(15 days)
The IS-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the IS-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Guidant Corporation regarding the IS-1 Hemostasis Valve. This type of document is a regulatory approval and does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, MRMC studies, etc.) that would typically be associated with performance evaluation of a device, especially an AI/ML medical device.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device (IS-1 Hemostasis Valve) was approved based on its substantial equivalence to existing predicate devices, not on a new, comprehensive performance study with the kind of metrics you've requested. The 510(k) process for such devices relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, I cannot extract the information you've requested from this document because it is not present within this regulatory approval letter. The document does not describe acceptance criteria for performance, detailed study designs, sample sizes for training or test sets, expert qualifications, or the use of AI/ML algorithms.
In summary, none of the requested information can be provided based on the given document.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.