Search Results

The O-Rad Radiographic System is indicated for use in obtaining diagnostic quality radiographic 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 Radiographic System is general-purpose radiographic (X-ray) system used for acquiring radiographic images of various portions of the human body. The Q-Rad System consists of a combination of several components including various models of Xray generators and control panels or workstation computers, various models of patient support tables with integrated image receptor(s), wall-mounted image receptor/detector units for upright imaging, tube supports (ceiling-suspended or floor-mounted), and an Xray source and collimator (beam-limiting device). The Q-Rad System is available with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors: systems equipped with DR or CR modalities can also be configured to include a workstation computer that is fully integrated with the X-ray generator to allow communication of information such as image exposure factors directly from a connected RIS/PACS (radiology information system / picture archiving and communications system). The currently marketed Q-Rad System requires manual motion control for 3axis alignment of the X-ray source (tube) and the image receptor/detector located in the patient table or wall stand.

This Special 510(k): Device Modification is for the introduction of optional Auto-Tracker functionality to improve the ergonomics of the user - device interface of the currently marketed Q-Rad Radiographic System. The Auto-Tracker function provides optional automated, motorized vertical tracking of the X-ray tube to the image receptor. Q-Rad Systems with the Auto-Tracker option will have a motor added to the X-ray tube support, and position sensors incorporated into the image receptors/detectors located in the patient table and/or in the wall-mounted image receptor unit. The motor and image receptors are linked via a CANbus communication interface, which allows the X-ray tube to automatically align with the vertical position of the image receptor, which is still manually positioned by the operator. The automated tracking feature applies only to vertical positioning; the operator must still manually align the X-ray tube with the image receptor in the X- and Y-axes (longitudinal and lateral/transverse positioning). The addition of a motor to the X-ray tube support also enabled the addition of optional motorized vertical positioning of the X-ray tube using a "tube-up" or "tube-down" switch; this option is independent of the auto-tracking capability, and is offered as a convenience to the operator as an alternative to the fully manual tube up/down positioning on standard (non-Auto-Tracker) Q-Rad Systems. The standard O-Rad System without Auto-Tracker option will still be available, and the operator will have the option of disabling the Auto-Tracker function at any time if fully manual tube positioning is preferred.

The provided document is primarily a 510(k) clearance letter and a summary for a modified medical device, the "Q-Rad Radiographic System with Auto-Tracker Option." This type of document focuses on establishing substantial equivalence to a predicate device, rather than detailing the full acceptance criteria and specific studies in the way one might find for a novel AI/software medical device.

Based on the provided text, here's an attempt to answer your questions, highlighting where information is not available or not applicable in this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, specificity) and corresponding device performance for image diagnosis. This device is an X-ray system with an auto-tracking feature, not a diagnostic AI algorithm that provides diagnostic output.

However, the document lists the types of performance testing conducted:

2. Sample Size for the Test Set and Data Provenance

This document does not describe a "test set" in the context of data for an AI algorithm. The performance testing references standards for hardware and software functionality (e.g., electrical safety, EMC, software V&V), implying physical testing of the device rather than evaluation on a dataset of images or patient cases. Therefore, information about sample size (e.g., number of images, patients) and data provenance (country, retrospective/prospective) is not applicable in this context.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is an X-ray system with an auto-tracking feature, not a diagnostic algorithm requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication Method

This information is not applicable for the same reasons as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The device's primary modification is an "Auto-Tracker" feature to improve ergonomics and alignment of the X-ray tube and image receptor, not a diagnostic aid that would influence human readers' diagnostic accuracy. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described.

6. Standalone Performance Study

The document states, "Software verification and validation testing was performed to confirm that the modified device performs as intended, and that no unintended errors or failure modes have been introduced." This indicates that the software's functionality (including the auto-tracker) was tested in a standalone manner to ensure it met its design specifications. However, this is not a standalone diagnostic performance study as typically understood for AI algorithms.

7. Type of Ground Truth Used

For the functional and safety testing described (electrical safety, EMC, software V&V), the "ground truth" would be compliance with the respective international standards (IEC 60601 series, IEC 62366) and the device's original design specifications. This is not "expert consensus, pathology, or outcomes data" as would be used for a diagnostic algorithm.

8. Sample Size for the Training Set

This information is not applicable as the device is an X-ray system with an auto-tracking feature, not an AI algorithm that learns from a training set of data.

9. How Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as above.

Summary of the Device and Study from the Document:

The device, "Q-Rad Radiographic System with Auto-Tracker Option," is a modified X-ray system. The modification introduces an optional Auto-Tracker functionality and motorized vertical positioning for the X-ray tube. This feature allows the X-ray tube to automatically align vertically with the image receptor (in the patient table or wall stand), improving ergonomics for the operator. The operator still manually aligns in the X and Y axes.

The study described is focused on demonstrating that these modifications do not compromise the safety or fundamental performance of the X-ray system and that the new features work as intended. This was achieved through:

• Risk Management: Per ISO 14971:2007, identifying and mitigating new risks.
• Design Controls: Adhering to 21 CFR 820.30 protocols.
• Performance Testing:
  • Electrical safety (IEC 60601-1)
  • X-ray system safety and performance (IEC 60601-2-54)
  • Radiation protection (IEC 60601-1-3)
  • Usability evaluation (IEC 60601-1-6 and IEC 62366)
  • EMC testing (IEC 60601-1-2)
  • Software verification and validation, confirming intended performance and absence of new errors or failure modes.

The conclusion is that the modified device is substantially equivalent to its predicate device (K011486) because its intended use and fundamental scientific technology remain the same, and the modifications have been verified through engineering and software testing to ensure safety and functionality.

Ask a specific question about this device

Ask a specific question about this device