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The Quantum Micro-Cardioplegia Delivery System is intended for delivery of micro-cardioplegia to the heart during open heart surgery lasting up to six hours in duration. It is intended to be used by an experienced and trained clinician. It is not intended to be used by a patient or other untrained personnel.

The Quantum Micro-Cardioplegia Delivery System is intended to assist in arresting a beating heart during cardiac surgery through controlled delivery of cardioplegia. The system consists of the Quantum Workstation, Quantum Micro-Cardioplegia Delivery Module, Quantum Roller Pump 4", Quantum Diagnostic/Ventilation Module, and Quantum Pureflow Cardioplegia Heat Exchanger. The Quantum Micro-Cardioplegia Delivery Module was developed to supplement the existing Quantum technology and to allow users a more integrated way of managing microplegia delivery during cardiopulmonary bypass.

The Quantum Micro-Cardioplegia Delivery System is intended specifically for procedures where microplegia (i.e., whole blood cardioplegia) strategy is used. The Quantum Micro-Cardioplegia Delivery Module adds cardioplegia drugs (i.e., arrest agent and additive) to the main carrier solution (blood) which is circulated by a Quantum Roller Pump. The two devices, working in unison and controlled by the Quantum Workstation, deliver cardioplegia to the patient’s heart.

The premise of the Quantum Micro-Cardioplegia Delivery System is to interlock forward cardioplegia flow with medication delivery rates, ensuring delivery of arrest agent at a given ratio to the blood. The system includes a separate, dedicated heat exchanger, which is intended to be fitted in the cardioplegia blood line to allow for temperature regulation of the cardioplegia solution. The heat exchanger can be connected to any available heater cooler device which will manage the temperature regulation.

This document is an FDA 510(k) clearance letter for a medical device called the "Quantum Micro-Cardioplegia Delivery System." The letter grants clearance based on the device being "substantially equivalent" to legally marketed predicate devices.

Key takeaway regarding your request:

The provided document does not contain the specific acceptance criteria and study results in the detail you are requesting. It only states that a "suite of nonclinical tests was performed" and lists the types of tests conducted, concluding that these tests demonstrate substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

The device described is a physical medical device (a system for delivering micro-cardioplegia during open-heart surgery), not an AI/software-driven diagnostic tool that would typically involve the type of performance metrics (sensitivity, specificity, AUC, human reader improvement, etc.) you are asking about.

I can, however, extract what is available about the non-clinical tests and the device's characteristics:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed reported performance metrics. It only states that testing was performed to demonstrate substantial equivalence to the predicate device. The general performance aspects implicitly evaluated would be related to the device's functional integrity, safety (electrical, electromagnetic), and usability.

Study Details (Based on the provided document)

Since the device is a physical medical device, not an AI model, many of the requested fields are not applicable or not detailed in a typical FDA clearance letter for such a product.

1. Sample size used for the test set and the data provenance: Not mentioned. The testing involves bench and non-clinical evaluations of the device's hardware, software, and performance, not a clinical data set in the context of an AI study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to a physical device performance test, not a diagnostic interpretation. Clinical experts (experienced and trained clinicians) are the intended users, and Human Factors/Usability tests would involve them, but specifics are not provided.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device and testing.
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: Not applicable. This is a physical medical device, not an AI diagnostic tool involving human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device. The "algorithm" refers to the device's control software, which performs its functions whether a human is "in-the-loop" as an operator or not during functional testing.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a diagnostic AI. For a physical device, the "ground truth" for functional testing would be the engineering specifications, regulatory standards (e.g., IEC 60601-1), and expected physical and chemical performance parameters (e.g., flow rate accuracy, temperature control).
7. The sample size for the training set: Not applicable. This is not an AI model requiring a training set in the machine learning sense.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA clearance letter focuses on establishing substantial equivalence for a physical medical device (Quantum Micro-Cardioplegia Delivery System) through non-clinical bench testing, not on the performance of a diagnostic AI tool using clinical data. Therefore, most of the specific metrics and study design details you requested, which are pertinent to AI/software performance, are not present in this document.

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Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.

The Vanguard Blood Cardioplegia Systems are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs.

They are cardiopulmonary bypass devices allowing cardioplegia fluid delivery; they also regulate cardioplegia fluid temperature and trap air emboli.

Vanguard devices are indicated for use for patients undergoing surgical procedures requiring cardiopulmonary bypass procedures.

These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours.

The Vanguard Blood Cardioplegia Systems are the modified version of the disposables currently marketed in the SORIN BLOOD CARDIOPLEGIA SYSTEM (K934763) and the NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847).

The provided document is an FDA 510(k) approval letter for the VANGUARD Blood Cardioplegia Systems. It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through novel clinical studies.

Therefore, many of the requested sections regarding acceptance criteria, new study design, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not applicable to this type of regulatory submission and are not present in the document.

The document emphasizes a non-clinical performance evaluation to demonstrate equivalence, primarily focusing on material changes and updated technical specifications, without conducting new clinical trials.

Here's an analysis based on the provided text, indicating where information is not present or not applicable:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, there are no explicit "acceptance criteria" defined as performance metrics that the device must meet in a novel clinical trial. Instead, the "acceptance" is based on demonstrating that the modified devices perform equivalently to the existing, cleared predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document explicitly states: "No clinical testing was conducted in support of the Vanguard Blood Cardioplegia Systems..." (Page 7).
• The "test set" for performance evaluation was based on non-clinical verification and validation testing. The specific sample sizes for these tests (e.g., number of devices tested for material compatibility, flow rates, temperature regulation, etc.) are not detailed in this summary document.
• Data provenance is also not specified regarding country of origin or whether it was retrospective/prospective, as it pertains to internal lab testing for device verification.

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

• Not applicable. Since no clinical testing was performed, there was no need for experts (e.g., radiologists) to establish a clinical "ground truth" for a test set. The validation was based on engineering and performance criteria against standards.

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

• Not applicable. As there was no clinical test set requiring expert interpretation or adjudication, no such method was employed.

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 device is a hardware system (cardioplegia set), not an AI/software device. No MRMC study was done, and the concept of "human readers improving with AI assistance" is irrelevant here.

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

• Not applicable. This device is not an algorithm or software. It is a physical medical device.

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

• For the non-clinical performance data, the "ground truth" (or reference) would be engineering specifications, regulatory standards, and the established performance characteristics of the predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

• Not applicable. As there is no training set for this device.

Summary regarding the Study:

The "study" that proves the device meets the (implied) acceptance criteria is a non-clinical verification and validation testing program. This means the manufacturer conducted a series of tests in their labs to ensure the modified device functions as intended, meets design specifications, is biocompatible with the new materials, and performs equivalently to the predicate devices, all in accordance with relevant national and international standards. This type of evidence is common for 510(k) submissions, particularly when changes are made to materials or manufacturing processes of existing device types where substantial equivalence can be demonstrated without new clinical data.

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The MYOtherm XP with Cortiva bioactive surface is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardion is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

The MYOtherm XP cardioplegia delivery system is a device intended for the mixing, warming/cooling, and delivery of bxvgenated blood/cardioplegia solution in a predetermined rationulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

The Cortiva coated and Uncoated MYOtherm XP™ Cardioplegia Delivery System is designed to mix arterial blood from an oxygenator with sanguineous cardioplegia solution in specific ratios, depending upon the system chosen. The patient delivery line is packaged separately to allow for ease of sterile transfer to the operative field prior to connection to the delivery outlet of the cardioplegia system. A pressure monitoring line, three-way stopcock, and gauge protector, as well as a pressure relief line with pressure relief valve are preconnected.

The Cortiva coating is a BioActive Surface that is non-leaching and provides thromboresistant blood contact surface. The A10378001, CBXP41 and the CBXP41B MYOtherm Cardioplegia Delivery Systems are identical except for the bypass loop. The XP41B and CBXP41B contains a bridge between the blood and crystalloid line allowing the physician to deliver 100% blood, if needed.

The male-to-male Luer connector component 61399405213 that is the 'subject' of this special 510(k) connects with MYOtherm via a pressure relief valve and tubing. 61399405213 gets connected to a pressure relief valve on one end, and a cap on the other end. A perfusionist can remove the cap to connect a PVC tubing of choice, during Cardioplegia intervention.

This document K240190 describes a Special 510(k) submission for the Medtronic MYOtherm XP™ Cardioplegia Delivery System. The submission focuses on a change in the polycarbonate resin used in a component (connector 61399405213).

Therefore, the acceptance criteria and study described pertain to the biocompatibility of the device with the new resin formulation, rather than a clinical performance study involving AI or human readers.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (e.g., number of animals for in vivo tests, number of samples for in vitro tests) used for each biocompatibility test. It only states that "The samples built for the testing included the connector component with proposed resin formulation."

The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, biocompatibility testing is typically conducted in a laboratory setting under controlled conditions.

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

This information is not applicable to a biocompatibility study. Biocompatibility tests follow established ISO standards, and the "ground truth" is determined by the specific biological reactions observed against predetermined criteria for each test. These results are usually interpreted by qualified toxicologists or biologists, but the document does not specify their number or qualifications.

4. Adjudication Method for the Test Set

This is not applicable to biocompatibility studies, which rely on objective measurements and established pass/fail criteria according to international standards (e.g., ISO 10993 series).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study is focused on the biocompatibility of a material change in a medical device, not on diagnostic accuracy involving human readers or AI.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI software.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on the objective biological and physiochemical responses observed in the standardized biocompatibility tests. These tests assess potential adverse biological effects such as cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, and hemostatic changes, according to recognized international standards (e.g., ISO 10993).

8. The Sample Size for the Training Set

This is not applicable as this study is a biocompatibility assessment of a material change, not a machine learning model. There is no "training set" in this context.

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

This is not applicable as there is no training set for this type of study.

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The CMO8 Adult PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The CMO8 Adult PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal crculation during cardiopulmonary bypass procedures, lasting 6 hours or less.

The CMO8 Adult PMP oxygenator (CMO8) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The CMO8 facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The CMO8 is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The qas exchanger part of the CMO8 is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the CMO8 is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated. The Tubing Pack, which contains blood lines, gas lines, a venous reservoir and the CMO8 Oxygenator, is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.

The provided text is a 510(k) summary for a medical device (CMO8 Adult PMP Oxygenator with Tubing Pack) and not a report or study describing the acceptance criteria or performance of an AI/ML powered device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them from this document. The document primarily discusses the substantial equivalence of a physical medical device (an oxygenator) to predicate devices through in vitro and non-clinical testing.

The questions you asked are highly relevant to AI/ML device submissions, particularly regarding:

• Acceptance Criteria and Performance Table: This is typically a key component of AI/ML device validation.
• Sample Size and Data Provenance: Crucial for understanding the representativeness and generalizability of AI/ML model testing.
• Expert Ground Truth (Number of Experts, Qualifications, Adjudication): Essential for establishing reliable labels for AI/ML training and testing data.
• MRMC Studies: Often used to evaluate the impact of AI on human reader performance.
• Standalone Performance: Evaluating the AI algorithm's capabilities independently.
• Type of Ground Truth: The gold standard used to assess AI accuracy.
• Training Set Details: Information about the data used to develop the AI model.

To answer your request, I would need a document detailing the clinical validation or performance study for an AI/ML-powered medical device.

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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) procedure up to 6 hours in duration. Devices are intended for adult patients.

The subject of the present Special 510(k) is the Quantum PureFlow Standard Heat Exchanger product family for inclusion of three additional variants with respect to the currently cleared (K220110) portfolio.

Quantum PureFlow Standard Heat Exchanger devices are designed to manage the temperature of blood during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.

HX-S devices are designed to:

• 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.

Quantum PureFlow Standard Heat Exchangers have been designed to be powered by heatercooler systems that use

• Water
  or
• Glycol-based solution
  as Heat Transfer Fluid (HTF).

The provided text is an FDA 510(k) summary for a medical device called the "Quantum PureFlow Standard Heat Exchanger." It outlines the device's purpose, regulatory classification, and the comparison to an existing predicate device to demonstrate substantial equivalence.

However, the information requested in your prompt (Acceptance Criteria, Study Details, Sample Sizes, Expert Qualifications, Adjudication Methods, MRMC study, Standalone Performance, Ground Truth, Training Set Details) is typically related to the performance evaluation of AI/ML-based medical devices, particularly regarding diagnostic accuracy or clinical effectiveness.

The Quantum PureFlow Standard Heat Exchanger is a physical medical device (a cardiopulmonary bypass heat exchanger), not an AI/ML software device. Therefore, the types of studies and acceptance criteria described in your prompt (e.g., accuracy metrics, human reader improvement with AI, ground truth establishment by experts, training set details) are not applicable to this device.

The "Performance Data" section in the document (Page 5) does mention "NON-CLINICAL TESTING" and lists:

• Updating labeling and IFU according to ISO 15223-1:2021.
• Performance tests for new REF codes according to ISO 7199:2016.

This indicates that the acceptance criteria for this device would be related to meeting the standards outlined in ISO 7199:2016 for cardiopulmonary bypass heat exchangers (e.g., heat exchange efficiency, pressure drop, biocompatibility), as well as general safety and performance requirements for medical devices. The "study that proves the device meets the acceptance criteria" would be the non-clinical testing performed according to these standards.

In summary, none of the specific details you requested regarding AI/ML performance evaluation (such as number of experts for ground truth, MRMC study, sample sizes for test and training sets for an algorithm, etc.) are present in this document because it describes a hardware medical device, not an AI/ML software.

If this were an AI/ML device, the requested information would be crucial for understanding its validation and demonstrating its safety and effectiveness. Since it's a heat exchanger, the relevant "acceptance criteria" revolve around its physical performance (e.g., heat transfer rate, flow resistance) as per recognized standards (like ISO 7199), and the "study" would be bench testing to verify compliance with those standards.

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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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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 Quest MPS 3 ND Myocardial Protection System, consisting of the Quest MPS 3 ND Console, the Quest MPS 3 Controller, and the Quest MPS 3 ND Disposables (Quest MPS 3 ND Delivery Set and optional Accessories) together is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and/or cardioplegia solutions to the heart during open-heart surgery on either an arrested or beating heart for use up to six hours in duration.

The Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) is a software controlled system designed to aid the perfusionist in cardioplegia delivery to a patient during Cardiopulmonary Bypass Surgery. The Quest MPS 3 ND System combines blood from the heart-lung machine and crystalloid from the IV-bag in a specified ratio and then adds in the drug (arrest or additive agent) for delivery to the patient. The Quest MPS 3 ND System consists of a reusable MPS 3 ND Console, a reusable MPS 3 Controller, and single use MPS 3 ND Disposables.

The Quest MPS 3 ND Console incorporates two Blood/Crystalloid pumps (B/C pumps), pressure and temperature monitors, a sensor interface, an Arrest Agent pump, an Additive pump and ultra-sonic air detection sensors. The Quest MPS 3 ND Console monitors and controls the blood:crystalloid ratio, drug concentration, flow rate, pressure and delivery route of the cardioplegia solution delivered to the patient. The MPS 3 ND Console also monitors the temperature of the cardioplegia solution which is regulated by an external heater cooler device.

The Quest MPS 3 Controller is a touchscreen user interface utilized by the operator to select all parameters, initiate/stop cardioplegia delivery, monitor delivery parameters and view/save relevant case information and data.

The Quest MPS 3 ND Disposables includes single use delivery sets (also known as the "MPS 3 ND Delivery Sets"), delivery set accessories and blood bypass tubing. The MPS 3 ND Delivery Sets and accessories consist of a flexible cassette, a heat exchanger with water line, drug cartridges and relevant tubing and connectors used to complete the cardioplegia circuit for use with the Quest MPS 3 ND Console. The blood bypass tubing is used as a backup in the event the Quest MPS 3 ND Console becomes unusable.

The provided text is a 510(k) premarket notification for a medical device, the Quest MPS 3 ND Myocardial Protection System. It outlines the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

However, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop study. The device in question is a medical protection system for cardiopulmonary bypass surgery, not an AI-powered diagnostic or assistive tool.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and its 510(k) submission.

Here's how to address the request based on the provided document:

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

The document broadly mentions "Performance Specifications" and "Software Verification Tests," "MPS 3 ND System Performance Tests," as well as other bench and nonclinical tests. It concludes that "The collective results of the performance testing demonstrate that the Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) meets the established specifications necessary for consistent performance during its intended use."

However, specific numerical acceptance criteria and their corresponding achieved performance values are not detailed or tabulated in this summary document. This level of detail would typically be found in the full test reports submitted to the FDA, not in the public 510(k) summary.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in the provided document. The tests performed are primarily bench and nonclinical (e.g., software verification, electrical safety, system performance). These are not tests on a "test set" of patient data in the way an AI algorithm is evaluated.
• Data Provenance: Not applicable in the context of clinical data for AI. The tests are benchtop, simulated use, and engineering verification.

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 not an AI diagnostic device that requires expert-established ground truth from medical images or patient data. Its performance is evaluated against engineering specifications and safety standards.

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

• Not applicable. This is not a study involving human readers or interpretation of data beyond standard engineering and quality control procedures.

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, a MRMC study was not done. This is not an AI-assisted device. The device's function is to deliver medical solutions during surgery, not to aid human readers in diagnostic interpretation.

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

• Not applicable. This is a hardware and software system for medical fluid delivery, not an AI algorithm evaluated for standalone performance. Its "performance" refers to its ability to accurately pump, heat/cool, and control fluids as designed.

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

• Not applicable in the context of typical AI ground truth. For this device, "ground truth" would equate to established engineering standards, physical laws (e.g., pressure, flow, temperature measurements), and functional requirements for a medical device of its type. For example, a flow rate "ground truth" would be the expected flow rate based on pump settings and calibration, not a medical diagnosis.

8. The sample size for the training set:

• Not applicable. This device is not an AI system trained on a dataset. Its software is deterministic and based on specified operating parameters.

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

• Not applicable. See point 8.

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The Quest Medical MPS 3 Myocardial Protection System, consisting of the MPS 3 Controller, and the MPS 3 Disposables (MPS 3 Delivery Set and optional Accessories) together is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and/or cardioplegia solutions to the heart surgery on either an arrested or beating heart for use up to six hours in duration.

The MPS 3 Myocardial Protection System (MPS 3) is a software controlled system designed to aid the perfusionist in cardioplegia delivery to a patient during Cardiopulmonary Bypass Surgery. The MPS 3 System combines blood from the heartlung machine and crystalloid from the IV-bag in a specified ratio and then adds in the drug (arrest or additive agent) for delivery to the patient. The MPS 3 System consists of a reusable MPS 3 Console, a reusable MPS 3 Controller, and single use MPS 3 Disposables.

The MPS 3 Console incorporates two Blood/Crystalloid pumps (B/C pumps), a temperature- controllable water circulation system, pressure and temperature monitors, a sensor interface, an arrest agent pump, an additive pump and ultra-sonic air detection sensors. The MPS 3 Console monitors and controls the blood:crystalloid ratio, drug concentration, flow rate, pressure, temperature, and delivery route of the cardioplegia solution delivered to the patient.

The MPS 3 Controller is a touchscreen user interface utilized by the operator to select all parameters, initiate/stop cardioplegia delivery, monitor delivery parameters and view/save relevant case information and data.

The MPS 3 Disposables includes single use delivery sets (also known as the "MPS 3 Delivery Sets"), delivery set accessories and blood bypass tubing. The MPS 3 Delivery Sets and accessories consist of a flexible cassette, a heat exchanger, drug cartridges and relevant tubing and connectors used to complete the cardioplegia circuit for use with the MPS 3 Console. The blood bypass tubing is used as a backup in the event the MPS 3 Console becomes unusable.

The provided text describes the 510(k) premarket notification for the Quest Medical, Inc. MPS 3 Myocardial Protection System. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device, as implied by the structure of the requested output (e.g., ground truth, MRMC study, training sets).

The MPS 3 Myocardial Protection System is a hardware system for delivering cardioplegia solutions during heart surgery, and its 510(k) submission is based on demonstrating substantial equivalence to a predicate device (MPS 2 Myocardial Protection System) through non-clinical bench testing. It is not an AI/algorithm-driven diagnostic or assistive device that would typically involve the types of studies outlined in your request (e.g., assessing sensitivity/specificity based on expert consensus, multi-reader multi-case studies, or standalone algorithm performance).

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document explicitly states:

• "Clinical Testing Summary [807.92(b)(2)] Not applicable. Clinical testing was not performed to support this 510(k) submission." This means there was no human clinical trial assessing the device's performance in patients in the manner that would generate the data for the requested metrics (e.g., accuracy against ground truth).
• The performance data sections detail bench and nonclinical tests (e.g., sterilization, shelf-life, biocompatibility, electrical safety, system performance, mechanical hemolysis, human factors/usability, disposables performance), which are standard for hardware medical devices but do not involve the types of acceptance criteria you've outlined for an AI/algorithm.

To directly answer your request based on the provided document:

1. A table of acceptance criteria and the reported device performance:
* N/A. The document does not present quantitative acceptance criteria or reported performance metrics in the format of precision, recall, accuracy, sensitivity, specificity, etc., which are typical for AI/algorithm-driven devices. Instead, it lists various non-clinical tests (e.g., "Sterilization, Shelf-Life, and Packaging Testing", "System Performance Tests", "Mechanical Hemolysis Test," "Leak Test," "Efficiency Test") that would have their own internal acceptance criteria (e.g., sterility must be maintained, pressure must hold, flow rate within tolerance). These specific criteria and their results are not detailed in this summary document. The document simply states "The collective results of the performance testing demonstrate that the MPS 3 Myocardial Protection System (MPS 3) meets the established specifications necessary for consistent performance during its intended use."

2. Sample sized used for the test set and the data provenance:
* N/A. As no clinical or AI-centric performance study was conducted, there are no "test sets" of patient data in the context of an AI/algorithm. The "samples" used would be the physical devices and components subjected to various bench and non-clinical tests (e.g., multiple units for reliability testing, materials for biocompatibility). The document does not specify the number of units/samples for each bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* N/A. Not relevant for this type of device and its non-clinical testing.

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

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. The device is a hardware system, not an AI assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. The device is a hardware system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* N/A. Not applicable for the bench testing performed. Ground truth for the device's function would be based on engineering specifications and physical measurements (e.g., flow rate accuracy measured against a calibrated standard, pressure measurements).

8. The sample size for the training set:
* N/A. Not applicable as this is not an AI/ML device requiring a training set.

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

In summary, the provided document details the regulatory submission for a physical medical device (Myocardial Protection System) and relies on demonstrating substantial equivalence through non-clinical performance testing. It does not involve an AI component or the types of clinical/AI performance studies that would generate the specific data points requested in your prompt.

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