(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.
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Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, sans-serif font, positioned above a shield-like emblem. The emblem contains a circle with two wavy lines and two four-pointed stars inside it.
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is presented in a straightforward, unadorned manner, emphasizing its clarity and legibility.
JAN 2 2 1998
Philips Medical Systems
510 (k) Summary of Safety and Effectiveness
| Company Name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 710 Bridgeport AvenueShelton, CT 06484 |
| Contact Person | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | October 31, 1997 |
| Device Name: | Philips Easy Vision Family Workstation OptionEasyCorrect |
| Classification Name: | Image Processing System(90 LLZ) |
| Common/Usual Name | Workstation |
| Predicate Device | Easyvision Workstation |
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System Description:
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.
Intended Use:
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.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1998
Peter Altman Director of Regulatory Affairs Philips Medical Systems, Inc. North America Company 710 Bridgeport Avenue Shelton, CT 06484-0917
Re:
K974207 EasyVision Workstation with Easy Correct Option Dated: November 7, 1997 Received: November 10, 1997 Regulatory class: Unclassified Procode: 90 LLZ
Dear Mr. Altman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). "You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
h7liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Unknown K974-207
Philips Easy Vision Workstation Easy Correct Option Device Name :
Indications For Use :
EasyCorrect is intended for use in situations where digital images acquired from fluoroscopic imaging systems are desired or required without distortion. The corrected images may be either hard-copy or soft-copy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Grand le. Leggon
(Division Sign-Off) Abdominal, EN Division of Reproductive, and Radiological Dev
510(k) Number K974207
Prescription Use ( Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).