(31 days)
The Capiox® AF125X Arterial Blood Filter is intended to filtere non-biologic particles and The Capiox® AFT25X Arterial Blood Finer is Interior is Interior of the only of the bypass circuit for up to 6 hours.
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The provided text is a 510(k) premarket notification for a medical device, the Capiox® AF125X Arterial Filter. This type of submission is used to demonstrate that the new device is "substantially equivalent" to an existing, legally marketed predicate device. This process generally relies on comparing the new device's design, materials, and performance to a predicate device, rather than conducting new clinical studies to establish novel safety and effectiveness.
Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way one might expect for a de novo device or a more complex medical AI/ML product. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, and the "study" is a comparison conducted by the manufacturer, Terumo Cardiovascular Systems.
However, I will extract the relevant information and interpret it within the context of a 510(k) submission for this type of device.
Here's the breakdown of the requested information based on the provided text:
Acceptance Criteria and Study for Terumo Cardiovascular Systems Capiox® AF125X Arterial Filter
The Capiox® AF125X Arterial Filter obtained clearance through a 510(k) premarket notification, demonstrating substantial equivalence to a predicate device, the Capiox® AF200X Arterial Filter (cleared by FDA on September 6, 2000). The "acceptance criteria" and "study" are framed within this substantial equivalence pathway, focusing on design, technology, materials, and specifications, rather than new clinical trial performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Implied by Manufacturer's Comparison) |
|---|---|
| Intended Use: To filter non-biologic particles and microemboli during cardiopulmonary bypass (CPB) for up to 6 hours. | Intended Use: The Capiox® AF125X Arterial Blood Filter is intended to filter non-biologic particles and microemboli during a cardiopulmonary bypass circuit for up to 6 hours. (Identical to predicate and stated in 510(k)). This implies the device performed adequately for this intended use in internal assessments or comparisons. |
| Design, Technology/Principles of Operation, Materials, and Specifications: Substantially equivalent to the Capiox® AF200X Arterial Filter. | Design, Technology/Principles of Operation, Materials, and Specifications: "The device submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials and specifications to the Capiox® AF200X Arterial Filter." Differences were analyzed and "do not raise new questions of safety and effectiveness." (Specific details of the comparison are not provided in the extracted text but were part of the full 510(k) submission). |
| Biocompatibility: Meet relevant biocompatibility standards (implied by FDA Blue Book Memorandum G95-1). | Compliance with FDA Blue Book Memorandum G95-1 (Biocompatibility Evaluations) is stated as a guidance document used in preparation of the submission, implying the device meets biocompatibility requirements. |
Important Note: For a 510(k) submission of this nature, the "reported device performance" is primarily a demonstration of equivalence to the predicate, often through bench testing and material characterization, rather than a clinical study with specific performance metrics (e.g., sensitivity, specificity for an AI device). The document states "A comparison of the similarities and differences is presented in this submission," but the specific details of that comparison are not included in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the extracted text. For a medical device like an arterial filter seeking 510(k) clearance, the "test set" would typically refer to the samples used in bench testing (e.g., blood filtration efficiency, pressure drop, particle removal) and biocompatibility testing. The text mentions "A comparison of the similarities and differences is presented in this submission," which would detail the data used for the comparison, but these specifics are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable or provided for this 510(k) submission. The assessment of an arterial filter's performance for substantial equivalence primarily relies on engineering specifications, material science, and bench testing, not expert-adjudicated ground truth as would be relevant for diagnostic AI.
4. Adjudication Method for the Test Set
This type of information is not applicable or provided for this 510(k) submission. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluation, which is not the primary focus of this 510(k) for an arterial filter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging, which is outside the scope of this device's function and regulatory pathway.
6. If a Standalone Performance Study Was Done
No, a standalone (algorithm only without human-in-the-loop performance) study in the context of AI/ML was not done. The "standalone performance" of the arterial filter would be evaluated through various bench tests (e.g., filtration efficacy, pressure drop, priming volume), which are part of the comparison demonstrating substantial equivalence, but specific details or results are not included in the provided text. The device itself is not an "algorithm."
7. The Type of Ground Truth Used
The "ground truth" for this device, within the context of a 510(k) for substantial equivalence, relies on:
- Engineering specifications and performance of the predicate device: The Capiox® AF200X Arterial Filter serves as the benchmark against which the new device is compared.
- Bench testing standards: Performance characteristics (e.g., filtration rates, pressure drop, particle capture efficiency) would be assessed against established engineering criteria, potentially informed by the predicate's performance.
- Biocompatibility testing: Compliance with established biocompatibility standards (e.g., as outlined in FDA Blue Book Memorandum G95-1).
There is no mention of pathology, outcomes data, or expert consensus in a clinical diagnostic sense used for 'ground truth' in this document.
8. The Sample Size for the Training Set
This information is not applicable or provided. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As mentioned above, this device does not involve a training set as it is not an AI/ML algorithm.
§ 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.”