(21 days)
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
The Revolution XR/d with Image Pasting and Autopositioning is the latest version of the Revolution XR/d digital radiographic x-ray system. It includes features and functions that have been developed since the introduction of the original XRd in 2001. Auto image pasting enables the operator to electronically join several sequentially acquired radiographs into a single image (such as spine images). Autopositioning offers improved end user workflow by minimizing the number of steps needed to set up and initiate imaging.
The provided documentation for the Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning (K050704) does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Instead, the document primarily focuses on establishing substantial equivalence to a predicate device based on its intended use and fundamental scientific technology.
Here's why the requested information cannot be extracted from the provided text:
- No mention of specific performance metrics: The document does not define any quantitative or qualitative metrics that would serve as acceptance criteria (e.g., image quality scores, diagnostic accuracy, efficiency improvements, specific error rates).
- No detailed study report: The "Summary of Studies" section only states that the device was evaluated for electrical and radiation safety and conforms to applicable medical device safety standards. It does not describe any performance-based study methodology, results, or statistical analysis.
- "Clinical Tests: None required.": This explicit statement indicates that no clinical performance study was conducted or deemed necessary for this 510(k) submission.
Therefore, I cannot populate the requested table or provide details on the study design elements (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment methods) as this information is absent from the provided text.
The key takeaway from the document regarding acceptance criteria and performance is that the device was considered substantially equivalent to a predicate device (Revolution XR/d with image pasting application, K042602) because its new features (Image Pasting and Autopositioning) primarily offered improved workflow and ease-of-use without altering the intended use or fundamental scientific technology of the device.
If acceptance criteria and a corresponding study were conducted, they would typically be detailed in a separate, more comprehensive study report submitted as part of the 510(k) application, or summarized with specific performance metrics within the "Summary of Safety and Effectiveness" document. This particular document serves as a high-level summary that doesn't delve into that level of detail.
§ 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.