(64 days)
MedicLung I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semiautomatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROI. MedicLunq I provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.
MedicLung™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of nodules and other lesions in the lug. The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of nodules and other lesions, and measurement of nodule characteristics such as size and volume.
Here's an analysis of the acceptance criteria and study information for the MedicLung™ Release 1 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for MedicLung™ Release 1. It primarily focuses on demonstrating substantial equivalence to predicate devices through functional similarity and safety assessments.
However, based on the description, the implicit "acceptance criteria" are tied to demonstrating the device's ability to assist in the evaluation of lung lesions, measure nodule characteristics, and track changes over time, consistent with the performance of its predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Assist Radiologists in Lung Lesion Evaluation: The device should effectively aid clinicians in identifying and evaluating nodules and other lesions in the lung. | "MedicLung™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of nodules and other lesions in the lung." It "assists users in assessing CT images for the identification and evaluation of nodules and other lesions in the colon." The "Intended Use" also states it is "for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules)." |
| Provide 2D and 3D Visualization: The device should offer both 2D and 3D views of nodules and lesions. | "It provides 2D and 3D visualisation of nodules and other lesions." |
| Enable Nodule Measurement: The device should allow for the measurement of nodule characteristics. | "measurement of nodule characteristics such as size and volume." "MedicLung I provides quantative information for measurement of lesion volume and other measured characteristics over time." |
| Facilitate Region of Interest (ROI) Selection: The device should offer manual and semi-automatic ROI selection. | "The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by sem_autonatic detection of the ROI boundary." The "Intended Use" reiterates this: "The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROL." |
| Track Changes Over Time: The device should allow for reviewing and tracking changes in physician-indicated lesions. | "allowing the user to review and track any changes in the physician-indicated nodules or lesions." |
| Safety: The device should not introduce new safety risks and residual risks should be acceptable. | "A comprehensive hazard analysis was carried out on MedicLung 1, which concluded that any residual risks were as low as reasonably practicable and judged as acceptable when weighed against the intended benefits of use of the system." "MedicLung 1 docs not raisc any new potcntial safety risks." |
| Equivalence to Predicate Devices: The functional features and intended use should be substantially equivalent to predicate devices. | "As in the predicate devices, GE Advanced LungAnalysis-1 and Siemens LunCarcC'1, Mediclung 1 assists users in assessing CT images for the identification and evaluation of nodules and other lesions in the colon." "The functional features and the intended use of MedicLung 1 are substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "'I'cst data are provided to validate the performance of the system and its substantial equivalence to the predicate devices."
However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it provide an effect size for human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as a "software tool designed to assist radiologists and other clinicians." The functionality includes user selection of ROIs and "interactive fine-tuning." This strongly suggests a human-in-the-loop system. The document does not provide information about a standalone (algorithm-only) performance study. Its intended use implies it's an assistive tool, not a fully autonomous diagnostic system.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of a 510(k) submission for an assistive evaluation tool, it's highly probable that some form of expert consensus or clinically validated findings would have been used as a reference, but this is not confirmed in the provided text.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set was established.
§ 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).