(70 days)
The Xaminer (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatinc patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Xaminer (510k submission device) is not intended for mammography. These intended uses are identical to the Xplorer 1000 (predicate device).
The Xaminer is the latest version of Xplorer digital radiographic detectors. It includes features and functions that have been developed since the introduction of the original Xplorer in a dicital format will in a digital format without use of film, chemistry, cassettes or expensive imaging plates. With 98 % of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector with 9 mega pixel digitized at 14 bits per pixels
The provided text is a 510(k) summary for the Xaminer Digital Radiographic Detector. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device (Xplorer 1000 Digital Radiographic x-ray detector). However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
The 510(k) summary primarily focuses on:
- Device Description: The Xaminer is the latest version of Xplorer digital radiographic detectors, offering features like a 98% fill factor, lower dose requirement, single CCD detector, and 9-megapixel resolution digitized at 14 bits per pixel.
- Intended Use: For head-to-toe diagnostic radiographic exposures on adult and pediatric patients for various body parts, not intended for mammography.
- Substantial Equivalence: It claims identical intended uses to the predicate device, Xplorer 1000.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone performance study.
- Type of ground truth used.
- Training set sample size.
- How training set ground truth was established.
This type of information would typically be found in a more detailed technical report or study protocol, not usually summarized in a 510(k) notification's public summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for new performance endpoints, especially for devices like digital X-ray detectors where image quality is often assessed against established standards or a predicate.
§ 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.