Search Results

LessRay® with Tracking is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay® where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability') of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging. - LessRay® works by combining the current image being taken with a prior "Baseline" image of the same anatomy. The initial image, taken at regular radiation dose settings, serves as a baseline to which images taken at lower dose radiation settings can be compared and enhanced. In procedures where instruments are introduced into the field of view, LessRay® images provide information that is not available with conventional images. By merging an image of interest containing tools with the unencumbered Baseline image, the radio dense metallic tools and implants that obscure the underlying anatomy can be rendered partially translucent in the merged image. In addition, by alternating the new image with the Baseline a user can make these metallic tools or implants disappear and reappear from the image, revealing the anatomy blocked by the tool. The subject of this 510(k) is the addition of tracking capability to be used with LessRay LessRay can be interfaced with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay® with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.

The provided document is a 510(k) summary for the LessRay with Tracking device. It primarily focuses on demonstrating substantial equivalence to a predicate device (LessRay®) and details performance testing related to the tracking features, rather than image enhancement performance in a clinical context with acceptance criteria for diagnostic accuracy.

Therefore, the information required to populate all sections of your request (especially regarding acceptance criteria and a study proving image processing performance meets these criteria, ground truth specifics, multi-reader multi-case studies, and human reader improvement) is not fully available in this document. The document explicitly states that the substantial equivalence is for the addition of tracking capability.

However, I can extract what is available regarding the device's performance related to the image enhancement aspect and the tracking feature.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide explicit numerical "acceptance criteria" for the image enhancement capabilities or a study demonstrating the device meets a specific clinical performance metric. Instead, it describes general improvements and relies on substantial equivalence to a predicate device. For the tracking functionality, the "acceptance criteria" are implied by the performance tests conducted.

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

• Image Enhancement / Regression Testing: "a side by side visual comparison of 30 image pairs with and without LessRay processing."
• Tracking Functionality: The document lists several tests for tracking (Glyph Tracking, NDI Vicra, Patriot M, Patriot M with Dynamic Metal Distortion, Fluoroscope Navigation Validation). It does not specify the sample size (e.g., number of tracking instances, number of trials) for these tests.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

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

• Image Enhancement: "As evaluated by a human observer in a side by side visual comparison of 30 image pairs with and without LessRay processing." Only one human observer is explicitly mentioned. No qualifications for this observer are provided.
• Tracking Functionality: Not specified. The nature of these tests suggests they might be engineering or bench performance tests rather than clinical expert evaluation.

4. Adjudication Method for the Test Set

• Image Enhancement: Based on "a human observer in a side by side visual comparison," there does not appear to be an adjudication method (like 2+1 or 3+1 consensus) described. It seems to be a single observer's assessment.
• Tracking Functionality: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done as described in the provided text for the image enhancement features. Only a single human observer is mentioned.
• The document focuses on "substantial equivalence" based on similar technological characteristics and performance tests, not clinical comparative effectiveness in terms of human reader performance with or without AI assistance.
• Effect Size: Not applicable, as no such study was performed or reported here.

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

• The document implies that the image processing itself is an algorithm-only function that enhances the image before display to a human. The "Regression/Image Recognition Compared to LessRay v1.0" test could be considered a standalone evaluation of the algorithm's output consistency.
• The performance tests for tracking accuracy (e.g., with NDI Vicra or Patriot M systems) are likely standalone technical evaluations of the tracking functionality itself, without direct human intervention as part of the performance measurement.

7. The Type of Ground Truth Used

• Image Enhancement: For the "human observer" evaluation, the "ground truth" is subjective human judgment of image quality (clarity, contrast, noise level, usability) by that single observer.
• Tracking Functionality: The ground truth for tracking accuracy tests would implicitly be the known, precise positions or movements of the C-arm or markers as measured by the optical or electromagnetic tracking systems themselves, or a known spatial relationship being correctly identified.

8. The Sample Size for the Training Set

• The document does not mention a training set for the image enhancement algorithm(s) or the tracking software. This document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed technical report on algorithm development. The core image enhancement algorithm (summation of prior full dose images) seems to be based on a fixed logic rather than a machine learning model that requires a training set.

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

• Not applicable, as no training set is described in the document.

Ask a specific question about this device