(31 days)
The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.
The Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter is an arterial blood filter with a 40 µm screen. The fitter is designed to permit the effective separation of gaseous emboli and remove blood components aggregates present in the arterial line. The blood contact surfaces of the arterial filter have been modified to improve blood compatibility.
The provided document describes a 510(k) premarket notification for a medical device, the Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or establishing performance against specific acceptance criteria for a new clinical indication.
Therefore, many of the requested categories in your prompt are not applicable to this specific submission. The document explicitly states:
- "The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter. The devices are identical in design, method of operation, and fundamental scientific technology."
- "In-vitro tests were performed to demonstrate that the Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter."
This indicates that the "study" was primarily in-vitro testing to confirm that the new device (with a surface coating) performed comparably to its predicate device, rather than a clinical study establishing new performance metrics against specific acceptance criteria for a novel application.
Here's a breakdown based on the information available:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of specific performance thresholds. The acceptance criterion was "substantial equivalence" to the predicate device, demonstrated through in-vitro tests. These tests would have focused on verifying that the new surface coating did not negatively impact the filter's existing performance characteristics (e.g., filtration efficiency, blood flow compatibility, pressure drop).
- Reported Device Performance: The document states that the in-vitro tests demonstrated substantial equivalence. Specific quantitative performance data from these tests is not included in the provided text.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The tests were "in-vitro," meaning they were conducted in a laboratory setting.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As an in-vitro study, this information is typically less relevant than for clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was an in-vitro performance test, not a study requiring expert interpretation of clinical data or images to establish ground truth.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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. This is not an AI-assisted device, nor is it a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithmic device.
7. The type of ground truth used:
- For an in-vitro test demonstrating substantial equivalence, the "ground truth" would be established by the measured performance of the predicate device as a baseline, and the new device would be compared against that baseline in controlled laboratory conditions. The specific metrics (e.g., particle removal efficiency, pressure drop, blood compatibility markers) would constitute the ground truth for performance comparison.
8. The sample size for the training set:
- Not Applicable. This device does not have a "training set" as it's not a machine learning or AI-driven device.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary, the provided document is a 510(k) premarket notification for a minor modification to an existing device (adding a surface coating). The "study" was an in-vitro comparison to demonstrate that the modified device is substantially equivalent to the predicate device, not a performance study against novel clinical acceptance criteria. Therefore, most of the questions regarding clinical trials, expert ground truth, and AI-related metrics are not relevant to this specific submission.
§ 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.”