.

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The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is used for extracorporeal circulation during cardiopulmonary bypass in the field of openheart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

The application and use of the oxygenator is the sole responsibility of the attending physician.

The Quadrox D Bioline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.

In open heart surgery it is used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Bioline is therefore a component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide. The utilization period of this device is restricted to six hours.

The Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is exactly the same oxygenator as the Quadrox D Safeline (K061628) in design, materials, sterilization process and intended use, but the coating is different. The new device comes with a Bioline coating, the already cleared device comes with the Safeline Coating.

With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.

The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.

The Quadrox D Bioline may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to the Jostra Quadrox D Safeline (K061628).

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device by demonstrating that the new device, with a different coating, performs comparably and meets relevant safety and performance standards. The acceptance criteria are implicit in the comparison to the predicate and adherence to specified international standards.

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

The document does not specify a distinct "test set" in terms of patient data or a specific number of devices. The evaluation appears to be based on laboratory testing of the device itself.

• Sample Size: Not explicitly stated. The text refers to "testing and evaluation" of the device, likely involving multiple units to ensure reproducibility and statistical validity for the various integrity, performance, and biocompatibility tests.
• Data Provenance: Not explicitly stated about country of origin. The study appears to be a non-clinical, benchtop, and laboratory-based evaluation conducted by the manufacturer (Maquet Cardiopulmonary AG, Germany). It is retrospective in the sense that it evaluates a final product against established standards.

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

This section is not applicable to this type of device submission. The "ground truth" for this device is not established by human experts interpreting data (like radiologists for imaging devices). Instead, the ground truth is defined by:

• Established international performance standards (ISO 7199).
• Established biological safety standards (ISO 10993-1).
• The performance characteristics of the legally marketed predicate device.
  The evaluation involves engineering and laboratory testing against these predefined objective standards.

4. Adjudication method for the test set

This is not applicable as there is no expert adjudication needed for this type of non-clinical, objective testing. The results of the tests are compared directly against the specified standards and the predicate device's performance.

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 submission is for a medical device (oxygenator) used during open-heart surgery, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. This is not an algorithm or AI device.

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

The ground truth used for this device's evaluation is primarily:

• International Standards: ISO 10993-1 (Biologic Evaluation of Medical Devices) and ISO 7199: 1996 ("Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators)").
• Predicate Device Performance: The established and legally marketed performance data of the Jostra Quadrox D Safeline Hollow Fiber Membrane Oxygenator (K061628). The objective was to demonstrate comparable safety and effectiveness.

8. The sample size for the training set

This is not applicable. This type of device does not involve a "training set" in the context of machine learning or AI models.

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

This is not applicable. See point 8.

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The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.

The application and use of the oxygenator is the sole responsibility of the attending physician.

The Quadrox D Safeline is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user.

In open heart surgery it is used in combination with the heartlung machine for the oxygenation of blood and removal of carbon dioxide. The Quadrox D Safeline is therefore a component in the extracorporeal perfusion circulation system, for oxygenation of blood and removal of carbon dioxide. The utilization period of this device is restricted to six hours.

The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is a model of the Quadrox Safeline Hollow Fiber Membrane Oxygenator. In contrast to the Quadrox, a tight diffusive membrane instead of a microporous membrane is used for the gas exchange.

With this diffusive membrane the gas exchange takes place by diffusion through the membrane wall. This membrane has no pores, therefore a passover of air bubbles or plasma leakage is not possible.

The diffusive membrane has the same outer diameter as the open-pored membrane. The outer diameters are 1.8 m² gas exchange surface and 0.6 m² heat exchanger surface available.

The performance data of the Quadrox D Safeline are comparable with the performance data of the Quadrox Safeline Oxygenator.

The complete construction, priming volume and the connections are the same for the Quadrox D Safeline as well as for the Quadrox Safeline Oxygenator.

It may be marketed both as single product and pre-mounted with the venous hardshell cardiotomy reservoir (K003551, K982136), equivalent to Jostra Quadrox Safeline Oxygenator (K992559). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator will be provided with a Jostra Manifold Sampling Line.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size in terms of patient data or clinical trials. The testing appears to be primarily engineering and bench testing, focused on verifying the device's physical and functional properties. The data provenance is internal testing performed by Maquet Cardiopulmonary AG ("Non-clinical Testing"). There is no mention of country of origin for specific data or whether it was retrospective or prospective.

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

There is no information provided about experts establishing ground truth for a test set. This type of device evaluation relies on objective measurements against established engineering and biological standards (e.g., ISO standards), rather than expert consensus on a "ground truth" derived from clinical cases.

4. Adjudication Method for the Test Set

Not applicable. The evaluation is based on meeting pre-defined standards and specifications through testing, not on adjudicated clinical outcomes.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative medical devices where human readers play a critical role in diagnosis or assessment (e.g., radiology AI). The Jostra Quadrox D Safeline Diffusion Membrane Oxygenator is a life-support device, and its performance is evaluated through engineering and biocompatibility testing.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the testing described appears to be for the standalone device's performance. The "Non-clinical Testing" section states that the device was tested to meet specific ISO standards and for various performance aspects (integrity, performance, stability, biocompatibility, sterility). This refers to the device's inherent functional characteristics, not its performance in conjunction with a human operator.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation is established by international consensus standards (ISO 10993-1 and ISO 7199:1996) and the performance characteristics of the legally marketed predicate device (Jostra Quadrox Safeline Oxygenator). The goal of the testing was to demonstrate that the new device meets these established benchmarks and is "substantially equivalent" to an existing, approved device.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The device's design and manufacturing process would involve extensive engineering development and testing, but these are not described as "training sets" for an AI model.

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

Not applicable, as there is no "training set" for an AI/ML algorithm.

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