(140 days)
Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.
When images are reviewed and used as an element of diagnosibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.
XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.
Enterprise Imaging XERO Viewer is a web based software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. XERO Viewer enables authenticated users to search for and display patient studies (reports and images) using a web browser, user's do not need to download or install any additional software or plug-ins to use XERO Viewer.
It is the successor to Agfa's ICIS View predicate (K143397) and adds the following new functionality: it adds Xtended study viewing) desktop diagnostic support for additional modalities, supports Xtend 3D visualization and ECG mobile (Full Fidelity) diagnostic support utilizing the newer iPad version.
Here's a breakdown of the acceptance criteria and study details from the provided document, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria (e.g., minimum accuracy percentages, specific measurement tolerances) typically found in performance studies for diagnostic devices. Instead, the "acceptance criteria" are implied to be the successful demonstration of equivalence in image quality and functionality compared to predicate devices, as assessed by qualified medical professionals.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Equivalent Diagnostic Image Quality | Qualified radiologists provided an overall score evaluating diagnostic image quality as equivalent when comparing XERO Viewer to the Enterprise Imaging Diagnostic Desktop (K142316). |
| Equivalent ECG Viewing and Functionality on Mobile (iPad) | Validation and non-clinical (bench) testing confirmed that ECG viewing (DICOM and PDF), layout changes, waveform adjustments, and tools (zoom, measurements) performed consistently between desktop and iPad mobile platform. |
| Met Performance, Safety, Usability, and Security Requirements | Verification and validation testing confirmed the device meets these requirements. (No specific metrics provided). |
| Conformance to Standards (ISO, IEC, ACR/NEMA) | Agfa's in-house standard operating procedures, used for development, conform to listed standards (ISO 13485:2003, ISO 14971:2012, ISO 27001:2013, ISO 62366:2007, IEC 62304:2006, ACR/NEMA PS3.1-3.20: 2011 DICOM). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Image Quality Evaluation: An average of 5 or 6 imaging studies per modality were evaluated for comparing diagnostic image quality. The modalities are listed as CR, DX, CT, MR, US, ECG implicitly through the device's stated capabilities and predicate comparisons.
- Sample Size for ECG Viewing: Not specified beyond "users were asked to display ECG's."
- Data Provenance: Not explicitly stated, but it is implied to be retrospective as the evaluation involved existing "imaging studies" and the document explicitly states "No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated how many "qualified radiologists" or "qualified medical professionals" were involved. The phrasing "qualified radiologists were asked to provide an overall score" suggests multiple, but a specific number is not given.
- Qualifications of Experts: Described as "qualified medical professionals" and "qualified radiologists." No specific years of experience or sub-specialties are mentioned.
4. Adjudication Method for the Test Set
- The document states that "Qualified radiologists were asked to provide an overall score when comparing the diagnostic image quality..." It does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "overall score" suggests a consensus or individual assessment without a detailed adjudication process mentioned for resolving discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not explicitly done in the traditional sense. The study compared the image quality of the XERO Viewer against a predicate diagnostic desktop using qualified radiologists, but it was to establish equivalence, not to measure an improvement in human reader performance with AI assistance versus without AI assistance. The device itself is a viewer, not an AI-assisted diagnostic tool. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable in the context of typical AI device standalone performance. The device is a "Picture archiving and communications system (PACS)" and a "software application used for reference and diagnostic viewing." It's an image viewer, not a standalone diagnostic algorithm that would typically generate its own interpretations without human intervention. The performance evaluations focused on the quality and functionality of the viewer itself for human use.
7. The Type of Ground Truth Used
- The "ground truth" for the image quality evaluation was based on the expert judgment of qualified radiologists comparing the diagnostic image quality between the new viewer and an existing FDA-cleared diagnostic desktop. For the ECG viewing, the ground truth was implied by the consistent performance and functionality when compared to the desktop version. No pathology, outcomes data, or other objective "ground truth" standards were mentioned.
8. The Sample Size for the Training Set
- Not applicable. The document explicitly states, "No clinical trials were performed in the development of the device," and "No animal or clinical studies were performed in the development of the new device." This device is a PACS viewer, not an AI/machine learning algorithm that typically requires a discrete training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a viewing device and not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for a training set does not apply here.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).