Search Results

VT75-E1
Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.
Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².

VT75-E2
Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use.
Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².

The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.
Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethylpentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.
All the device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating.

The provided document, K231982, is a 510(k) Premarket Notification for a medical device (Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2). This document details the device's technical specifications, intended use, and comparison to predicate devices, along with performance data regarding non-clinical testing.

However, it does not describe acceptance criteria, nor a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. The document explicitly states:

• "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices."
• "No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018".

The performance data mentioned (Gas transfer performance, Temperature probe and Pressure sensor verification, Mechanical Blood Cell Damage, Device pressure Drop, Mechanical Integrity, Mechanical resistance of connectors, Coating coverage and durability, Air handling) are engineering and functional tests relevant to a blood oxygenator, not the kind of AI/ML performance metrics typically found in documents describing acceptance criteria for an AI-powered diagnostic or assistive device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as it pertains to an AI/ML device, because this document is for a non-AI/ML medical device and does not contain such information.

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Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.

Device is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).

Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use.

Devices is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).

Quantum Perfusion Blood Oxygenator devices, VT75-C1U and VT75-C2U, consist of an oxygenator with an integrated arterial filter. The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surqical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

The provided text describes a 510(k) premarket notification for a medical device, the "Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U" and "Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U". This document outlines the device's characteristics, intended use, and comparison to predicate devices. It states that the submission does not include clinical data and relies on non-clinical testing to demonstrate substantial equivalence.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device, particularly those related to human-in-the-loop performance, expert ground truth, and training sets, are not applicable to this submission. This device is a traditional medical device (oxygenator), not an AI/ML-powered diagnostic or therapeutic tool.

Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is not applicable:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted, but does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for the device alongside those criteria. It only states that "all testing passed by meeting the established requirements."

2. Sample sizes used for the test set and the data provenance

The document does not specify sample sizes for the non-clinical performance tests (e.g., how many oxygenators were tested for gas exchange). The tests are described as "non-clinical testing" and appear to be laboratory or bench testing. Data provenance is not applicable in the sense of patient data; it's device performance testing.

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

Not applicable. This device is an oxygenator, not an AI/ML diagnostic. Ground truth would be defined by engineering specifications and physical measurements, not expert consensus on medical images or clinical data.

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

Not applicable. This concept pertains to human review of ground truth in AI/ML performance studies, which is not relevant here.

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 not an AI-assisted device. The submission explicitly states "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate devices."

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

Not applicable. This is not an AI/ML algorithm. The performance tests mentioned (gas exchange, hemolysis, etc.) are inherent performance characteristics of the physical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this type of traditional medical device, "ground truth" for performance relates to:

• Engineering specifications and standards: Adherence to established performance parameters outlined in standards like ISO 7199 for Cardiopulmonary Bypass Oxygenators.
• Physical and chemical measurements: Examples include flow rates, pressure drops, gas transfer rates (O2 and CO2), and hemolysis rates.
• Biocompatibility testing results: As per ISO 10993.

8. The sample size for the training set

Not applicable. This is not an AI/ML-powered device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/ML-powered device.

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The Quantum Perfusion Centrifugal Blood Pump CP37 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:

(i) Full of 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.

Devices are intended for adult patients.

The Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors.

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.

This document is a 510(k) premarket notification for a medical device called the "Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors." The purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a predicate device already on the market. In this case, the predicate device is the "Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors" (K201320), and a reference device is the "Quantum Perfusion Centrifugal Blood Pump CP37" (K202169).

The filing states that the new device, CP37 with Integrated Sensors, is essentially a variant introduced into the existing product family, aligning with the general structure, principle of operation, intended use, manufacturing, and sterilization processes of the previously cleared predicate and reference devices.

Based on the provided text, the device's acceptance criteria and the study that proves it meets those criteria are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of crisp, quantitative acceptance criteria and corresponding reported device performance metrics in the format typically seen for a new algorithmic or diagnostic device. Instead, the approach taken is to demonstrate substantial equivalence to existing cleared devices (CP22 with Integrated Sensors and CP37).

The implicit "acceptance criteria" appear to be that the new device variant (CP37 with Integrated Sensors) performs equivalently to the predicate (CP22 with Integrated Sensors) and reference (CP37) devices for its intended use, without raising new issues of safety or effectiveness.

The reported device performance is conveyed through the statement:
"Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices. Applicable testing activities demonstrated that the proposed device model does not raise any issues of safety and effectiveness as compared to the currently cleared predicate and reference product."

Therefore, the "performance" is that it met the same standards as the cleared devices.

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

The document states:
"The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact:

• ...
• Review and Assessment of data available on predicate( K201320) and reference (K202169) devices submission and applicability to new variant introduced in the product family portfolio."

This indicates that the "test set" for demonstrating safety and effectiveness was primarily based on a review and assessment of existing data from the previously cleared predicate (K201320) and reference (K202169) devices. There is no mention of a new, distinct "test set" with a specific sample size.

Data Provenance: The original data for the predicate and reference devices would have been generated during their respective premarket clearances. The current submission is a Special 510(k) for a device variant, often relying on existing data and non-clinical bench testing. The document does not specify the country of origin or whether the original data was retrospective or prospective beyond referring to previous submissions.

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

This information is not applicable/provided in the document. The submission is for a physical medical device (blood pump with sensors), not an AI/software diagnostic device that requires expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance would be engineering specifications, physical measurements, and biocompatibility testing, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Since the "test set" primarily involved a review of existing data and non-clinical testing for a physical device, there isn't an "adjudication method" in the sense of reconciling differences in expert interpretations of data as would be found in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that are interpreted by human readers, often with and without AI assistance, to measure the impact of AI on reader performance. This submission is for a physical device, not an AI diagnostic tool.

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

No, a standalone study was not done in the context of an algorithm's performance without human intervention. This device is a physical centrifugal blood pump with integrated sensors, not an AI algorithm. Its performance is measured by its mechanical and biocompatibility characteristics, not by an algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used:

The "ground truth" for this device relates to its engineering specifications, functional performance (e.g., pumping efficiency, pressure monitoring accuracy), material properties, and biocompatibility. This is established through:

• Engineering specifications and design documents.
• Bench testing results measuring flow rates, pressure accuracy, material strength, etc.
• Biocompatibility testing (e.g., ISO 10993 standards).
• Sterilization validation data.
• Compliance with applicable standards (e.g., ISO 15223-1:2021 for labeling).

The document explicitly states: "Technical specifications have been verified through testing activities performed according to the same internal applicable standards/protocols of the original cleared devices." This implies that the "ground truth" and verification methods align with the established standards and protocols used for similar devices.

8. The Sample Size for the Training Set:

This information is not applicable/provided. This device is a physical medical device, not an AI/machine learning model that undergoes "training." Therefore, there is no training set sample size to report.

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

This information is not applicable/provided. As the device is not an AI/machine learning model, there is no training set or corresponding ground truth establishment process in that context.

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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."

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Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

All medical devices pertaining to Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal.

Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter.

Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.

Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholinebased biocompatible material.

The provided text describes a 510(k) premarket notification for Qura's Quantum Perfusion Dual Lumen Cannula, which introduces new REF codes (different sizes) and a warning in the Instruction for Use. It does not describe acceptance criteria for an AI/ML powered device or a study involving human readers or sophisticated ground truth establishment.

Therefore, most of the requested information (related to AI/ML device performance, reader studies, type of ground truth, training sets, etc.) cannot be extracted from this document, as it pertains to a medical device's physical and mechanical performance rather than an AI/ML algorithm.

However, I can extract the relevant information regarding the non-clinical testing for this specific medical device submission.

Here's what can be extracted based on the provided text:

Study and Acceptance Criteria Information (as per the provided document's scope):

The document describes the performance data and conclusions for new variants of a Quantum Perfusion Dual Lumen Cannula. The "study" here refers to the non-clinical bench testing conducted to demonstrate product safety and effectiveness for these new variants.

1. A table of acceptance criteria and the reported device performance:

The document mentions "Performance tests for new REF codes introduced in the portfolio, according to applicable Recognized Consensus Standard ISO 18193:2021" specifically, "Evaluation of devices' Pressure Drop." However, the specific acceptance criteria values (e.g., "Pressure drop must be less than X mmHg at Y flow rate") and the reported device performance values are not detailed in this summary. It only states that testing was performed "as per same internal applicable standards/protocols applied for predicate devices (K203067)."

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Quantum SuperPAC Tubing set is a set of tubing intended for use during cardiopulmonary bypass for a duration up to 6 hours.
Quantum SuperPAC Cardioplegia Set is a tubing set used for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.

Quantum SuperPAC Tubing set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set such as oxygenators, pumps, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support, for a maximum duration of 6 hours.
Quantum SuperPAC Cardioplegia set devices are designed to connect different devices that are not provided in the Quantum SuperPAC tubing set for the infusion of cardioplegia solutions and physiological fluids during cardiac surgery procedures on the heart and great vessels for up to six hours.
Quantum SuperPAC devices (all variants) are non-toxic, non-pyrogenic, and sterilized by ethylene oxide. Devices are intended for single use only and are not to be resterilized by the user.
All the device surfaces in contact with blood are treated with a phosphorylcholine-based coating.
Quantum SuperPAC devices (all variants) are mainly constituted of polyvinyl chloride (PVC) DOP free tubing and additional components composing the set; different variants are available, varying for tubing dimension and set configuration in order to address customer and surgical procedure specifications.

This document is a 510(k) summary for the Quantum SuperPAC Tubing Set and Quantum SuperPAC Cardioplegia Set. It details the device's intended use, comparison to predicate devices, and performance testing. However, it does not contain information regarding studies that establish acceptance criteria for device performance in the manner of an AI/ML algorithm's effectiveness in diagnostic tasks, nor does it provide details on sample sizes, ground truth establishment, or expert adjudication typical for such studies.

Instead, this document focuses on demonstrating substantial equivalence to existing medical devices through non-clinical performance and biocompatibility testing for a medical device (tubing sets) rather than a diagnostic AI system.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary, as it pertains to a physical medical device.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance in the context of an AI/ML diagnostic system. Instead, it states that "All testing passed by meeting the established requirements set for the devices." The performance tests conducted are listed as:

• Operating Parameters
• Mechanical Integrity
• Device pressure drop
• Spallation and Tubing Life
• Connection strength

These tests were mainly performed according to ISO 15676. Additional tests included:

• Evaluation of product shelf life (according to EP/UPS requirements)
• Validation of EtO Sterilization process (according to ISO 11135:2014)
• Packaging Validation tests (according to ISO 11607-1:2019, ASTM F1886/F1886M-16, EN 868-5 and ASTM F1929-15)
• Biocompatibility (according to ISO 10993-1:2018 and FDA Guidance)

The document asserts that the devices met these established requirements, implying that the acceptance criteria were defined by these standards and the device's performance aligned with them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system requiring a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system requiring expert-established ground truth.

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

This information is not applicable as the document describes non-clinical performance testing for a physical medical device.

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 as the document describes non-clinical performance testing for a physical medical device, not a diagnostic AI/ML system.

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

This information is not applicable as the document describes a physical medical device, not an algorithm.

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

This information is not applicable for the type of device described. The "ground truth" for this device would be its adherence to performance specifications and safety standards as determined by the listed non-clinical tests (e.g., mechanical integrity tests, biocompatibility tests).

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

This information is not applicable as the document describes a physical medical device, not a machine learning model.

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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 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 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:

• 트 keep circulating blood at a specific temperature, depending on the type of surgery being performed;
• maintain blood/patient thermoregulation during the CPB;
• 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;
• remove air measure/monitor temperature in the circuit.

Differently from the original submission K212688, 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
  or
• 트 Glycol-based solution
  as Heat Transfer Fluid (HTF).

This document is a 510(k) premarket notification for Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger. It describes the devices and their intended use, and importantly, declares their substantial equivalence to a predicate device.

However, the provided text does not contain the information requested about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "NON-CLINICAL TESTING: The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact: update of labeling and Instructions for Use (IFU) according to ISO 15223-1:2016 ... Performance tests for new REF code introduced in the portfolio, according to ISO 7199:2016 (only for sections applicable to Heat Exchangers). This 510(k) provided testing to demonstrate compatibility with a glycol-based heat transfer fluid (HTF) called CoolFlow DTX." (Page 7)
• "Animal Study: No animal studies have been performed to support changes object of the present 510(k)." (Page 7)
• "CLINICAL TESTING: No clinical data on Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger have been included in the current 510(k) submission." (Page 8)

This means the submission relies primarily on non-clinical performance testing against recognized standards (ISO 7199:2016 and ISO 15223-1:2016) and a demonstration of compatibility with a new heat transfer fluid, likely to show that the new device remains substantially equivalent to a previously cleared device (K212688).

Therefore, I cannot provide the requested information, which pertains to a de novo or comprehensive clinical study that would typically involve a test set, ground truth establishment, expert adjudication, or MRMC studies. The device is a "Class II Product Code: DTR Cardiopulmonary Bypass Heat Exchanger," which often relies on performance standards and substantial equivalence rather than extensive new clinical studies for clearance.

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Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U and Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.

Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U and Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use.

Devices are intended for adult patients.

Quantum Perfusion Blood Oxygenator devices (acronym VT-C) consist of an oxygenator with an integrated arterial filter.

The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.

The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli.

Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.

All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

The provided text describes a 510(k) premarket notification for a medical device, the "Quantum Perfusion Blood Oxygenator," and its various models. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that the device meets specific numeric acceptance criteria for performance in an AI/data science context.

Therefore, the information required to answer your specific questions about AI/ML acceptance criteria and a study proving those criteria (such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in this document.

The document states:

• "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices."
• "No animal studies have been performed except for mandatory biocompatibility tests..."

Instead, the submission relies on non-clinical bench testing to demonstrate performance and safety characteristics, comparing them to the properties of the predicate devices. The non-clinical tests listed are related to the physical and functional aspects of the oxygenator itself (e.g., priming volume, pressure drop, gas transfer, mechanical integrity, etc.), not the performance of an AI algorithm.

Here's what can be extracted, albeit not directly answering your AI/ML specific questions:

1. A table of acceptance criteria and the reported device performance:
* The document implies acceptance criteria by stating "All testing passed by meeting the established requirements set for the devices." However, the specific numerical acceptance criteria for each non-clinical test are not explicitly detailed in this summary. Instead, it refers to standards like ISO 7199 and FDA Guidance for Cardiopulmonary Bypass Oxygenators.
* The "reported device performance" are implied to have met these unspecified criteria, but no quantitative results for these tests are presented in this summary.

2. Sample sizes used for the test set and the data provenance:
* Not applicable/Not provided. The document describes non-clinical bench testing, not a clinical study with a test set of patient data for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided, as there is no mention of an AI/ML algorithm requiring expert ground truth for its performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided.

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/Not provided. No AI component is described or evaluated in this medical device submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not applicable/Not provided for an AI/ML context. The "ground truth" for the non-clinical tests would be the established engineering and biological standards and measurements.

8. The sample size for the training set:
* Not applicable/Not provided. No AI/ML model training is described.

9. How the ground truth for the training set was established:
* Not applicable/Not provided.

In summary: This document is a regulatory submission for a physical medical device (blood oxygenator) seeking substantial equivalence based on its physical and functional characteristics and non-clinical bench testing. It does not involve AI or machine learning, and therefore the information you requested regarding AI/ML model evaluation is not present.

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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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Quantum Perfusion Blood Oxygenator ECC VT200-E1 and Quantum Perfusion Blood Oxygenator ECC VT160-E1 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.

Quantum Perfusion Blood Oxygenator ECC VT200-E2 and Quantum Perfusion Blood Oxygenator ECC VT160-E2 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use.

Devices are intended for adult patients.

The Quantum Perfusion Blood Oxygenator ECC (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours..

Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethy|pentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator.

The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.

All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

This document is a 510(k) Premarket Notification from the FDA regarding the Quantum Perfusion Blood Oxygenator ECC (various models). It details the device's characteristics, intended use, and comparison to predicate devices for demonstrating substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a detailed quantitative manner for all parameters. Instead, it states that "All testing passed by meeting the established requirements set for the devices." The performance data is summarized under "NON-CLINICAL TESTING" as a list of tests performed.

However, we can infer some of the performance characteristics from "Table 5-1 —Main characteristics" on page 7 and "Table 5-2 – Comparative Data" on page 9-10, which provide technical specifications of the device and its comparison to predicate devices. These act as the de facto acceptance criteria and reported performance values.

Here's an attempt to construct a table based on the provided information, noting that specific "acceptance criteria" values are often inferred from the device's technical specifications and the predicate device's characteristics, which the new device aims to match or perform similarly to. The "Reported Device Performance" here are the self-declared specifications of the applicant's device.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the non-clinical tests (e.g., how many devices were tested for priming volume, pressure drop, etc.). It mentions that in-vitro testing was performed.

• Data Provenance: The manufacturer is Qura S.r.l. in Mirandola, Modena, Italy. The testing was non-clinical (in-vitro), so there is no patient data provenance in terms of country or retrospective/prospective nature. The tests were performed to demonstrate compliance with international standards (ISO, EP/UPS) and FDA guidance.

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

This section is not applicable as the studies described are non-clinical, in-vitro performance, and biocompatibility tests for medical devices, not diagnostic studies requiring expert adjudication of images or patient outcomes. The "ground truth" here is defined by physical and chemical measurements against engineering specifications and international standards.

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

This is not applicable as there is no human-in-the-loop diagnostic task or medical imaging analysis requiring adjudication. Adjudication methods are typically used in clinical studies or expert reviews of diagnostic interpretations.

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 is not applicable. The device is a blood oxygenator, not an AI-powered diagnostic tool. No MRMC study was performed or is relevant for this type of device. 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 devices."

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

This is not applicable as the device is not an algorithm or AI system. Its "performance" is mechanical, physical, and biological (biocompatibility, gas exchange efficiency). These were tested in a standalone (device-only) manner as non-clinical, in-vitro tests, as described in the "NON-CLINICAL TESTING" section.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation is established through:

• Engineering specifications and design parameters.
• Relevant international standards (e.g., ISO 7199 for oxygenators, ISO 11135 for sterilization, ISO 11607-1 for packaging, ISO 10993-1 for biocompatibility).
• FDA guidance documents specific to cardiopulmonary bypass oxygenators.
• Performance characteristics of the predicate and reference devices, against which substantial equivalence is claimed.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This is not applicable for the reason stated in point 8.

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