(211 days)
The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes
The KSS 400 Image Storage System is a software product that permits users to analyze corneal images made by Konan specular microscopes in a separate computer and to store them in the computer's memory
This document is a 510(k) summary for the Konan KSS-400 Image Storage System, submitted to the FDA in 2009. It describes a software product designed for automatic image analysis and data storage of corneal images captured by Konan specular microscopes. The software analyzes cell density, coefficient of variation, and hexagonality.
Based on the provided text, the following information can be extracted regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria or provide a table outlining them. It generally states that "The software has been extensively validated and tested." and "Extensive clinical tests were performed for this system as part of the clearance of one of the predicate devices."
The conclusion drawn is that the "Konan KSS 400 is equivalent in safety and efficacy to the legally marketed predicate devices." This implies that the performance of the KSS-400, in terms of safety and efficacy for analyzing corneal images (cell density, coefficient of variation, and hexagonality), meets the established standards set by its predicate devices. However, the specific quantitative metrics are not provided.
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 provided in the document. The text only states that "Extensive clinical tests were performed for this system as part of the clearance of one of the predicate devices," but no details about the sample size, type of study (retrospective/prospective), or data provenance are given for either the KSS-400 or the predicate device's tests.
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 provided in the document. The details about ground truth establishment are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of comparing human readers with and without AI assistance. The device is a "software product intended to be used for automatic image analysis," suggesting a standalone analysis rather than an AI-assisted human reading workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the description strongly implies a standalone performance evaluation. The device is described as "automatic image analysis," and its intended use is to "analyze cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes." This suggests the algorithm performs these analyses without direct human intervention in the analysis process itself (though a human would interpret the output). The performance data section refers to "Non-clinical tests" and "Clinical tests" for "this system," implying evaluation of the software's inherent analytical capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated in the document. Given that the software analyzes "cell density, coefficient of variation, and hexagonality," the ground truth for these features would likely involve manual expert measurements or validated reference methods for these specific corneal endothelial cell characteristics, but the document does not specify.
8. The sample size for the training set
This information is not provided in the document. The 510(k) summary focuses on the device's performance validation rather than its development or training details.
9. How the ground truth for the training set was established
This information is not provided in the document, as details about the training set itself are absent.
In summary:
The document primarily focuses on establishing substantial equivalence to predicate devices based on the device's intended use and general performance claims. It lacks the specific, quantitative details regarding acceptance criteria, study design (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies that would typically be found in a more detailed technical report or clinical study summary. The claim of "extensive validation and testing" and "extensive clinical tests" is made, but without the supporting data.
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Image /page/0/Picture/0 description: The image contains the text 'KSS-400' in a bold, sans-serif font. The text is horizontally oriented and appears to be a label or identifier. There is a dark, blurry object to the left of the text, but it is not clear what it is.
JAN 2 2 2009
バ、リ
Konan Medıcal Inc
Konan KSS-400 Image Storage System
510(k) Submissıon
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510(k) Summary
- (1) Submitter Information
Name Konan Medical Inc
Address 10-29 Mıyanıshı-Cho
Nıshımomıya
662 Japan
Telephone Number 011-81-798-36-3456
Contact Person Dr George Myers (Official Correspondent)
Medsys Inc
377 Rt 17 S
Hasbrouck Heights, NJ 07604
201-727-1703
Date Prepared January 16, 2009
(2) Name of Device
Trade Name Konan KSS-400 Image Storage System
Common Name Computer system for analysis of specular microscope images
Classification Name System, Image management, Ophthalmıc
(3) Equivalent legally-marketed devices
Konan Noncon Robo Pachy, K980357
SNT Image Processing System, K992354
Konan Noncon Robo F&A Specular Microscope, K062763
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(4) Description
The KSS 400 Image Storage System is a software product that permits users to analyze corneal images made by Konan specular microscopes in a separate computer and to store them in the computer's memory
(5) Intended Use
The KSS-400 Image Storage System is a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonality using images taken by the specular microscopes "
(6) Technological characterist1cs
The KSS-400 1s a software product, to be used with the purchaser's own Personal Computer
(b) Performance data
(1) Non-clinical tests
The software has been extensively validated and tested
(2) Clinical tests
Extensive clinical tests were performed for this system as part of the clearance of one of the predicate devices
(3) Conclusions
The Konan KSS 400 is equivalent in safety and efficacy to the legally marketed predicate devices
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Konan Medical. Inc c/o George H Myers, Sc D Medsys, Inc 377 Route 17 South Hasbrouck Heights, NJ 07604
JAN 2 2 2009
Re K081797
Trade/Device Name Konan KSS-400 Image Storage System Regulation Number 21 CFR 892 2050 Regulation Name Picture archiving and communications system Regulatory Class Class II Product Code NFJ, NQE Dated January 7, 2009 Received January 8, 2009
Dear Dr Myers
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, Insting 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 such 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 your 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 (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours.
M.B. Egolston, mD
Malvina B Evdelman, M D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (1f known) K081797
Device Name KSS-400 Image Storage System
Indications for Use
"The KSS-400 Image Storage System 1s a software product intended to be used for automatic image analysis and data storage for corneal images taken with Specular Microscopes The program analyzes cell density, coefficient of variation, and hexagonalıty usıng ımages taken by the specular mıcroscopes "
Prescription Use_ X___________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use ------------
(Per 21 CFR 810 109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rebel Re
f Onhthalmic and Far. and Throat Dev
K081797 510(k) Number.
§ 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).