(29 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 Pie ultrasound systems.
The IMT.LAB software is a Windows 2000/XP software 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 Pie ultrasound systems.
This submission focuses on establishing substantial equivalence for the IMT.LAB software, a picture archiving and communication system (PACS) intended for automatic measurement of intima media thickness (IMT) of the carotid artery from ultrasound images. The provided document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices (SonoMetric Health's SonoCalc and Philips Medical Systems' QLAB) based on technological characteristics and intended use.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from this document. The document also does not describe a standalone study with a test set, expert ground truth, adjudication methods, or MRMC comparative effectiveness study results.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the document. The submission focuses on substantial equivalence based on intended use and technological characteristics compared to predicate devices, not on quantitative performance metrics or specific acceptance criteria for IMT accuracy.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. As there's no described performance study, there's no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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:
- Not provided. The document does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not explicitly described as a standalone performance study with metrics. The device's "automatic measurement" function implies a standalone algorithmic capability, but no dedicated study demonstrating its performance in isolation is detailed in this submission. The comparison to predicate devices for "automatic distance measurement of the intima media thickness of an artery" is the closest information provided, but it's not a performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided.
8. The sample size for the training set:
- Not provided.
9. How the ground truth for the training set was established:
- Not provided.
Summary of available information related to performance/validation (indirectly):
The submission argues for substantial equivalence primarily by comparing the IMT.LAB software's intended use and technological characteristics to two predicate devices: SonoMetric Health's SonoCalc (K030223) and Philips Medical Systems' QLAB (K021966).
- Key shared characteristics (implying similar performance expectations):
- Intended Use: Automatic measurement of intima media thickness of the carotid artery from ultrasound video images.
- Image Source: Ultrasound images.
- Operating environment: Standalone application on a personal computer with Microsoft Windows.
- Functionality: Automatic distance measurement of the intima media thickness of an artery.
This type of 510(k) submission, particularly for software that performs automated measurements and is compared to existing devices offering similar functionality, often relies on the predicate devices having already established safety and effectiveness. The current submission's focus is on demonstrating that the new device does not introduce new questions of safety or effectiveness compared to the predicates. Specific performance metrics (accuracy, precision, etc.) and studies to prove them are not detailed in this summary.
§ 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).