(120 days)
Syringe for injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors.
The Disposable CT/MR Syringes for Nemoto Injectors are plastic, single-use, disposable syringes to be offered in 20mL, 100mL and 200mL sizes. The syringes will be offered made of polypropylene or PET - both materials, of which, are available in current legally marketed products. The Nemoto Disposable CT and MR Disposable Syringes are designed for use on Nemoto CT and MR injectors and perform similarly to predicate devices.
This document describes a 510(k) premarket notification for "Disposable CT/MR Syringes for Nemoto Injectors." This is a medical device and not a software algorithm, therefore, the requested information about acceptance criteria, study details, ground truth, and training sets is not applicable in the context of this submission.
The 510(k) process for devices like these primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving performance against specific acceptance criteria through an AI study.
Here's why many of your specific questions cannot be answered from the provided document:
- No AI or Software Component: The device is a physical, disposable syringe. It does not involve any artificial intelligence, machine learning, or software algorithms that would require a study of its diagnostic performance.
- Substantial Equivalence: The submission aims to show that the new disposable syringes are substantially equivalent to existing, legally marketed syringes, not to demonstrate superior performance through a clinical trial or AI-based assessment.
- Focus on Physical and Material Equivalence: The description focuses on physical attributes (plastic, single-use, sizes) and materials (polypropylene or PET) being similar to existing products. The intended use is also identical to predicate devices.
- No Diagnostic Claims: There are no diagnostic claims being made by the syringe itself, only that it is used for the injection of contrast media or saline for CT and MR imaging. The diagnostic performance is related to the imaging system and interpretation, not the syringe.
Therefore, I cannot provide a table of acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or information about AI-specific studies (MRMC or standalone) because the provided document relates to a physical medical device submission that does not involve these types of evaluations.
The document confirms that this device was approved for marketing based on its substantial equivalence to predicate devices, not on a performance study against acceptance criteria in the way you've outlined for AI/software.
§ 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.