(236 days)
for injecting contrast media and saline, for angiography
Not Found
I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for "Disposable Angiographic Syringes for Nemoto Injectors," which primarily addresses regulatory approval based on substantial equivalence to predicate devices, not performance studies with detailed acceptance criteria.
Therefore, I cannot extract the requested information, which includes:
- A table of acceptance criteria and reported device performance
- Sample sizes and data provenance for the test set
- Number and qualifications of experts for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size and ground truth establishment for the training set
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.