(67 days)
The intended use of CAAS is:
- Quantification of coronary artery dimensions
- Quantification of peripheral arteries and aorta
- Quantification of left and right ventricles
- Management of data resulting of the quantitative analysis
Indications For Use:
CAL: Calculate the pixel size of the image to be analyzed
MEAS: Perform basic length, angle and density measurements.
QCA: Detect the contour of the coronary vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the coronary artery segment.
QVA: Detect the contour of the peripheral vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the peripheral vessel segment.
LVA biplane: Delineate the outline of the left ventricular wall automatically and/or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of left ventricular volumes based on several established models for children and adults calculations of derived parameters; quantification of the right ventricular wall.
RVA: Delineate the outline of the right ventricular wall semi-automatically or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of right ventricular volumes based on several established models for children and adults calculations of derived parameters; quantification of the motion of the right ventricular wall.
CAAS is a new generation of CAAS medical device software that includes and elaborates on previously developed and marketed CAAS software and modules. CAAS is designed as a modulation in perfously devices that includes the functionality of the previously cleared Pie Medical Imaging software as a nocular sortwale passage that news. CAAS consists of reused algorithm with the addition of several improvements that do not influence the indications for use. CAAS is composed out of six modules CAL, MEAS, QCA, QVA, LVA biplane and RVA.
The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or the methodology and results of such a study. The document is a 510(k) summary for a medical device (CAAS software package) which focuses on establishing substantial equivalence to previously cleared predicate devices.
Therefore, I cannot provide the requested table or answer most of the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment.
However, I can extract information about the device, its intended use, and substantial equivalence.
Here's what can be inferred from the provided text:
- Device Name: CAAS (Cardiovascular Angiography Analysis System)
- Manufacturer: Pie Medical Imaging BV
- Intended Use (from the 510(k) summary):
- Quantification of coronary artery dimensions.
- Quantification of peripheral arteries and aorta.
- Quantification of left and right ventricles.
- Management of data resulting from the quantitative analysis.
- Indications for Use (more detailed from the "Indication For Use Statement"):
- CAL: Calculate the pixel size of the image to be analyzed.
- MEAS: Perform basic length, angle, and density measurements.
- QCA: Detect the contour of the coronary vessel in the angiographic X-ray image; Generate absolute measurements about the dimensions of the coronary artery segment.
- QVA: Detect the contour of the peripheral vessel in the angiographic X-ray image; Generate absolute measurements about the dimensions of the peripheral vessel segment.
- LVA biplane: Delineate the outline of the left ventricular wall automatically and/or manually in angiographic X-ray images (monoplane or biplane analysis); absolute measurements of left ventricular volumes based on several established models for children and adults; calculations of derived parameters; quantification of the right ventricular wall.
- RVA: Delineate the outline of the right ventricular wall semi-automatically or manually in angiographic X-ray images (monoplane or biplane analysis); absolute measurements of right ventricular volumes based on several established models for children and adults; calculations of derived parameters; quantification of the motion of the right ventricular wall.
- Basis for Clearance: Substantial equivalence to predicate devices (K945540 CAAS II, K982203 CAAS II LVA biplane, K012475 CAAS II QVA, K033920 CAAS II RVA) by using the same technological characteristics and intended use. The document states CAAS is a "new generation... that includes and elaborates on previously developed and marketed CAAS software" and consists of "reused algorithm with the addition of several improvements that do not influence the indications for use."
Due to the lack of specific study documentation in the provided text, the table for acceptance criteria and device performance, and the detailed answers to questions 1-9 cannot be generated. The document focuses solely on the regulatory submission for substantial equivalence rather than a detailed performance study report.
§ 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).