(174 days)
The Vision Hollow Fiber Oxygenator with Guardian™ Coating is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours.
The Gish Vision Hollow Fiber Oxygenator with Guardian™ Coating consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The hollow fiber membrane consists of a polypropylene gas permeable mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a one piece, stainless steel bellows configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The Gish Vision Hollow Fiber Oxygenator with Guardian™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.
The provided text describes a 510(k) premarket notification for a medical device (Vision Hollow Fiber Oxygenator with Guardian™ Coating) seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics as might be seen for novel devices requiring PMA approval.
Therefore, the information typically requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance evaluation for software-based diagnostic devices is not applicable and not present in this 510(k) summary for a hardware medical device like an oxygenator.
The document generally states that "The Vision Hollow Fiber Oxygenator with Guardian™ Coating has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards." However, it does not detail these specific tests, their acceptance criteria, or the reported performance in a quantitative manner.
Here's an attempt to answer your questions based on the limited and different nature of information in a 510(k) summary for this type of device:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document states "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." However, it does not specify what those functional requirements or performance specifications are, nor does it present a table of acceptance criteria versus reported performance. The focus is on demonstrating "substantial equivalence" to a predicate device, implying that its performance is comparable, but not quantifying it.
2. Sample sized 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. The summary only mentions "extensive safety, performance, and validations prior to release" and "Final testing". It does not specify sample sizes for any test sets, nor does it detail data provenance. Given the device type (oxygenator), the "testing" would likely involve bench testing, animal studies, or cadaveric studies, rather than human clinical data in the way a diagnostic AI would.
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 and not provided. For a hardware device like an oxygenator, "ground truth" in the context of expert consensus (as used for diagnostic AI) is not relevant. Performance criteria would be based on engineering specifications, physiological measurements (e.g., oxygen transfer rate, CO2 removal), and material biocompatibility, likely evaluated by biomedical engineers, toxicologists, and in-vitro/in-vivo studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers/experts in diagnostic imaging studies to establish a ground truth. This is not relevant for the testing of a medical hardware device like an oxygenator.
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 and not provided. MRMC studies are used to evaluate the performance of diagnostic AI systems, specifically how AI assistance impacts human reader performance on diagnostic tasks. The device in question is a medical hardware device (an oxygenator) and does not involve human interpretation of outputs assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. Standalone performance evaluations are conducted for AI algorithms that perform a diagnostic or analytical task without immediate human intervention. The device here is a physical oxygenator, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in a way that aligns with "ground truth" for diagnostic AI. For an oxygenator, "ground truth" for performance would likely be established through:
- Engineering Specifications: Meeting predefined oxygenation and CO2 removal rates, blood flow rates, priming volume.
- Biocompatibility Testing: According to ISO standards, potentially including in-vitro cytotoxicity, hemolysis, thrombogenicity tests.
- Mechanical Integrity Testing: Pressure resistance, leak tests.
- Sterility Testing.
- Pre-clinical (animal) studies: Demonstrating functional performance in a living system.
The 510(k) summary only generally states that "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
8. The sample size for the training set
This information is not applicable and not provided. As a physical medical device (oxygenator) and not an AI or machine learning algorithm, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no "training set" for this type of device, the concept of establishing ground truth for it is irrelevant.
§ 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.”