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The user will enter Exam Information and/or display Patient information from HIS/RIS at one of the RCIS terminal(s). This information will be transmitted via a network to the primary Quality Control Workstation of the CR-400 System. The primary QCW will update other QCW's and their respective KESPR Readers. After the phosphor cassette containing the Latent Image is scanned by a KESPR Reader the images are transmitted to a workstation which allows for the proper display of the images for diagnostic purposes. The information stored in the Readers and the will be updated by removing Exam and Patient Information. The phosphor readers are not for supporting or sustaining human life, nor do they present a potential for unreasonable risk for illness or injury.

The general hardware configuration of the KODAK Digital Science Remote Cassette Identification Station contains the following major components,

• Touch screen monitor
• Central Processing Unit(CPU)
• Bar-code reader

This document, K962896, describes the KODAK Digital Science Remote Cassette Identification Station (RCIS). It is an accessory device designed to manage patient and exam information within the KODAK Ektascan Image Link Model 400 System.

Unfortunately, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or imaging device's clinical application.

The document primarily focuses on:

• Introduction and General Information: Device name, manufacturer, classification.
• Device Description: Hardware components (touch screen monitor, CPU, bar-code reader).
• Indication for Use: How the device functions within the overall system to transmit and update patient/exam information.
• Regulatory & Consensus Standard Compliance: This section details safety and electromagnetic compatibility (EMC) standards the device adheres to (e.g., UL, CSA, IEC, EN, FCC). These are product safety and manufacturing compliance standards, not clinical performance acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as this information is not present in the provided text. The device described is an information management accessory, not an AI or diagnostic imaging device that would typically have such performance criteria.

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