(267 days)
The See Factor CT3™ is a flat panel cone beam computed tomography X-ray imaging system that is indicated for acquiring images of the head, neck, and limbs in all adult patients. It can also acquire portions of the thorax, spine, and pelvic bones with high x-ray attenuation such as bony structures in supine body parts no wider than 60cm. The device has a 62.5cm gantry bore with a 30cm field of view that can provide 2D and 3D images for all of the stated anatomical areas for both intra-operative and clinical use. The device is also capable of acquiring digital radiography and fluoroscopy images of the anatomical areas identified above.
The See Factor CT3™ consists of a Diagnostic CBCT (Cone Beam Computed Tomography) device that integrates High-Definition Computed Tomography (HDCT) for obtaining High Resolution 3D Volume with 2D High Resolution Scouting, through Dynamic Scouting and Single Pulse Modality. Flat panel detector technology allows for multimodality utilization for computed tomography, digital radiography, and fluoroscopy. The gantry of the device is mounted to a battery powered mobile platform that allows use in various clinical settings such as an imaging center, a hospital, or an operating room where adequate radiation shielding is installed. Stray radiation mapping demonstrates no significant difference from the predicate See Factor CT3. The energy source and methodology for obtaining diagnostic CT images utilized by the See Factor CT3™ remains the same as its predicate device. No part of the See Factor CT3™ is intended to come into contact with patients during typical scans that take less than 20 minutes.
The provided text is a 510(k) summary for the Epica International, Inc.'s See Factor CT3™ device. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Siemens Artis zeego) rather than presenting a detailed study proving the device meets specific performance acceptance criteria for an AI/algorithm-driven function.
Therefore, the requested information regarding acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC studies, training set details, etc.) cannot be extracted from the provided text because it does not describe such a study for an AI/algorithm.
The document discusses performance data in broader terms, covering:
- Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC standards (60601-1, 60601-1-6, 60601-2-43, 60601-2-44, 60601-2-54, 60601-1-2).
- Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance.
- Bench Testing: Performed as outlined in "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Section VI," and 3D clinical sample images were obtained.
The statement "In all instances, the See Factor CT3™ functioned as intended" is the closest the document comes to a performance claim, but it's a general statement about the device's overall functionality and not a specific acceptance criterion for an AI/algorithm component.
In summary, the provided text does not contain the information needed to fill out the requested table or answer the detailed questions about an AI/algorithm performance study. The device cleared is an "Image-intensified fluoroscopic x-ray system" (a hardware device), not explicitly an AI/algorithm for image analysis, though it does generate 2D and 3D images (which could potentially be analyzed by AI, but no such AI performance study is detailed here). The software V&V mentioned is for the device's operational software, not an AI for diagnosis or measurement.
§ 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.