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The system is indicated for the storage, reading, interpretation, clinical review, analysis, annotation, distribution, printing, editing and processing of digital images and data acquired from any DICOM device by healthcare professionals, including radiologists, physicians, technologists and clinicians.

With the Teleradiology option it can be used to consult and share information with remote users.
With the Mammography option it can be used for screening and diagnosis (with MG, "For presentation" images only) from FDA approved modalities in softcopy and printed formats.
With the Orthopedic option it can be used to perform common orthopedic measurements of the hip, knee, spine (Coxometry, Gonometry, Lipman Cobb).
With the Slice Imaging option it can be used to process basic 3D rendering: MIP, MPR or series synchronization.
With the Quality Assurance option it can be used by PACS administrators or technologists to perform quality control activities related to patient images and data.

Device Description

The new device is a multifunction PACS workstation for displaying and interpretation of medical images. It includes functions similar to the predicates. It can be used as a general radiography or orthopedic workstation. It displays "for presentation" (MG) mammography images. Image processing is handled by the mammography modalities. It can also display 3D images acquired from CT and MR modalities. It provides user teleradiology functionalities to share information and consult with remote users and can be used to perform quality control activities related to patient images and data.

AI/ML Overview

This 510(k) submission for the Impax SE SigmaCom Client (PACS Medical Imaging Display Workstation) does not contain detailed acceptance criteria or a specific study demonstrating its performance against those criteria in the way a clinical validation study for an AI-powered diagnostic device would.

Instead, this submission is centered on demonstrating substantial equivalence to existing legally marketed predicate devices. The "testing" section states: "Agfa's Impax SE SigmaCom Client (PACS Medical Imaging Display Workstation) has been tested for conformance to specifications." This typically refers to internal engineering and software validation testing, rather than a clinical multi-reader, multi-case study or a standalone algorithm performance study.

Therefore, many of the requested sections cannot be filled as the information is not present in the provided document.

Here's an attempt to answer based only on the provided text, indicating where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformance to specifications (general statement)	Device has been tested for conformance to specifications. (No specific performance metrics are provided in this document).
Substantial Equivalence to Predicate Devices	Principles of operation and technological characteristics are the same as predicate devices (OT3000 (K050751), Embrace (K040555), Web1000 (K053458)). Descriptive characteristics and data provided are sufficiently precise to assure substantial equivalence.
Functionality (various options)	Can perform operations relating to display, digital processing, review, transfer, storage, printing, measurements, teleradiology exchange, screening/diagnosis with MG "For presentation" images, orthopedic measurements, 3D rendering (MIP, MPR, series sync), and quality control activities.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified. The submission refers to "testing for conformance to specifications," which implies internal validation, but no specific test set or clinical data set size is mentioned.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This type of submission relies on demonstrating functional equivalence to existing devices rather than performance against a clinical ground truth established by experts.

4. Adjudication method for the test set

Not applicable/Not specified.

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. This is not an AI-powered device, and no MRMC study is mentioned. The device is a PACS workstation for displaying and interpreting medical images.

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

Not applicable/Not specified. This is a workstation that aids human interpretation, not a standalone diagnostic algorithm.

7. The type of ground truth used

Not applicable/Not specified. The "ground truth" for this device's validation appears to be its ability to perform functions as intended and to be comparable to predicate devices, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable/Not specified. This is a PACS workstation, not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable/Not specified.

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