(70 days)
The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of MRI images.
The product is a kit containing software and hardware (PCI graphics processor board) which is intended to be installed on a personal computer. Typically the personal computer receives MRI images in DICOM 3 format over a network connection. The received image is stored locally, then accessed, then enhanced by the software/hardware combination, then stored in the enhanced format. The original file can still be accessed and is not modified.
The provided text is a 510(k) summary for the SharpView Image Enhancement System. It outlines the device's identification, intended use, description, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain detailed information about specific acceptance criteria, a formal study proving the device meets those criteria, or quantitative performance metrics.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing both bench and user testing data, it is the conclusion of Contextvision AB SharpView Image Enhancement System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance | Comments |
|---|---|---|
| As safe as the predicate device (IES Image Enhancement System, K922470) | Bench and user testing indicates the device is as safe as the predicate. | No specific safety metrics or criteria are provided. The claim is qualitative and based on the substantial equivalence argument. |
| As effective as the predicate device (IES Image Enhancement System, K922470) | Bench and user testing indicates the device is as effective as the predicate. | No specific effectiveness metrics or criteria are provided. The claim is qualitative and based on the substantial equivalence argument. |
| Few technological differences compared to the predicate device | As outlined in the "Substantial Equivalence Chart," differences include: | The differences are primarily in the hardware platform (PC compatible vs. Sun computer), operating system (Windows 98, NT 4.0 vs. Unix), storage methods, and image input (DICOM 3 vs. direct from MRI console). The software core "GOP® Enhancement software" is stated as "SAME." |
| No new indications for use | The intended use is "SAME" as the predicate device: "for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of MRI images." | This criterion is met. |
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 mentions "bench and user testing data" but does not provide any details regarding the sample size of the test set, the data provenance (country of origin), or whether the data was retrospective or prospective.
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):
The document refers to "user testing" but does not specify the number of experts used, their qualifications, or how ground truth was established for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method used for a 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:
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is an image enhancement system, implying it modifies images, but it's not positioned as an AI-assisted diagnostic tool in the text.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the "SharpView Image Enhancement System" as a standalone software and hardware kit for image enhancement. The "bench testing" mentioned likely refers to standalone performance, but no specific details on standalone algorithm-only performance metrics or studies are provided. The focus is on substantial equivalence to a predicate image enhancement system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not specify the type of ground truth used for any testing. Given the nature of an "image enhancement system" and the lack of diagnostic claims, ground truth in the traditional sense (e.g., pathology for disease detection) might not have been directly applied in the same way as for a diagnostic AI. Instead, subjective evaluation of image quality or objective measures of enhancement properties might have been used, but these are not disclosed.
8. The sample size for the training set:
The document does not mention any training set size as this is an older 510(k) and the device description does not explicitly state it uses machine learning/AI models that would require a distinct training set. The "GOP® Enhancement software" is a core component, which might be a rule-based or algorithmic image processing technique rather than a data-trained AI model in the modern sense.
9. How the ground truth for the training set was established:
Since no training set is mentioned or implied for a machine learning model, there is no information on how its ground truth would have been established.
{0}------------------------------------------------
JAN 1 8 2000
EXHIBIT 2
ContextVision AB Storgatan 24 SE-582 23 Linköping SWEDEN Phone: +46 (0)13 35 85 50 Fax: +46 (0)13 10 42 82 CONTACT: Magnus Aurell
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: SharpView Classification Name: Picture Archiving and Communications system Product Code LNH Common/Usual Name: MRI Image Enhancement System
- Equivalent legally marketed devices: This product is similar in design and function to 2. the IES Image Enhancement System, K922470
- Indications for Use (intended use) The SharpView Image Enhancement System is used 3. for the intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of MRI images.
-
- Description of the Device: The product is a kit containing software and hardware (PCI graphics processor board) which is intended to be installed on a personal computer. Typically the personal computer receives MRI images in DICOM 3 format over a network connection. The received image is stored locally, then accessed, then enhanced by the software/hardware combination, then stored in the enhanced format. The original file can still be accessed and is not modified.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
{1}------------------------------------------------
6. Substantial Equivalence Chart
| Characteristic | IES ImageEnhancementSystem (K922470) | SharpView ImageEnhancementSystem |
|---|---|---|
| Intended Use: | The ImageEnhancementSystem is intendedfor use by aqualified/trainedtechnologist fortransfer, storage,enhancement, andviewing of MRIimages. | SAME |
| Physicalcharacteristics: | ||
| Computer | Sun computer (MRIconsole) | PC compatible |
| Operatingsystem | Unix | Windows 98, NT4.0 |
| Storage | Hard disk or OpticalDisk | Hard disk or anycompatible PCmethod: Optical,CDROM, Tape |
| Imageprocessingboard | MIP-S | MIP-PCI |
| Softwarecore | GOP®Enhancementsoftware | SAME |
| Image input | Direct from MRIconsole (product isinstalled in MRIunit) | DICOM 3 |
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Contextvision AB SharpView Image Enhancement System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The central graphic features three curved lines that resemble a bird in flight or a stylized representation of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Constance Bundy ContextVision AB c/o C.G. Bundy Associates 6470 Riverview Terrace Minneapolis, MN 55432
Re:
K993802 SharpView Image Enhancement System Dated: November 1, 1999 Received: November 9, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Ms. Bundy:
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 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). 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 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 requirements, 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
j) Indications for Use
510(k) Number_K99 380 2
Device Name:
Indications for Use: The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of MRI images.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Seggern.
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Kyaz807 510(k) Number
Prescription Use_ 1
OR Over the Counter Use (Per 21 CFR 801.109)
§ 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).