(73 days)
This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Beam Limiting Device R-30H). This document does not contain information about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment for a device's performance.
The letter's purpose is to state that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It focuses on regulatory compliance rather than detailed performance study results.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text.
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(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 § 892.9.