(88 days)
The dicomPACS® DX-R with flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
The dicomPACS®DX-R with flat panel digital imaging system consists of two components, the dicomPACS®DX-R software for viewing captured images on a Windows based computer, and one of three solid state X-ray imaging devices: Thales Pixium Portable 2430 EZ (wireless), Thales Pixium Portable 3543 EZ (wireless), or the Perkin Elmer 4336 XRpad (also wireless). The system will display high quality images in less than five seconds over a wide range of X-ray dose settings. The software has the following characteristics: The dicomPACS® DX-R software runs on an off-the shelf PC which forms the operator console. Images captured with the flat panel digital detector are communicated to the operator console via LAN or WLAN connection, depending on the model and the user's choice. dicomPACS®DX-R software uses the software API of the panel manufacturers to control the flat panels and to receive and to calibrate image data. The dicomPACS® DX-R software is an independent product for the acquisition, processing and optimization of X-ray images (raw images) provided by flat panel (DR) systems or CR systems. In general, such software is also called "console software" as it is installed on the so-called "console PC" of the imaging device. dicomPACS® DX-R carries out the image processing of the raw images provided by the particular device and provides the radiographer / X-ray assistant with optimum workflow for their work. The key difference between the modified device and our predicate device is the panels are wireless, Wi-Fi.
The provided text describes the dicomPACS DX-R with flat panel digital imaging system. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding device performance metrics. Instead, it relies on a qualitative assessment against predicate devices and standard performance measurements.
| Acceptance Criteria Category | Reported Device Performance (Qualitative Description) |
|---|---|
| Image Quality (Clinical) | "The panels produce images that are clinically acceptable. The images are of excellent quality, high resolution and are comparable to or better than the images from the predicate devices." |
| Safety (Electrical & EMC) | "Electrical safety and EMC testing was conducted by the respective panel manufacturers in compliance with IEC 60601-1 and IEC 60601-1-2." |
| Software Validation & Risk | "Software validation and risk analysis was conducted in compliance with FDA guidance documents." |
| Technical Performance (Panel) | "MTF, DQE, linearity, and resolution measurements" performed by panel suppliers. (No specific values reported in this document.) |
| Wireless Coexistence | "Wireless coexistence is assured via use of standard 802.11(n)." |
| Substantial Equivalence | "The dicomPACS® DX-R with flat panel, as designed, is as safe and effective as the predicate devices, and the device is determined to be substantially equivalent to the referenced predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Images from all three panels were reviewed by a US Board Certified Radiologist." It does not specify the exact sample size (number of images or patients) used for this clinical review of the test set.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Number of Experts: One.
Qualifications: "US Board Certified Radiologist." No specific years of experience are mentioned.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The review was conducted by a single radiologist.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not explicitly mentioned for comparing human readers with and without AI assistance. The study described focuses on the standalone performance of the imaging system and its equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The study described is essentially a standalone performance evaluation of the dicomPACS DX-R system with flat panels. It assesses the basic imaging capabilities (image quality, technical metrics) of the device itself rather than its performance in conjunction with an AI algorithm for diagnosis. The "software" referred to in the description is "console software" for image acquisition, processing, and optimization, not an AI diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth for the clinical image review was established by expert consensus (in this case, by a single US Board Certified Radiologist who determined clinical acceptability, resolution, and comparability to predicate devices). It's based on the radiologist's interpretation and judgment of the images.
8. The Sample Size for the Training Set
The document does not mention a training set, as the device described is an imaging system and associated software, not an AI diagnostic algorithm that requires a separate training phase. The "software" mentioned (dicomPACS DX-R) handles image acquisition, processing, and optimization, not diagnostic interpretation based on learned patterns.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI algorithm is mentioned in this document.
§ 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.