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The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit and to monitor pressure 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.

Device is intended for adult patients.

The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours.

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

The furnished document is a 510(k) clearance letter for a medical device which is a physical blood pump, not an AI/software as a medical device (SaMD). Therefore, the questions related to AI/SaMD testing methodologies (such as sample size for training/test sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.

However, I can extract the relevant information regarding the performance data and the conclusion of the substantial equivalence for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that performance testing was conducted according to the special controls of 21 CFR 870.4360 and confirmed the subject device is equivalent to the predicate. While specific numerical acceptance criteria and precise performance data are not explicitly detailed in this summary, the categories of tests performed indicate the areas where the device's performance was evaluated against established benchmarks (likely derived from the predicate device's performance or regulatory standards).

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

This information is not provided in a quantifiable manner (e.g., number of units tested).

• Sample Size: Not specified. The document states "Performance testing...was performed with the subject device (CP22V-NG)." This implies a sufficient number of devices were tested to draw conclusions, but the exact count is not given.
• Data Provenance: The tests were likely conducted by the manufacturer, Spectrum Medical S.r.l., as part of their 510(k) submission. The document lists the company's address in Mirandola, MO, Italy. It's a retrospective study from the perspective of the submission, as the tests were completed before the submission.

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

This is not applicable as the device is a physical blood pump, not an AI/SaMD requiring human expert annotation for ground truth. The "ground truth" for this type of device would be established through engineering specifications, validated test methods, and performance against established physiological or mechanical standards as outlined in the special controls (21 CFR 870.4360).

4. Adjudication Method for the Test Set

Not applicable for a physical device. Performance is measured objectively through lab tests and engineering evaluation, not through subjective reviewer adjudication.

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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool designed to be used by human readers.

6. Standalone Performance

Yes, standalone performance testing was conducted. The non-clinical performance tests listed (Operating Parameters, Dynamic Blood Damage, Heat Generation, Air Entrapment, Mechanical Integrity, and Durability/Reliability) directly evaluate the device's inherent performance characteristics independently. The device's performance was then compared to that of the predicate device to establish substantial equivalence.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

• Engineering Specifications: The device is designed to meet specific technical parameters (e.g., flow rate, pressure monitoring accuracy, heat generation limits).
• Regulatory Standards: Performance was measured against the special controls outlined in 21 CFR 870.4360, which define acceptable parameters for non-roller type blood pumps.
• Predicate Device Performance: The primary method for proving substantial equivalence was demonstrating that the subject device's performance was equivalent to that of its predicate device, which has a proven safety and effectiveness record.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/Machine Learning model that requires a training set.

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

Not applicable, for the reason stated above.

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The Quantum Perfusion Centrifugal Blood Pump CP20, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, 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

Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

The Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure 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 procedures on (i) the heart or great vessels; or

Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)

Quantum Perfusion Centrifugal Blood Pump CP20 and Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors are standalone single use device intended to pump blood into the extracorporeal circulation circuit and to monitor pressure for periods lasting less than 6 hours.

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors is equipped with two sensors integrated in the blood inlet and outlet connectors.

Devices are 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.

This document describes the Qura S.r.l. Quantum Perfusion Centrifugal Blood Pump CP20 and CP20 with Integrated Sensors (K220842).

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical targets in a table format for each performance test. Instead, it lists the types of performance tests conducted to demonstrate substantial equivalence to the predicate and reference devices, implying that the acceptance criterion for each test was to perform comparably or within expected safety limits as per relevant standards and guidance.

Below is a table summarizing the reported device characteristics relevant to performance and the tests conducted. The "Acceptance Criteria" column will be inferred as "Compliance with applicable standards and demonstration of substantial equivalence to predicate/reference devices."

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

The document describes non-clinical (in-vitro) performance tests. It states: "In-vitro testing was performed to comply with user needs and safety and effectiveness requirements and demonstrate substantial equivalence with the predicate and reference devices..."

• Sample Size: The specific sample sizes for each in-vitro performance test (e.g., number of devices tested for durability, blood damage, etc.) are not specified in this summary.
• Data Provenance: The tests are described as "in-vitro testing," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms typically apply to clinical studies rather than bench testing.

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

This section is not applicable as the studies are non-clinical (in-vitro performance tests). Ground truth, in the context of expert review, usually refers to the establishment of disease status or other clinical observations by human experts for comparison with AI or device performance in clinical settings. The document indicates that no clinical data was included in this 510(k) submission.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved to establish a definitive "ground truth."

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:

No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." The device is a centrifugal blood pump, not an AI or imaging diagnostic tool that would typically involve human readers.

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

The device is a medical pump, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance, which typically applies to AI diagnostics, is not applicable. The device's performance relies on its mechanical and physical properties when operated by a perfusionist with a centrifugal drive. The section on "Performance Data VII. NON-CLINICAL TESTING" details standalone performance in a laboratory setting against engineering, material, and safety standards.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by:

• Compliance with recognized standards: ISO 18242 (for performance tests), ISO 11135 (for sterilization), ISO 11607-1 (for packaging), and ISO 10993-1:2018 (for biocompatibility).
• Comparison to predicate and reference devices: The device demonstrates substantial equivalence in technological characteristics and performance to the Levitronix PediMag Blood Pump (K090051) and Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (K201320).
• Physical measurements and laboratory analyses: These are used to determine operating parameters (flow rate, pressure), assess blood damage, heat generation, air entrapment, mechanical integrity, durability, and evaluate shelf life and biocompatibility.

There is no "expert consensus, pathology, or outcomes data" ground truth as this was a non-clinical submission.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a medical device (blood pump), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI development.

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

Not applicable. As stated above, this is not an AI/ML device, so there is no training set or associated ground truth establishment for such a set.

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