(88 days)
The Synthesis is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. The Synthesis is an adult oxygenator intended for use in operations on adult patients. Synthesis must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.
The Synthesis Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and with an arterial filter and connected to a an hardshell venous/cardiotomy reservoir.
The provided text discusses the SYNTHESIS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir, hereafter referred to as "the device." The information describes its characteristics, indications for use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a typical quantitative pass/fail table format. Instead, it states that various tests "met established specifications" and that the device was found to be "comparable to the predicate devices concerning with all characteristics" and "substantially equivalent" in relevant functional parameters.
Therefore, the "acceptance criteria" are implied to be the established specifications and performance characteristics of the predicate devices. The "reported device performance" is that it met these specifications and demonstrated substantial equivalence.
| Performance Characteristic | Predicate Device Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Requirements of ISO 10993-1:1995 and FDA May 1, 1995 Memorandum for raw materials | Met established specifications |
| Hemolysis | Established specifications | Met established specifications |
| Cytotoxicity | Established specifications | Met established specifications |
| Irritation | Established specifications | Met established specifications |
| Acute Systemic Toxicity | Established specifications | Met established specifications |
| Mutagenicity | Established specifications | Met established specifications |
| Sterility | Established specifications | Met established specifications |
| Pyrogenicity | Established specifications | Met established specifications |
| ETO residuals | Established specifications | Met established specifications |
| Package integrity | Established specifications | Met established specifications |
| In Vitro Functional Performance (Oxygenator) | "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - Final Guidance for Industry and FDA Staff" (Nov 13, 2000), ISO 7199 (1996) | Met established specifications; Comparable and substantially equivalent to D 903 Avant 2 Ph.I.S.I.O. predicate |
| Gas transfer characteristics | Established specifications | Met established specifications |
| Pressure drop | Established specifications | Met established specifications |
| Plasma leakage data | Established specifications | Met established specifications |
| Operating blood volumes | Established specifications | Met established specifications; Advantageous (lower operating blood volumes) compared to predicate for integrated arterial filter feature |
| Heat exchanger performance | Established specifications | Met established specifications |
| Hemolysis/cell depletion | Established specifications | Met established specifications |
| Mechanical integrity | Established specifications | Met established specifications |
| In Vitro Functional Performance (Arterial Filter) | "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" (Nov 29, 2000) | Met established specifications; Comparable and substantially equivalent to D 734 Micro 40u predicate |
| Filtration efficiency | Established specifications | Met established specifications |
| Air removal (handling) | Established specifications | Met established specifications |
| In Vitro Functional Performance (Venous/Cardiotomy Reservoir) | "Guidance for Blood Extracorporeal Blood Circuit Defoamer 510(k) Submission" (Nov 29, 2000) | Met established specifications |
| Breakthrough times and volumes | Established specifications | Met established specifications |
| Reservoir graduated scale accuracy | Established specifications | Met established specifications |
| Residual blood volume | Established specifications | Met established specifications |
| Defoaming capacity | Established specifications | Met established specifications |
| Filtration efficiency | Established specifications | Met established specifications |
| Leaching studies | Established specifications | Met established specifications |
| Blood compatibility characterization | Established specifications | Met established specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact numerical sample sizes for the "test set" for any of the in vitro or biocompatibility tests. It states that "A complete battery of tests were carried out" and "In vitro testing were carried out."
- Data Provenance: The studies were performed by the manufacturer, Dideco S.p.A., located in Mirandola (MO), Italy. The tests were conducted according to US FDA guidance documents and international ISO standards. The data is prospective, as it describes a series of tests performed on the device.
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 product is a medical device (oxygenator, filter, reservoir) for cardiopulmonary bypass. The evaluation of its performance relies on objective laboratory testing and adherence to published performance standards and guidance documents, not on human expert interpretation of data like in an imaging study. Therefore, the concept of "experts used to establish ground truth" with specific qualifications in the context of interpretation (e.g., radiologists) is not applicable here.
The "ground truth" for device performance is defined by the established specifications and requirements outlined in the relevant guidance documents and ISO standards (e.g., ISO 10993-1, ISO 7199, FDA guidances for oxygenators, defoamers, and arterial filters). The experts involved would be the engineers, scientists, and technicians who designed the tests, performed them, and analyzed the results according to these standards, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective expert opinion is used to establish ground truth from complex medical data (e.g., images for diagnostic AI). For this device, the tests are primarily objective laboratory measurements against predefined performance metrics and specifications. Therefore, an adjudication method in the sense of resolving conflicting expert opinions is not applicable. The results are either within specifications or they are not.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study design is used for evaluating diagnostic or interpretive AI systems that assist human readers (e.g., radiologists interpreting images). The device in question is a mechanical medical device, not an AI system.
- Effect Size of Human Readers with/without AI: Not applicable, as there is no AI component or human reader interaction with an AI system described for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This concept is typically relevant for AI algorithms. The studies performed were in vitro laboratory tests evaluating the device's physical and functional performance (e.g., gas transfer, filtration, biocompatibility) as a standalone medical product. While these tests evaluate the device without a human "in-the-loop" in the sense of interpretation, it's not an "algorithm only" study as understood in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of this medical device is established by:
- Referenced Standards and Guidances: Adherence to established international standards (ISO 10993-1, ISO 7199) and US FDA guidance documents for cardiopulmonary bypass oxygenators, defoamers, and arterial filters. These documents define the accepted performance metrics and test methodologies.
- Predicate Device Performance: The functional and safety characteristics of the legally marketed predicate devices (D 903 Avant 2 Ph.I.S.I.O. and D 734 Micro 40u Arterial Filter) served as the benchmark for substantial equivalence. The "ground truth" is that the new device must perform comparably or equivalently to these established devices across all functional parameters.
- Established Specifications: The document repeatedly refers to "established specifications" for various tests, which represent the target performance metrics that the device must meet.
8. The sample size for the training set
This device is a physical medical device, not an AI model. Therefore, the concept of a "training set" (used to train a machine learning algorithm) is not applicable.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical 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.”