(50 days)
Flat Panel Digital X-ray Detectors are indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in general purpose diagnostic procedures all and not to be used for mammography
The 14HK701G-W is the solid state x-ray imager, which can generate radiographic images of any part of the body. These devices intercept x-ray photons and the scintillator (CSI:TI) emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images are displayed on monitors. The digital value can be communicated to the operator console via wiring connection.
The 14HK701G-W consists of the following components: Flat Panel Detector, Control Box, battery Charger, 2 packs of battery, power adapter for charger, Calibration Software, power cord and cables. The 14HK701G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications.
The provided document is a 510(k) summary for the LG Electronics Inc. device 14HK701G-W, a Flat Panel Digital X-ray Detector. While it mentions "Clinical Test Summary" and "Clinical data has been provided", it explicitly states that the data "was not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended."
Therefore, based on the provided text, there is no detailed information about an actual clinical study (MRMC study or standalone study) with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics, non-clinical tests (electrical safety, EMC, software validation, biocompatibility, imaging performance, cybersecurity, and labeling).
The "Performance Test" section refers to IEC 62220-1 for "Determination of the Detective Quantum Efficiency," which is a performance metric for X-ray detectors themselves, not a study evaluating clinical efficacy or diagnostic accuracy with AI.
To answer your request thoroughly, I must highlight that the document does not contain the information you are seeking about a study proving the device meets acceptance criteria related to AI performance, human-in-the-loop improvement, or a standalone algorithm. The device described is a digital X-ray detector, not an AI-powered diagnostic tool.
If this were an AI-powered device, the requested information would be crucial. However, for a digital X-ray detector, the "acceptance criteria" and "study" are typically more focused on physical and technical performance metrics, safety, and equivalence to existing cleared devices, as outlined in the provided 510(k) summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer the questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies as the provided text does not describe such a study for this device.
§ 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.