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. 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 K152279 wherein we have changed the panel scintillator to Cesium Iodide in addition to having the GOS scintillator available. Changing the scintillator is the only modification.

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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vizion DR + Wireless device, presented in the requested format:

1. A table of acceptance criteria and the reported device performance

The document describes a modification to an existing device (K152279) where the scintillator material was changed from Gadolinium Oxysulfide (GOS) to Cesium Iodide (CSI). The primary acceptance criteria for equivalence appear to be related to imaging performance metrics (MTF and DQE) and clinical image quality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated for either the quantitative (MTF/DQE) or clinical image evaluation. For the clinical images, it states "Clinical images were acquired," implying a set of images, but no number is given.
• Data Provenance: Not explicitly stated. The document is from the US FDA, and the company address is in North Carolina, USA, suggesting the study was likely conducted in the USA, but this is not confirmed. It is implied to be prospective or specifically acquired for this evaluation, as it mentions "Clinical images were acquired and evaluated..."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: One
• Qualifications of Experts: "a board certified radiologist" (no mention of years of experience).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: None. A single board-certified radiologist performed the evaluation.

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

• MRMC Study: No. The study described is a comparison of two imaging technologies (different scintillators), not an AI-assisted reading study. The device is a digital X-ray receptor, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This device is an imaging acquisition system, not an AI algorithm. The performance evaluation focuses on the image quality produced by the system itself before interpretation. The quantitative metrics (MTF, DQE) are "standalone" in the sense that they measure the physical performance of the sensor, but this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth:
  • For MTF and DQE: These are objective physical measurements of image quality, not dependent on a "ground truth" derived from patient data in the same way clinical diagnostics are. They are measured against known physical standards.
  • For Clinical Image Quality: The "ground truth" for clinical image quality comparison was the subjective opinion of a board-certified radiologist, who evaluated whether images from the modified panel were "as good as or better than" images from the predicate panel. This is a form of expert opinion/subjective evaluation rather than an objective clinical endpoint like pathology.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The Vizion DR + Wireless is a hardware device (digital X-ray detector) and associated software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software" was previously cleared and confirmation testing was performed after the hardware modification.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device