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The DATACOM™ DC-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.

The DATACOM™ PACS system is based on DICOM standard application. The main function of DC-PACS is about medical image management within a PACS environment. It's including Image archival, retrieval and distribution of medical images.

This document is a 510(k) summary for the DATACOM™ DC-PACS system. It does not provide detailed information about acceptance criteria or specific study results to prove a device meets those criteria. The provided text is primarily focused on establishing substantial equivalence to a predicate device and outlining the intended use and technological characteristics of the DC-PACS.

Here's an analysis of the information not present in the provided text, based on your request:

Information Not Present in the Provided Text:

1. A table of acceptance criteria and the reported device performance: This information is completely absent. The document focuses on regulatory approval based on equivalence rather than performance metrics against specific criteria.
2. Sample sizes used for the test set and the data provenance: There is no mention of a test set, its sample size, or the provenance of any data used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is described, there's no information on experts or ground truth establishment.
4. Adjudication method for the test set: No test set is described, so no adjudication method is mentioned.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: An MRMC study is not mentioned. The device is a PACS system for image management and display, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is a PACS system designed for human interpretation of images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

What the Documents DO Indicate about the Device and its Evaluation:

• Intended Use: The DATACOM™ DC-PACS is intended for the manipulation, management, and display of medical images across different modalities. It distributes images to workstations, storage, and printing devices using DICOM or similar standards.
• Users: Trained medical professionals, including physicians, nurses, technicians, and computer system professionals.
• Technological Characteristics: It's a software server application, does not contact patients, and does not control life-sustaining devices. A physician interprets the displayed images and information.
• Evaluation Method: The primary evaluation for regulatory clearance was a claim of "Substantial Equivalence (SE)" to a predicate device, Smart PACS (K022710). The submission included results of software validation, risk analysis, and hazard classification (minor).
• Approval Basis: FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls provisions of the Act.
• Device Type: This is a Picture Archiving and Communications System (PACS), classified as a Class II device under regulation 21 CFR 892.2050.

In summary, the provided text does not contain the specific performance acceptance criteria and study data you requested because the regulatory submission was based on substantial equivalence to an existing PACS system rather than a de novo performance study against defined metrics.

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