Search Results

Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

PRIMO S is an image acquisition and processing software application, in radiography mode for Flat Panel detectors. The software is specifically designed for integration with production equipment of the SEDECAL group. The PRIMO S application will be used on different types of Sedecal equipment / systems:

• mobile units
• fixed installations.

The PRIMO S VP application provides the following functions:

• User login: the device is usable only by authenticated users
• Management of the operator interface GUIs and setup of the application itself
• The operator interface GUI must reserve a space on the monitor for the Sedecal equipment/system GUI (choice of examination (APR), X-ray generator commands, collimator, stand, etc.)
• Management of patient data through manual entry and reception from the DICOM WORKLIST service
• Management of image processing algorithms for each type of examination
• Management of the automatic advancement procedures of the operations during the study.
• Image acquisition and processing
• Saving in Hard Disk of the acquired images
• Automatic and manual image stitching procedure
• Off-line image editing and optimization using process and graphic functions
• Documentation of images and study data using DICOM services of STORE, PRINT, CDROM, MPPS, RDSR, STORAGE COMMITMENT
• Application configuration setup
• Export and automatic saving of images on external support (USB key)

The application communicates with the Sedecal equipment through software modules (DLL) for:

• The choice of the examination, made by the operator through a GUI defined by Sedecal (APR)
• Send the exposure parameters foreseen by the selected exam (kV, mA, mAs, ms, collimator aperture, stand position, ...)
• Receive the system status parameters and the exposure result

While the provided text describes the PRIMO S device and its 510(k) submission, it explicitly states:

"6. Clinical testing. Not required for a determination of substantial equivalence."

This indicates that a clinical study with detailed acceptance criteria and performance metrics, as requested in your prompt, was not performed or required for the FDA clearance of this specific device. The clearance was based on substantial equivalence to a predicate device, supported by non-clinical testing and adherence to various standards.

Therefore, I cannot provide the specific information you requested regarding validation studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical test set, as such a study was not conducted or reported in this document.

The document primarily focuses on:

• Device Description: What PRIMO S is and what it does.
• Indications for Use: The medical conditions and body parts it's intended for.
• Technological Characteristics Comparison: How it compares to its predicate device (Sedecal SA K130883) in terms of X-ray generator, digital detectors, panel sizes, operating system, etc.
• Non-Clinical Testing: A list of standards (IEC 62304, EN/IEC 62366-1, ISO 14971, NEMA DICOM, ISO 15223-1) that were employed in development, and mention of software validation based on FDA guidance and cybersecurity considerations.

Since there's no clinical trial data, I cannot populate the table or answer the specific questions about the study design that would prove the device meets acceptance criteria based on clinical performance.

Ask a specific question about this device