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The Sectra IDS5 device is intended for the manipulation and displaying of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The IDS5 is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.

The Sectra IDS5 Workstation is in fact a family of devices, including several workstations or types of workstations, e.g. the following:

• . Primary diagnostics workstation and the most powerful version of IDS5 -IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis.
• Dedicated workstation for mammography IDS5/mx.net. It has all functionality as an . IDS5/dx.net but with an additional mammography package.
• Quality assurance workstation, mainly used by the technologists to prepare the images . for the reviewing radiologist.
• Clinicians workstation used by the clinicians within the hospital to view the medical ● images and to read the report.
• "Web" workstation that can be used by remote clinics to view images and reports. .
• "At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.

The provided document is a 510(k) summary for the Sectra IDS5 Workstation, a Picture Archiving and Communications System (PACS). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive performance studies with acceptance criteria and detailed study results typical for novel devices.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The key takeaway from this document regarding performance is that the device is deemed "safe, effective, and substantially equivalent to the predicate device" based on a comparison to its predecessor, K040376, which was also a Sectra IDS5 Workstation.

Here's a breakdown of why the specific information requested is not present in this type of submission:

• Acceptance Criteria and Reported Device Performance: This document describes the device's functions and purpose but does not contain a quantitative performance evaluation with predefined acceptance criteria. This is common for PACS workstations, which are tools for displaying and managing images, rather than diagnostic AI algorithms that generate specific findings.
• Sample Sizes (Test/Training) and Data Provenance: Not applicable as no specific performance study is detailed.
• Number of Experts and Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned, as the focus is on equivalence in functionality for a PACS workstation, not improved diagnostic accuracy with AI assistance.
• Standalone Performance: Not explicitly detailed as an algorithm-only performance study would be. The device's performance is tied to "competent human intervention."
• Type of Ground Truth: Not applicable, as there isn't a diagnostic algorithm being evaluated against a ground truth. The device facilitates viewing and processing images, and the interpretation is by human professionals.
• Training Set Sample Size and Ground Truth Establishment (for training): Not applicable for this type of device.

Conclusion stated in the document:

The conclusion emphasizes that the device:

• Does not contact the patient.
• Does not control any life-sustaining devices.
• Images and information are interpreted by a physician or trained medical personnel, allowing for "competent human intervention."
• Shares the same certification or conformance to performance standards as the predicate device.
• Functions as an Image Processing System (LZ).
• Device failures can be recovered.
• Requires passwords for operation and security.

This re-affirms that the evaluation relies on functional equivalence and human oversight rather than quantitative performance metrics against a medical condition's ground truth.

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INTEGRADWeb MPR/MIP™ by Dynamic Imaging, Inc. is a device that receives medical images (including mammograms) 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. 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 FDA.

INTEGRADWeb MPR/MIP ™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb MPR/MIP ™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on INTEGRADWeb MPR/MIP ™ have been received from DICOM compliant modalities and/or systems.

This document is a 510(k) Summary of Safety and Effectiveness for the INTEGRADWeb MPR/MIP™ system by Dynamic Imaging, Inc., submitted to the FDA in 2004. It focuses on declaring substantial equivalence to a predicate device, rather than presenting a study for acceptance criteria.

Therefore, much of the requested information, such as acceptance criteria, specific performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and details on standalone or MRMC studies, is not available in the provided text. The document is primarily a regulatory submission for market clearance.

However, based on the information provided, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that the submission "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This indicates a qualitative comparison rather than a quantitative performance evaluation against pre-defined metrics within the document.

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

Not available. The document does not describe a "test set" in the context of evaluating the device's performance against specific metrics. It indicates the device handles various medical images from different modalities (CT, MR, US, NM, CR, DR, DX, XA, PT), but no details on specific image datasets used for a performance study are provided.

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

Not applicable/Not available. As no specific performance study with a "test set" is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable/Not available. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention an MRMC study or any comparison of human readers with and without AI assistance. The focus is on the device's functionality as a Picture Archiving Communications System (PACS) and its substantial equivalence to a predicate device.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. The document describes the INTEGRADWeb MPR/MIP™ as a software system for image management, processing, and display within a PACS environment, not as an AI algorithm providing diagnostic interpretations. Therefore, a standalone algorithm performance study is not relevant to the described device. The device "does not produce any original medical images" and "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/Not available. As no specific performance study that required ground truth for evaluation is described, the type of ground truth used is not mentioned.

8. The Sample Size for the Training Set

Not applicable/Not available. The device is a PACS, not a machine learning model that would require a dedicated training set in the typical sense. Its functionality revolves around accepting, transferring, displaying, storing, and digitally processing existing medical images.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not available. As there's no mention of a training set for a machine learning model, this information is not provided.

In summary, the provided document is a regulatory submission for a PACS device, attesting to its safety and substantial equivalence based on its functionalities and adherence to standards, rather than a detailed report of a clinical performance study with acceptance criteria.

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