(48 days)
QXR-16 Digital Radiography system is 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 all general purpose diagnostic procedures. Not to be used for mammography.
The QXR-16 Digital Radiography Systems is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of Detector, Power Supply Unit, Accessories, and SM. The SM is operated at a workstation that is using Windows XP based OS as its operating system. The system allows the operator to acquire and display images(Image size : 4096x4096 pixels) on 1600 x1200 high resolution monitor.
The provided text describes a 510(k) submission for a digital radiography system (QXR-16) and contains information about its general features, intended use, and comparison to a predicate device. However, it does not contain specific details about acceptance criteria, device performance metrics, or the study conducted to prove these criteria were met.
The document states that:
- "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' was performed."
- "All test results were satisfactory."
This indicates that some form of evaluation was done, but the specifics of that evaluation, including the acceptance criteria and the detailed performance results, are not present in the provided text.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not in the text.
- Sample size used for the test set and the data provenance: This information is not in the text.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not in the text.
- Adjudication method for the test set: This information is not in the text.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not in the text.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not in the text.
- The type of ground truth used: This information is not in the text.
- The sample size for the training set: This information is not in the text.
- How the ground truth for the training set was established: This information is not in the text.
The document primarily focuses on the device's technical specifications, regulatory classification, and substantial equivalence to a predicate device, rather than detailed clinical performance study results.
§ 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.