(73 days)
EasyCorrect is intended for use in situations where digital images acquired from fluoroscopic imaging systems without distortion are required. The corrected images may be either hard-copy or soft-copy. Examples of (but not limited to) such situations are: making stereotactic measurements for Radiation Treatment Planning Systems or reconstructing digital spotfilm series into composite (survey) images.
The EasyCorrect package is an option to the Vascular Analysis Package. EasyCorrect will support the creation of images acquired by a digital image intensifier based system that can be compared to conventional acquired images (cassette film). Thereby the same measurements can be performed on the digital acquired image as on the conventional acquired image. The EasyCorrect package will correct images for distortion through the following process: Calibration and clinical images are acquired according to acquisition protocols described in documentation delivered with the system. The calibration image will be acquired with a grid phantom included in the package. The software will compare the geometric characteristics of the calibration image (taken with the grid) with the actual geometrical characteristics of the grid. The difference(s) in geometrical characteristics between the two images is a measure of the distortion(s) in the digital acquired image. By applying the result of this calculation of distortion to clinical images taken under the same conditions as the calibration grid image, the clinical images can be corrected for the distortion(s) introduced by the digital technique.
The provided text is a 510(k) summary for the Philips EasyVision Family Workstation Option (EasyCorrect). It describes the device, its intended use, and the regulatory approval process, but it does not contain explicit acceptance criteria or a detailed study report demonstrating how the device meets specific performance metrics.
However, based on the information provided, we can infer some aspects and highlight what is missing.
Inferred Acceptance Criteria and Reported Device Performance (Based Solely on the Provided Text)
| Acceptance Criteria | Reported Device Performance (Inferred from description) |
|---|---|
| Primary Goal: Correct images for distortion introduced by digital image intensifier-based systems. | The EasyCorrect package performs distortion correction by comparing geometric characteristics of a calibration image (grid phantom) with the actual grid characteristics. This calculation is then applied to clinical images taken under the same conditions. |
| Intended Use Outcome: Produce digital images without distortion from fluoroscopic imaging systems. | The system "will support the creation of images acquired by a digital image intensifier based system that can be compared to conventional acquired images (cassette film)." The corrected images enable "the same measurements can be performed on the digital acquired image as on the conventional acquired image." |
| Output Format: Corrected images can be hard-copy or soft-copy. | Explicitly stated: "The corrected images may be either hard-copy or soft-copy." |
| Example Applications: Enable stereotactic measurements for Radiation Treatment Planning Systems or reconstructing digital spotfilm series into composite (survey) images. | Explicitly stated: "Examples of (but not limited to) such situations are: making stereotactic measurements for Radiation Treatment Planning Systems or reconstructing digital spotfilm series into composite (survey) images." |
Missing Information (Not Available in the Provided Text)
The provided document is a 510(k) summary, which typically focuses on substantial equivalence and intended use. It does not contain the detailed study information requested. Therefore, the following points cannot be answered from the given text:
- Sample size used for the test set and the data provenance: No information on the number of images or cases used for demonstrating the correction capability, nor their origin (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or their qualifications involved in evaluating the corrected images.
- Adjudication method: Not discussed.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No information on human reader studies or comparison with/without AI assistance. The device is a correction tool, not necessarily an AI interpretation tool in the modern sense.
- Standalone performance (algorithm only without human-in-the-loop performance): While the description details how the algorithm works, there are no reported quantitative performance metrics (e.g., distortion reduction percentage, accuracy of measurements on corrected images) that would typically be part of a standalone performance study.
- Type of ground truth used: The "ground truth" for distortion is inherently the known geometry of the grid phantom. However, how the effectiveness of the correction was validated against a ground truth (e.g., pathology, clinical outcomes, or expert consensus on linearity/measurement accuracy) is not detailed.
- Sample size for the training set: Not applicable or not described, as the correction method relies on a calibration image (grid phantom) and a calculation from that, rather than a large "training set" in the machine learning sense.
- How the ground truth for the training set was established: As above, the "ground truth" for the calibration is the known, ideal geometry of the grid phantom.
Summary of What the Document Provides vs. What it Lacks:
The Philips 510(k) summary provides a high-level description of the EasyCorrect device, its mechanism for distortion correction using a grid phantom calibration, and its intended use. It emphasizes that the corrected images can be used for measurements typically done on conventional images. However, it does not delve into the detailed performance metrics, validation studies, sample sizes, expert involvement, or statistical analyses that would typically be required to fully address the requested points regarding acceptance criteria and proof of their fulfillment. The document's purpose is to establish substantial equivalence for regulatory clearance, not to provide a comprehensive technical performance 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).