(249 days)
The Mitaya aluminum interspaced x_ray grid is a standard style of ... x-ray grid, used in conventional radiography techniques.
X-Ray Grid
The provided text is a 510(k) premarket notification letter from the FDA to William Hague X-Ray Accessory Corporation regarding their "Mitaya Aluminum Interspaced X-Ray Grid" (K964025). This document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any details related to AI or MRMC studies.
The letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device for the stated indications for use, and therefore, it can be marketed.
Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving the device meets those criteria based on the provided text. The device described (an X-Ray Grid) is a physical accessory for conventional X-ray machinery, not an AI-powered device, and the document is a regulatory clearance letter, not a study report.
§ 892.1910 Radiographic grid.
(a)
Identification. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.