(178 days)
Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the result to the user. The result can be stored for future analysis.
Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations,
The software application can be configured based on user needs.
The investigation of physiological or pathological states using measurement and analysis functionality provided by Hybrid Viewer is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management,
Hybrid Viewer provides general tools for viewing and processing nuclear medicine and radiology images. It includes software fornuclear medicine (NM) processing studies for specific darts of the body and specific diseases using predefined workflows. Hybrid Viewer 7.0 includes the following additional clinical features compared to Hybrid Viewer 2.8:
• Additional DICOM file support for Segmentation (SEG), RT Dose and CT Fluoroscopy
· Three energy window (TEW) correction for whole body studies
• Automatic motion correction and additional motion correction option for dual isotope
• Display quantitative SPECT studies in SUV units
• Additional NM processing workflows for:
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Assessment of the percentage of activity which is shunted to the lung prior to Y90 microsphere treatment planning.
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Assessment of the ratio of activity in the heart compared to the mediastinum. The workflow contains specific options for the GE Healthcare product AdreView™, a radiopharmaceutical agent used in the detection of primary or secondary pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
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Assessment of the relative uptake in right, left and duplex kidneys in DMSA™ (dimercaptosuccinic acid) SPECT studies. This is an extension of an existing workflow for planar DMSA studies.
This document describes the premarket notification (510(k)) for the Hermes Medical Solutions AB Hybrid Viewer (Premarket Notification Number K241364).
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of acceptance criteria or reported device performance in the traditional sense of a clinical study with quantitative metrics. However, it outlines the validation approach for new clinical features and indicates that they met acceptance criteria.
| Feature Category | Acceptance Criteria / Validation Method | Reported Performance |
|---|---|---|
| New NM Processing Workflows: | ||
| DMSA SPECT | Validated using analytical verification, where results were based on relevant publications. | "All analytical verifications concluded that the new workflows introduced since the predicate device fulfill the acceptance criteria and are therefore safe to use." |
| Lung Liver Shunt | Validated using analytical verification, where results were based on relevant publications. | "All analytical verifications concluded that the new workflows introduced since the predicate device fulfill the acceptance criteria and are therefore safe to use." |
| DICOM SEG file support | Validated using analytical verification, where results were based on relevant publications. | "All analytical verifications concluded that the new workflows introduced since the predicate device fulfill the acceptance criteria and are therefore safe to use." |
| New Features (non-advanced calculations): | ||
| RT Dose and CT Fluoroscopy support | Verified by comparing acceptance criteria against test results from scripted verification testing during the development process. | (Implicitly met as no issues or non-conformance are reported) |
| New motion correction options | Verified by comparing acceptance criteria against test results from scripted verification testing during the development process. | (Implicitly met as no issues or non-conformance are reported) |
| SUV display | Verified by comparing acceptance criteria against test results from scripted verification testing during the development process. | (Implicitly met as no issues or non-conformance are reported) |
| TEW correction | Verified by comparing acceptance criteria against test results from scripted verification testing during the development process. | (Implicitly met as no issues or non-conformance are reported) |
| Heart Mediastinum | Verified by comparing acceptance criteria against test results from scripted verification testing during the development process. | (Implicitly met as no issues or non-conformance are reported) |
| Overall Safety and Effectiveness | Comparison to predicate device (Hybrid Viewer 2.8), including software design, principles of operation, critical performance, and compliance with the Quality System (QS) regulation. Usability testing and validation. | "There is no change in the overall safety and effectiveness of Hybrid Viewer version 7.0 compared to predicate Hybrid Viewer version 2.8." |
| Cybersecurity | Updating Software of Unknown Provenance (SOUPs) to the latest versions. | "In 7.0 they have been updated to the latest versions for cybersecurity." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient cases or images for a clinical performance evaluation. The validation described is primarily analytical verification and scripted verification testing of software features. Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The validation relied on "relevant publications" for analytical verification and scripted software testing, rather than expert-established ground truth on a specific clinical test set.
4. Adjudication Method for the Test Set
This information is not provided, as the validation method did not involve an adjudication process on a clinical test set with experts.
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
An MRMC comparative effectiveness study is not mentioned as part of this submission. The device is described as a software application for viewing, processing, displaying, and analyzing imaging data, and its "measurement and analysis functionality...is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management." This implies an assistance role rather than a standalone diagnostic or primary reader device that would typically warrant an MRMC study for AI improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
While the device performs calculations and analyses, the document emphasizes that it is "not intended to replace visual assessment" and its output is used "in conjunction with other patient related data." This suggests that a standalone, algorithm-only performance evaluation, typically associated with AI algorithms making diagnostic decisions without human intervention, was not the focus of this submission given its intended use as an assistive tool for image processing and analysis. The validation focused on the accuracy of the software's processing and computational features.
7. The Type of Ground Truth Used
For the new clinical workflows employing advanced calculations (DMSA SPECT, Lung Liver Shunt, DICOM SEG file support), the ground truth for validation was based on "relevant publications" referenced in the verification documents. This suggests that established scientific and clinical literature provided the reference for the expected outcomes of these calculations.
For new features without advanced calculations, the "ground truth" was essentially the pre-defined acceptance criteria used in the scripted verification testing.
8. The Sample Size for the Training Set
No information regarding a "training set" or machine learning (ML)/AI model development is provided in the document. The description of the device's validation focuses on analytical verification and scripted testing of its processing and display functionalities, which are characteristic of traditional software development and verification rather than ML model training.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned, this information is not applicable.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.