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510(k) Data Aggregation
(14 days)
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
The indications for use of the Fuji Computed Radiography (FCR) Velocity Image Reader with Image Plate (IP) reading is the identification, capture, digitization, and processing of diagnostic x-ray images, and associating palient and exam identification with the images.
A Fuji Computed Radiography (FCR) system typically consists of an image reader (IR), palient ID terminal, imaging plates (IPs), IP cassettes, interface board, positioning monitor, laser printer for hard copy oulput, and optionally an image workstation, optical disk file, and network interface. This notification is for the image reader and associated imaging plates. IPs are used as twodimensional radiation detectors in place of radiographic film and intensifying screens to capture a portion of the projected x-ray patient image in space. In the image reader, the captured image data is associated electronically with patient and exam identification data and the latent image is read by laser emission by the phenomenon of photostimulable luminescence. The photostimulated fuminescence is collected, detected, sampled, and digitized. The image data is then digitally processed according to exam and user-specified parameters and may be displayed on a CRT monitor to confirm patient positioning, printed by a hard copy device (such as laser printer, or dry printer), or output to a workstation, optical disk file, or other destination. The device performs no lossy compression of image data.
FCR Velocity consists of an Image Reader and an Imaging Plate (described below). The Image Reader is cassetteless because the Image Plate is built into the upright exam stand configuration of the FCR Velocity Image Reader. Imaging plates are exposed via conventional X-ray devices. The Xray irradiated IP is then moved from the exposure position to the reading position, and images are read. After reading, the IP is erased, and moved to the exposure position again.
As with other FCR image readers, the FCR Velocity will feature a photostimulable phosphor imaging plate (IP) composed of europium activated barium fluorohalaid compounds in a crystal form held in an organic binder. The IP used with the subject device will have a rigid substrate, which enables it to be held in a constant plane. IPs are used as two-dimensional radiation detectors in place of radiographic film and intensitying screens to capture a portion of the projected x-ray palient image in space. In the image reader, the captured image data is associated electronically with patient and exam identification data and the latent image is read by laser emission by the phenomenon of photostimulable luminescence. The photostimulated luminescence is collected, sampled, and digitized. The image data is then digitally processed according to exam and user-specified parameters and may be displayed on a CRT monitor to confirm patient positioning, printed by a hard copy device (such as laser printer), or dry printer), or output to a workstation, optical disk file, or other destination. The device performs no lossy compression of image data.
This document describes the Fuji Computed Radiography (FCR) Velocity Image Reader, a medical device for capturing and processing diagnostic x-ray images. The provided text, however, focuses heavily on outlining the device's technical specifications, intended use, and substantial equivalence to a predicate device, rather than detailing specific clinical acceptance criteria or a comprehensive study demonstrating its performance.
Based on the information provided, here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the comparison with the predicate device, FCR 9501-HQ. The underlying assumption for "acceptance" is that the FCR Velocity performs equivalently or better than the predicate device across various technical parameters. There are no explicit clinical performance metrics (e.g., diagnostic accuracy, sensitivity, specificity) stated as acceptance criteria in this document.
| Acceptance Criterion (Implied/Technical) | Reported Device Performance (FCR Velocity) | Predicate Device Performance (FCR 9501-HQ) |
|---|---|---|
| Image Recording | ||
| Patient Identification | Digital Data (from Console) | Digital Data (from Console) |
| Recording Method | Photostimulable Luminescence | Photostimulable Luminescence |
| No. of Imaging Plates Used | One Built-in Imaging Plate | Four Built-in Imaging Plates |
| Imaging Plate Size | 497x456 mm | 495x377 mm |
| Image Reading | ||
| Reading Laser | Laser Diodes (658 nm) | He-Ne Laser (675 nm) |
| Gray Scale | 10 bits (1024 gray levels) | 10 bits (1024 gray levels) |
| Sampling Raster | 10 Pixels/mm (for various IP sizes: 17x17 in., 17x14 in., 14x17 in., 14x14 in., 10x12 in., 12x10 in., 8x10 in., 10x8 in., 18x43 cm) | 10 Pixels/mm (for various IP sizes: 14x17 in., 14x14 in., 10x12 in., 8x10 in.) |
| Physical | ||
| WxHxD (mm) | 645x1835x450 (Image Reader) | 1163x1733x935 (Image Reader) |
| Weight (kg) | 220 | 580 |
| Throughput (Approximate) | 240 14x17 in. IP's/hr. | 80 14x14 in. IP's/hr |
| Processing Time | 80 seconds | 132 seconds |
Missing Information Regarding Device Performance Study:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical performance study with explicit acceptance criteria for diagnostic efficacy. Therefore, much of the requested information about a specific study proving the device meets acceptance criteria is not present.
- Sample size used for the test set and the data provenance: Not mentioned. The document primarily focuses on technical specifications and comparison to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No clinical test set or ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is an imaging reader, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance would not be applicable in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device is an image reader, not an algorithm for standalone diagnostic performance. It captures and processes images for human interpretation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned. No clinical ground truth is described.
- The sample size for the training set: Not applicable. This device is an image capture and processing system, not a machine learning model that requires a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable, as there is no training set in the context of machine learning.
Summary of What is Provided:
The document details the technical specifications of the FCR Velocity and compares them to its predicate device, the Fuji FCR 9501-HQ. The "acceptance criteria" here are implied by its substantial equivalence to the legally marketed predicate device, indicating that its technical performance is at least comparable and that it does not introduce new safety and efficacy issues. The compliance with various mandatory and voluntary standards (21 CFR 1040.10, 21 CFR 1020.30, UL Standard 60601-1, IEC 60601-1-2) also serves as a form of acceptance criteria for safety and electrical performance.
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