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510(k) Data Aggregation
(14 days)
DIRECTFLOW ARTERIAL CANNULA
The DirectFlow™ arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The DirectFlow cannula also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. The DirectFlow cannula is intended for introduction and use through a thoracic trocar or incision.
The subject device is substantially equivalent in intended use and method of operation to the currently marketed DirectFlow arterial cannula.
The provided text is a 510(k) premarket notification for the Heartport® DirectFlow™ arterial cannula. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the context of device accuracy or efficacy.
Therefore, the requested information elements such as device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, and detailed ground truth establishment are not present in the provided document. The document states that "Performance testing demonstrated that the subject device meets established specifications," but it does not elaborate on what those specifications are, nor does it provide a table of acceptance criteria and reported performance.
Below is a table reflecting the information that can be extracted (or is explicitly absent) based on the provided text:
Acceptance Criteria and Device Performance
There is no specific table of acceptance criteria or detailed device performance metrics provided in the document. The statement "Performance testing demonstrated that the subject device meets established specifications" is a high-level summary without specifics.
Study Information Table
| Information Element | Details from Provided Text |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Acceptance Criteria: Not explicitly stated or detailed in the document. The document only mentions "meets established specifications." |
| Reported Device Performance: Not provided in quantitative terms. The document only states "Performance testing demonstrated that the subject device meets established specifications." | |
| 2. Sample size and Data Provenance (test set) | Sample Size: Not specified. |
| Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is referred to as "Non-clinical Test Results." | |
| 3. Number of experts and qualifications (ground truth for test set) | Number of Experts: Not specified. |
| Qualifications of Experts: Not specified. The document does not describe the establishment of a "ground truth" using human experts for the non-clinical performance tests mentioned. | |
| 4. Adjudication method (test set) | Not applicable/Not specified. There is no mention of a clinical study or expert review process that would require adjudication. |
| 5. MRMC Comparative Effectiveness Study | Not performed or reported. The document focuses on substantial equivalence based on intended use and technological characteristics, not on comparative effectiveness with human readers. |
| 6. Standalone (algorithm only) performance study | Not performed or reported. This device is a physical medical device (arterial cannula), not an algorithm. |
| 7. Type of ground truth used | Not applicable/Not specified in the sense of analytical ground truth for accuracy. For "Non-clinical Test Results," the "ground truth" would be the established engineering specifications or benchmarks against which the device was tested. The document does not detail these. |
| 8. Sample size for the training set | Not applicable/Not specified. This is a hardware medical device, not a machine learning algorithm that requires a training set. |
| 9. How ground truth for the training set was established | Not applicable/Not specified. As this is a hardware device, there is no "training set" in the context of AI/ML. |
Summary of Study (as described in the 510(k) Summary):
The "study" mentioned in the document is "Performance testing" which demonstrated that the device "meets established specifications." This is described under "Non-clinical Test Results." The primary purpose of this 510(k) submission is to demonstrate "substantial equivalence" to a predicate device based on intended use, technological characteristics, and biocompatibility, rather than providing detailed clinical or algorithm performance data.
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