(466 days)
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:
- A table of acceptance criteria and the reported device performance (with numerical values): The document only lists the categories of tests.
- 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.
- 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.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device is not an AI diagnostic/prognostic tool.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable.
- 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.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- 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.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”