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The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.

The ECC.O System with Integrated Venous Air Removal Device, Centrifugal Blood Pump, Pump Bracket. Hollow Fiber Oxygenator and Heat Exchanger is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. ECC.O consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger connected to a venous air removal device (defoamer) (Ideal Mimesys' Venous Air Removal Device, K032040), a centrifugal pump (Ideal Mimesys' Centrifugal Pump, K032040) and a pump bracket.

The acceptance criteria and the study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list a table of acceptance criteria with numerical targets. Instead, it refers to compliance with established specifications and guidance documents. The reported device performance is presented as meeting these specifications.

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

The document does not explicitly state a sample size for the test set in terms of number of devices or data points used for each specific in vitro test. It generally states that "Applicable tests were carried out" and "In vitro testing was carried out."

Regarding data provenance:

• Country of Origin: Not specified for the test data, but the submitter (Dideco S.r.l.) is based in Mirandola (MO), Italy.
• Retrospective or Prospective: The testing described appears to be prospective as it involves new in vitro tests on the ECC.O system, as well as comparative testing with the D 905 EOS assembled with predicate devices. The biocompatibility data from predicate devices are used as a reference, which could be considered retrospective in a way, as it leverages prior testing. The ECC.O devices were "accelerated aged to an equivalent of three years real time aging" for some tests.

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

Not applicable in this context. This submission describes non-clinical (in vitro) testing and substantial equivalence to predicate devices, not studies involving human interpretation or clinical outcomes where expert ground truth would be established.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical evaluation based on laboratory testing against established specifications and comparative performance with predicate devices.

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

No, an MRMC comparative effectiveness study was not conducted or described in this document. This submission is for a medical device (extracorporeal circulation system), not an AI-powered diagnostic or imaging interpretation tool where such studies would be relevant.

6. Standalone Performance:

Yes, a standalone performance evaluation was conducted in the sense that the ECC.O system was subjected to various in vitro tests to assess its algorithm-only equivalent performance (i.e., the device's functional and safety performance without human intervention during the test itself). The results were then compared to established specifications and the performance of predicate devices.

7. Type of Ground Truth Used:

The "ground truth" for this device evaluation is primarily based on:

• Established Specifications: Predetermined performance targets and safety limits derived from regulatory standards (e.g., ISO 10993-1, ISO 7199), FDA guidance documents (e.g., for Cardiopulmonary Bypass Oxygenators, Blood Extracorporeal Blood Circuit Defoamers), and internal validated engineering and design specifications.
• Predicate Device Performance: The functional performance of the predicate devices (D 905 EOS, Ideal Mimesys' Centrifugal Pump, Ideal Mimesys' Venous Air Removal Device) served as the benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a "training set." The testing described is for a physical medical device.

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

Not applicable, as there is no "training set" for this type of device.

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Ideal Mimesys is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control. Ideal Mimesys must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal Mimesys is intended for use with the Stöckert Centrifugal Pump Console.

IDEAL MIMESYS System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter Mimesys Treated (PhosphoryIcholine coating hereinafter called PC coating) is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. IDEAL MIMESYS consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Mimesys Adult Membrane Oxygenator, K031223) connected to an active venous air removal device (defoamer), a centrifugal pump (Cobe Revolution Centrifugal Blood Pump with PC coating, K030462) and a pump bracket.

The provided text describes the 510(k) summary for the IDEAL MIMESYS System. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document, but rather are implicitly defined by meeting established specifications and demonstrating substantial equivalence to predicate devices. The reported device performance is described qualitatively.

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

The document does not explicitly state the numerical sample size for the test set. It mentions that "a complete battery of tests were carried out" and "in vitro testing were carried out."

• Data Provenance: Not explicitly stated regarding country of origin. The studies appear to be prospective in nature, as they involve performing tests on newly manufactured devices (including aged devices) to evaluate their performance against established specifications and predicate devices.

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

This information is not provided in the document. The studies are primarily focused on in vitro and biocompatibility testing of the medical device itself, rather than diagnostic interpretation requiring expert human assessment to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The studies involve laboratory and engineering testing, not human interpretation that requires 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

This information is not applicable and therefore not provided. The device is an extracorporeal blood circuit system, not an AI-assisted diagnostic tool.

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

This information is not applicable and therefore not provided. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

• Established Specifications: Compliance with pre-defined performance and safety parameters.
• Predicate Device Performance: Demonstrating substantial equivalence to the performance of legally marketed predicate devices through comparative testing.
• Regulatory Guidance Documents: Adherence to requirements outlined in FDA guidance documents (e.g., "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions") and international standards (e.g., ISO 10993-1:1995, ISO 7199 (1996)).

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As this is a medical device and not an AI/machine learning algorithm, there is no "training set" in the conventional sense. The development of the device would involve engineering, design, and manufacturing processes, with validation through the described testing.

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

This information is not applicable and therefore not provided for the same reason as point 8.

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