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SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an anti-scatter grid.

The SmartGrid II software is designed to improve contrast and reduce the appearance of scatter in radiographic images that have been acquired without a physical grid. SmartGrid II encapsulates an algorithm for estimating and removing scatter from radiographic images.

The SmartGrid II software feature is accessible through the DirectView application software. Users will be able to select SmartGrid II processing before an image is acquired, or to change whether SmartGrid II processing is applied to a previously acquired image.

The Carestream SmartGrid II is a software option designed to reduce visible x-ray scatter in diagnostic radiograph images, similar to the effect of an anti-scatter grid. It is an improvement to the original SmartGrid software.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not explicitly state the numerical sample size of images used for the clinical reader study. It mentions "existing clinical research images" were evaluated.
• Data Provenance: The document does not specify the country of origin. It indicates the study used "existing clinical research images," implying a retrospective nature where stored images were processed and then evaluated.

3. Number of Experts and Qualifications:

• Number of Experts: One board-certified radiologist was used for the clinical evaluation.
• Qualifications: Board-certified radiologist. No specific number of years of experience is provided.

4. Adjudication Method for the Test Set:

• The document describes a reader study where a single board-certified radiologist evaluated images processed with both the original SmartGrid and SmartGrid II. There is no mention of an adjudication method as only one reader was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader, multi-case comparative effectiveness study was not explicitly described. The clinical evaluation involved a single radiologist. Therefore, there is no reported effect size of human readers improving with AI vs. without AI assistance from an MRMC study in this document.

6. Standalone Performance Study (Algorithm only):

• Yes, a standalone performance evaluation of the algorithm was conducted as part of the non-clinical (bench) testing. This included verifying consistent diagnostic quality image production, sufficient noise reduction, and appropriate contrast/brightness for clinical diagnosis.

7. Type of Ground Truth Used:

• For the clinical evaluation, the ground truth was essentially based on the expert opinion/consensus (or lack thereof, since only one expert) on diagnostic image quality comparison between the two software versions (SmartGrid II vs. predicate SmartGrid). The study aimed to confirm "no unexpected negative effects with respect to diagnostic image quality" and that SmartGrid II images were "equivalent in diagnostic quality" to predicate images.
• For the non-clinical bench testing, the ground truth would be represented by the predefined specifications and requirements for image quality metrics (noise, contrast, brightness) and system functionality.

8. Sample Size for the Training Set:

• The document does not provide information regarding the sample size of the training set used for developing the SmartGrid II algorithm. It primarily focuses on the validation of the updated algorithm.

9. How the Ground Truth for the Training Set was Established:

• The document does not provide information on how the ground truth for the training set was established for the SmartGrid II algorithm. It mentions that "the SmartGrid and SmartGrid II algorithms differ slightly to further improve the scatter estimation and correction," suggesting an iterative development process that would have involved some form of ground truth or reference data, but details are not included.

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SmartGrid feature is a software option that provides, upon request by user, a diagnostic radiograph image with a reduction in visible x-ray scatter similar to the effect of an anti-scatter grid.

The SmartGrid software is designed to improve contrast and reduce the appearance of scatter in radiographic images that have been acquired without a physical grid. SmartGrid encapsulates an algorithm for estimating and removing scatter from radiographic images. The SmartGrid feature is accessible through DirectView DR Product application software. Users will be able to select SmartGrid processing before an image is acquired, or to change whether SmartGrid processing is applied to a previously acquired image.

The provided text describes the SmartGrid software, which aims to reduce visible x-ray scatter in diagnostic radiographic images. The acceptance criteria and the study proving the device meets these criteria can be extracted from the "Discussion of Testing" section.

Here's the breakdown of the information requested:

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

The text doesn't explicitly list acceptance criteria in a quantitative table format. Instead, it describes the findings of the study related to image quality. We can infer the acceptance criteria from these reported outcomes.

2. Sample sized 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: The text states that "images of cadaveric specimens and phantoms were acquired and used in the study." It does not specify the exact number of images or cases in the test set.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not explicitly stated, but the acquisition of "images of cadaveric specimens and phantoms" for the study suggests a prospective acquisition for the purpose of the study, rather than leveraging pre-existing clinical images.

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: The study was conducted as a "radiologist reader study," implying multiple radiologists. The exact number is not specified.
• Qualifications of Experts: The individuals are referred to as "Radiologists." Specific experience levels or board certifications are not mentioned.

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

The text states that "Radiologists reviewed and rated investigational and reference images (both grid and non-grid), for diagnostic quality, using a Radlex subjective diagnostic rating scale." It does not describe any specific adjudication method (e.g., majority vote, consensus after discussion, or a senior radiologist as tie-breaker) if there were disagreements among readers.

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: Yes, a "radiologist reader study" was performed, comparing SmartGrid processed images against grid and non-grid reference images. This inherently involves multiple readers (radiologists) reviewing multiple cases (images).
• Effect Size of Human Reader Improvement: The study focused on the diagnostic quality of the images produced by SmartGrid, rather than the improvement of human readers with AI assistance.
  • It reports that SmartGrid images were rated "as good as or better than the non-grid reference images."
  • And "statistically equivalent diagnostic quality at lower exposures than the grid reference acquisitions."
    The study does not quantify how much human readers "improved" in their diagnostic performance when assisted by SmartGrid compared to not using SmartGrid. Instead, it validates the image quality produced by the software.

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

No, the primary study described is a "radiologist reader study," which by definition involves human readers evaluating the images processed by the algorithm. There is no mention of a standalone algorithm performance evaluation without human input in the document.

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

The ground truth was established by expert subjective ratings using a "Radlex subjective diagnostic rating scale." This is a form of expert consensus on image quality rather than an objective clinical truth like pathology or patient outcomes. The text explicitly states that the images were rated for "diagnostic quality."

8. The sample size for the training set

The provided text does not mention the sample size for the training set used to develop the SmartGrid algorithm. The "Discussion of Testing" solely focuses on the performance evaluation study.

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

The provided text does not mention how the ground truth for the training set was established, as it does not discuss the training phase of the algorithm development.

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