(35 days)
The IQQA-Chest is a PC-Based, self-contained, non-invasive image analysis package used during the review of digital chest radiographic images. Combining image viewing, evaluation and reporting tools, the software is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the confirmation, evaluation and documentation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation for the visual identification of possible lesions. The tools also allow for regional analysis of possible lesions in terms of size, shape and position, thus aiding the physician in the characterization of physician-identified suspicious lesions. Image source: DICOM
The IQQA-Chest Software Package is a self-contained, non-invasive thoracic radiographic image analysis package that is designed to run on standard PC hardware. Combining image viewing tools (e.g. image window level, pan, zoom, enhancement viewing), evaluation tools (e.g. automatic/interactive segmentation, quantitative measurements derived from marking and segmentation), and reporting tools (e.g. saved lesion, measurement information, physician-input nodule characterization, and etc), the software package is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the the physician in the laonificance or entation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation IQQA-Chost software package bapple lesions (nodule enhanced viewing). Based on physician's request, the tool segments locations in the lung area containing circular prysional o requeed, invites fulfiling intensity signal and circular shape constraints) that would typically correlate with lung nodules. The tools also allow for regional that would typessible lesions with respect to size, shape and position, aiding the anaryold or pobo characterization of physician-identified suspicious lesions.
The provided text describes the IQQA-Chest Software Package's 510(k) summary. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics beyond a general statement of equivalency.
Therefore, I cannot populate the requested tables and information adequately. The document states:
- "Testing was performed according to internal company procedures."
- "Software testing and validation were done according to written test protocols established before testing was conducted."
- "Test results were reviewed by designated technical professionals before software proceeded to release."
- "Test results support the conclusion that actual device performance satisfies the design intent."
This indicates that internal testing was conducted, but the specifics such as criteria, methods, and results are not provided in this 510(k) summary.
Here's what I can provide based on the given text, highlighting the missing information:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Expected Performance) | Reported Device Performance (Achieved Performance) |
|---|---|
| Not specified in the document. | Not specified in the document beyond a general statement that "actual device performance satisfies the design intent." |
Study Information
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not specified (e.g., 2+1, 3+1, none).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Was an MRMC study done? Not specified.
- Effect size of improvement with AI vs. without AI assistance: Not applicable, as no MRMC study or effect size is reported. The device is described as "designed to support the physician in the identification of lung lesions," implying assistive capabilities, but no comparative effectiveness data is presented.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Was a standalone study done? Not explicitly stated, though the device's function involves "automated segmentation for the visual identification of possible lesions," which is an algorithm-only function. However, performance metrics for this standalone function are not provided.
7. The type of ground truth used:
- Type of ground truth: Not specified (e.g., expert consensus, pathology, outcomes data).
8. The sample size for the training set:
- Training set sample size: Not specified.
9. How the ground truth for the training set was established:
- Ground truth establishment method: Not specified.
§ 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).