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Imagecast™ PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

The Imagecast™ PACS is a modification of the iSite PACS that replaces the iSite worklist software with the Imagecast™ Worklist software. The Imagecast™ PACS is designed to optimize the clinician's workflow, and targets activities fundamental to their work: organizing, finding, reading, sharing and reporting. The Imagecast™ PACS trade name is also currently in use by IDX to resell the iSite PACS product.

The provided text describes the Imagecast™ PACS (Picture Archiving and Communication System), a modification of the iSite PACS. However, it does not contain a study with detailed acceptance criteria and performance metrics in the way a clinical superiority or non-inferiority study would.

Instead, the document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device, not on proving new performance claims with specific acceptance criteria and detailed study results.

Here's an analysis based on the available information, noting what isn't present based on your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document states, "Prospectively defined verification and validation activities for the Imagecast™ PACS assure that the Imagecast™ PACS is substantially equivalent to the cleared iSite PACS and meets design and performance specifications as well as user needs when operated according to the operating instructions."
  • Interpretation: The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to the predicate device (iSite PACS, K042292) in terms of intended use, indications for use, technological characteristics, and operational characteristics. Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task) are not provided nor required for this type of clearance, as it's not a new diagnostic algorithm.
• Reported Device Performance: No specific numerical performance results (e.g., sensitivity, specificity, or image quality metrics) are reported in this document. The "performance testing" section broadly refers to "verification and validation activities" that assure substantial equivalence and meeting design/performance specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe a clinical test set or data specific to evaluating the Imagecast™ PACS's diagnostic performance. The "performance testing" mentioned is likely focused on system functionality, integration, and user interface, demonstrating that the modifications (replacing iSite worklist with Imagecast™ Worklist) do not negatively impact the system's core PACS functionality or safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. Since there's no diagnostic performance study described, there's no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. (See point 3).

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, an MRMC study was NOT done. The Imagecast™ PACS is described as an "image management system," a Picture Archiving and Communication System (PACS) with a modified worklist software. It is not an AI diagnostic tool or an AI-assisted reading system designed to improve human reader performance. Therefore, an MRMC study for AI assistance is not relevant to this device's clearance.

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

• No, a standalone algorithm performance study was NOT done. The Imagecast™ PACS is a system for image management, transmission, processing, and storage, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable/Not provided. (See point 3).

8. The sample size for the training set

• Not applicable/Not provided. This device is an image management system with modified worklist software, not an AI algorithm that requires a training set of medical images.

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

• Not applicable/Not provided. (See point 8).

Summary of what the document does state regarding performance:

The core of the "Performance Testing" section (Section 7) is a statement of assurance:

"Prospectively defined verification and validation activities for the Imagecast™ PACS assure that the Imagecast™ PACS is substantially equivalent to the cleared iSite PACS and meets design and performance specifications as well as user needs when operated according to the operating instructions."

This indicates that the manufacturer performed internal testing (verification and validation) to ensure the modified PACS system functions as intended and safely, and that these activities supported the claim of substantial equivalence to the predicate device. For a PACS system, such testing would typically cover aspects like:

• Image acquisition and display integrity
• Data transmission reliability and speed
• Storage and retrieval functionality
• Worklist management functionality and integration
• System security
• Compliance with standards (e.g., DICOM)
• User interface functionality and usability

However, the specific metrics or detailed results of these verification and validation activities are not included in this high-level 510(k) summary. The FDA's clearance is based on the determination that these activities were sufficient to demonstrate substantial equivalence, not on a clinical performance study with specific diagnostic outcomes.

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