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LessRay® System 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 provides the additional feature of being able to interface LessRay 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. LessRay System has additional capability of instrument tracking to aid the user in positioning an instrument using prior baseline x-rays. A tracker is attached to the instrument and as the instrument moves, the tracking system connected to LessRay tracks the location of the instrument. LessRay System uses this information to aid the user in positioning the instrument.

The provided text is a 510(k) summary for the LessRay® System. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain detailed information about acceptance criteria or specific study results demonstrating device performance against those criteria.

Specifically, the document states:

• "Nonclinical testing was performed to demonstrate that the subject LessRay System is substantially equivalent to the predicate device."
• "The results demonstrate that the subject LessRay System is substantially equivalent to the predicate."

However, it does not provide the acceptance criteria for these tests, nor the reported device performance against those criteria. It lists the types of tests performed:

• Verification of Instrument Tracking
• Verification of Alignment Accuracy
• Verification of Image Registration Performance
• Software Validation
• Electrical Safety and Electromagnetic Compatibility (EMC) testing

Without access to the actual test reports or a more detailed summary of the performance studies, it's impossible to create the table and answer most of the specific questions.

Here's an analysis of what can be extracted or deduced from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for any of the verifications. There is a note (footnote 1) mentioning "a side by side visual comparison of 30 image pairs with and without LessRay processing" by a human observer. It's unclear if this was part of the "Instrument Tracking," "Alignment Accuracy", or "Image Registration Performance" tests, or a separate informal assessment for image quality.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that the testing is "nonclinical," the data is likely not from human patients in a clinical setting but could be simulated, phantom, or animal data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Experts: Not specified for any of the verification tests.
• Qualifications: Not specified.

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

• Not specified.

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

• A formal MRMC comparative effectiveness study is not mentioned. Footnote 1 refers to a "side by side visual comparison of 30 image pairs with and without LessRay processing" by a "human observer," but this does not constitute an MRMC study and no "effect size" is reported. The focus of the reported "nonclinical testing" seems to be on the technical performance of the features (tracking, alignment, registration) rather than clinical effectiveness with human readers.

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

• The mentioned "Verification of Instrument Tracking," "Verification of Alignment Accuracy," and "Verification of Image Registration Performance" tests are likely standalone algorithm performance assessments. However, the details of these tests (e.g., how accuracy was measured, what metrics were used) are not provided.

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

• Not specified for any of the verification tests. For "Instrument Tracking," "Alignment Accuracy," and "Image Registration," the ground truth would likely be a precisely measured or known physical position/alignment/transformation.

8. The sample size for the training set

• The document describes the LessRay System as utilizing "averaging algorithm" and "contrast and brightness enhancement." This suggests traditional image processing algorithms rather than deep learning or machine learning models that typically require a distinct "training set." Therefore, a "training set sample size" is likely not applicable in the context of the described algorithms. If there were machine learning components, no details are provided.

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

• As a training set is likely not applicable (see point 8), this information is not provided.

In summary: The 510(k) summary indicates that nonclinical testing was performed to demonstrate substantial equivalence, but it lacks the specific details regarding acceptance criteria, quantitative performance results, sample sizes, ground truth establishment, and reader study information that would be necessary to fully answer the request. The document appears to focus on demonstrating the technical functionality and safety of the device's new features (instrument tracking, wired remote) in comparison to its predicates, rather than providing detailed clinical efficacy data.

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