(47 days)
LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to
- visualize chest CT datasets acquired in low or normal dose;
- mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;
- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)
- generate automatic reports.
LMS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients.
LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.
LMS-Lung/TRACK provides visualization and analysis tools for chest CT images acquired in low or normal dose.
LMS-Lung/TRACK segments pulmonary lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics such as size, volume and intensity. Alternatively, the user can do its own 2D measurements on the lesion.
LMS-Lung/TRACK matches and compares lesions identified by the physician present in two different datasets of the same patient acquired at different dates. It computes the differences of volume and diameters and volume growth.
LMS-Lung/Track provides tool to generate report with snapshots, and results.
The provided 510(k) summary for HD70868 (LMS-Lung/TRACK) does not contain a specific section outlining acceptance criteria or a detailed study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on functional comparison and safety analysis.
Therefore, many of the requested details, such as specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, and ground truth information for both test and training sets, are not explicitly provided within this document.
The document mainly highlights the device's intended use and features, and compares them with predicate devices, concluding that it is substantially equivalent and does not raise new safety risks.
Based on the provided text, here's what can be inferred or directly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The document focuses on feature comparison and substantial equivalence to predicate devices rather than specific quantitative performance metrics against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not provided in the document.
4. Adjudication Method for the Test Set
Not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not reported or implied in the document. The document does not describe any MRMC studies or human reader improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not directly stated as a formal study result. However, the device description strongly implies standalone algorithmic functions for "segmenting pulmonary lesions," "comput[ing] its characteristics such as size, volume and intensity," and "match[ing] and compar[ing] lesions identified by the physician present in two different datasets." The performance of these automatic functions in isolation is not quantitatively detailed with acceptance criteria in this document.
7. The Type of Ground Truth Used
Not provided in the document.
8. The Sample Size for the Training Set
Not provided in the document.
9. How the Ground Truth for the Training Set was Established
Not provided in the document.
Summary of what is present:
- Device Name: LMS-Lung/TRACK
- Intended Use: Visualization, marking, automatic/manual measurement of lung nodule characteristics (diameter, volume), comparison of CT scans over time for lesion evolution, and report generation in adult patients for diagnostic thoracic CT examinations. Not for patients with prior thoracotomy.
- Comparison to Predicate Devices: The document primarily establishes substantial equivalence by comparing the functionalities of LMS-Lung/TRACK with three predicate devices (CA-1500, Lung nodule assessment and comparison option, Primelung). Key comparable features include input CT scans, interactive 2D and 3D visualization, segmentation of lung lesions, extraction and computation of lesion characteristics (2D and 3D), manual measurement, lesion matching over time, lesion comparison over time, and report generation.
- Safety: A hazard analysis was conducted, concluding that residual risks were acceptable when weighed against the intended benefits.
The provided 510(k) summary is a high-level overview establishing substantial equivalence for market clearance and does not delve into the detailed performance validation studies that would contain the specific information requested.
§ 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).