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The Embrace™ Diagnostic PACS Workstation is intended for softcopy reading and diagnosis by Radiologists. It is also intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).

The Embrace™ DS3000 Diagnostic PACS Workstation is intended for use with rno Embraoo ved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality images (1800) images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).

The Embrace™ DS3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with EDA approved monitors and only when viewing Lossless format images.

The Embrace™ DS3000 Diagnostic PACS Workstation is also intended for softcopy reading and diagnosis by Radiologists.

IMPAX Client Embrace™ delivers a diagnostic softcopy breast imaging workstation for the Women's Care initiative at AGFA.

The following features are available:

· Display of regionally approved DICOM DR Digital Mammography Images (MG SOP class)

· Display of regionally approved DICOM CR Digital Mammography Images (CR SOP class)

· Embrace™ product branding

The Hardware configuration of Embrace™ will consist of the following:

| System (Per Host Machine): | Dell Precision™ Workstation 650;
Compaq xw6000 |
|----------------------------|-----------------------------------------------------------------|
| Number & Details of CPU's | 1 or 2 CPU's depending on configuration |
| Hard Drive space: | 40GB IDE |
| CD-ROM: | Yes |
| Floppy: | Yes |
| Network interfaces: | System comes with an integrated
10/100/1000 Ethernet adapter |
| Power Supplies: | Default |
| Chassis: | Tower |
| Peripherals: | Microsoft IntelliMouse or IntelliMouse
Explorer; Keyboard |

Embrace™ will support the following monitors:

• BARCO Mammography MeDis 5MP CRT monitor package -- MGD . 521M
• BARCO Mammography 5MP and 3MP Flat Panel LCD's (EU) .

This K040553 submission is for a PACS workstation (Embrace™ Workstation), which is a medical image display system. The provided text does not include a description of any specific study that establishes acceptance criteria for device performance in the way one might assess an AI algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technological and functional similarity.

Therefore, many of the requested sections (e.g., sample size for test/training set, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as they pertain more to performance evaluation of an analytical or diagnostic algorithm rather than a display system.

However, I can extract information related to the device itself and its intended use.

Acceptance Criteria and Device Performance (Not applicable in the context of an AI-driven study)

For a PACS workstation like Embrace™, "acceptance criteria" are generally related to its ability to correctly display DICOM images, integrate with other systems, and meet performance specifications (e.g., image loading speed, display quality). This document primarily establishes "substantial equivalence" to a predicate device. Performance criteria would typically be met through technical specifications and validation rather than a clinical study with reported performance metrics like sensitivity/specificity for a diagnostic task.

The document states: "Technological and functional characteristics of the Agfa's Embrace™ software are identical to those of Seno Advantage." This implies that the acceptance criteria are met by demonstrating this identity, rather than by achieving specific quantitative performance targets.

Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is for a PACS workstation, not a diagnostic algorithm that would typically undergo a test set evaluation with specific diagnostic performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device (General Electric Medical Systems' Seno Advantage) based on technological and functional characteristics. No specific "test set" of patient data for performance evaluation is described.

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. As no diagnostic test set is described, there is 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. No test set or ground truth establishment method is described.

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

• Not Applicable. This device is a PACS workstation, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

• Not Applicable. The device is a workstation designed for human interaction (softcopy reading and diagnosis by Radiologists), not a standalone algorithm.

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

• Not Applicable. No ground truth for diagnostic performance evaluation is described.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm is described.

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

• Not Applicable. No training set or ground truth establishment method is described.

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