(60 days)
AFFINITY® Pediatric Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gascous microemboli.
The AFFINITY® Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive Surface that is non-leaching and provides a thromboresistant blood contact surface.
This document is a 510(k) Summary for the Medtronic AFFINITY® Pediatric Arterial Filter. It describes the device, its intended use, comparison to predicate devices, and the performance data that supports its substantial equivalence. The document does not contain information about an AI/ML device. Therefore, I cannot provide details on acceptance criteria and study designs relevant to AI/ML.
However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets the acceptance criteria for this non-AI medical device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it relies on demonstrating "substantial equivalence" to a predicate device (Terumo AF02) to prove satisfactory performance. The "reported device performance" is implicitly that it met or matched the performance characteristics of the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Filtration Efficiency | Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter. | Demonstrated substantial equivalence to the Terumo AF02. |
| Air Handling Capabilities | Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter. | Demonstrated substantial equivalence to the Terumo AF02. |
| Effect on Cellular Blood | Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter, indicating minimal adverse impact. | Demonstrated substantial equivalence to the Terumo AF02. |
| Components | ||
| Pressure Drop | Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter (i.e., not cause excessive pressure). | Demonstrated substantial equivalence to the Terumo AF02. |
| Structural Integrity | Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter, ensuring device robustness. | Demonstrated substantial equivalence to the Terumo AF02. |
| Priming Volume | Must be substantially equivalent to or better than the Terumo AF02 pediatric arterial filter. | Demonstrated substantial equivalence to the Terumo AF02 (implies a suitable priming volume for pediatric applications). |
2. Sample sized used for the test set and the data provenance
The document states, "Functional testing was used to establish the performance characteristics... Clinical testing was not required." This indicates that the testing was benchtop or laboratory-based functional testing.
- Sample size: Not explicitly stated. It would typically involve a specific number of manufactured units of the device tested under controlled laboratory conditions, as well as units of the predicate device for comparison.
- Data provenance: Laboratory data. It does not mention country of origin or whether it was retrospective or prospective, but functional testing is inherently prospective, as it involves newly conducted experiments.
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 this is a traditional medical device (hardware) and not an AI/ML device where expert ground truth labeling would be required. The "ground truth" for functional testing is typically defined by engineering specifications and validated test methods.
4. Adjudication method for the test set
This information is not applicable for a functional performance study of a physical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML evaluations to resolve discrepancies in expert interpretations.
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
No, a MRMC comparative effectiveness study was not done. This type of study applies to diagnostic imaging or AI devices involving human interpretation, which is not the case for this arterial filter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this is not an algorithm or AI device. Therefore, a standalone algorithm performance evaluation is not applicable.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation was based on established engineering and performance specifications for cardiopulmonary bypass arterial filters, demonstrated by comparison to a legally marketed predicate device (Terumo Capiox Arterial Filter, AF02, Pediatric). The implicit ground truth is that the device must perform at least as well as the predicate device across the specified functional characteristics.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device and thus does not have 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/ML device.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”