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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 1000 & 800 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 1000 & 800 LT are neonate, infant oxygenators intended for use at blood flow rates of 0.2 to 1.0 liters per minute for the HILITE 1000 and 0.2 to 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 Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 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.

The provided text describes a 510(k) submission for the MEDOS HILITE 1000 & 800 LT Oxygenators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a comparative effectiveness study with human readers or a standalone AI algorithm.

Therefore, many of the requested information points (e.g., acceptance criteria, device performance table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this document, as the submission follows a different regulatory pathway.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable / Not Provided. The document does not describe specific acceptance criteria (e.g., a certain percentage accuracy, sensitivity, or specificity) or present a table of device performance against such criteria. The submission is based on demonstrating equivalence to a predicate device through safety, performance, and validation testing.

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

• Not Applicable / Not Provided. The document mentions "extensive safety, performance, and validation testing." However, it does not specify the sample size of devices used in these tests, nor does it detail a "test set" in the context of performance metrics that would be used for AI or diagnostic devices. Data provenance (country of origin, retrospective/prospective) is also not specified for these tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable / Not Provided. This information is relevant for studies involving human interpretation or AI performance evaluation where a "ground truth" needs to be established (e.g., by experts reviewing images). For an oxygenator, the "ground truth" during testing would be objective physical measurements of performance (e.g., gas exchange rates, pressure drops) rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. Adjudication methods (like 2+1 or 3+1) are typically used when there's disagreement among experts in establishing ground truth for diagnostic studies. This is not relevant for the type of device and testing described.

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

• No, an MRMC study was not done. MRMC studies assess the change in human reader performance (e.g., diagnosis accuracy) with and without AI assistance. This type of study is not relevant for an oxygenator device, which is a therapeutic rather than a diagnostic tool. The document focuses on the physical and functional performance of the oxygenator itself.

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

• Not Applicable. Standalone algorithm performance is relevant for AI or software as a medical device. The MEDOS HILITE oxygenator is a physical medical device. The "performance" here refers to its mechanical and physiological function, not an algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for the oxygenator's performance would be objective physiological and engineering measurements. This includes parameters like oxygen transfer rates, carbon dioxide removal rates, pressure drop across the device, heat exchange efficiency, and material compatibility. The document states "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." These specifications are typically derived from industry standards and clinical requirements for oxygenators.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. The concept of a "training set" applies to machine learning algorithms. For a physical device like an oxygenator, there isn't a "training set" in this context. Device design and development involve engineering principles and testing, not AI training.

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

• Not Applicable / Not Provided. As there is no training set for an AI algorithm, this question is not relevant.

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