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The CARD 43 is a cardiotomy reservoir specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. CARD 43 can be used postoperatively for chest drainage. The CARD 43 should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The CARD 43 Cardiotomy Reservoir with phosphoryIcholine coating is intended for use in cardiovascular procedures requiring cardiopulmonary by-pass. It defoams, filters and stores the blood coming from the operating field through thoracic, intracardiac and general suction. The device is a modified version of the currently marketed Synthesis R (K022450). The design modifications consist of: eliminating the venous return inlet connector on the top of the reservoir lid. eliminating the venous section of the filtering system and updating of product specifications in the IFU. The modification enables the device to be suited for filtration, defoaming and collection only of blood aspirated from the operative field during cardiopulmonary bypass procedures or postoperatively during chest drainage. Other than this change the CARD 43 and the Synthesis R are similar in their intended use, materials and manufacturing processes.

The Sorin Group Italia S.r.I. CARD 43 Cardiotomy Reservoir with phosphorylcholine coating (CARD 43) is a modified version of the previously marketed Synthesis R (K022450) and is intended for use in cardiovascular procedures requiring cardiopulmonary bypass. The modifications include eliminating the venous return inlet connector and the venous section of the filtering system, making it primarily suited for the collection and removal of microemboli or microaggregates from suctioned blood. The device's performance was evaluated through non-clinical and in vitro testing to demonstrate substantial equivalence to the unmodified device and compliance with safety and effectiveness requirements.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for individual tests. Instead, it refers to "a complete battery of tests" and "in vitro testing was carried out." The provenance of the data is not specified but is assumed to be from experiments conducted by Sorin Group Italia S.r.I. The studies are by nature prospective, as they evaluated the modified device's performance against predefined criteria.

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 "ground truth" for these types of device performance studies is typically established by adhering to recognized international standards (ISO 10993-1:2003, ISO 15674:2001) and FDA guidance documents. The expertise would lie in the accredited labs and personnel performing the tests according to these standards, rather than a panel of clinical experts establishing ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical/in vitro device performance study, not a clinical study involving human assessment or diagnostic interpretation. The results are quantitative and compared against predefined technical specifications.

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

Not applicable. This is a medical device performance study, not a diagnostic AI study involving human readers or interpretation of medical images/data. The device is a physical product (cardiotomy reservoir), not an AI algorithm.

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

Not applicable, as this is a physical medical device and not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device modification acceptance is based on:

• Established Specifications: Performance benchmarks derived from relevant international standards (ISO 10993-1:2003 for biocompatibility, ISO 15674:2001 for hardshell cardiotomies), FDA guidance documents ("Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission"), and prior validated performance of the predicate device (Synthesis R, K022450).
• Scientific Principles: Underlying principles of engineering, material science, and blood-material interactions relevant to cardiotomy reservoirs.

8. The Sample Size for the Training Set

Not applicable. This is a device performance study, not an AI model requiring a training set.

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

Not applicable, as this is a device performance study and not an AI model.

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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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Synthesis Mimesys is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. Synthesis Mimesys is an adult oxygenator intended for use in operations on adult patients. Synthesis Mimesys must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

SYNTHESIS MIMESYS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter and connected to a hardshell cardiotomy venous reservoir.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Dideco S.p.A. Synthesis Mimesys Hollow Fiber Oxygenator:

Acceptance Criteria and Device Performance

The provided document describes the SYNTHESIS MIMESYS Adult Membrane Oxygenator and its substantial equivalence to predicate devices. The acceptance criteria for this device are primarily demonstrated through in vitro testing and biocompatibility assessments, aligning with established industry standards and FDA guidance. The reported device performance indicates that the SYNTHESIS MIMESYS met these established specifications.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. This is not a study designed to prove the device meets pre-defined acceptance criteria in the same way a clinical trial might, but rather to show it performs as safely and effectively as existing devices.

1. Sample sizes used for the test set and data provenance:

   • Test Set (In Vitro): The document references testing performed on the "device aged up to 3 years." It does not specify the exact number of devices tested in the in vitro studies.
   • Data Provenance: The studies are described as "in vitro testing" carried out in accordance with FDA guidance and ISO standards. The location of these labs is not explicitly stated, but the manufacturer is Dideco S.p.A. in Italy, suggesting the primary testing was likely conducted in Europe or by contracted labs. The data is retrospective in the sense that it refers to testing of the manufactured product.

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

   • This type of information (expert review for ground truth) is not applicable to this submission, as it relates to a medical device's engineering and biological performance rather than diagnostic accuracy.

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

   • Not applicable. Adjudication methods are typically employed in clinical studies or imaging-based diagnostic trials where expert consensus is needed to establish ground truth for a subjective assessment. This submission relies on objective, measurable performance characteristics.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools, not for a hollow fiber oxygenator.

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

   • Not applicable. This device is a medical device, not an algorithm. Its performance is assessed independently of human operators for its intrinsic function.

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

   • The "ground truth" for the in vitro tests was established by pre-defined specifications and established scientific and engineering standards (e.g., ISO 10993-1:1995 for biocompatibility, ISO 7199 (1996) and FDA guidances for oxygenators for performance). For biocompatibility, this involves laboratory analysis against toxicity thresholds. For in vitro performance, it involves direct measurement of physical and physiological parameters against engineering targets.

7. The sample size for the training set:

   • Not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning algorithms for this product. The design and manufacturing processes are refined through engineering development and testing, not algorithmic training.

8. How the ground truth for the training set was established:

   • Not applicable for the reasons stated above.

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