(30 days)
The Q-Rad Radiographic System is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography
The Q-Rad System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, tube supports (ceiling-suspended or floormounted), x-ray tube, and collimator (beam-limiting device).
The Q-Rad System can be used with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator.
The modified (subject) device is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows:
- Integration of the FDA-Cleared ImageView Software (K163203) with the Q-Rad ● System.
- A circuit board (CIB+ Board) has been implemented on the Q-Rad System to ● facilitate a new communication protocol between the ImageView Software and the generator.
- The QMI (Quantum Medical Imaging) high voltage generator has been replaced with a Carestream-designed high voltage generator.
- The VacuTec Dose Area Product (DAP) meter Model 1560015 has been replaced ● with an equivalent DAP from a different supplier, the IBA Kermax plus with Ethernet interface 120-131 ETH (Standard Size).
- The Generator Control Box has been replaced. This control box is used to switch ● the generator on and off. Changes to the control box are cosmetic only and do not impact its functionality.
Here's an analysis of the acceptance criteria and study information provided, focusing on the Q-Rad System:
This document is a 510(k) summary for a modified X-ray system, comparing it to a predicate device. It primarily focuses on demonstrating substantial equivalence rather than a clinical study proving new diagnostic performance. Therefore, many typical AI/software study elements (like expert ground truth, MRMC studies, specific performance metrics like AUC) are not detailed here because they aren't generally required for this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Safety | No new unmitigated risks identified due to modifications. | Risk assessment of the modifications did not identify any new unmitigated risks. |
| Effectiveness/Performance | Conforms to specifications and provides equivalent safety and performance to predicate. | Non-clinical test results demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met, demonstrating the device is as safe, as effective, and performs as well as or better than the predicate device. Performance characteristics, operation/usability, intended workflow, related performance, overall function, verification, and validation of requirements were evaluated. |
| Software Requirements | Reliability of system software requirements. | Reliability of the system software requirements was demonstrated. |
| Regulatory Compliance | Meets recognized prevailing consensus standards. | Testing to recognized prevailing consensus standards was performed. |
| Functional Equivalence | Identical Indications for Use to the predicate device. | The Indications for Use for the subject device are identical to the predicate device's, and the intended use remains unchanged. |
| Hardware Equivalence | Components are equivalent or replacement does not impact functionality. | A circuit board, generator, and DAP meter were replaced with functionally equivalent or "cosmetically only" changed components. The ImageView Software (already cleared) was integrated. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical (bench) testing rather than a clinical study with patient data. Therefore, there is no "test set" in the traditional sense of patient cases or images for evaluating diagnostic performance. The testing was focused on the system's technical and functional performance.
- Sample Size: Not applicable in the context of patient data. The "sample" would be the modified Q-Rad System itself and its components undergoing various bench tests.
- Data Provenance: Not applicable for patient data. The testing was described as "non-clinical (bench) testing." No information on country of origin for any data or retrospective/prospective nature is provided, as it's not a clinical data study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided and is not applicable because the study described is non-clinical bench testing for substantial equivalence of an X-ray system, not a clinical diagnostic performance study requiring expert ground truth for patient findings.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC study was performed. This submission is for an X-ray imaging system, not an AI-powered diagnostic algorithm for which an MRMC study would typically be conducted to evaluate human reader performance with and without AI assistance. The "ImageView Software" mentioned is already FDA-cleared (K163203) and its integration into the Q-Rad System is one of the modifications, but its diagnostic performance with human readers is not reassessed here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This is not applicable. The Q-Rad System is an X-ray imaging device, not an AI algorithm performing a standalone diagnostic task. While it integrates an "ImageView Software," the 510(k) submission describes physical and software modifications to the system overall, not a standalone evaluation of an AI algorithm.
7. The Type of Ground Truth Used
This is not applicable for a clinical sense of "ground truth" (e.g., pathology, outcomes data). The ground truth for bench testing would typically involve engineering specifications, defined performance metrics, and compliance with consensus standards.
8. The Sample Size for the Training Set
This is not applicable. This document describes modifications to an existing X-ray system and its non-clinical testing. It does not mention any machine learning or AI models being trained as part of this specific submission. The ImageView Software is already cleared.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #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.