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CLARISO PACS is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. CLARISO PACS is used by hospitals, imaging centers, radiologist reading practices.

CLARISO PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

CLARISO PACS™ is a software system to be used to view DICOM compliant studies, which are stored within the CLARISO PACS™ . CLARISO PACS™ is intended for professional use only as a viewing tool for studies within a medical facility. CLARISO PACS™ is a 'Continuous Use' device. This device is also compliant with HIPAA regulations regarding patient privacy (such as restricting access to particular studies, logging access to data.). Since there is no direct patient interaction with the device, there is no possibility that CLARISO PACS™ might lead to a fatal fault or injury to the patient. The only two most likely causes of a fault would be the change of the computing environment of the Client system, or a mislabeling of the DICOM studies used by the Viewer. In the best-case scenario, CLARISO PACS™ would be able to operate safely in spite of such faults. The strategy of CLARISO PACS™ in fault handling is to keep its normal operation as much as it can. The CLARISO PACS™ is intended to work as a standalone service that provides common PACS functionality. The main objective of CLARISO PACS™ is to be a service that can be embedded in other applications that require PACS functionality.

CLARISO PACS™ has four main uses:

• Hard copy replacement: PACS replaces hard-copy based means of managing . medical images, such as film archives.
• Remote access: It expands on the possibilities of conventional systems by providing . capabilities of off-site viewing and reporting (distance education, tele-diagnosis). It enables practitioners in different physical locations to access the same information simultaneously for teleradiology.
• . Electronic image integration platform: PACS provides the electronic platform for radiology images interfacing with other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), Practice Management Software, and Radiology Information System (RIS).
• . Radiology Workflow Management: PACS is used by radiology personnel to manage the workflow of patient exams.

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI-powered diagnostic device.

The document, K132799 for CLARISO PACS™, is a 510(k) premarket notification for a Picture Archiving and Communication System (PACS). Its purpose is to demonstrate substantial equivalence to a predicate device (ERAD PACS), not to prove the clinical performance of a new diagnostic algorithm.

Here's an analysis based on the information provided, highlighting why some requested information is not applicable or unavailable in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on comparing the functionalities and technical characteristics of CLARISO PACS™ with its predicate device, ERAD PACS. The "acceptance criteria" here are implicit in demonstrating that CLARISO PACS™ performs similarly to the predicate while not introducing new safety or efficacy risks.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the document as it's not a clinical performance study. The testing described is non-clinical verification and validation testing of the software itself. It refers to "all input functions, output functions, and actions performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not provided and is not applicable to this type of submission. Ground truth for clinical diagnostic performance is not relevant for a PACS system which is a viewing and archiving tool, not a diagnostic algorithm.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable. Adjudication methods are typically used in clinical studies involving human readers to establish a definitive diagnosis or outcome.

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:

No, a MRMC comparative effectiveness study was not done. This type of study is used for AI algorithms that assist in diagnosis, which is not the primary function of CLARISO PACS™. CLARISO PACS™ is a system for archiving and viewing images, not for providing diagnostic AI assistance.

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

No, a standalone AI algorithm performance study was not done. Again, the device is a PACS system, not a diagnostic AI algorithm.

7. The type of ground truth used:

This information is not applicable as there is no diagnostic algorithm being evaluated for clinical performance. The "ground truth" for a PACS system would pertain to its functional correctness (e.g., does it display images correctly, store them reliably, etc.), which is verified through non-clinical testing.

8. The sample size for the training set:

This information is not provided and is not applicable. CLARISO PACS™ is a software system, not a machine learning model that requires a training set of medical images for learning.

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

This information is not provided and is not applicable for the same reason as point 8.

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