(49 days)
The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.
The product is a software or a kit containing software and hardware (Image processing board), which is intended to be installed on a personal computer. Typically the personal computer receives digital medical images in DICOM 3 format over a network connection. The enhanced and original image can be sent in DICOM 3 format over the network connection. The original file and the enhanced file can be kept locally if selected.
The provided documentation does not contain detailed acceptance criteria for device performance or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes.
Here's an analysis of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided text. The document states that "The result of bench and user testing indicates that the modified device is as safe and effective as the predicate device" (Section 5) and "After analysing both bench and user testing data, it is the conclusion of ContextVision AB that the multi-modality SharpView Image Enhancement System is as safe and effective as the predicate device..." (Section 7). However, it does not provide specific acceptance criteria (e.g., quantitative metrics for image quality, enhancement effectiveness, processing speed, or diagnostic accuracy) or the reported performance data against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available. The document mentions "bench and user testing data" but does not specify the sample size used, the nature of the data (e.g., number of images, modalities, or clinical cases), or the provenance of the data.
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 available. The document does not describe how ground truth was established for any testing, or if experts were involved in a formal capacity to define a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available. The document does not describe any adjudication methods used for the test set.
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:
This information is not available. The document describes the device as an "Image Enhancement System" intended to assist a "qualified/trained technologist" for transfer, storage, enhancement, and viewing of images. While it's an image processing tool, the document does not mention a clinical performance study using human readers, let alone an MRMC study or any effect size related to human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document implies "bench and user testing," which would likely include standalone algorithm performance (e.g., image processing speed, image quality metrics). However, specific details about standalone performance tests and their results are not provided. The core function of the device is image enhancement, which is inherently an "algorithm only" function in terms of its direct output on an image. The "user testing" would then evaluate the impact of this enhanced image on the user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not available. Given the nature of an "Image Enhancement System," the "ground truth" for evaluating its performance would likely involve subjective image quality assessments, objective image metric improvements (e.g., signal-to-noise ratio, contrast-to-noise ratio), or a direct comparison to the predicate device's enhanced images. However, the document does not specify how this was established.
8. The sample size for the training set:
This information is not available. The document does not explicitly state that the device uses machine learning or AI that would require a dedicated "training set." It mentions "GOP® Enhancement software" which is a proprietary image processing method, but whether this involves a training phase akin to machine learning is not detailed.
9. How the ground truth for the training set was established:
This information is not available for the same reasons as point 8.
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EXHIBIT 2
JAN 2 4 2003
ContextVision AB Storgatan 24 SE-582 23 Linköping SWEDEN Phone: +46 (0)13 35 85 61 Fax: +46 (0)13 10 42 82 CONTACT: Kent Strandlund
November 29, 2002
510(k) Summary of Safety and Effectiveness
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- Identification of the device: Proprietary-Trade Name: SharpView Classification Name: Image Processing, System Product code: 90LLZ Common/Usual name: SharpView Image Enhancement System
- Equivalent legally marketed devices: This product is similar in design and function to 2. the ContextVision SharpView Image Enhancement System, K993802
- Indications for Use (intended use); The SharpView Image Enhancement System is 3. intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.
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- Description of the device: The product is a software or a kit containing software and hardware (Image processing board), which is intended to be installed on a personal computer. Typically the personal computer receives digital medical images in DICOM 3 format over a network connection. The enhanced and original image can be sent in DICOM 3 format over the network connection. The original file and the enhanced file can be kept locally if selected.
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- Safety and Effectiveness, comparison to predicate device. The result of bench and user testing indicates that the modified device is as safe and effective as the predicate device.
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- Substantial Equivalence Chart
| Characteristics: | SharpView ImageEnhancement System | SharpView ImageEnhancement System, modified |
|---|---|---|
| Intended use: | The ImageEnhancement System isintended for use by aqualified/trainedtechnologist for transfer,storage, enhancement,and viewing of MRIimages. | The ImageEnhancement System isintended for use by aqualified/trainedtechnologist for transfer,storage, enhancement,and viewing of multi-modality images. |
| Physicalcharacteristics: | ||
| Computer | PC compatible | Same |
| Operating system | Windows 98, NT 4.0 | Windows 98, NT 4.0,2000 and XP |
| Storage | Hard disk or anycompatible PC method:Optical, CDROM, Tape | Same |
| Image processingboard | MIP-PCI | Javelin (PCI-bus) |
| Software core | GOP® Enhancementsoftware | Same(Trademark is theproperty ofContextVision) |
| Image input | DICOM 3 | Same |
7. Conclusion
After analysing both bench and user testing data, it is the conclusion of ContextVision AB that the multi-modality SharpView Image Enhancement System is as safe and effective as the predicate device, has few technological differences, and only a minor change to the indications for use compared with the predicate device, thus rendering it substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kent Strandlund Quality & Regulatory Affairs ContextVision AB Storgatan 24 SE-582 23 Linköping SWEDEN
Re: K024028 Trade/Device Name: SharpView Image Enhancement System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 29, 2002 Received: December 6, 2002
Dear Mr. Strandlund:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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j) Indications for Use
510(k) Number_Ko24028
Device Name: SharpView Image Enhancement System
Indications for Use: The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
Over the Counter Use_ (Per 21 CFR801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Rons and Radiologi 510(k) Nul
§ 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).