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The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

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The provided FDA 510(k) clearance letter (K051258) for the "Kodak DirectView DR 7500 System" does not contain the detailed information required to answer your specific questions about acceptance criteria and study design.

This document is a regulatory clearance letter acknowledging that the device is substantially equivalent to a predicate device. It confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device can be marketed.

Why the information is not present:

• 510(k)s focus on substantial equivalence: The primary purpose of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove its absolute performance against specific metrics in a detailed clinical study for novel devices.
• Detailed study data is often proprietary: Even if a study was conducted, the detailed methodology, acceptance criteria, specific performance metrics, and a full breakdown of the study population are typically found in the full 510(k) submission document itself, which is not usually made public in its entirety as part of the clearance letter. The clearance letter summarizes the FDA's decision.
• The device is an X-ray system: This device is a "Stationary x-ray system" used for generating x-rays. While image quality is crucial, the "performance" here likely refers to technical specifications, dose output, and image acquisition capabilities, rather than a diagnostic AI algorithm's performance metrics like sensitivity/specificity for disease detection.

Therefore, I cannot provide the requested information from the given text.

To find the details you're looking for, you would typically need to:

1. Access the full 510(k) submission: Sometimes these are available through Freedom of Information Act (FOIA) requests, or summaries might be present in publicly accessible FDA databases if the manufacturer chose to make more information public.
2. Review supporting documentation from the manufacturer: The manufacturer (Eastman Kodak Company, in this case) would have these details in their internal documentation or perhaps in published technical specifications for the device.

Based only on the provided document, here's what I can infer but not directly answer:

• Device Name: Kodak DirectView DR 7500 System
• Intended Use/Indications: "The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions." This means it's for general diagnostic radiography.
• Regulatory Class: Class II
• Product Codes: KPR (System, X-Ray, Stationary) and MQB (Radiographic System, Digital)

Without the actual study report or further sections from the 510(k) submission that discuss performance data, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or clinical study design.

Ask a specific question about this device