Search Results

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.

Ask a specific question about this device