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The LASER IMAGER, DRYPRO MODEL 873 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 devices are intended to be used by trained medical personnel in a clinic or hospital environment.

The LASER IMAGER, DRYPRO MODEL 873 is a Medical Image Hardcopy Device 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, film transferring unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning and it complies with the Federal Performance Standard 21 CFR Part 1040.10.

The provided text is a 510(k) Summary for a medical image hardcopy device, the LASER IMAGER, DRYPRO MODEL 873. This document does not describe acceptance criteria, device performance, or any study involving AI or human readers.

The document focuses on:

• Company and Submitter Information: (Konica Minolta Medical & Graphic, Inc.)
• Device Identification: LASER IMAGER, DRYPRO MODEL 873 (Medical Image Hardcopy Device)
• Classification: Class II, 21 CFR 892.2040, Product Code 90 LMC
• Predicate Device: DRY LASER IMAGER, DRYPRO MODEL 793 (K042133)
• Device Description: Functions as a dry film printer for medical images from various diagnostic equipment (CT, MRI, DSA, Digital Mammography).
• Indications for Use: To acquire and print images from diagnostic equipment on medical dry-film, used by trained medical personnel in clinics or hospitals.
• Substantial Equivalence: Claims substantial equivalence to the predicate device due to similar intended use and technological characteristics.
• Compliance Standards: Mentions IEC60601-1, IEC60601-1-2, 21 CFR 1040.10, IEC60825-1 for safety and radiation.
• Conclusion: Reaffirms substantial equivalence to the predicate device.
• FDA Correspondence: An FDA letter confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or AI-related metrics as it is not present in the provided text.

This 510(k) is for a hardware device (a printer), not an AI/ML software device. The evaluation process for such a device typically involves demonstrating adherence to safety standards, electromagnetic compatibility, and performance specifications like print quality and speed, usually by showing it is equivalent to a previously cleared device. It does not involve "acceptance criteria" related to diagnostic accuracy, sensitivity, or specificity in the way an AI diagnostic tool would.

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