(75 days)
HEPATIQ is a nuclear medicine software application used to display and process liver-spleen images. The results obtained may be used as a tool, by a nuclear physician, in quantifying liver-spleen images. The data processed may be derived from any nuclear medicine liver-spleen procedure. The HEPATIQ software should only be used by qualified nuclear medicine professionals.
HEPATIQ is Microsoft Windows software that allows the user to display and process nuclear medicine liver-spleen images. HEPATIQ software runs on any nuclear medicine workstation running Windows XP SP3 or later. HEPATIQ software provides the user a means for quantification of nuclear medicine liver-spleen images.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:
Device Acceptance Criteria and Performance Study
The HEPATIQ device is a nuclear medicine software application used to display and process liver-spleen images for quantifying Perfused Hepatic Mass (PHM). The study aimed to demonstrate substantial equivalence to its predicate device, PEGASYS Ultra, particularly regarding its automation feature for PHM calculation.
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for HEPATIQ was its ability to calculate PHM values that are highly correlated with the manual PHM calculations from the predicate device, PEGASYS.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum R² (coefficient of determination) of 90% | Achieved an R² of 97% between manual PHM calculations using PEGASYS and automatic PHM calculations using HEPATIQ. This exceeded the 90% validation criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "a set of test images" was used. The exact sample size for the test set is not explicitly provided. The data provenance is also not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., multiple radiologists independently reviewing images). Instead, the validation was a direct comparison between HEPATIQ's automated calculations and the predicate device's manual calculations. The predicate device's manual calculations were presumed to be the "ground truth" or reference for comparison.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned because the validation was a direct comparison between two calculation methods (HEPATIQ vs. PEGASYS), not a human-adjudicated review of medical imagery.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. The validation focused on the correlation of the automated calculation feature of HEPATIQ with the manual calculation of the predicate device. Therefore, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported.
6. Standalone Performance Study
Yes, a standalone (algorithm only) performance study was performed. The study directly compared the automatic PHM calculations of HEPATIQ with the manual PHM calculations of the predicate device (PEGASYS) for a given set of images. This demonstrates the performance of the algorithm without human intervention, specifically for the automated calculation feature.
7. Type of Ground Truth Used
The "ground truth" used for this validation was the manual PHM calculations performed by the predicate device, PEGASYS. This served as the reference against which HEPATIQ's automated calculations were compared.
8. Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The focus of the provided text is on the validation study comparing HEPATIQ's performance to its predicate device. This suggests that the development and training (if any involving machine learning) happened prior to this validation, and details are not included in this summary.
9. How Ground Truth for the Training Set Was Established
As no training set is described, the method for establishing its ground truth is also not mentioned.
§ 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).