(14 days)
QXR-9 Digital Radiography system is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
The QXR-9 Digital Radiography Systems is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of Detector, Power Supply Unit, Accessories, and S/W, The S/W is operated at a workstation that is using Windows XP based OS as its operating system. The system allows the operator to acquire and display images(Image size : 3072x3072 pixels) on 1600 x1200 high resolution monitor.
Here's an analysis of the provided text regarding the acceptance criteria and study for the QXR-9 Digital Radiography System, structured according to your request:
Based on the provided 510(k) summary (K073056) for the QXR-9 Digital Radiography System, the information regarding specific acceptance criteria and detailed study outcomes for device performance is limited. The document primarily focuses on demonstrating substantial equivalence to predicate devices through compliance with a set of general safety and performance standards, rather than presenting a performance study with detailed clinical metrics.
Here's a breakdown of the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clinical context. Instead, it indicates compliance with recognized safety and performance standards for medical devices specializing in X-ray imaging.
| Acceptance Criteria Category | Device Performance (as stated in document) |
|---|---|
| Electrical, Mechanical, Environmental Safety | Performed according to IEC 60601-1 and IEC 60601-1-1. All test results were satisfactory. |
| Electromagnetic Compatibility (EMC) | Conducted in accordance with IEC 60601-1-2(2001). All test results were satisfactory. |
| Biocompatibility | Conducted in accordance with ISO 10993-1. All test results were satisfactory. |
| Digital Imaging Characteristics | High resolution image with 3.5 lp/mm. Wide dynamic range with 14-bit digitization. Image Acquisition within 3.5 seconds after x-ray exposure. Display processed image within 10 seconds after x-ray exposure. |
| Non-clinical & Clinical Considerations | Performed according to FDA Guidance for the Submission of 510(k) for Solid State X-ray Imaging Devices. All test results were satisfactory. |
Note: The performance listed for "Digital Imaging Characteristics" are features of the device, not explicitly presented as "acceptance criteria" against which a study was measured in this document. The "satisfactory" test results for the standards indicate that the device met the requirements of these standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical performance evaluation. The "tests" mentioned are primarily for compliance with general safety and performance standards (IEC, ISO), which typically involve device testing rather than patient case studies. The document does not mention the country of origin of any data, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. No clinical test set with associated ground truth established by experts is described.
4. Adjudication Method
This information is not provided in the document. No clinical test set with associated ground truth requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not described or referenced in this 510(k) summary. The document does not mention any studies evaluating human reader performance with or without AI assistance. The device in question (QXR-9) is described as a "Digital Radiography System," which itself is a fundamental imaging modality, not an AI-assisted interpretation tool.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for an algorithm (without human-in-the-loop performance) was not described or referenced in this 510(k) summary. The QXR-9 is a hardware system for image acquisition and display, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
This information is not provided in the document. As no clinical performance study for image interpretation using a "test set" is described, no ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned.
8. Sample Size for the Training Set
The document does not mention any training set sample size. This is consistent with the nature of the device as a digital radiography system, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document, as no training set or associated ground truth establishment is mentioned.
In summary: The provided 510(k) summary for the QXR-9 Digital Radiography System focuses on proving substantial equivalence to predicate devices through adherence to established medical device safety and performance standards (IEC, ISO). It describes the technical specifications and features of the imaging system itself. It does not present a clinical performance study with detailed acceptance criteria, test sets, expert ground truth, or comparisons of human reader performance, which would be typical for more advanced AI-driven diagnostic devices.
§ 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.