(211 days)
Occlusion of the aorta, delivery of cardioplegia, and monitoring of aortic root pressure during cardiopulmonary bypass.
Endoaortic Clamp Catheter
The provided text is a 510(k) summary for the Heartport Endoaortic Clamp Catheter, dating back to 1996. This document is a regulatory submission for a medical device and does not contain the level of detail typically found in a scientific study report, especially concerning acceptance criteria and detailed study methodology as would be expected for modern AI/ML medical devices.
Based on the provided text, here's what can be extracted:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or performance metrics in a table format. It broadly states the device "successfully maintained cardiopulmonary pass."Acceptance Criteria Reported Device Performance Maintain cardiopulmonary bypass (implicit acceptance) Successfully maintained cardiopulmonary pass in ten subjects Function safely and efficaciously Demonstrated to function safely and efficaciously Meet anticipated clinical requirements Demonstrated to meet anticipated clinical requirements -
Sample size used for the test set and the data provenance
- Sample Size: Ten subjects.
- Data Provenance: The study was a "clinical investigation," implying a prospective collection for this specific device evaluation. There is no information on the country of origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable (N/A). This device is a mechanical clamp, not an AI/ML diagnostic system. The "ground truth" would be established by direct physiological measurements and clinical outcomes, not expert interpretation of outputs. -
Adjudication method for the test set
N/A. As this is not an interpretive diagnostic device, an adjudication method for establishing ground truth is not relevant in the context of expert consensus. Clinical outcomes and physiological parameters would be directly observed. -
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
N/A. This is a mechanical medical device, not an AI-assisted diagnostic tool requiring human reader studies. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a mechanical medical device. -
The type of ground truth used
The ground truth would be based on direct clinical observation of the device's function during cardiopulmonary bypass in human subjects, including physiological parameters (e.g., maintaining blood flow, pressure monitoring) and patient outcomes. The text states the device "successfully maintained cardiopulmonary pass," implying successful physiological functioning. -
The sample size for the training set
N/A. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The device was likely developed and refined through engineering testing and potentially pre-clinical (animal) studies, but these are not referred to as "training" in this context. -
How the ground truth for the training set was established
N/A. See explanation for point 8.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).