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The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 200 ml/min (0.2 liters/minute) to 1000ml/min (1.0 liters per minute) for the Hilite 1000 and 200 ml/min (0.2 liters/minute) to 800 ml/min (0.8 liters per minute) for the Hilite 800 LT for periods of up to six (6.0) hours.

The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 infant hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 LT infant hollow fiber membrane consists of a polymetbylpentene plasma tight mat. The unique mat design increases tbe interaction between blood and gas, creating a highly efficient blood oxygenator. Tue heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through tbe inner lumen of the fibers and tberefore effects heat exchange while minimizing priming volume.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medos Hilite 1000 & 800 LT Infant Oxygenator:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than defining specific acceptance criteria for a new, novel device's performance. Therefore, explicit, quantitative acceptance criteria and direct performance metrics against those criteria are not explicitly stated in a typical "acceptance criteria vs. reported performance" table format for a medical device that generates data (like an AI/diagnostic device).

Instead, the "acceptance criteria" for this oxygenator are implicitly met by demonstrating that the device is substantially equivalent to a legally marketed predicate device (K090449, Medos Hilite Infant Oxygenator, Model 1000 & 800 LT Oxygenator). The reported performance is primarily established through a series of tests to ensure safety and function, particularly due to a change in potting material.

Here's an interpretation of what could be considered "acceptance criteria" in this context, and how the "reported performance" addresses them:

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

• Sample Size: The document does not specify exact sample sizes for the performance and safety tests listed. These types of tests (e.g., integrity, chemical analysis, cytotoxicity, hemolysis) are typically performed on a statistically relevant number of device units or material samples.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer (Medos Medizintechnik AG, Germany) and the testing descriptions, it's highly likely the data originated from laboratory testing conducted in Germany or by contract labs supporting the manufacturer. These are in vitro or ex vivo laboratory tests on the device itself or its components, not clinical data from patients.

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

This section is not applicable to this device. The Medos Hilite 1000 & 800 LT Infant Oxygenator is a physical medical device (an oxygenator), not a diagnostic algorithm or an AI system that generates interpretations requiring human ground truth. The "ground truth" for its performance is established through direct physical, chemical, and biological testing against established standards and validated methods, not through expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This section is not applicable to this device for the same reasons as point 3. There is no ambiguous output or interpretation that would require an adjudication method. Test results are typically objective measurements (e.g., leakage rate, chemical composition, cell viability count).

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 is relevant for diagnostic devices or AI algorithms where human reader performance is being evaluated, especially in comparison to an AI-assisted workflow. This oxygenator is a treatment device, not a diagnostic one.

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

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

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance relies on:

• Validated Test Methods and Standards: The performance tests (e.g., blood pathway integrity, chemical analysis, cytotoxicity, hemocompatibility) are conducted using internationally recognized and validated laboratory methods and standards relevant to medical devices (e.g., ISO standards for biocompatibility).
• Engineering Specifications: The device is tested against its own engineering design specifications for functional parameters (e.g., flow rates, heat exchange efficiency, oxygenation capacity - though specific values are not detailed in the summary).
• Predicate Device Performance Profile: The overarching "ground truth" or benchmark is the performance and safety established by the legally marketed predicate device (K090449). The new device must perform comparably.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device would be its design, engineering, and manufacturing processes.

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

Not applicable. As per point 8, there is no "training set" in the AI/ML sense for this physical medical device.

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The Medos hilite 2800 & 2400 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 0.5 to 2.8 liters per minute for the hilite 2800 and 0.5 to 2.4 liters per minute for the hilite 2400 LT for periods of up to six (6.0) hours.

The Medos Hilite 2800 & 2400 LT Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The Medos Hilite 2800 hollow fiber membrane consists of a polypropylene gas permeable mat. The Medos Hilite 2400 LT hollow fiber membrane consists of a polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to affect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume.

The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The Medos Hilite 2800 and 2400 LT Oxygenators may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

The provided text is a 510(k) summary for the Medos Hilite 2800 & 2400 LT Oxygenators. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain the kind of detailed information about acceptance criteria and a specific study that proves the device meets those criteria, which would be typically found for an AI/ML-based medical device.

Therefore, it is not possible to fill in all the requested information as the document is for a traditional medical device (blood oxygenator) and not an AI/ML diagnostic tool.

Here's an attempt to address the points based on the available information, noting where an AI/ML context does not apply:

Acceptance Criteria and Device Performance:

The document describes "Performance Testing" which is generally for demonstrating functional requirements and safety. It doesn't present a table of specific numerical acceptance criteria with corresponding reported device performance values in the way you'd expect for, say, sensitivity or specificity of a diagnostic algorithm.

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

Study Details (as they pertain to a traditional medical device submission for substantial equivalence):

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: Not applicable in the context of an AI/ML test set. The "tests" listed are bench performance and biocompatibility tests on the device materials and components, not a diagnostic test on a data set. No human or animal subject sample size is specified for these tests, nor is there a "test set" in the AI/ML sense.
• Data Provenance: Not applicable. The document focuses on demonstrating physical and biological equivalence, not data analysis from specific patient populations.

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)

• Not applicable. This is not a diagnostic device relying on expert-labeled ground truth for algorithm performance validation. The "ground truth" for the performance tests would be established by validated test methodologies and industry standards for medical device materials and function.

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

• Not applicable. This is not a diagnostic device requiring adjudication of human-labeled classifications.

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-assisted diagnostic device.

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

• Not applicable. This is not an algorithm-based device. The "performance" described is the functional and biological safety performance of the physical oxygenator device itself.

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

• Not applicable for AI/ML ground truth. For the physical device, the "ground truth" is implied by adherence to established engineering specifications, material standards, and biocompatibility guidelines. The testing confirms the device's physical and chemical properties and interaction with blood.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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The MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1 .0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.

The MEDOS HI LITE 7000 & 7000 L T Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 LT hollow fiber membrane consists of a Polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifyigal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit,

The provided document is a 510(k) summary for a medical device (Medos Hilite 7000 & 7000 LT Oxygenator), not an AI/ML product. Therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, standalone performance, training set details, ground truth for AI, etc.) are not applicable and cannot be found in this document.

However, I can extract information related to the device's performance testing and the criteria it meets based on the provided text.

Here's a summary of the requested information, adapted for a medical device rather than an AI/ML product:

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

The document does not explicitly present quantitative acceptance criteria in a table alongside reported performance values for each criterion. Instead, it states that "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." It then lists the types of tests performed. The overall conclusion is that "The Medos Hilite 7000 & 7000 LT Oxygenator meets design specifications," implying that all tested parameters fell within acceptable ranges.

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 does not specify the quantitative sample sizes for the performance and safety tests. It mentions "extensive safety, performance, and validations prior to release" and "Final testing" as well as specific types of tests. There is no information regarding the data provenance (country of origin, retrospective/prospective). The testing appears to be internal validation by the manufacturer, Medos Medizintechnik AG, located in Germany, suggesting in-house prospective testing.

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 to the evaluation of this type of medical device. The "ground truth" for device performance typically refers to established engineering specifications, safety standards, and biological compatibility requirements, assessed through laboratory testing by qualified technicians and scientists, rather than expert clinical review of data for diagnostic accuracy.

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

This concept (adjudication for ground truth in diagnostic tests) is not applicable to the engineering and biocompatibility testing of this device.

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 as the device is a blood oxygenator, not an AI/ML diagnostic or assistive tool.

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

This is not applicable as the device is a blood oxygenator, not an AI/ML algorithm.

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

The "ground truth" for this device's performance and safety is derived from:

• Established mechanical and material engineering specifications.
• Biocompatibility standards and test protocols (e.g., ISO 10993 series used for cytotoxicity, hemolysis, sensitization, etc.).
• Functional performance specifications (e.g., blood flow rate capabilities, oxygenation efficiency, CO2 removal efficiency, heat exchange capacity – although explicit values are not detailed in this summary, they are implied to be met).

8. The sample size for the training set

This is not applicable as the device is a blood oxygenator, not an AI/ML product that requires a training set.

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

This is not applicable as the device is a blood oxygenator, and no training set or ground truth in that context is relevant.

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