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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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Model BB811 and Model BB811-NS: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Model BB841: Oxygenator with Integrated Arterial Filter: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Cardiotomy/Venous Reservoir: The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811), Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text discusses the Affinity Fusion Oxygenator and its acceptance criteria, specifically focusing on the addition of an alternate hollow fiber supplier.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Biocompatibility Testing:

*Note on "Pressure Integrity": Devices conditioned only to factors significant for leaks (per Two Proportion statistical test).

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

The document does not explicitly state the sample sizes for the test sets (number of oxygenator units tested) for design verification or biocompatibility. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The nature of the tests (engineering performance and biocompatibility) suggests these were primarily laboratory-based prospective tests.

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 to the type of device and testing described. The "ground truth" for a medical device like an oxygenator is established through objective performance measurements and standardized biocompatibility tests, not subjective expert assessment as would be the case for image interpretation or diagnosis.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective human interpretation (e.g., radiology reads) to resolve discrepancies. The tests described here are objective performance and safety tests.

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 an oxygenator, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is an oxygenator, not an algorithm.

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

The ground truth for this device is based on:

• Engineering specifications and standards: For performance characteristics like O2 Transfer, CO2 Transfer, Pressure Drop, Burst, Filtration Efficiency, etc. "PASS" implies meeting predefined, objective measurable criteria.
• International standards for biocompatibility (ISO 10993-1:2018): For tests like cytotoxicity, sensitization, genotoxicity, hemocompatibility, etc. "PASS" means meeting the established safety thresholds for these biological endpoints.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set. The "study" described is a series of laboratory-based design verification and biocompatibility tests.

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 device.

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Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541);
The AFFINITY NT Integrated CVR Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Indications for Use(541B)
The Affinity NT oxygenator with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity NT cardiotomy/venous reservoir (CVR) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine CPB procedures up to 6 hours in duration.

The Affinity NT Oxygenator with /without Balance Biosurface is a sterile membrane Oxygenator with plasma resistant fiber. It is a single-use gas exchange device with integral stainless-steel heat exchanger. Models 541 and 541B include a cardiotomy/venous reservoir.

The Luer cap 1140008-503 that is the 'subject' of this special 510(k) serve as protection of the Luer Access Port. This port can be used to prime the circuit or connect to another support device with a luer connector.

This is a 510(k) summary for a medical device change, not a study proving device meets acceptance criteria. Here's a breakdown of why and what information is provided:

This document describes a "Special 510(k) submission" for a change in a small component (a luer cap) within an already cleared medical device (Affinity NT Oxygenator). It is not a standalone study proving the device meets general acceptance criteria for a new device. The purpose of this submission is to demonstrate that the change to the luer cap does not adversely affect the safety and effectiveness of the previously cleared device, maintaining substantial equivalence to the predicate.

Therefore, most of the requested information (sample sizes, expert consensus, MRMC studies, etc.) is not applicable or not provided in the context of this specific regulatory submission.

Here's how to address the prompt based on the provided text:

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

The document doesn't explicitly define acceptance criteria in a quantitative table form for the overall device's performance. Instead, it focuses on demonstrating that the change to the luer cap does not negatively impact the device's functionality. The "acceptance criteria" for this specific change are implicitly tied to maintaining the original device's performance and safety.

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

• Test Set Sample Size: Not explicitly stated for specific tests related to the luer cap change. The document mentions "Risk-based testing and evaluations," suggesting a sample size appropriate for these specific tests, but the number is not provided.
• Data Provenance: Not specified. Given it's a regulatory submission by Medtronic, it's presumably internal testing conducted to support the change.

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)

Not applicable. This is a technical validation of a component change, not an evaluation requiring expert clinical interpretation for ground truth.

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

Not applicable. This is not a study requiring adjudication of 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

Not applicable. This is not an AI-enabled device or an MRMC study.

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

Not applicable. This is not an algorithm-only device.

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

For the luer cap change, the "ground truth" is established through engineering and biological testing:

• Biocompatibility: Conformance to ISO 10993-1:2018 standards, which involves specific chemical and biological tests. The "ground truth" here is the pass/fail result based on laboratory analysis against these standards, leveraged from a previous clearance (K240534) for a higher-risk product.
• Functionality: Direct measurements and observations (dimensional comparison, torque removal, pressure integrity) against established engineering specifications.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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The D100 devices are indicated for use for neonatal patients undergoing surgical procedures requiring cardiopulmonary bypass. The oxygenator is intended to be used for six hours or less.

The D101 devices are indicated for use for infant patients undergoing surgical procedures requiring cardiopulmonary bypass The oxygenator is intended to be used for six hours or less

The D100 KIDS and D101 KIDS oxygenators (hereinafter identified as KIDS) consist of an oxygenator with an integrated heat exchanger and hard-shell cardiotomy venous reservoir.
The KIDS consist of the following main components
• a heat exchanger consisting of a grooved and pleated stainless steel that is placed into a polycarbonate housing with integrated Hansen connectors and is sealed with resin potting at both ends. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
• an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood.
• a hard shell cardiotomy/venous reservoir attached to the top of the oxygenator by means of a molded fitting joint. It is a single chamber reservoir comprised of a rigid polycarbonate housing with an internal hollow support. The filtering system surrounds the internal hollow support and work as a cardiotomy section in the upper part and as a venous reservoir in the bottom part. It collects and filter blood coming from suckers and from the venous return.

The provided document is a 510(k) premarket notification for D100 KIDS and D101 KIDS cardiopulmonary bypass oxygenators. It's a regulatory submission and not a research paper detailing an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria and study details for AI/ML performance (such as sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices by evaluating the impact of modified materials through non-clinical in vitro testing.

Here's the relevant information that can be extracted:

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

The document states that "The modified device successfully met all acceptance criteria." However, it does not provide a specific table or list of quantitative acceptance criteria and corresponding performance metrics. It only lists the types of tests performed:

The document also notes that these tests were conducted on "sterile aged devices; accelerated aging for a period of time equivalent to at least 3 years as per device labeling."

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

• Sample size: Not specified. The document only mentions "in vitro testing" without detailing the number of devices or test repetitions.
• Data provenance: In vitro testing; likely performed in Italy (country of the applicant, Sorin Group Italia S.R.L.). The document does not specify if the data is retrospective or prospective, as it's not a clinical study on patient data.

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

• This is not applicable. The device is an oxygenator, and the testing involves physical and mechanical performance metrics (pull strength, pressure resistance, flow rates), not a subjective assessment like expert reads of medical images. Ground truth would be established by validated measurement equipment and protocols, not by human experts in this context.

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

• This is not applicable. As it's in vitro physical testing, there's no need for adjudication among human readers/experts.

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. This is not applicable. The device is a medical device (cardiopulmonary bypass oxygenator), not an AI/ML software. No MRMC study was performed.

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

• No. This is not applicable. The device is a physical medical device, not an AI/ML algorithm.

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

• The "ground truth" for this type of in vitro testing would be established by physical measurements using calibrated instruments, adhering to engineering and performance specifications. For example, a "pull test" would have a specified force threshold, and the device either meets or fails that. There is no biological or clinical "ground truth" in the sense of a diagnosis or outcome.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" as this is not an AI/ML device.

In summary: This document is a regulatory submission for a physical medical device (oxygenator) demonstrating substantial equivalence based on in vitro performance testing of material modifications. It does not involve AI/ML technology or clinical studies with patient data, and therefore, most of the questions relating to AI/ML device performance evaluation are not relevant to this document.

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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 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 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text is a 510(k) Summary for the Medtronic Affinity Fusion Oxygenator System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information about a specific study proving the device meets acceptance criteria is not explicitly provided in this type of regulatory submission.

However, I can extract the relevant information that is available and clarify what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics relevant to an "AI system" or "medical device performance" in the general sense, as typically sought in such a request. Instead, it refers to "predetermined requirements" and "improved bond performance" for specific components.

The "performance" referred to in this document primarily relates to the device meeting its intended function as an oxygenator and arterial filter during cardiopulmonary bypass. The summary states that "Operation and performance qualification... were completed" and that "the manufacturing process consistently produces product that meets predetermined requirements."

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

The document does not specify a "test set" in the context of an AI/algorithm evaluation. For the physical device modifications, it mentions "random sampling and statistical modeling" for the TMA seal, but no specific sample sizes or data provenance (country, retrospective/prospective) are provided for these manufacturing/design evaluations.

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

This information is not applicable to the provided document. The submission pertains to modifications of a physical medical device (oxygenator) and its manufacturing process, not to an AI/algorithm that requires expert-established ground truth from a dataset.

4. Adjudication Method

This information is not applicable to the provided document, as it does not describe an AI/algorithm evaluation requiring adjudication of ground truth.

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

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve AI assistance to human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve an AI algorithm.

7. Type of Ground Truth Used

This information is not applicable in the context of an AI/algorithm. For the physical device, the "ground truth" or verification is based on engineering specifications, performance testing (pressure integrity, burst, torque, insertion depth), and biocompatibility standards (ISO 10993).

8. Sample Size for the Training Set

This information is not applicable to the provided document, as it does not describe an AI/algorithm that would require a training set.

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

This information is not applicable to the provided document, as it does not describe an AI/algorithm.

Summary of what the document does provide:

The document describes a 510(k) premarket notification for the Affinity Fusion Oxygenator System, which involves modifications to a legally marketed predicate device (K203111). The core of the submission is to demonstrate substantial equivalence to this predicate device.

The study presented is not a classic "clinical trial" or "AI validation study" but rather a series of engineering and qualification tests to ensure that the modifications (specifically, changes to the Temperature Monitoring Adapter (TMA) insert component material and insertion depth, and different bioactive surfaces) do not alter the fundamental performance, safety, or efficacy of the device.

Key points from the document regarding "proof" and "acceptance":

• Proof of Meeting Acceptance Criteria: The proof is based on "Operation and performance qualification (OQ/PQ)" and "Design Characterization" activities. These activities evaluate various physical properties and manufacturing consistency.
• Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device's performance (e.g., pressure integrity, burst, torque, insertion depth, biocompatibility) meets internal predetermined requirements and does not introduce new hazards compared to the predicate device. For example, the TMA bond evaluation "indicated improved bond performance relative to the current material," suggesting a performance target was met or exceeded. Biocompatibility was accepted based on the new material already being used in another cleared device and conforming to ISO 10993.
• Study Design: The study is a non-clinical engineering and bench testing evaluation rather than a clinical trial or AI performance study. It's focused on validating the impact of specific component changes.
• Conclusion: The manufacturer concluded, and the FDA agreed by clearing the device, that these modifications maintain substantial equivalence to the predicate device, meaning it is as safe and effective as a device already on the market.

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The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.

The Abiomed OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support for up to six hours in duration. The OXY-1 System includes:

• A Disposable pump and oxygenator .
• A Pump Driver (blood pump) ●
• Blood tubing .
• A Console for controlling the pump and managing gas flow .
  These components are designed to operate together, simplify operation, and reduce the overall equipment footprint at the bedside.

The provided text is a 510(k) summary for the Abiomed OXY-1 System, a cardiopulmonary bypass oxygenator. It is not a document describing an AI/ML-driven medical device, nor does it contain information about acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them, specifically in the context of an AI/ML device, as the provided document pertains to a traditional medical device (a cardiopulmonary bypass oxygenator).

The information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are all relevant to the validation of AI/ML models. Since this document describes a physical medical device, these concepts are not applicable.

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The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass 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 necessary for open surgical procedures on the aorta or vena cava.

CentriMag Pre-connected Pack is to be used with the CentriMag™ Acute Circulatory Support System components (console, motor, flow probe and monitor) to provide extracorporeal circulation for full or partial cardiopulmonary bypass support for less than 6 hours. The CentriMag™ Pre-connected Pack contains sterile disposable components: a blood pump, oxygenator, and priming bag pre-connected by tubing. The pack also includes disposable accessories commonly used in the setup of pump and oxygenator connections to the cardiopulmonary bypass extracorporeal circuit.

Several types of performance testing were conducted to demonstrate the substantial equivalence of the CentriMag Pre-connected Pack. Unfortunately, the provided document does not contain all the information requested. Here's a breakdown of what information is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for any of the performance tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). All tests appear to be laboratory-based performance tests, not clinical studies involving patient data.

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

This information is not applicable as the tests described are performance tests of a medical device's physical and functional characteristics, not studies that require expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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

An MRMC study was not conducted. This document describes the performance testing of a physical medical device (CentriMag Pre-connected Pack), not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable as an algorithm or AI system is not the subject of this 510(k) submission.

7. The type of ground truth used

For the performance tests, the "ground truth" would be the established engineering and medical standards for device performance, as referenced by the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions Final Guidance for Industry and FDA Staff" and ISO 10993-1 for biocompatibility. The tests aim to demonstrate that the device meets these pre-defined physical, chemical, and biological requirements.

8. The sample size for the training set

This information is not applicable as this is not an AI or machine learning device that requires a training set.

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

This information is not applicable as this is not an AI or machine learning device that requires a training set.

Summary of the Study:

The studies conducted for the CentriMag Pre-connected Pack were a series of performance tests in accordance with FDA guidance and international standards for cardiopulmonary bypass oxygenators and biocompatibility. These tests aimed to demonstrate the device's integrity, durability, and functionality, as well as its biological safety. The document explicitly states that "No animal studies or clinical studies are required." The performance testing and comparative testing with reference devices (Rotaflow Centrifugal Pump, Quadrox-iD Adult Oxygenator, HLM Tubing Set, CentriMag Acute Circulatory Support System, Eurosets PMP Sterile Oxygenator) were used to demonstrate substantial equivalence to the predicate device, the OXY-1 System (K200109). The conclusion is that the CentriMag Pre-connected Pack is substantially equivalent as the technological characteristics and performance testing do not raise different questions of safety and effectiveness compared to the predicate device.

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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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