(242 days)
This device is a Computed Radiography Scanner and intended for use in producing digital X-Ray lmages for general radiography purposes. It comprises of scanner, cassette with reusable imaging plate and workstation software. It scans X-Ray exposed image plate and produces X-Ray lmage in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff. This device is not approved for the acquisition of mammographic image data.
The FireCR is Computed Radiography System which produces the X-ray diagnostic image in digital formation wasn't broutinnal screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat flelding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
The provided text describes a 510(k) submission for the FireCR Computed Radiography Scanner. However, it does not contain any information about acceptance criteria or a specific study proving the device meets those criteria, nor does it include details about a test set, ground truth experts, or training data.
The document primarily focuses on:
- Device Description: What the FireCR is and how it works.
- Comparison to Predicate Device: Stating substantial equivalence to the AGFA ADC Compact Plus.
- Safety, EMC, and Performance Data: Mentions that testing according to IEC 60601-1 and IEC 60601-1-2 was performed, and FDA Guidance for Solid State X-ray Imaging Devices was followed, with all results being "satisfactory."
- Indications for Use: General radiography, not mammography.
- FDA Communication: The letter from the FDA confirming substantial equivalence and an internal memo about a regulation number reassignment.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.
Based on the provided text, the following information is missing and cannot be extracted:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader, multi-case (MRMC) comparative effectiveness study or its effect size.
- Information about a standalone (algorithm only) performance study.
- (Specifically for an AI/algorithm device, which this is not described as) The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- (Specifically for an AI/algorithm device, which this is not described as) The sample size for the training set.
- (Specifically for an AI/algorithm device, which this is not described as) How the ground truth for the training set was established.
The document confirms that safety and performance testing was done according to IEC 60601-1 and IEC 60601-1-2, and non-clinical & clinical considerations were performed according to FDA guidance for Solid State X-ray Imaging Devices. It states that "All test results were satisfactory," but it does not specify what those test results were, what the acceptance criteria for them were, or the details of any clinical studies.
§ 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.