(60 days)
The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote ultrasound systems.
The IMT LAB software is a Windows 2000/XP software application package that runs on a stand-alone personal computer. Video images from the carotid artery made with a standard ultrasound system can be used as input for the IMT.LAB software package. These images can be transferred digitally by means of a DICOM, BMP, or JPEG files from the ultrasound system to the IMT.LAB software. IMT.LAB uses proprietary techniques and algorithms to measure the Intima Media Thickness (IMT) from the far wall of the carotid artery. This information is used in addition to other medical data by a physician to help assess the cardiovascular health of a patient.
IMT.LAB can store the images and the measurement results on the hard disk for future reference.
Here's a summary of the provided 510(k) document regarding the IMT.LAB software, focusing on acceptance criteria and study details.
Please note: The provided 510(k) summary (K062598) primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific performance acceptance criteria or a dedicated study demonstrating the device meets those criteria. The document asserts equivalence based on intended use and technological characteristics. Therefore, many of the requested fields will be marked as "Not Provided in Document."
IMT.LAB Software: Acceptance Criteria and Study Details (K062598)
This 510(k) summary for the IMT.LAB software primarily establishes substantial equivalence to previously cleared devices. It describes the device's intended use as an automatic measurement tool for carotid artery Intima Media Thickness (IMT) from ultrasound images. The document does not detail specific performance acceptance criteria or present a formal study proving the device meets such criteria in the way a clinical trial or performance study report might. Instead, equivalence is drawn to predicate devices that presumably already met applicable performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Accuracy, Precision) | Reported Device Performance |
|---|---|
| Not Provided in Document | Not Provided in Document |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not Provided in Document
- Data Provenance: Not Provided in Document (No specific test set or study is detailed)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not Provided in Document
- Qualifications of Experts: Not Provided in Document
4. Adjudication Method for the Test Set
- Adjudication Method: Not Provided in Document
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No
- Effect Size of Human Readers with AI vs. Without AI: Not Applicable (No MRMC study was described)
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done?: No (The document describes the software and its intended use, but not a standalone performance study with metrics.)
7. Type of Ground Truth Used (for Test Set)
- Type of Ground Truth: Not Provided in Document
8. Sample Size for the Training Set
- Sample Size for Training Set: Not Provided in Document
9. How the Ground Truth for the Training Set Was Established
- Method for Establishing Ground Truth: Not Provided in Document
Summary of Device Claimed Equivalence:
The IMT.LAB software is deemed substantially equivalent based on similarity in:
- Intended Use: Automatic measurement of intima media thickness of the carotid artery from ultrasound images.
- Image Source: Ultrasound images.
- Operating Environment: Standalone application on a personal computer with Microsoft Windows.
- Image Format: DICOM, JPEG, and Windows BMP (IMT.LAB v2.0 as submitted, vs. only JPEG and BMP for predicate SonoCalc, and AVI/BMP for QLAB).
- Features: Image storage, report generation, automatic distance measurement.
- Classification: 90LLZ (Radiological Image Processing System).
The 510(k) process for this device relies on demonstrating that the new version (IMT.LAB C:2.0) has technological characteristics and intended use that are equivalent to already legally marketed predicate devices, rather than presenting a de novo performance study against pre-defined acceptance criteria.
§ 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).