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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.

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

I.essRay* is a software only device that is used to enhance the utility of low dose images by comparing them to a baseline image taken at a regular dose setting. A computer running LessRay" is interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer where the images are enhanced and then displayed on the monitor of the computer running LessRay®. Each image is displayed by LessRay at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).

The provided text describes a 510(k) summary for the LessRay® device, which is a software-only device designed to enhance low-dose fluoroscopic images. However, the submission K132970 is about a modification to a previously cleared device (K123226). The modification entails providing the software on a CD for user installation, rather than preloaded on a computer.

Crucially, the document explicitly states: "These modifications represent a minor device modification and do not affect the indications for use. To assess the impact of this change a risk analysis was conducted. Based on the risk analysis verification testing was performed to ensure proper functioning of the software on four computer platforms."

This means the performance data provided in this submission (K132970) focuses on the software's functionality on different hardware platforms after the modification, not on the clinical performance or effectiveness of the image enhancement algorithm itself. The clinical effectiveness and acceptance criteria for the image enhancement would have been part of the original 510(k) submission (K123226), which is not fully detailed here. Therefore, many of the requested details about acceptance criteria, sample sizes for test sets, expert qualifications, and ground truth for clinical performance cannot be extracted from this specific document.

The document states: "The algorithm used and the user experience are identical to that of the previously cleared version." and "Algorithm used to improve image quality - NO CHANGE from K123226". This implies that the clinical performance evaluation was done for K123226 and is considered unchanged.

Here's what can be extracted from the provided text for K132970, focusing on the modification rather than the original clinical performance:

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

For K132970, the acceptance criteria and performance relate to the software's ability to function correctly on various computer platforms after being installed by the end-user, as stated after the risk analysis. The document lists the specific hardware configurations tested.

1. ONYX 175z
2. Sony VAIO L Series
3. Maxant Mediport 3000
4. Dell Precision M6700 |

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

• Test Set Sample Size: Four computer platforms were used for testing the software's functionality after installation.
• Data Provenance: Not specified, but given it's functional testing of software installation, it's likely internal testing by the manufacturer.

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)

Not applicable for this modification. The testing described is functional verification of software on different hardware, not a clinical evaluation requiring expert ground truth.

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

Not applicable. This was functional testing, not a clinical 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

Not applicable for this modification. This study pertains to a minor software distribution change, not a re-evaluation of the image enhancement algorithm's clinical effectiveness. The original 510(k) (K123226) would likely have addressed this type of study if relevant.

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

Not explicitly stated for K132970. The original submission (K123226) would have addressed the standalone performance of the image enhancement algorithm. The current submission focuses on the software's ability to run on various platforms after user installation.

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

Not applicable for the testing described in K132970, which is functional verification of software installation. For the image enhancement algorithm itself (from K123226), the document states the device "Improves quality of low does images" and "Displays reduced noise images", implying that subjective or objective measures of image quality (which would typically involve expert review or image quality metrics) were used as ground truth in the original clearance, but these details are not in K132970.

8. The sample size for the training set

Not mentioned in this document for the image enhancement algorithm, as this submission is for a modification, not the initial clearance of the algorithm. The software is described as using "data from prior images to improve quality of subsequent images" and "summation of prior full dose images with subsequent images", implying it is an adaptive/real-time processing rather than a 'trained' AI in the modern sense (e.g. deep learning requiring a large training dataset).

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

Not mentioned. As above, this information would pertain to the original clearance (K123226) of the image enhancement algorithm, not the current modification. The description of the algorithm (summation of prior full dose images) suggests a traditional image processing approach rather than a machine learning one that requires a "training set" with ground truth in the typical sense.

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

The LessRay™ is a stand-alone computer display system interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer where the images are enhanced and then displayed on the LessRay™ monitor. Each image is displayed on the LessRay™ monitor at the same time as the corresponding original image is displayed on the fluoroscope monitor(s).

Here's an analysis of the acceptance criteria and study information for the LessRay™ device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary does not explicitly state quantitative acceptance criteria in the form of specific metrics (e.g., minimum SNR improvement, maximum noise reduction percentage) that the LessRay™ device needed to meet. Instead, the "Performance Data" section discusses "validation tests" designed to establish substantial equivalence to the predicate device.

The reported device performance is described more qualitatively in relation to these tests and the comparison with the predicate device.

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

The document mentions "Validation Test 4 Pig Study." This implies the test set involved animal data. However:

• The sample size for the test set (e.g., number of pigs, number of images acquired) is not specified.
• The data provenance (e.g., country of origin, retrospective or prospective) is not specified beyond it being a "Pig Study."

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

There is no information provided regarding the number or qualifications of experts used to establish ground truth for any of the validation tests, including the Pig Study. The document primarily focuses on technical and comparative performance rather than human-in-the-loop evaluation for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The validation tests appear to be primarily focused on the device's technical performance and comparison to a predicate, not on how it impacts human reader performance or an "AI assistance" scenario (as the device is image enhancement, not an AI diagnostic tool in the modern sense).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are predominantly standalone performance assessments of the LessRay™ device. The "Validation Test 1 Low Dose/Pulse Image Improvement," "Validation Test 2 Blocked Anatomy," "Validation Test 3 Parallax Test," and "Validation Test 4 Pig Study" appear to evaluate the algorithm's output directly, rather than its impact on a human reader's decision-making. The description states, "The images produced by the fluoroscope are transmitted to a frame grabber in the computer where the images are enhanced and then displayed on the LessRay™ monitor." This workflow implies the device processes and displays enhanced images, and the validation tests would assess the quality of these enhanced images.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the validation tests.

• For "Low Dose/Pulse Image Improvement," ground truth might involve comparing enhanced images to high-dose images or using objective image quality metrics.
• For "Blocked Anatomy" and "Parallax Test," ground truth would likely involve successful visualization or elimination of artifacts under controlled conditions.
• For the "Pig Study," while not explicitly stated, ground truth would likely refer to the actual anatomical structures or known pathological conditions within the pig model, potentially confirmed by other imaging modalities or direct observation, against which the fluoroscopic images were judged for clarity and diagnostic utility.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. The LessRay™ device is described as using an "averaging algorithm" to enhance images, which implies a rule-based or signal-processing approach rather than a machine learning model that typically requires a large training set.

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

Since there is no mention of a training set, there is no information provided on how ground truth for a training set would have been established.

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