(28 days)
The uDR 592h, uDR596i Radiographic system is intended to use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk .Not for mammography.
The uDR 592h, uDR 596i is a digital medical X-ray imaging system that the X-ray generated by the X-ray tube assembly is converted into digital signal through flat panel detector, finally image data using TCP/IP protocol transfers to image process software.
The system consists of Bucky Wall Stand, Tube Stand, Table, High-voltage Generator, X-ray Tube Assembly, Collimator, Flat Panel Detector, Power Distribute Unit, Control Console, Pluggable Grid, Ionization Chamber, Stitching Stand, Image Processing System and Monitor. The system software is a program used for patient administration, acquisition and post processing, image transmission and filming.
The system software provides functions such as import/export images, image viewing, image annotation, patient and study administration, store/delete/rec-over rejected images, exposure index monitoring, image documentation and achieving, automatic exposure control (AEC), stitching.
For automatic exposure control function, high voltage generator can terminate exposure automatically and the stitching provided in uDR 596i can stitch 2-4 single frame images into a full image.
Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study information for the uDR 592h and uDR 596i devices:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria alongside reported device performance for a specific clinical endpoint. Instead, the "acceptance criteria" are implied by adherence to various electrical, safety, and performance standards, and the "reported device performance" is a general statement about meeting these standards and specifications.
However, a specific "Note 12" under "Comparison of Technological Characteristics" mentions acceptance criteria for the stitching function:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stitching function has met software requirement specifications. | "the testing results show that the function has met the acceptance criteria." |
| Clinical images of stitching feature are of sufficient diagnostic quality. | "The clinical images of stitching feature have been reviewed by a board-certified radiologist, and it is indicated that the provided images are of sufficient diagnostic quality." |
Other "performance data" are described in terms of conformance to various standards:
| Acceptance Criteria (Implied by Standard Conformance) | Reported Device Performance |
|---|---|
| Electrical Safety & EMC Standards: | Conducted in accordance with the following standards. |
| IEC 60601-1:2005 (basic safety and essential performance) | Conforms |
| IEC 60601-1-2 Ed 4.0 2014-02 (EMC) | Conforms |
| IEC 60601-1-3 Ed 2.1 2013-04 (radiation protection) | Conforms |
| IEC 60601-2-54 Ed 1.1 2015-04 (X-ray equipment for radiography and radioscopy) | Conforms |
| IEC 60601-2-28 Ed 2.0 2010-03 (X-ray tube assemblies) | Conforms |
| IEC 60825-1 Ed 2.0 2007-03 (laser safety) | Conforms |
| Performance Verification: | Conducted for product development. |
| Clinical Evaluation for sample clinical images evaluation | Conducted |
| AEC Test Report | Conducted |
| Software Standards: | Included as part of the submission. |
| NEMA PS 3.1-3.20(2011) (DICOM) | Conforms |
| IEC 62304 (software life cycle process) | Conforms |
| FDA Guidance (software content in medical devices) | Conforms |
| FDA Guidance (Cybersecurity) | Conforms |
| Biocompatibility Standards: | Conducted. |
| ISO 10993-5 (in vitro cytotoxicity) | Conforms |
| ISO 10993-10 (irritation and skin sensitization) | Conforms |
| Other Standards: | Conforms |
| ISO 14971 (risk management) | Conforms |
| 21 CFR Part 820 (Quality System Regulation) | Conforms |
| 21 CFR Subchapter J (Radiological Health) | Conforms |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No Clinical Study is included in this submission."
Therefore, there is no information on a sample size for a clinical test set or its data provenance in the provided text. The only mention of "clinical images" for evaluation is in the context of the stitching feature and "sample clinical images evaluation" under performance verification, but no details on size or origin are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the specific "stitching feature" evaluation, it states: "The clinical images of stitching feature have been reviewed by a board-certified radiologist". This implies one expert.
The qualification provided is: "board-certified radiologist". No information on years of experience is given.
For any other "sample clinical images evaluation," no details regarding experts or their qualifications are provided.
4. Adjudication Method for the Test Set
There is no mention of a formal adjudication method (like 2+1 or 3+1) for any test set. For the stitching feature, it appears to be a single "board-certified radiologist" review, not a consensus or adjudication process.
5. 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
No MRMC comparative effectiveness study was done as "No Clinical Study is included in this submission." The devices are referred to as "digital medical X-ray imaging system" and there is no indication of AI assistance in the available text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as a "digital medical X-ray imaging system," not an AI algorithm. Therefore, no standalone algorithm performance study would be relevant in this context. The "software" section details verification and validation of the software components as part of the system.
7. The Type of Ground Truth Used
For the stitching feature, the ground truth was based on expert opinion/consensus by a board-certified radiologist who "indicated that the provided images are of sufficient diagnostic quality."
For the broader "Performance Verification" and "Non-Clinical Testing," the ground truth is indirectly established by adherence to recognized international standards for electrical safety, EMC, radiation protection, and imaging performance parameters (e.g., dosimetry, image performance tests like DQE, MTF).
8. The Sample Size for the Training Set
The document states, "No Clinical Study is included in this submission." Therefore, there is no information on a training set or its sample size. The device is a traditional X-ray system, not an AI-driven image analysis tool requiring a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (since it's not an AI device relying on one), there is no information on how ground truth for a training set was established.
§ 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.