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The Quantum PureFlow Centrifugal Blood Pump CP22 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) 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 pathway necessary for open surgical procedures on the aorta or vena cava.

The Quantum PureFlow Centrifugal Blood Pump CP37 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical (i) procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The Quantum PureFlow Centrifugal Blood Pump CP22/Quantum PureFlow Centrifugal Blood Pump CP37 is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circulation circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circuits for periods lasting up to 6 hours. The pump is designed to allow the passage of blood through an impeller rotating around its axis.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

Here's a breakdown of the acceptance criteria and study information for the Quantum PureFlow Centrifugal Blood Pump CP22 and CP37, based on the provided FDA 510(k) summary:

The primary purpose of this 510(k) submission is to document a change in labeling regarding the removal of a warning and a package symbol related to DEHP content. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that this labeling change does not negatively impact the safety or effectiveness, and that the device remains substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the traditional sense for this submission. The "test set" here refers to the review of standards compliance and labeling changes. No new physical device testing with a specific sample size is detailed.
• Data Provenance: The referenced standards (ISO 10993-18, ISO 15223-1:2016) are international standards. The evaluation of DEHP compliance and labeling update would have been conducted by Qura S.r.l. internally, likely using existing device specifications and documentation. The data is retrospective in that it refers to the original device design and its compliance with updated labeling and material standards.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The activities performed were:
  • DEHP evaluation: This is typically performed by specialists in material science, biocompatibility, and regulatory affairs, often with expertise in ISO 10993 series standards.
  • Labeling and IFU update: This would involve quality assurance and regulatory affairs personnel with expertise in medical device labeling regulations (e.g., ISO 15223-1:2016) and FDA requirements. The contact person is Raffaella Tommasini, QA&RA Director.

4. Adjudication Method for the Test Set

• Not applicable. This submission is about a labeling update and demonstrating continued substantial equivalence based on no design changes. It does not involve a "test set" in the context of clinical or performance data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This device is a blood pump, not an AI/imaging diagnostic tool, so MRMC studies are not relevant.

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

• No, this is not applicable. This device is a physical medical device (blood pump), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" here is compliance with established international standards for biocompatibility (ISO 10993-18) and medical device symbols/information (ISO 15223-1:2016), as well as the device's original design specifications from K192850. The "truth" is that the device's fundamental design and performance characteristics have not changed, and the labeling updates align with current regulatory expectations.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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The Quantum PureFlow Centrifugal Blood Pump indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) 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 pathway necessary for open surgical procedures on the aorta or vena cava.

The Quantum PureFlow Centrifygal Blood Pump is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circulation circuits for periods lasting up to 6 hours. The pump is designed to allow the passage of blood through an impeller rotating around its axis.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Quantum PureFlow Centrifugal Blood Pump". This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria for AI/ML performance.

Therefore, many of the requested details, such as those related to AI/ML study design (sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment, effect sizes of AI assistance), are not applicable and are not present in this document.

However, I can extract information related to the performance data presented to the FDA for this particular medical device.

Acceptance Criteria and Device Performance (Non-AI Device)

The document primarily discusses non-clinical testing to demonstrate performance and substantial equivalence to a predicate device. The general "acceptance criteria" here are that the device meets established requirements for safety and effectiveness, similar to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device, the performance data presented is focused on physical and biological characteristics. The acceptance criteria are implied to be "passed by meeting the established requirements," which are likely specific threshold values for each test (e.g., a certain hemolysis index, no air entrapment, stable operating parameters). The document states that "All testing passed by meeting the established requirements set for the use of Quantum PureFlow Centrifugal Blood Pump."

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

• Sample Size: Not explicitly stated for each test. The performance data section broadly mentions "in-vitro testing" and "evaluated devices' performances," which implies multiple test runs or units. Specific sample sizes for each test (e.g., number of pumps tested) are not provided in this summary.
• Data Provenance: The testing was conducted by Qura S.r.l. in Italy, where the company is located. The tests are "in-vitro" and "non-clinical," implying laboratory-based testing rather than patient data. The document does not specify whether the tests were retrospective or prospective, but in-vitro testing for device performance is typically conducted prospectively as part of the development and verification process.

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

• Not applicable. This is a non-AI, non-diagnostic device. "Ground truth" in the context of AI/ML for image analysis or diagnosis is not relevant here. Performance is evaluated against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

• Not applicable. As this is not an AI/ML study involving human interpretation or diagnosis, there's no adjudication method in the sense of reconciling expert opinions. Performance is assessed against pre-defined engineering and biological parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is relevant for AI/ML-assisted diagnostic devices to assess the impact on human reader performance. It is not applicable to a centrifugal blood pump.

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

• Not applicable. This device does not involve an algorithm with standalone performance metrics. Its performance is intrinsic to its mechanical and material properties.

7. The Type of Ground Truth Used

• Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by engineering specifications, international standards (e.g., ASTM, ISO), and established biological safety thresholds. For example, the "ground truth" for hemolysis is defined by the standard ASTM F1841-97.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML model that undergoes a training phase.

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

• Not applicable.

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