(164 days)
MAXIMA FORTÉ" Hollow Fiber Oxygenator with Plasma Resistant Fiber is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from blood and is designed to operate at blood flow rates between 1 and 7 liters per minute for periods up to six hours.
The Medtronic MAXIMA FORTE™ Hollow Fiber Oxygenator with Plasma Resistant Fiber is a single use, disposable, sterile, nonpyrogenic, gas exchange device with a self contained, venous side heat exchanger for regulating blood temperature. The MAXIMA FORTE" oxygenator consists of a polycarbonate outer case which incorporates an oxygenator fiber bundle and a self contained heat exchanger. The fiber bundle is separated from the self contained heat exchanger by a polycarbonate housing. The static priming volume of the oxygenator blood path is approximately 295 ml. The oxygenator is designed to operate at blood flow rates between 1 - 7 liters per minute for periods up to 6 hours.
The provided text is a summary of safety and effectiveness for a medical device called the MAXIMA FORTÉ™ Hollow Fiber Oxygenator. It does not describe a study involving "acceptance criteria" and "device performance" in the typical sense of a clinical trial or a study assessing an AI algorithm's diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable to this document. I will extract the relevant information and explain why other sections cannot be filled based on the provided text.
Here's the information derived from the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the MAXIMA FORTÉ™ device itself. Instead, it refers to "accepted scientific methods" from oxygenator standards (ISO/DIS 7199 and BG7199-1996) for assessing new technological characteristics. The "performance data" is used to demonstrate substantial equivalence to the predicate devices, rather than meeting specific, numerical acceptance criteria for the new device as a standalone.
The in-vitro bench testing aimed to show that the MAXIMA FORTÉ™ does not significantly affect safety and effectiveness when compared to predicate devices. The listed tests are the performance aspects evaluated.
| Performance Aspect | Reported Device Performance |
|---|---|
| Plasma Resistant Fiber (Key innovation) | Implied to maintain effectiveness for up to six hours within the specified blood flow rates (1-7 LPM), similar to predicates. (Improved Plasma Resistant Fiber in predicate MAXIMA PLUS PRF) |
| Blood pathway integrity | Demonstrated to not significantly affect safety and effectiveness compared to predicate devices. |
| Heat exchanger pathway integrity | Demonstrated to not significantly affect safety and effectiveness compared to predicate devices. |
| Blood volumes | Lower priming volume (~295 ml) compared to some, but comparable to others (e.g., Terumo Capiox SX at ~270 ml), not significantly affecting safety/effectiveness. |
| Connectors | Demonstrated to not significantly affect safety and effectiveness compared to predicate devices. |
| Oxygenator and Carbon Dioxide Transfer Rates | Demonstrated to not significantly affect safety and effectiveness compared to predicate devices. |
| Heat Exchanger Performance Factor | Demonstrated to not significantly affect safety and effectiveness compared to predicate devices. |
| Blood Cell Damage | Demonstrated to not significantly affect safety and effectiveness compared to predicate devices. |
| Time Dependent Performance Changes | Demonstrated to not significantly affect safety and effectiveness compared to predicate devices. |
| Pressure Drop | Demonstrated to not significantly affect safety and effectiveness compared to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes in-vitro bench testing. This means the testing was performed in a laboratory setting, not on human patients or live animal models, for the purpose of demonstrating substantial equivalence to predicate devices.
- Sample size: Not specified. Typical bench testing for devices like this involves a certain number of units tested to ensure repeatability and consistency, but the exact number of MAXIMA FORTÉ™ units or predicate units tested is not stated.
- Data provenance: In-vitro bench testing data. No country of origin is specified, and it is inherently prospective for the device under review, but comparative to existing predicate devices.
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 concept of "experts establishing ground truth" is not applicable to the described in-vitro bench testing of an oxygenator. The "ground truth" here is determined by physical measurements and engineering assessments according to established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, often in clinical or diagnostic scenarios. In-vitro bench testing relies on objective measurements.
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 or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in-vitro bench testing, the "ground truth" would be established by:
- Engineering measurements and performance specifications as defined by the oxygenator standards (ISO/DIS 7199 and BG7199-1996).
- Comparative performance data from the predicate devices.
The goal was to demonstrate that the MAXIMA FORTÉ™ performs similarly and safely according to these objective measures, not that it aligns with a subjective expert judgment.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 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.”