(82 days)
CAREGRAPH is an angiographic system accessory for recording, displaying and documenting the regional distribution of the skin entry dose of a patient, depending on the relevant angulations in X-ray examination. The dose is calculated depending on the format size, the angulation and the table position and displayed on a graphical patient body surface.
CAREGRAPH is a PC program which provides a graphical display of the dose exposure to the patient as measured by a commercially available dose measurement system whose sensor is mounted in the imaging chain. CAREGRAPH can be used with all Siemens Angio and Fluoro systems that are configured with the ACS-, or XCS-interface. The software, which is delivered on CD-ROM, runs on Windows 95/Windows NT 4.0, and is designed to operate with existing Siemens dose counter features in products such as the cardiac workstations (marketed as Siemens Quantcor and Siemens ACOM.PC). The program follows the Microsoft conventions and can be configured by the customer. Minimum PC requirements are:
- Pentium 133 MHz (or better), 16 Mbyte RAM (or more) for Windows 95 .
- Pentium 133 MHz (or better), 32 Mbyte RAM (or more) for Windows NT 4.0. ●
The standard display is a two dimensional presentation of the radiation impact in a scaled window, with numerical indications at foci of skin doses for certain limits. The numerical value of the "Hot Spot" is focused in the graphical presentation, which is updated every 10 seconds. The radiation field must be presented within 2 seconds if relevant parameters have been changed. Calculation is done with an accuracy of ±5%.
The "Hot Spot" resolution shall be ≤ 5x5 mm² and limits and colors for the indication of the spot is configurable by the user. The program is operated with keyboard and mouse. The customer can set the skin dose alarm limit, though not higher than 2000 mGy. When a critical dose is reached an alarm sounds. The display of the dose area is possible without radiation. Patient data can be set parallel to data survey. It is possible to process the patient data afterwards and also generate a report on the patient and examination data. As a minimum, one week's patient reports shall be storable. Data may then be transferred and stored on another media.
The provided K982319 document describes the CAREGRAPH software program, an accessory for angiographic and image-intensified fluoroscopic X-ray systems. However, its purpose is to record, display, and document the regional distribution of the skin entry dose based on X-ray examination parameters. It is an information display system, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC.
Therefore, the acceptance criteria and study information requested in the prompt (pertaining to device performance that would be found in AI/diagnostic studies) are not applicable to this device and its 510(k) submission.
The document does mention:
- Accuracy of calculation: The dose calculation is stated to be with an accuracy of ±5%.
- Hot Spot resolution: This shall be ≤ 5x5 mm².
- Update frequency: The graphical presentation is updated every 10 seconds, and the radiation field must be presented within 2 seconds if relevant parameters change.
These are functional and technical specifications, not clinical performance metrics related to diagnostic accuracy or AI effectiveness. The submission focuses on substantial equivalence to existing dose measurement systems (like Diamentor) and compliance with standards, indicating that its primary function is to accurately display information from a recognized dose-measurement system.
Given this context, I cannot fill out the requested table or sections concerning AI performance, ground truth, expert adjudication, or MRMC studies, as they are not relevant to the described device.
§ 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.