(28 days)
The KODAK DirectView CR Long-Length Imaging System is used with the KODAK DirectView CR 800/ CR 900 Systems which are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiology applications. The Long Length Imaging feature is used for examinations of long areas of anatomy such as the leg and spine.
The Kodak DirectView CR Long-Length Imaging System extends the capability of the Kodak CR 800 and CR 900 computed radiography systems to allow the capture of long length images with an image area up to 130 cm high x 43 cm wide. Individual CR images are limited to the size of a CR cassette, the largest being 35 x 43 cm. The Kodak Long-Length Imaging System includes a vertical cassette holder, which can hold up to four CR screens and image stitching software, which will operate on the CR 800 or CR 900 system. Image capture is accomplished using standard x-ray equipment and technique. The CR screens are then removed form the vertical cassette holder and placed in the CR 800 or CR 900 system to be scanned. The image stitching software processes the images correcting for magnification, translation, and rotation differences among the images, eliminates redundant pixels in the overlap region and stitches together the individual images. The resulting single composite image covers an image area of up to 130 cm x 43 cm, and can be stored to a PACS workstation or printed to film using a laser imager.
The provided text is a 510(k) summary for the Kodak DirectView CR Long-Length Imaging System. It describes the device, its intended use, and substantial equivalence to existing devices.
However, the document does not contain the following information required to answer your request:
- Acceptance criteria: There is no mention of specific performance metrics that the device needs to achieve.
- Study details: While it discusses the device's functionality, there is no description of a study conducted to prove the device meets any performance criteria.
- Reported device performance: No specific performance results are provided.
- Sample size and data provenance for the test set: Not mentioned. The document describes how the system works without detailing a test set.
- Number of experts and qualifications for ground truth: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone performance: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned as there's no mention of a training process.
- How ground truth for the training set was established: Not mentioned.
This 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing a rigorous performance study with acceptance criteria. It describes the technology and functionality of the image stitching software, emphasizing that it corrects for "magnification, translation, and rotation differences among the images, eliminates redundant pixels in the overlap region and stitches together the individual images." However, it does not quantify how well it performs these tasks or list any acceptance metrics for that performance.
§ 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.