(224 days)
The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
The DLP™ Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.
The provided text describes a 510(k) premarket notification for a medical device, the DLP Silicone Coronary Artery Ostial Cannulae. It discusses a material formulation change to an adhesive used in the device and the testing performed to demonstrate substantial equivalence to a predicate device.
However, the request asks for information related to a study proving device meets acceptance criteria for an AI/machine learning device, including aspects like:
- Acceptance criteria table and reported performance
- Sample size and data provenance for test sets
- Number and qualifications of experts for ground truth
- Adjudication methods
- MRMC studies for human reader improvement
- Standalone algorithm performance
- Type of ground truth
- Training set sample size and ground truth establishment
The provided FDA document is for a physical medical device (cannulae) and focuses on demonstrating substantial equivalence due to a material change, not on the performance evaluation of an AI or machine learning algorithm. Therefore, the document does not contain any of the information requested regarding acceptance criteria, study design, expert involvement, or AI performance metrics.
In summary, none of the specific information requested in the prompt can be extracted from the provided text because the text describes a physical medical device submission, not an AI/machine learning device submission.
§ 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).