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iPACS Prism-5.0™ from Real Time Image Inc. is a device that receives medical images, (including mammographic images), and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. iPACS Prism-5.0TM only supports lossless compression for primary mammography image interpretation. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions ind other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

iPACS Prism-5.0 is a modified version of iPACS Prism (K030751). Both devices are picture, archiving and communications system software applications from RealTimelmage. The main significant difference between the modified device and the predicate device is that the modified device will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make viewing of these images more convenient for the user. Both systems are a complete PACS solutions designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. IPACS Prism-5.0 is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism-5.0 are needed The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.

This 510(k) submission for iPACS Prism-5.0 (K050298) does NOT contain information regarding acceptance criteria and a study to prove the device meets these criteria.

The provided document describes iPACS Prism-5.0 as a modified version of iPACS Prism (K030751), with the key difference being the ability to display presentation quality digital mammography images. The submission focuses on substantial equivalence to the predicate device and adherence to regulatory requirements for PACS systems.

Specifically, the document DOES NOT include any sections discussing:

• Performance data or evaluation studies.
• Acceptance criteria (e.g., accuracy, reliability metrics).
• Sample sizes for test or training sets.
• Expert involvement for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or any effect sizes of AI assistance.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, clinical outcomes).

Therefore, I cannot populate the requested table or answer the specific questions about studies and ground truth based on the provided text. The submission is a regulatory notification of intent to market a device, primarily focusing on its description, indications for use, and technological characteristics relative to a predicate device, rather than detailed performance study results.

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iPACS Prism™ from RealTimeImage Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

iPACS Prism™ is a complete PACS solution designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.

The provided text describes a 510(k) submission for the iPACS Prism™ system. The document focuses on establishing substantial equivalence to a predicate device and does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or the types of information requested in the prompt related to clinical performance testing (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth details for training or testing).

The document is a regulatory filing for a Picture Archiving and Communication System (PACS), which primarily handles the storage, communication, processing, and display of medical images and data. Its substantial equivalence is based on its technological characteristics being similar to a legally marketed predicate device (ISITE RADIOLOGY, K013630).

Therefore, based on the provided text:

1. A table of acceptance criteria and the reported device performance:
Not available in the provided text. The document focuses on regulatory equivalence rather than specific performance metrics against pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance:
Not applicable. No clinical or performance test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set:
Not applicable. No test set or its adjudication is described.

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:
Not applicable. This device is a PACS system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This device is an image management system, not a standalone diagnostic algorithm. The text explicitly states, "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

7. The type of ground truth used:
Not applicable. No ground truth for performance evaluation is described.

8. The sample size for the training set:
Not applicable. No training set for an AI algorithm is described.

9. How the ground truth for the training set was established:
Not applicable. No training set or its ground truth establishment is described.

Summary of what the document does provide:

• Device Name: iPACS Prism™
• Common Name: Picture Archiving Communications System
• Device Classification: 892.2050 (System, Image Processing, Radiological)
• Predicate Device: ISITE RADIOLOGY (K013630)
• Indications for Use: Receives medical images and data from various imaging sources; images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Typical users are trained professionals (physicians, nurses, technicians).
• Technological Characteristics: Medical device image software used with computer hardware in a PACS environment. Does not contact the patient, nor does it control any life-sustaining devices. A physician interprets images and information with human intervention.
• Conclusion: The device is substantially equivalent to the predicate device.

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