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The Dry Laser Imager, DRYPRO Model 793 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film.

The Dry Laser Imager, DRYPRO Model 793 is a Laser Imager to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print them on medical dry-film. The device consists of film supplying unit and film transferring unit and exposing unit and heat developing unit and operating unit and power supplying unit and main control unit. This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10.

The provided text is for a 510(k) summary for a medical image hardcopy device, the Dry Laser Imager, DRYPRO Model 793. This document focuses on the substantial equivalence of the new device to a predicate device and outlines its intended use and compliance standards. However, it does not contain the specific information requested about acceptance criteria for device performance and a detailed study proving the device meets those criteria.

A 510(k) summary typically establishes substantial equivalence, often by comparing technical characteristics to an already-cleared device. It does not usually include detailed performance studies with acceptance criteria, ground truth establishment, or multi-reader studies in the way you've outlined for AI/standalone algorithm performance.

Therefore, many of your requested points cannot be answered from the provided text. I will answer the questions that can be inferred or directly addressed from the document.

Summary of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

The provided 510(k) summary for the Dry Laser Imager, DRYPRO Model 793, does not detail specific acceptance criteria for image quality or performance metrics (like sensitivity, specificity, or accuracy) in the way one would find for a diagnostic algorithm. It primarily focuses on establishing substantial equivalence to a predicate device based on technical characteristics and compliance with general standards.

The "study" referenced in this type of document is a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study with specific acceptance criteria that demonstrate diagnostic accuracy or efficacy.

Here's an attempt to address your points based on the available information:

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

This information is not available in the provided 510(k) summary. The document does not specify quantitative acceptance criteria for image quality or other performance metrics, nor does it report specific performance data for the device against such criteria. The closest information is the "Comparison of the principal characteristics of the two devices" mentioned, but its content is not included.

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

This information is not available in the provided 510(k) summary. There is no mention of a test set, sample size, or data provenance as would be relevant for a performance study of a diagnostic algorithm.

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

This information is not available in the provided 510(k) summary. Ground truth establishment is not discussed as there is no performance study described.

4. Adjudication method for the test set:

This information is not available in the provided 510(k) summary.

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:

This information is not applicable and not available in the provided 510(k) summary. The device is a "Medical Image Hardcopy Device" (a printer for medical images), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device type.

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

This information is not applicable and not available in the provided 510(k) summary. The device is a physical printer, not a standalone algorithm.

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

This information is not applicable and not available in the provided 510(k) summary. Ground truth is not relevant for a hardcopy device approval based on substantial equivalence.

8. The sample size for the training set:

This information is not applicable and not available in the provided 510(k) summary. There is no mention of a training set as the device is not an AI algorithm.

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

This information is not applicable and not available in the provided 510(k) summary.

Information that is available or inferable from the document:

• Intended Use: The device is "intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print the images on medical dry-film."
• Compliance Standards: The device complies with UL60601-1, IEC60601-1, IEC60601-1-2, IEC60825, 21 CFR 1040.10, and DICOM. These standards serve as compliance criteria, though not specific performance metrics.
• Predicate Device: The Dry Laser Imager, DRYPRO Model 793, is substantially equivalent to DRYVIEW 8900 manufactured by Eastman Kodak Company (510(k) No. K033821). This comparison forms the basis of the "study" for 510(k) clearance.
• Performance Equivalence: The document states that a "Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is attached below" (though the attachment itself is not provided in the excerpt). This implies that the performance aspects considered for equivalence are likely related to imaging specifications (e.g., resolution, density, contrast, print speed) of the output film, which would be compared to the predicate.

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