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The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 1.5 liters/minute. PATIENT POPULATION: Infants.

AMG PMP INFANT is an oxygenator used to exchange gases between blood and gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. It is composed by PMP (Polymethylpentene) hollow fiber membrane with an integrated heat exchanger. It is provided together with the accessories that are the gas line and the convenience kit. Oxygenator module, AMG PMP INFANT consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the blood temperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device center is surrounded by an outer compartment that contains a microporous membrane of Polymethylpentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air form the gas mixer rich in O2 follows the gas path: is insufflated through the gas inlet port on the top of the device, goes through microporous PMP fibers and exit from gas escape port, at the same time blood go outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator centers allows making a biologically inert surface capable of achieving the desired rate of heat exchange, without producing any localized overheating of the blood.

The provided document is a 510(k) premarket notification for a medical device called "AMG PMP INFANT," which is a cardiopulmonary bypass oxygenator. It assesses the substantial equivalence of this new device to previously cleared predicate devices.

The document discusses performance testing, but it fundamentally does not contain the level of detail requested for acceptance criteria and the specifics of a study proving a device meets those criteria for human clinical/AI related outcomes. The performance data section broadly lists the types of tests performed (e.g., Blood cell damage, Gas transfer rate & pressure drop, Heat exchanger performance evaluation), stating that the device "met the safety and performance requirements as per its indication for use." However, it does not provide numerical acceptance criteria or the specific results obtained for each criterion.

Furthermore, the nature of the device (a cardiopulmonary bypass oxygenator) means that the "performance data" refers to hardware performance specifications (e.g., flow rates, pressure drops, gas transfer efficiency, material compatibility, biological safety) rather than the kind of AI-driven diagnostic or prognostic performance (e.g., sensitivity, specificity, AUC) that would involve human readers, ground truth consensus, or large datasets of medical images.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance (with numerical values): The document only lists the categories of tests.
2. Sample size used for the test set and the data provenance: Not applicable in the context of this device's testing. The "test set" here refers to the physical devices undergoing engineering and biological performance evaluations, not a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for this device is based on physical and chemical measurements against established engineering standards and biological safety guidelines, not expert human interpretation of data.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device is not an AI diagnostic/prognostic tool.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable.
7. The type of ground truth used: Indirectly, the ground truth is established regulatory standards (e.g., ISO 7199:2016, FDA Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions) and internal engineering specifications, rather than clinical outcomes or expert consensus on patient data.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document explicitly states: "A program of design verification and validation testing was performed according to the standards 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000'; and ISO 7199:2016 'Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)'." This indicates that the "acceptance criteria" are derived from these established regulatory and international standards for medical device performance and safety, and the "study" is the verification and validation testing against these standards. However, the specific numerical results of these tests are not included for public dissemination in this summary document.

In summary, the provided document details the regulatory clearance process for a traditional medical device (oxygenator), focusing on its substantial equivalence to predicate devices based on engineering and biological performance testing, rather than the AI/software-as-a-medical-device (SaMD) type of study that would involve expert interpretation of data or patient outcomes.

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The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 4 liters/minute. PATIENT POPULATION: Pediatric / small adults.

AMG PMP PEDIATRC is an oxygenator used to exchange gases between blood and gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. It is composed by PMP (Polymethylpentene) hollow fiber membrane with an integrated heat exchanger. It is provided together with the accessories that are the gas line and the convenience kit. Oxygenator module, AMG PMP PEDIATRIC consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the bloodtemperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device is surrounded by an outer compartment that contains a microporous membrane of Polymethy|pentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air from the gas mixer is rich in O2 and follows the gas path. It enters through the gas inlet port on the top of the device, goes through microporous PMP fibers and exits from gas escape port, at the same time blood flows outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator utilizes a biologically inert surface to achieve the desired rate of heat exchange without producing any localized overheating of the blood.

The provided text is a 510(k) Summary for the AMG PMP PEDIATRIC device and primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study proving the device meets acceptance criteria. However, it does list the types of performance tests conducted and states that the device met safety and performance requirements.

Here's an attempt to derive the requested information based on the provided text, acknowledging that much of it is not explicitly stated in detail:

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

The document does not provide a table with specific numerical acceptance criteria and corresponding reported device performance values. It generally states that the device "met the safety and performance requirements." It does, however, indirectly compare some technical features to predicate devices, which implies an expectation for performance within a similar range.

Study details are not provided in the document for any specific study proving these criteria. The document only lists the types of tests performed.

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 provided in the document. The text mentions "design verification and validation testing" but does not detail the sample sizes, data provenance, or study design (retrospective/prospective) for these 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 provided in the document. The device is a cardiopulmonary bypass oxygenator, not an imaging or diagnostic AI device that would typically involve human expert consensus for "ground truth" in the way described. Its performance is evaluated through engineering and biocompatibility tests against established standards.

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

This information is not applicable/not provided as the performance evaluation is based on objective measurements against engineering and biological standards, not on subjective interpretations requiring adjudication.

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/not provided. The device is a medical device for extracorporeal circulation, not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable/not provided. The device is an oxygenator, not an algorithm. Its performance is inherent to its physical design and materials, not software.

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

The "ground truth" for this device's performance evaluation would be established by objective measurements against the requirements set by recognized standards like ISO 7199:2016 and the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000." These standards specify methodologies and acceptance criteria for measuring parameters like gas transfer, pressure drop, blood cell damage, priming volume, etc.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable/not provided for the same reason as above.

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The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.

The Advanced Membrane Gas Exchange and accessories PMP STERILE (A.M.G. PMP STERILE) is a microporous hollow-fiber oxygenator with an integral heat exchanger, used to perform cardiopulmonary bypass or surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. It includes a detachable 4.5 liter blood reservoir.
The A.M.G. PMP STERILE is equipped with polymethyl pentene fibres, more hydrophobic than the polyethylene used for the predicate device and so considered a more reliable barrier between the blood pathway and gas pathway of the oxygenator.
The A.M.G. PMP STERILE is provided in different configurations:

• microporous hollow-fiber oxygenator with temperature probe and pre-connected venous cardiotomy reservoir (“A.M.G. PMP STERILE”),
• microporous hollow-fiber oxygenator with temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP STERILE”),
• microporous hollow-fiber oxygenator without temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP NO TP STERILE”),
• Venous Cardiotomy Reservoir 4500 PMP (“VCR 4500 PMP STERILE”).
  The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. The device can be use with adult patients.

The provided text describes the 510(k) summary for the "Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE)" device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a standalone study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the requested information elements related to AI device performance are not applicable to this document. This document describes a medical device, specifically a cardiopulmonary bypass oxygenator, and its regulatory submission for market clearance. It does not involve an AI/ML algorithm or a study demonstrating the performance of such an algorithm.

However, I can extract the acceptance criteria and a summary of the performance testing for the manufacturing and functional aspects of the described medical device:

1. Table of acceptance criteria and reported device performance:

The document states that the new device, "Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE)," met the acceptance criteria defined in the product specification and performed comparably to the predicate device. While specific quantitative acceptance criteria are not detailed in this summary, the areas tested and successfully met are listed.

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

This information is not provided in the document. The document refers to "in vitro bench tests" but does not specify the sample sizes (e.g., number of devices tested) or the provenance of any data used (as it's bench testing, not clinical data from patients or countries).

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 document describes bench testing for a physical medical device, not an AI model or a dataset requiring expert ground truth labeling.

4. Adjudication method for the test set:

This information is not applicable as the document describes bench testing for a physical medical device, not an AI model or a dataset requiring expert adjudication.

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 a physical medical device (oxygenator) and not an AI/ML algorithm.

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 (oxygenator) and not an AI/ML algorithm.

7. The type of ground truth used:

This information is not applicable as the document describes bench testing against predefined product specifications and regulatory standards for a physical medical device, not against "ground truth" in the context of AI model evaluation (e.g., pathology, expert consensus on images).

8. The sample size for the training set:

This information is not applicable as the document describes a physical medical device and its manufacturing/functional testing, not an AI/ML model that undergoes "training."

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

This information is not applicable as the document describes a physical medical device and its manufacturing/functional testing, not an AI/ML model.

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The AMG Adult Hollow Fiber Oxygenator is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

The AMG oxygenating device for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.

The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood.

AMG is a single use device.

The AMG Adult Hollow Fiber Oxygenator is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

The AMG oxygenating device for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.

The provided 510(k) summary for the Eurosets Advanced Membrane Gas Exchange (AMG) device details the device's substantial equivalence to predicate devices, but does not contain the specific acceptance criteria or a study proving the device meets those criteria in the way a typical AI/ML medical device submission would.

This document is a premarket notification for a traditional medical device (an oxygenator), which follows a different regulatory pathway and relies on different types of performance testing than an AI/ML device. Therefore, many of the requested categories for AI/ML device studies (like sample size for test/training sets, ground truth by experts, MRMC studies, standalone performance with metrics like AUC or sensitivity/specificity) are not applicable to this submission.

Instead, this submission focuses on demonstrating substantial equivalence through:

• Comparison to predicate devices: Highlighting similarities in design, intended use, method of operation, components, packaging, and fundamental scientific technology.
• In vitro performance testing: To show that the device meets established specifications, primarily related to its physical and functional properties, as guided by relevant ISO standards and FDA guidance for oxygenators.

Here's a breakdown of the available information based on your request, with explanations for why some categories are not present:

Acceptance Criteria and Device Performance (Not Applicable for AI/ML metrics)

The document states that "The results of these tests met established specifications," but the specific numerical acceptance criteria for each test are not explicitly detailed in this summary. Instead, the focus is on the device demonstrating equivalence to its predicates and meeting general safety and effectiveness requirements through standard in vitro tests for oxygenators.

Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Study Information (Acknowledging N/A for AI/ML Specifics):

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

   • Sample Size (Test Set): Not specified in terms of "cases" or "patients" as this is an in-vitro performance study of a physical device, not an AI/ML diagnostic system. The "sample" would likely refer to the number of devices tested, but this detail is not provided.
   • Data Provenance: Not applicable in the context of clinical data. The tests were "in vitro," meaning they were conducted in a controlled laboratory environment using test fluids/blood, not on human subjects. The testing was carried out by Eurosets srl (Italy).

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

   • Not Applicable: This type of "ground truth" (e.g., expert consensus on medical images) is not relevant for the performance testing of an oxygenator. The "ground truth" here is determined by physical and chemical measurements against engineering specifications and industry standards (ISO 7199).

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

   • Not Applicable: Adjudication is not part of this type of engineering and laboratory performance testing. Results are typically quantitative measurements compared to predefined thresholds.

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/ML algorithm that assists human readers. No MRMC study was conducted.

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

   • Not Applicable: There is no AI/ML algorithm involved. The performance described is that of the physical device. The "standalone" performance is the intrinsic functional performance of the oxygenator itself in various in-vitro tests (e.g., gas transfer, pressure drop).

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

   • Standard Specifications/Engineering Measurables: The "ground truth" for this device's performance is objective measurements (e.g., gas concentrations, flow rates, temperature, and material integrity) against established engineering specifications and international standards (ISO 7199) for cardiopulmonary bypass oxygenators.

7. The sample size for the training set:

   • Not Applicable: There is no AI/ML algorithm requiring a "training set."

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

   • Not Applicable: There is no AI/ML algorithm requiring a "training set" or its associated ground truth.

Summary:

This 510(k) pertains to a traditional medical device (oxygenator) and demonstrates substantial equivalence through comparative analysis with predicate devices and in-vitro performance testing against established industry standards and specifications. It does not involve AI/ML technology, and therefore, many of the detailed questions related to AI/ML device study design (like ground truth establishment by experts, training/test set sizes for algorithms, or MRMC studies) are not pertinent to this submission. The device successfully met all "established specifications" for the performed biocompatibility and in-vitro functional tests.

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