(15 days)
The FCR Go is indicated for use in generating radiographic images of the human anatomy. This device is not intended for mammographic applications.
The FCR Go battery powered, mobile x-ray system features a built-in Carbon XL CR reader and a notebook version of the CR Console (Flash IIP) or technologist console. Because the CR reader and CR console are incorporated in the equipment, the images are available to the technologist in a very short time, allowing the technologist to assure the exam has been performed adequately, minimizing return trips. Wireless communication is available, as an option, for updates to the patient worklist from the RIS/HIS. The FCR Go uses the same Image Plates (IPs) and cassettes used with other FCR systems.
The FCR Go provides smooth and quiet motorized travel capability via rear wheels independently driven by dual motors, a versatile radiography range through the telescopic arm, and easy-to-operate positioning of detector cassette providing sharp image quality with a short exam completion time.
Radiographic technique and exposure settings (KV, mAs) can be set up on the generator's control panel, as well as pre-configured from the CR console, based on exam type and typical recommended pre-programmed settings.
The provided document is a 510(k) summary for the FUJIFILM FCR Go, a mobile X-ray system. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data. Therefore, many of the requested details about a study proving device performance against acceptance criteria are not found in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or a "reported device performance" in a structured table. The 510(k) process for a mobile X-ray system typically involves demonstrating that the device is substantially equivalent in terms of technical characteristics, safety, and effectiveness to legally marketed predicate devices. This largely relies on engineering tests and comparisons rather than clinical performance metrics like sensitivity, specificity, or reader improvement.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a "test set" for performance evaluation is provided, as the submission focuses on equivalence. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Since a detailed clinical performance study with a test set and ground truth establishment is not described, there is no information about the number or qualifications of experts.
4. Adjudication Method:
No adjudication method is mentioned as a clinical performance study is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The FCR Go is described as a mobile X-ray system with a CR reader and console, not primarily an AI-driven image analysis tool.
6. Standalone Performance Study:
No standalone (algorithm-only) performance study is mentioned. The FCR Go is a hardware system for image acquisition and initial processing.
7. Type of Ground Truth Used:
No type of ground truth is specified, as the document does not describe a performance study requiring ground truth. For an X-ray system, "ground truth" related to image quality would typically involve physical phantoms and expert review of image characteristics rather than patient-level diagnostic outcomes for a device like FCR Go.
8. Sample Size for the Training Set:
No information about a training set is provided. The FCR Go is a hardware device; any image processing algorithms would likely be based on established principles of digital radiography rather than deep learning models requiring large training sets in the modern sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided as no training set is mentioned.
Summary of Device and 510(k) Context:
The FUJIFILM FCR Go is a mobile X-ray system. Its 510(k) submission (K080945) primarily focuses on demonstrating substantial equivalence to existing predicate devices (Mobilett XP CR and GE Definium AMX 700) regarding its intended use, technical specifications, and safety. The 510(k) process for such a device does not typically require extensive clinical performance studies with acceptance criteria in the manner that an AI diagnostic algorithm would. Instead, the focus is on engineering safety, performance testing (e.g., radiation output, image quality parameters with phantoms), and comparison of technical features to proven predicate devices.
The "Indications for Use" for the FCR Go are: "generating radiographic images of the human anatomy. This device is not intended for mammographic applications." This indicates the device's function is to produce images, and the substantial equivalence claim implies that the images it produces are diagnostically acceptable and of comparable quality to those from predicate devices. The document does not delve into the nuances of diagnostic accuracy metrics.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.