(58 days)
The PEDRA-17F detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
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I am sorry, but the provided text from the FDA 510(k) letter for the PEDRA-17F Digital Flat Panel X-ray Detector does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI/ML-driven device.
This document is a standard 510(k) clearance letter for a digital flat panel X-ray detector, which is a hardware device for capturing X-ray images, not an AI/ML software device for image analysis. The letter focuses on the substantial equivalence of the hardware device to existing predicate devices based on its indications for use and general controls.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text. The information required for your request (e.g., acceptance criteria for diagnostic accuracy, sample sizes for AI model validation, expert qualifications for ground truth, etc.) is not present in this document.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.