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The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory necessary for open surgical procedures on the aorta or vena cava.

CentriMag Pre-connected Pack is to be used with the CentriMag™ Acute Circulatory Support System components (console, motor, flow probe and monitor) to provide extracorporeal circulation for full or partial cardiopulmonary bypass support for less than 6 hours. The CentriMag™ Pre-connected Pack contains sterile disposable components: a blood pump, oxygenator, and priming bag pre-connected by tubing. The pack also includes disposable accessories commonly used in the setup of pump and oxygenator connections to the cardiopulmonary bypass extracorporeal circuit.

Several types of performance testing were conducted to demonstrate the substantial equivalence of the CentriMag Pre-connected Pack. Unfortunately, the provided document does not contain all the information requested. Here's a breakdown of what information is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for any of the performance tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). All tests appear to be laboratory-based performance tests, not clinical studies involving patient data.

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 as the tests described are performance tests of a medical device's physical and functional characteristics, not studies that require expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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

An MRMC study was not conducted. This document describes the performance testing of a physical medical device (CentriMag Pre-connected Pack), not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable as an algorithm or AI system is not the subject of this 510(k) submission.

7. The type of ground truth used

For the performance tests, the "ground truth" would be the established engineering and medical standards for device performance, as referenced by the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions Final Guidance for Industry and FDA Staff" and ISO 10993-1 for biocompatibility. The tests aim to demonstrate that the device meets these pre-defined physical, chemical, and biological requirements.

8. The sample size for the training set

This information is not applicable as this is not an AI or machine learning device that requires a training set.

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

This information is not applicable as this is not an AI or machine learning device that requires a training set.

Summary of the Study:

The studies conducted for the CentriMag Pre-connected Pack were a series of performance tests in accordance with FDA guidance and international standards for cardiopulmonary bypass oxygenators and biocompatibility. These tests aimed to demonstrate the device's integrity, durability, and functionality, as well as its biological safety. The document explicitly states that "No animal studies or clinical studies are required." The performance testing and comparative testing with reference devices (Rotaflow Centrifugal Pump, Quadrox-iD Adult Oxygenator, HLM Tubing Set, CentriMag Acute Circulatory Support System, Eurosets PMP Sterile Oxygenator) were used to demonstrate substantial equivalence to the predicate device, the OXY-1 System (K200109). The conclusion is that the CentriMag Pre-connected Pack is substantially equivalent as the technological characteristics and performance testing do not raise different questions of safety and effectiveness compared to the predicate device.

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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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