(209 days)
The OriGen Reinforced Dual Lumen cannula is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
The OriGen Reinforced Dual Lumen catheter (RDLC) is the same design as the OriGen Dual Lumen Catheter (the predicate device), but with the addition of a wire reinforcement layer on the tip of the device. Both are dual lumen catheters with unequal lumen areas for drainage and reinfusion. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. Other characteristics of the catheter are the same.
This is not an AI/ML medical device. It is a dual-lumen catheter used for extracorporeal life support. Therefore, the questions related to AI/ML device studies are not applicable.
However, I can extract the acceptance criteria and the summary of the study performed for this device:
1. Table of acceptance criteria and the reported device performance:
| Test Classification - Title | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical/mechanical - structural integrity | Pass | Pass |
| Physical/mechanical - burst testing | Pass | Pass |
| Physical/mechanical - kink testing | Pass | Pass |
| Functional/Performance - flow testing | Pass | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "applicable tests were carried out," but does not specify the number of units tested for each in vitro test.
- Data Provenance: The tests were conducted "in accordance with the requirements of ISO 10993-1 and the FDA 1995 memorandum." These are non-clinical, in-vitro tests, not involving human data (retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a medical device (catheter), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or other patient data. The "ground truth" for this device's performance is established by objective engineering and material science standards as per ISO 10993-1 and FDA guidelines.
4. Adjudication method for the test set:
- Not applicable. As this is not an AI/ML device assessing patient data, no adjudication method for a test set by human experts is relevant.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- For this device, the "ground truth" can be considered the established engineering and performance specifications and safety standards defined by ISO 10993-1 and FDA guidance for medical device biocompatibility, structural integrity, and functional performance (e.g., flow rates). These are objective, measurable criteria.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not an AI/ML model.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).