Search Results

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.

Ask a specific question about this device