(57 days)
ART.LAB is a software package to be used on an external personal computer for the real time automatic measurement of the Intima Media Thickness, diameter and distension of the carotid artery from RF based signal processing obtained from Esaote or Pie Medical ultrasound systems. The Arterial Stiffness Indicator is calculated from distension and blood pressure (systolic and diastolic).
The ART.LAB software product is an optional software package to be used on an external personal computer for the real time automatic measurement of the Intima Media Thickness, diameter and distension of the carotid artery. The measurements are based upon RF signal processing obtained from Esaote or Pie Medical ultrasound systems. The Arterial Stiffness Indicator is calculated from the distension and blood pressure (systolic and diastolic). The ART.LAB software operates in conjunction with an ultrasound system, a linear probe and is installed on an external PC, used for signal processing.
Specifications: Ultrasound scanner with Fast-B-mode scanning capabilities and a linear probe PC P3 1 GHz with 256 MG memory Microsoft Windows 98 or XP Data acquisition card (for acquisition of RF-signals obtained from ultrasound system) Connection cable (from ultrasound system to PC, for RF, Z & trigger signals) ART.LAB software
The provided 510(k) summary for ART.LAB does not contain details about acceptance criteria or a specific study proving the device meets said criteria with quantitative performance results.
The document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and general specifications. It lacks the quantitative performance data, sample sizes, ground truth establishment methods, and expert details typically found in acceptance criteria studies for medical devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided document is a 510(k) summary, which is a high-level overview for regulatory submission, and it generally refers to more detailed studies that would have been submitted as part of the full 510(k) application, but these details are not present in this particular 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).