(78 days)
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.
The Version 3.0 DICOMed Family Software System consists of the following components:
- DICOMed DIG.IT image acquisition and CD recording station
- DICOMed P@CS image archiving manager
- DICOMed Review Cardio review workstation for cardiology
- DICOMed Review diagnostic review workstation for radiology
The provided text is a 510(k) summary for the AETmed Image Processing Software. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, many of the requested items cannot be extracted directly from this document. The document primarily uses a Substantial Equivalence Comparison Chart (Table 1) to compare the features of the AETmed Image Processing Software with predicate devices. This comparison implicitly serves as the "study" for acceptance, indicating that if the new device has comparable or superior features to legally marketed predicate devices, it is considered substantially equivalent.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of measurable performance metrics with thresholds. Instead, it demonstrates "substantial equivalence" by comparing device features with legally marketed predicate devices. The "reported device performance" is implicitly shown through this feature comparison.
| Feature | Acceptance Criteria (Implied: Substantially Equivalent to Predicates) | Reported Device Performance (AETmed Image Processing Software) |
|---|---|---|
| Manufacturer | AETmed | AETmed |
| Classification | 892.2050; Class II | 892.2050; Class II |
| Intended Use | Comparable to predicates for medical image capture, viewing, processing, archiving, and communication for cardiac catheterization, echocardiography, and general radiological studies. | Capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images (cardiac catheterization, echo-cardiography, general radiological studies). Similar to predicates. |
| Graphical User Interface | Yes | Yes (Matches predicates) |
| Platform | PC | PC (Matches predicates) |
| Operating System | Windows NT, Windows 2000 (at least Windows NT as per predicates) | Windows NT, Windows 2000 (Broader than one predicate, similar to another) |
| Display Resolution | Up to 2048x2560 (Comparable to leading predicates) | Up to 2048x2560 (Matches leading predicates) |
| Gray scale resolution | From 8 bits, 256 levels to 24 bits true color (Comparable to leading predicates) | From 8 bits, 256 levels to 24 bits true color (Matches leading predicates) |
| Multi-monitor support | Yes | Yes (Matches predicates) |
| Patient Demographics | Yes | Yes (Matches predicates) |
| Networking | TCP/IP | TCP/IP (Matches predicates) |
| Image Communication | DICOM Compliant | DICOM Compliant (Matches predicates) |
| DICOM Compliant | Yes | Yes (Matches predicates) |
| Image Compression | JPEG loss-less (at least) | JPEG loss-less (Comparable/matches some predicates) |
| Video signals grabbing | Yes | Yes (Matches predicates) |
| Analogic Video Input format | 525, 625, 1023, 1049, 1249; interlaced or progressive (Comparable to predicates) | 525, 625, 1023, 1049, 1249; interlaced or progressive (Matches one predicate, exceeds another) |
| Analogic Video Input rate |
§ 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).