Search Results
Found 1 results
510(k) Data Aggregation
(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 | <= 30 fps | <= 30 fps (Matches predicates) |
| Image Archiving (Hard Disk) | Yes | Yes (Matches predicates) |
| Image Archiving (Removable media) | CD-R, MOD, DVD, DLT, other DICOM Entities (Comparable to predicates) | CD-R, MOD, DVD, DLT, other DICOM Entities (Broader than one predicate, similar to others) |
| Image Review | Still images, cine-loops, Window, level, zoom, magnifying lens, Configurable layout (Comparable to predicates) | Still images, cine-loops, Window, level, zoom, magnifying lens, Configurable layout (Similar to predicates) |
| Image Processing | Annotations, Distances, Angles, Pixel Values, Pixel Distribution, Grey level statistics, Quantitative Coronary Analysis, Left Ventricle Analysis (Comparable to leading predicates) | Annotations, Distances, Angles, Pixel Values, Pixel Distribution, Grey level statistics, Quantitative Coronary Analysis, Left Ventricle Analysis (Matches a leading predicate, exceeds others) |
| 3D Image Processing | MPR, MIP, mip, Volume rendering (Comparable to leading predicates) | MPR, MIP, mip, Volume rendering (Matches a leading predicate, exceeds others) |
| Quality Control | Yes | Yes (Matches known predicates) |
| Workflow Management | Yes | Yes (Matches known predicates) |
| Image Database | Yes | Yes (Matches predicates) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of a performance study with patient data. It is a comparison of product features. Therefore, this information is not applicable and not provided.
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)
This information is not applicable as no "test set" with ground truth established by experts is described for a performance study. The ground truth for feature comparison is the specifications of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no test set or adjudication process for clinical performance is described.
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
No MRMC comparative effectiveness study is mentioned or implied. The device is image processing software, not an AI diagnostic tool designed to assist human readers in a diagnostic task that can be quantified with an effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is image processing software intended for use by "qualified medical professionals." It is not described as a standalone diagnostic algorithm. The demonstration of substantial equivalence focuses on functional features, not independent diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not report a ground truth based on clinical data or expert consensus in relation to diagnostic accuracy. The "ground truth" for the substantial equivalence claim is the features and specifications of the predicate devices.
8. The sample size for the training set
Not applicable. The document describes image processing software, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model described.
Ask a specific question about this device
Page 1 of 1