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510(k) Data Aggregation
(88 days)
These cannulae are intended for the perfusion of the ascending aorta during short-term (6 hours or less) cardiopulmonary bypass.
The Medtronic DLP Arterial Cannulae with 3D Tip represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. cannula. This baffled tip imparts a more diffuse pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.
The provided document is a 510(k) Summary for a medical device (Medtronic DLP Arterial Cannulae with 3D Tip - 22 Fr.) and describes non-clinical performance data rather than a study with acceptance criteria and device performance in the context of human data or AI algorithms. As such, many of the requested categories are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1 for externally communicating devices in contact with circulating blood for <24 hours. | Material biocompatibility testing was conducted in accordance with ISO 10993-1. |
| Dynamic Hemolytic Properties: Rates of hemolysis comparable to competitive comparator models. | Rates of hemolysis observed for the modified device were comparable to those measured for comparator cannulae. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for biocompatibility testing; for hemolytic properties, "Short circuits containing 1000 ml of freshly collected, heparinized bovine blood" were constructed. The number of such circuits or repetitions is not specified.
- Data Provenance: The hemolytic properties test used "freshly collected, heparinized bovine blood." This is an in vitro test, not human data. The country of origin for the data is not specified, but the test was likely conducted by Medtronic or a contracted lab.
- Retrospective/Prospective: Prospective (experimental).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical in vitro and material testing study, not requiring expert ground truth establishment in the traditional sense of clinical studies or AI algorithm evaluation.
4. Adjudication method for the test set
Not applicable. This was a non-clinical in vitro and material testing study.
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
Not applicable. This document describes a medical device, not an AI or imaging diagnostic tool, and therefore no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used
- Biocompatibility: Compliance with ISO 10993-1 standard.
- Dynamic Hemolytic Properties: Measurement of hemolysis rates in comparison to established performance of predicate/comparator devices. This is a scientific measurement rather than an expert consensus or pathology ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device.
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