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The Nautilus VF ECMO Oxygenator with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated fluid path pressure, temperature, and oxygen saturation monitoring is achieved by built-in sensor modules.

The Nautilus™ ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed.

The Nautilus™ VF ECMO Oxygenator device contains integrated sensors that connects to the VitalFlow Console (K230364) for the display of measured parameters. The following measured parameters are measured: inlet pressure, inlet oxygen saturation, outlet oxygen saturation, and outlet blood temperature. The difference between the inlet and outlet pressure, is calculated. The device is intended to be interconnected with a VitalFlow Console device that receives digital data from the oxygenator.

The oxygenator devices are single-use, nontoxic, non-pyrogenic, and not made from natural latex rubber materials.

The provided FDA 510(k) summary for the Nautilus VF ECMO Oxygenator describes the device and its substantial equivalence to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria within the context of AI/ML-powered medical devices.

This document is for a medical device (an oxygenator) and its associated monitoring components, not an AI/ML diagnostic or prognostic algorithm. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI vs. without AI, ground truth establishment for training sets, number of experts for ground truth, etc.) are not applicable in this context.

Here's an analysis of the information that is present or can be inferred, formatted to address your questions where possible, and noting where information is missing or irrelevant to this type of device:

Device Acceptance Criteria and Performance

The document describes "Performance Evaluations" and "Special Controls" that were met to demonstrate substantial equivalence to the predicate device (Nautilus™ Smart ECMO Module (K191935) and Nautilus™ ECMO Oxygenator (K191935)). These act as the acceptance criteria for the device clearance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "bench studies" for performance evaluations, and "in vivo evaluation" using a "biologic test system" and a "summary... described the initial real-world clinical experience... into the ELSO registry."

• Sample Size for Bench Studies: Not specified. Bench studies typically involve a set number of device units for various tests (e.g., electrical, mechanical, software).
• Sample Size for In Vivo Evaluation: Not specified, but refers to a "biologic test system" and "initial real-world clinical experience with the first records of clinical ECMO cases entered sequentially into the ELSO registry." The exact number of cases or subjects is not provided in this summary.
• Data Provenance: The "ELSO registry" implies multi-center, international data, but the specific country of origin or whether it's retrospective/prospective is not detailed for the "real-world clinical experience" summary. The "biologic test system" would be a controlled lab setting.

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 and not provided for this type of medical device. The evaluation of an oxygenator focuses on its physical, chemical, electrical, and biological performance characteristics, not on diagnostic accuracy requiring expert interpretation or "ground truth" establishment in the way an AI algorithm for image analysis would.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving interpretation (e.g., by radiologists) where there might be disagreements, which is not the case for an oxygenator's performance evaluation.

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 information is not applicable as this is not an AI/ML-driven diagnostic or assistive device requiring human reader interaction.

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

This information is not applicable as this is not an AI/ML-driven device. The device has integrated sensors and connects to a console for display, so there's a human-in-the-loop for monitoring parameters, but it's not an AI algorithm.

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

For an oxygenator, "ground truth" would refer to established scientific and engineering principles, validated measurement techniques, and regulatory standards. For example:

• Biocompatibility: Established by adherence to ISO 10993 standards.
• Sterility: Validated sterilization methods and testing.
• Performance (e.g., gas exchange, heat exchange): Measured against validated laboratory methods and established clinical ranges for physiological parameters (e.g., blood oxygenation, CO2 removal).
• Safety (Electrical/EMC): Adherence to relevant IEC standards.
• In vivo: Performance in a "biologic test system" and "real-world clinical experience" as mentioned, assessed against physiological outcomes.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML-driven device with a "training set" in the machine learning sense. The device is hardware with integrated sensors and software components that are validated, not trained.

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

This information is not applicable for the same reasons as #8.

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The Nautilus(tm) Smart ECMO Module with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated fluid path pressure, temperature, and oxygen saturation monitoring is achieved by built-in sensor modules and display.

The Nautilus(tm) ECMO Oxygenator with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use.

The Nautilus™ ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed.

The Nautilus™ Smart ECMO Module device contains integrated sensors with an electronic touch screen display. The following measured parameters are visible on the electronic display: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature. The difference between the inlet and outlet pressure, delta pressure, is calculated and also displayed on the screen. The touchscreen display allows users to set alarm limits for all measured parameters. The Nautilus™ Smart ECMO Module will alarm visually and audibly when the limits are exceeded.

The devices are single-use, nontoxic, non-pyrogenic, and not made from natural latex rubber materials.

The provided text describes performance evaluations for the MC3 Nautilus Smart ECMO Module and Nautilus ECMO Oxygenator. However, it does not explicitly state "acceptance criteria" in a tabulated format and then directly link each criterion to "reported device performance" in a separate column. Instead, it presents various performance evaluations and their findings.

Based on the information provided, here's a structured summary attempting to address your request as closely as possible:

1. Table of acceptance criteria and the reported device performance

While explicit acceptance criteria are not tabulated with specific numerical targets, the document implies that the device is considered acceptable if its performance is "comparable or better" than a state-of-the-art device and meets the "special controls" and standards.

• "The most common complication reported was circuit exchange in twenty percent of patients..."
• "Ten percent of patients had reports of blood infections on ECMO, which is similar to the rate of infections (11%) previously reported by others."
• "One patient suffered a CNS infarction event (5%), and another patient, a CNS hemorrhage." |
  | Compatibility with other circuit devices | Technological Characteristics: "The subject device is designed to be compatible with other extracorporeal circuit devices and accessories." |

The studies collectively show that the Nautilus device meets performance expectations by being comparable to or better than predicate/reference devices and established clinical norms, and by demonstrating safety and efficacy in various testing environments.

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

• Long-term Bench Gas Exchange testing: The sample size isn't explicitly stated as a number of devices, but it refers to "MC3 Nautilus oxygenators from accelerated age populations" and "competitive heparin coated oxygenators."
  • Provenance: In vitro, conducted according to ISO 7199:2016, using bovine blood/plasma.
• In-Vivo Study in Sheep:
  • Sample size: A total of 15 sheep. Specifically, 10 sheep were used to evaluate the Nautilus device (at either 2 or 5 L/min), and 5 control animals were studied with a state-of-the-art heparin-coated device (at 2 L/min).
  • Provenance: Prospective animal study.
• Clinical information (Real World Evidence):
  • Sample size: Not explicitly stated as a number of patients, but data were collected from patients at 7 centers in 4 countries. The average duration of ECMO support was 378.5 hours (15.8 days), with a range of 17 to 1271 hours (52.9 days). Given these durations, it implies a significant number of patient-hours of use.
  • Provenance: Retrospective, voluntarily entered into the ELSO registry from initial real-world clinical experience. Data from 7 centers in 4 countries.

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

This information is not provided in the text. The studies described are performance-based (bench, in-vivo) and real-world data collection, rather than studies requiring expert adjudication of device performance in a diagnostic sense.

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

This information is not provided in the text. The studies described (bench, animal, real-world registry data) do not appear to involve a human adjudication process for establishing a "ground truth" in the way a diagnostic algorithm might be evaluated.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human readers improving with AI assistance. The device is an ECMO module/oxygenator, not an AI-assisted diagnostic tool.

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

This question is not directly applicable. The device (ECMO module/oxygenator) is a medical device that physically interacts with a patient's blood, not an algorithm. The "Smart Module" has integrated sensors and an electronic display, which would operate in a "standalone" algorithmic sense for its sensor functions, but its primary function as an ECMO device is not an algorithm. The sensor accuracy was evaluated as part of "Smart Module Testing."

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

• Long-term Bench Gas Exchange testing: Ground truth for gas exchange and pressure drop was established by measurements according to the ISO 7199:2016 standard using bovine blood, providing objective scientific measurements.
• In-Vivo Study in Sheep: Ground truth for clotting was established by direct observation ("no clots in any location") and confirmation of oxygenator functionality in the animal model.
• Clinical information (Real World Evidence): Ground truth for complications and device performance in a clinical setting was derived from clinical observation and patient outcomes data voluntarily entered into the ELSO registry by clinicians at the participating centers.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical medical device, not a machine learning algorithm that requires a "training set" for its operation in the way an AI diagnostic tool would.

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

This information is not applicable/provided, as the concept of a "training set" does not apply to this type of device.

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