(87 days)
The indications for use of the Fuji Computed Radiography Dual Side Reading is the same as the predicate device: the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.
The Fuji Computed Radiography Dual Side Reading consists of an image reader (FCR 5501D Dual Side Reader) and Imaging Plates (described below). The image reader is cassetteless because the IPs are built-into this upright exam stand/reader. After exposure, the IP is in turn to the scanning, erasing, and holding areas. For the operator, this means that as soon as the IP is exposed , another is brought into the exposure area, without having to wait for reading and erasure. As with other FCR image readers, the FCR 5501D Dual Side Reader will feature a photostimulable phosphor imaging plate composed of europium activated barium fluorohalide compounds in a crystal form held in an organic binder. The Imaging Plate used with the subject device (ST-55 BD) will have a transparent support, which will allow emission detection from both the support side and phosphor side of the IP.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
This submission focuses on a Computed Radiography system (FCR 5501D Dual Side Reader), and the performance criteria are primarily related to image quality metrics rather than diagnostic accuracy for specific pathologies. The device itself is an image reader, not a diagnostic AI algorithm in the contemporary sense. Therefore, many standard AI/ML study components (like expert consensus for ground truth on disease, MRMC studies, standalone performance with human-in-the-loop, etc.) are not applicable here.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (FCR 5501D Dual Side Reader) |
|---|---|
| Modulation Transfer Function (MTF) equivalence to predicate device | Virtually identical MTF to predicate devices (FCR 9501 and FCR 9501HQ) |
| Detective Quantum Efficiency (DQE) improvement over predicate device | 30-40% increase in relative DQE compared to predicate device |
| Electrical Safety | Conforms to UL Standard 2601-1 Medical Electrical Equipment Part 1: General Requirements for Safety |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of number of images or patients. The performance data presented refers to laboratory tests measuring physical image quality characteristics (MTF, DQE).
- Data Provenance: The data provenance for these laboratory tests is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. Given the nature of the tests (measuring physical performance metrics of hardware), it's highly likely it was performed in a controlled laboratory setting by the manufacturer (Fuji Medical Systems U.S.A., Inc.) or a designated testing facility (e.g., Underwriters Laboratories Inc. for safety).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. For a device like a Computed Radiography system (an image acquisition and processing device), the "ground truth" for image quality metrics (MTF, DQE) is established through standardized physical measurements and scientific methodologies, not through expert consensus on diagnostic findings. These are objective engineering measurements.
4. Adjudication Method for the Test Set
- Not Applicable. As explained above, the "test set" involves objective physical measurements, not observational diagnostic tasks requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document does not mention any MRMC study. The device is an image acquisition and processing system, not an AI diagnostic assist tool for human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Partially Applicable / Implicit. The performance data (MTF, DQE) represents the intrinsic image quality capabilities of the device itself (the "algorithm" in a broad sense, referring to its image acquisition and processing pipeline) without direct human intervention in the measurement process. These are measurements of the device's technical specifications. However, this is not a standalone diagnostic algorithm performance study in the modern AI/ML context.
7. The Type of Ground Truth Used
- Objective Physical Measurements: The ground truth for this device's performance is based on objective physical measurements of image quality characteristics such as Modulation Transfer Function (MTF) and Detective Quantum Efficiency (DQE), and compliance with electrical safety standards (UL 2601-1). These are established through standardized testing procedures.
8. The Sample Size for the Training Set
- Not Applicable. This device is a Computed Radiography system, which is a hardware-based image acquisition and processing system. It does not employ machine learning or AI algorithms that require a "training set" in the conventional sense. Its "training" involves engineering design, calibration, and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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.