(108 days)
Xoran Workstation is an image processing and viewing software. The Xoran Workstation software provides tools for patient data management, image processing, viewing, interpretation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
Xoran Workstation is an image processing and viewing software for use with imported Xoran MiniCAT IQ, MiniCAT 2020, xCAT XL, and xCAT IQ patient image data. The Xoran Workstation runs on a Windows OS based PC with the following Minimum requirements:
- Laptop or desktop computer
- Windows 10 64-bit Professional or Enterprise
- 4GB of RAM or more
- Intel i5 or better
- USB Type A port
This document describes the Xoran Workstation, Model 10050, an image processing and viewing software. This submission focuses on its substantial equivalence to the predicate device, the MiniCAT. The provided text, however, does not describe specific acceptance criteria and detailed study results to prove that the device meets those criteria.
Based on the provided text, here is a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Xoran Workstation underwent "Verification. Software Validation and Product Validation testing to demonstrate its safety, effectiveness, and conformance to its user needs intended use, as required by 21 CFR 820.30 Design controls - (f) Design Verification, and (g) Design Validation." It also states, "Xoran Workstation meets all the evaluation criteria for Verification, Software Validation and Product Validation tests."
However, specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or image quality metrics) and the reported device performance against these criteria are not provided in the document. The document refers to these details being laid out in "Test Protocol and Test Cases" documents and results captured in "Test Results" documents, which are not included in the provided text.
The closest to "performance" comparison is the "Comparable Properties" table which outlines functional equivalence to the predicate device:
| Comparable Properties | Predicate Device: MiniCAT (Software Features) | Xoran Workstation (Software Features) | Comparison Result |
|---|---|---|---|
| Intended Use | X-ray imaging device constructs 3D model of head/neck from rotational X-ray sequence. | Image processing and viewing software. Provides tools for patient data management, image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting. | Software: Functionally Equivalent |
| Environment of Use | ENT, Allergy, and dental Offices | ENT, Allergy and dental Offices | Functionally Equivalent |
| Basic Technology | PC Based SW | PC Based SW | Functionally Equivalent |
| Principles of Operations | Browsing images by Patient, Date, Ordering physician, Protocol | Browsing images by Patient, Date, Ordering physician, Protocol | Equivalent |
| Viewing Images | Viewing Images | Viewing Images | Equivalent |
| 3D Reconstruction | 3D reconstruction of images taken by the MiniCAT | Can import raw 2D images acquired with MiniCAT or xCAT devices for 3D reconstruction and viewing. Can also import 3D images from any MiniCAT or xCAT device for viewing. | Equivalent |
| Annotation Tools | distance, circle, rectangle, text, label. Automatically saved with image planning file. | distance, circle, rectangle, text, label. Automatically saved with image planning file. | Equivalent |
| Viewing Tools | zoom and pan; continuous rotation up to +/- 45 degrees; Window/Level adjustment; slice thickness. | zoom and pan; continuous rotation up to +/- 45 degrees; Window/Level adjustment; slice thickness. | Equivalent |
| Administration | 3D Reconstruction of acquired images; User login (New/Edit/Delete/Active); Service mode for administration. | Can import raw 2D images acquired with MiniCAT or xCAT devices for 3D reconstruction; User login (New/Edit/Delete/Active); Service mode for administration. | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "test sample sizes" were "established" in the Test Protocol and Test Cases documents. However, the specific sample size used for the test set is not provided in the given text.
The data provenance (e.g., country of origin, retrospective or prospective) for any clinical data used in validation is not specified. The Xoran Workstation is intended to import data from Xoran MiniCAT IQ, MiniCAT 2020, xCAT XL, and xCAT IQ devices.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
The document states that "Product validation evaluations were performed by qualified physicians, who have anatomical and/or surgical expertise related to Xoran Workstation's intended use."
However, the exact number of experts used to establish ground truth or for product validation, and their specific qualifications (e.g., years of experience, specialty) are not provided.
4. Adjudication Method
The adjudication method used for the test set is not specified in the document.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The study described focuses on the substantial equivalence of the software's functionality to existing software, not on the impact of AI assistance on human performance. -
Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop performance) was implicitly performed in the sense that the software's functionalities (image processing, viewing, reconstruction algorithms, annotation tools, etc.) were verified and validated on their own. The document states: "Xoran Workstation has undergone Verification. Software Validation and Product Validation testing to demonstrate its safety, effectiveness, and conformance to its user needs intended use." The comparison table primarily highlights the standalone software features. However, specific performance metrics (e.g., accuracy of reconstruction, precision of measurements) from such a standalone study are not quantified in the provided text. -
Type of Ground Truth Used
The type of ground truth used is not explicitly stated. Given that "Product validation evaluations were performed by qualified physicians," it implies the ground truth might have been based on expert consensus or clinical interpretation by these physicians. There is no mention of pathology or outcomes data. -
Sample Size for the Training Set
The document does not mention a training set sample size. The Xoran Workstation is described as an "image processing and viewing software" that uses "reconstruction software algorithms." If the software relies on models that were trained (e.g., for image processing features), the details of such a training set are not included in this document. The focus of the submission is on functional equivalence and verification/validation processes, not on the development of AI/ML models. -
How the Ground Truth for the Training Set Was Established
As no training set is mentioned, the method for establishing its ground truth is not provided.
§ 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).