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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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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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