(46 days)
Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.
Vert-X is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. Vert-X acquires, processes, displays, and stores x-ray images, for image diagnosis.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI or clinical effectiveness.
Here's a breakdown of why and what information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not found. The document states "No clinical tests were performed" and describes "Performance Testing" only in terms of compliance with various IEC and ISO standards for electrical safety, electromagnetic compatibility, and risk management. These are regulatory compliance standards, not clinical performance metrics or specific device-performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task).
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable/Not found. Since no clinical tests were performed, there is no "test set" in the context of evaluating diagnostic or prognostic performance. The document refers to "Vert-X was tested according to the following standards," but this refers to compliance testing, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable/Not found. No clinical study was performed, so there was no need for experts to establish ground truth for a test set.
4. Adjudication Method for the Test Set:
- Not applicable/Not found. No clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical tests were performed." Therefore, there is no effect size related to human reader improvement with AI.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
- No, a standalone algorithm performance study was not done. The device, Vert-X, is a mobile fluoroscopic system, a hardware device for imaging, not an AI algorithm. The document states "No clinical tests were performed."
7. The Type of Ground Truth Used:
- Not applicable/Not found. No clinical study was conducted that would require a "ground truth" to evaluate diagnostic performance. The ground truth for the "Performance Testing" refers to the requirements of the listed standards.
8. The Sample Size for the Training Set:
- Not applicable/Not found. This device is a hardware imaging system, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not found. As it's not an AI model, there's no training set or associated ground truth.
Summary of Device and Approval:
The Vert-X device is a mobile fluoroscopic x-ray system. Its 510(k) approval (K061873) in 2006 was based on substantial equivalence to a predicate device (Direx 3Dscope, K053640). This was a "special 510(k)" because it was considered a "minor modification, which does not change the intended use, fundamental technology or reduce safety and effectiveness" of the predicate device. The performance testing mentioned specifically related to compliance with recognized electrical, safety, and risk management standards (IEC, ISO, FDA CDRH regulations), not clinical efficacy or diagnostic accuracy studies involving patient data or AI.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.