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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.

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

The ViZion DR + Wireless system represents the straightforward integration of a modified digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K123644 wherein we have changed panel to a wireless version of the previously cleared panel/software combination. Going wireless (with batterv operation possible) are the ONLY modifications.

ViZion DR + Wireless is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD). ViZion DR + Wireless is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our predicate is ViZion DR +, K123644. We do not supply the router, but any router meeting the IEEE 802.11 a/b/g/n specifications will work. With the advent of AED (automatic exposure detection) by the panel, integration with or connection to specific generators is no longer required. If the user decides NOT to use AED, wired synchronization with Sedecal Series SHF generators is known to work.

Here's a breakdown of the acceptance criteria and study information for the Viztek ViZion DR + Wireless device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not explicitly state formal "acceptance criteria" in a quantitative, measurable sense for the device, beyond equivalence to a predicate device. Instead, it focuses on demonstrating substantial equivalence through a comparison of technical specifications and performance characteristics, some of which could be considered de-facto acceptance criteria derived from the predicate's performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document simply states "Clinical images were acquired" and "bench, and test laboratory results." It does not specify the number of clinical images or cases used for evaluation.
• Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the U.S. FDA, it is likely that the clinical image acquisition was performed in the U.S. The study appears to be prospective in the sense that new images were acquired specifically for this evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: One board-certified radiologist.
• Qualifications: "board certified radiologist." No specific tenure or experience level is mentioned beyond board certification.

4. Adjudication Method for the Test Set

• Adjudication Method: None mentioned. A single radiologist evaluated the images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. The evaluation was based on a single radiologist's assessment of clinical images from the new panel compared to the predicate, and bench testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable / not a software-only algorithm. The device is a digital X-ray receptor panel (hardware) with associated software. The "performance" being evaluated is of the integrated system and its ability to produce diagnostic images. The comparison focuses on the image quality produced by the device, which is inherently designed for human interpretation.

7. Type of Ground Truth Used

• Expert Consensus / Expert Interpretation: The ground truth for image quality was established by the interpretation of a single board-certified radiologist. There is no mention of pathology, outcomes data, or other objective measures for ground truth.

8. Sample Size for the Training Set

• Not applicable / Not explicitly a machine learning model requiring a training set. The device is primarily a hardware modification (wireless panel) to an existing cleared system. While there's "software," the document states "Since no software modifications were required, confirmation testing was performed." This suggests the software itself was not re-trained or developed with a new dataset for this specific submission, but rather integrated with the new wireless panel.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As stated above, a distinct "training set" for a machine learning model isn't indicated as part of this device's submission or the testing described.

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