Static Vessel Analyzer (SVA) with VesselMap2 is intended to capture, display, store, and manipulate images of the eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. Specifically, the VesselMap2 software is intended to be used for semiautomated measurement and calculation of the retinal artery/vein diameter ratio.

Device Description

The IMEDOS SVA unit is designed as a complete Fundus Imaging system or the software can be sold separately as a standalone product. The SVA software consist of two components - VisualIS, an imaging software for capture, display, storage and manipulation of images of the eye and VesselMap2, an add-on for enhanced analysis of retina images. VisualIS captures the images which are provided by the fundus camera and the connected digital image sensor. Together with an image set the data of the patient are recorded and stored. The complete examination can be stored and opened for follow-up examination purposes. The add-on VesselMap2 offers a semi-automated measurement for Arterial -- Venous Ratio of retinal vessels. The software allows the user to select veins and arteries. Vessel diameters are estimated by the software and the ratio of the analyzed arteries to veins is calculated. The image is not altered in any way during this calculation.

AI/ML Overview

The provided text describes the IMEDOS GmbH's Static Vessel Analyzer (SVA) and its VesselMap2 software. The information focuses on a method comparison study between the semi-automated VesselMap2 software and a manual method for determining arterial-venous ratios.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with specific thresholds (e.g., "accuracy > 90%"). Instead, it describes performance in terms of agreement, repeatability, and reproducibility, and the absence of certain biases. The reported device performance is presented as conclusions from the study.

Acceptance Criteria (Implied)	Reported Device Performance (VesselMap2)
Agreement with manual method	"Agreement between manual and semi-automatic (VesselMap2) retinal vessel analysis, without any indication of statistically significant differences between methods."
Repeatability (Intragrader)	"Smaller intragrader variability for the semi-automatic method (VesselMap2) than for the manual method."
Reproducibility (Intergrader)	"Smaller [...] intergrader variability (reproducibility) for the semi-automatic method (VesselMap2) than for the manual method."
Absence of reader-to-reader bias	"In the manual method, a systematic bias between the two graders exists, which is not the case in the semi-automatic method. Thus, the comparison study demonstrated that the VesselMap software does not introduce reader-to-reader bias."
Intravisit Reproducibility	"Appropriate intravisit [...] reproducibility for the semi-automatic method."
Intervisit Reproducibility	"Appropriate [...] intervisit reproducibility for the semi-automatic method."
Low device-associated variability	"The visit-to-visit variability (whether for manual or semi-automated analysis) was shown to be much higher than the variability in results associated with the device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact number of retinal images or patients used in the method comparison study. It only mentions "representative retina images."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions "two graders" in the context of comparing manual methods and intergrader variability. It does not provide their specific qualifications (e.g., "radiologist with 10 years of experience"). It's implied these graders performed the manual measurements against which the semi-automatic method was compared.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for establishing ground truth. Instead, it describes a comparison between manual measurements performed by graders and the semi-automatic software.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, is not explicitly described. The study compared a semi-automatic method (VesselMap2) to a purely manual method, highlighting the improved repeatability and reproducibility of the semi-automatic method and the absence of reader-to-reader bias. It does not quantify an "effect size of how much human readers improve with AI vs. without AI assistance" in terms of observer performance but rather demonstrates the device's inherent performance characteristics.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The VesselMap2 is described as a "semi-automated measurement" tool where "the software allows the user to select veins and arteries." This indicates human-in-the-loop involvement, so a purely standalone (algorithm-only) performance evaluation is not detailed for the final output (arterial-venous ratio). The comparison performed was between this semi-automated approach and a manual approach.

7. The Type of Ground Truth Used

The "ground truth" for the test set was effectively the manual method of determining arterial-venous ratios performed by human graders, against which the "semi-automated calculation" of the VesselMap2 software was compared. The study aimed to show agreement with this established manual method and improvements in consistency.

8. The Sample Size for the Training Set

The document does not provide any information about a dedicated training set or its sample size. The focus is on the performance of the software in a comparison study.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth would have been established.

Summary

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JUN 1 6 2009

510(k) SUMMARY

Imedos GmbH's Static Vessel Analvzer

· 510(k) Number: K082196

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

IMEDOS GmbH Am Nasstal 4 D-07751 Jena GERMANY Tel .: +49-3641-6396-0 Fax .: +49-3641-6396-12

Date Prepared: June 12, 2009

Contact Person: Dr. Hans Stromever Stromeyer & Partners Consulting 317 Shore Breeze Lane League City. TX 77573 Phone: +1.281.467.3424 Email: hans@stromeyerconsulting.com

Trade/Device Name: Static Vessel Analyzer (SVA) Classification Name: Opthalmic camera Regulation Number: 21 CFR 886.1120 Product Code: HKI, Class II

Classification Name: Medical image communications device. Regulation Number: 21 CFR 892.2010 Product Code: NFF, Class I 510(k) exempt

Classification Name: Medical image storage device Regulation Number: 21 CFR 892.2020 Product Code: NFG, Class I 510(k) exempt

Indications for Use:

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Technological Characteristics:

VisualIS captures the images which are provided by the fundus camera and the connected digital image sensor. Together with an image set the data of the patient are recorded and stored. The complete examination can be stored and opened for follow-up examination purposes.

The add-on VesselMap2 offers a semi-automated measurement for Arterial -- Venous Ratio of retinal vessels. The software allows the user to select veins and arteries. Vessel diameters are estimated by the software and the ratio of the analyzed arteries to veins is calculated. The image is not altered in any way during this calculation.

The manual and semi-automatic calculation were compared and verified on representative retina images and the results show improved repeatability of the semi-automated calculations based on the uncertainty and precision of manual vessel diameter determination based on the user's subjective perception of vessel edges.

Performance Data

Imedos completed a comprehensive method comparison study assessing the VesselMap software function compared to an accepted, manual method for determining arterial-venous ratios. This study assessed agreement, reproducibility, and repeatability. The completed study demonstrated:

1. Agreement between manual and semi-automatic (VesselMap2) retinal vessel analysis, without any indication of statistically significant differences between methods;
1. Smaller intragrader variability) and intergrader variability (reproducibility) for the semi-automatic method (VesselMap2) than for the manual method;
1. In the manual method, a systematic bias between the two graders exists, which is not the case in the semi-automatic method. Thus, the comparison study demonstrated that the VesselMap software does not introduce reader-to-reader bias;
1. Appropriate intravisit and intervisit reproducibility for the semi-automatic method. The visit-tovisit variability (whether for manual or semi-automated analysis) was shown to be much higher than the variability in results associated with the device.

Substantial Equivalence

The Imedos SVA System has the same intended use, principles of operation and technological characteristics as the Carl Zeiss FF450plus VISUPAC System (K011877). The minor differences between the Carl Zeiss FF450plus VISUPAC System and the Imedos SVA system do not raise new questions of safety or effectiveness. Performance data demonstrate that the SVA System is as safe and effective its predicates. Thus, the SVA System is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three thick, curved lines forming the body and wings of the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Imedos GmbH c/o Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004

JUN 1 6 2009

Re: K082196

Trade Name: Static Vessel Analyzer (SVA) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI, NFF, NFG Dated: May 22, 2009 Received: May 26, 2009

Dear Mr. Kahan:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K082196

Device Name: Static Vessel Analyzer (SVA)

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) vision of Ophthalmic and Ear, ose and Throat Devices

510(k) Number K082196

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Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.