(55 days)
The Precision THUNIS 800+ is a digital remote R&F system intended to generate fluoroscopic and spot-film images of the patient during diagnostic procedures.
The system is indicated also for use in generating radiographic images of human anatomy in general purpose diagnostic procedures.
The system is not intended for mammographic or dental applications.
Precision THUNIS 800+ is a Radiographic and Fluoroscopic system which consists of a tilting patient support table with both local and remote motion controls, a High-Voltage generator, a touch screen X-ray control console in control room (protected area), a X-ray tube assembly, a beam limiting device, a 9" inch Image Intensifier with Charge Coupled Device (CCD) video Camera, a removable 14"X17" film cassette tray, a Power Distribution Unit for whole system, an integrated control console including a workstation, Image Display, remote controls of tilting patient support table, collimator controls, spot film control and Fluoroscopic exposure control.
An in-room image display and in-room Fluoroscopic control foot switch are provided as an option for certain procedure which may need local X-ray loading and imaging.
No traditional spot film device using a film changer is provided with this system, spot-film image acquisition is fulfilled through digital image frame grabber and video camera.
The provided document is a 510(k) summary for the GE Healthcare Precision THUNIS 800+ X-ray system. This type of document is typically for demonstrating substantial equivalence to a predicate device, focusing on technological characteristics and intended use, rather than presenting detailed acceptance criteria and performance studies that would be common for new medical algorithms or AI-driven devices.
Based on the content, there are no acceptance criteria, device performance results, or a study described in this document that proves the device meets specific performance criteria.
Here's why and what information is available:
- Device Type: The Precision THUNIS 800+ is a "Stationary Diagnostic Radiographic and Fluoroscopic X-ray System." This is a hardware device for image acquisition, not an algorithm or AI system for image analysis.
- 510(k) Purpose: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a legally marketed predicate device. This often involves showing similar technological characteristics and intended use, rather than conducting new clinical performance studies with specific statistical endpoints like sensitivity, specificity, etc., which would be typical for an AI/algorithm-driven device.
- Content Focus: The document focuses on:
- Identifying the submitter and the device.
- Comparing the Precision THUNIS 800+ with its predicate device (Prestige V, VH & VHD) in terms of generic name, classification, class, product code, and technological characteristics (X-ray imaging technology, materials, energy source).
- Stating the intended use, which is "to generate fluoroscopic and spot-film images... during diagnostic procedures" and "generating radiographic images... in general purpose diagnostic procedures."
- Confirming compliance with safety standards (UL60601-1:2003 and IEC60601 series).
Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in this 510(k) submission. This document does not describe a study to prove a device's performance against specific acceptance criteria in the manner that would be expected for a diagnostic algorithm.
Summary of available information relevant to your questions:
- 1. A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence based on technological characteristics and intended use, not performance metrics.
- 2. Sample sized used for the test set and the data provenance: Not applicable/available. No test set or data provenance is discussed as this is not a study of an algorithm's performance.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available.
- 4. Adjudication method for the test set: Not applicable/available.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a hardware device, not an AI or image interpretation algorithm.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/available.
- 8. The sample size for the training set: Not applicable/available.
- 9. How the ground truth for the training set was established: Not applicable/available.
Conclusion from the document: GE Healthcare states that the Precision THUNIS 800+ is "substantially equivalent" to the predicate device (Prestige V, VH & VHD) because they share "the same indications for use and meets the similar standards," and utilize "the same technological characteristics" (X-ray imaging technology, video camera, image intensifier, and compliant construction materials). The regulatory body (FDA) concurred with this substantial equivalence determination, allowing the device to be marketed.
§ 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.