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The Quantum PureFlow Cardioplegia Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool cardioplegic solution, to remove air and to monitor the temperature cardiopulmonary bypass (CPB) procedures up to 6 hours duration. Any blood to be treated must contain anticoagulant. Contact with cardioplegic solution for longer than this period is not permitted. Devices are intended for adult patients.

The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Devices are intended for adult patients.

The Qura S.r.l. Quantum PureFlow Heat Exchangers described in this 510(k) are classified in two different product families:

• -Quantum PureFlow Standard Heat Exchanger (HX-S);
• -Quantum PureFlow Cardioplegia Heat Exchanger (HX-C).

The devices have been designed to manage the temperature of blood (HX-S) or cardioplegic solution and physiological fluids (HX-C) during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.

HX-S is designed to:

• l keep circulating blood at a specific temperature, depending on the type of surgery being performed;
• l maintain blood/patient thermoregulation during the CPB;
• 트 rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition.

HX-C is designed to:

• I ensure heating/cooling of cardioplegic solution;
• 트 ensure the cardioplegic solution cooling in order to arrest myocardium activity during-CPB;
• 트 remove air measure/monitor temperature in the circuit.
• -Quantum PureFlow Heat Exchangers (both product families, HX-S and HX-C) described in this 510(k) have been designed to be powered by heater-cooler systems that use water as Heat Transfer Fluid (HTF).

The provided text is a 510(k) premarket notification for the Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger. It details the device description, intended use, comparison to predicate devices, and performance data.

However, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of an AI/algorithm-driven device. The document explicitly states:

• "No clinical data on Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger have been included in the current Traditional 510(k) submission." (Page 8)
• "No animal studies have been performed except for mandatory biocompatibility tests..." (Page 8)

The performance data section (VII. PERFORMANCE DATA) lists non-clinical testing such as:

• Evaluation of devices' performances (Operating Parameters, Air Entrapment, Mechanical Integrity, Dynamic Blood Damage, Thermal Performance and Compliance)
• Performance evaluation according to ISO 7199:2016
• Validation of the EtO Sterilization process
• Packaging Validation tests
• Biocompatibility

These tests are standard for medical devices like heat exchangers, confirming their physical and functional properties, but they do not involve AI or algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, or the establishment of ground truth by expert consensus.

Therefore, I cannot provide the requested information for an AI-based device, as the document describes a traditional medical device (heat exchanger) and its non-clinical performance evaluations, not an AI/algorithm study.

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The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation in cardiopulmonary bypass operations on pediatric patients for up to 6 hours: The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field of cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The Neonatal and Pediatric Reservoirs may be applied during the surgery in the extracorporeal circulation for collecting venous blood by gravitation or vacuum assist venous drainage (VAVD), air removal in venous blood, as a volume depot of blood, for collecting, defoaming and filtering cardiotomy blood. The Reservoirs may also be applied after the surgery on the intensive care unit for vacuum operated thoracic drainage and for the autotransfusion of autologous blood. If the application occurs in the intensive care unit the reservoir which was employed in the operation is usually used. The blood contacting surfaces are coated optionally with SOFTLINE Coating. The Neonatal and Pediatric Reservoirs are sterile and non-pyrogenic devices, for single use only and are not to be re-sterilized by the user.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the sense of specific thresholds for a device's performance metrics (e.g., "filtration efficiency must be >X%"). Instead, the acceptance criteria are framed as compliance with recognized standards and demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially a statement of compliance.

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

The document does not specify a sample size for any "test set" in the traditional sense of a clinical trial or large-scale device performance study. The testing described is primarily laboratory and bench testing against international standards (ISO 10993-1, ISO 15674) and direct comparison to a predicate device.

• Sample Size: Not specified.
• Data Provenance: The studies were likely conducted internally by the manufacturer (Maquet Cardiopulmonary AG) or by contracted laboratories, as part of the regulatory submission process.
• Retrospective or Prospective: Not explicitly stated, but typically, this type of non-clinical testing is prospective, meaning it's conducted specifically to support the 510(k) submission. There is no indication of patient data being used in this summary.

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 in the document. The "ground truth" for this medical device (a cardiotomy reservoir) is established by adherence to recognized engineering standards (e.g., ISO) and functional performance metrics, not by expert interpretation of data like in an AI/diagnostic imaging context. The "experts" involved would be engineers, biocompatibility specialists, and quality control personnel performing the tests according to standard protocols.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation (e.g., reading medical images) where there can be disagreement among experts. For device performance testing against objective standards (like ISO norms for a physical device), the results are typically quantitative measurements that either pass or fail the specified criteria, not subjective interpretations requiring 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 not provided. This document describes a physical medical device (a blood reservoir) and its regulatory clearance based on substantial equivalence and compliance with standards. It is not an AI algorithm or a diagnostic imaging device that would involve human readers or AI assistance.

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

This information is not applicable and not provided. The device is a physical hard-shell cardiotomy reservoir, not an algorithm.

7. The Type of Ground Truth Used

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

• Compliance with International Standards: Specifically ISO 10993-1 (Biologic Evaluation) and ISO 15674 (Hard-shell cardiotomy/venous reservoir systems). These standards define performance characteristics, safety requirements, and test methods.
• Comparison to Predicate Devices: Demonstrating that the new device performs as safely and effectively as legally marketed predicate devices (Capiox Reservoir RX 05 Baby and Resevoir D101 Dideco Kids Infant) in terms of indications for use, integrity, performance, biocompatibility, and sterility.

No pathology, expert consensus, or outcomes data from patients are mentioned for establishing the "ground truth" of the device itself for this 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not provided. Since there is no training set for an AI model, there's no ground truth established in this context.

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