CALLISTO eye Software is a software device intended for remote control of ophthalmic surgical microscopes of OPMI Lumera family and RESCAN 700, and display images of the anterior and posterior segment of the eye.

CALLISTO eye Software is indicated as graphical guidance aid to insert, align, position, and register an intraocular lens (IOL) including toric IOLs, limbal relaxing incisions, and capsulorhexis during anterior segment surgical procedures.

Device Description

CALLISTO eye Software, version 3.6, is an assistance, information, and documentation system to support ophthalmic surgical procedures. CALLISTO eye software operates as an adjunct to the OPMI Lumera family of ophthalmic surgical microscopes to process surgery videos and OCT data (B-Scan images). CALLISTO eye Software must be installed on a touchscreen Panel PC; the Panel PC is offered as an accessory. The software enables the visualization of the anterior and posterior segments of the eye and allows the connection and remote control of a surgical microscope.

CALLISTO eye software is provided with differing levels of functionality based on the option licensed. Some of these configurations provide a variety of assistant functions (tools) to assist the surgeon with implanting intraocular lenses (IOL), particularly toric intraocular lenses (tIOL). These tools are comprised of graphical templates including Incisions to insert a toric intraocular lens. Rhexis for opening the capsular bag. Z ALIGN for the alignment of toric intraocular lens, and LRI for the planning of limbal relaxing incisions.

AI/ML Overview

The provided text describes the CALLISTO eye Software and its substantial equivalence determination by the FDA. However, the document primarily focuses on regulatory approval and comparisons to predicate devices based on functionality and features, rather than presenting a performance study with specific acceptance criteria and detailed study results from a test set.

Therefore, I cannot fully address all parts of your request as the information is not present in the provided text. Specifically, there is no mention of:

A table of acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity).
Sample sizes used for a test set (only "verification and validation testing" is mentioned generally).
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone (algorithm only) performance study.
Specific types of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

The document discusses "Verification and Validation Activity" and states that "Verification and validation activities were successfully completed and prove that CALLISTO eye Software, version 3.6, meets the stipulated requirements and performs as intended." This general statement indicates that performance testing was done internally to meet specifications, but it does not provide the specific details of such a study that you requested.

The document focuses on the software's functionality, its integration with other devices, and its compliance with standards (ISO 14971, IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20 DICOM). The "performance data" section largely refers to software verification and validation activities rather than a clinical performance study with defined acceptance criteria for specific clinical metrics.

In summary, the provided FDA 510(k) summary does not contain the detailed performance study information with Acceptance Criteria, test set details, ground truth establishment, or clinical outcome effect sizes as requested. It only broadly states that the device was verified and validated to meet its requirements.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 27, 2018

Carl Zeiss Meditec, Inc Mandy Ambrecht Staff Regulatory Affairs Specialist 5160 Hacienda Drive Dublin, CA 94568

Re: K180858

Trade/Device Name: CALLISTO eye Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: March 29, 2018 Received: April 2, 2018

Dear Mandy Ambrecht:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{1}------------------------------------------------

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley S. Cunningham -A

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180858

Device Name CALLISTO eye

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY (per 21 CFR §807.92)

CALLISTO eye

GENERAL INFORMATION

Manufacturer:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-5207745 Jena, Germany+49 7364 206985+49 7364 954432
Contact Person:	Mandy AmbrechtStaff Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4561 (phone)(925) 557-4259 (fax)

Date Summary Prepared: 5-25-2018

	CALLISTO eye
Classification name	System, Image Management, Ophthalmic
Classification	892.2050
Class	II
Product Code	NFJ
Trade / Proprietary Name	CALLISTO eye
Common Name	Picture archiving and communications system
Primary Predicate Device
Company:	Carl Zeiss Meditec AG
Device:	CALLISTO eye, K123464
Secondary Predicate Device
Company:	Carl Zeiss Meditec AG
Device:	ZEISS Cataract Suite markerless, K141068
	(with CALLISTO eye software 3.5)
Secondary Predicate Device
Company:	Carl Zeiss Meditec AG
Device:	RESCAN 700, K141844
	(with CALLISTO eye software 3.2)

{4}------------------------------------------------

INDICATIONS FOR USE (21 CFR §807.92(a)(5))

DEVICE DESCRIPTION (21 CFR §807.92(a)(4))

Previously, CALLISTO eye offered some common features throughout all software versions; however, functions for some features were separated by software version according to the proposed use, i.e. the visualization of OCT data in conjunction with the OCT camera RESCAN 700 or the cataract surgery assistance. With CALLISTO eye Software, version 3.6, all functions are present in one software version in addition to a few additional functions, as described in the Table 1 below:

{5}------------------------------------------------

CALLISTO eye Functions	SWVersion3.0	SWVersion3.2	SWVersion3.5	SWVersion3.6
As cleared in premarket notification	K123464	K141844	K141068
Network connectivity	X	X	X	X
User management	X	X	X	X
UpdatedPatient management	X	X	X	X
Import of patient and treatment datafrom the IOLMaster Models 500 and700			X	X
Surgery documentation (videorecording and still images)	X	X	X	X
Ophthalmic surgical microscoperemote control (OPMI LUMERA 700)	X	X	X	X
Live video	X	X	X	X
UpdatedAssistance functionalities:Reference axis marker-based, Incision,Rhexis, Z ALIGN, LRI, and Ktrack	X	X	X	X
NewImage Quality for Reference Assistant				X
Reference axis markerless, utilizingthe IOLMaster Models 500 and 700reference image			X	X
CALLISTO eye Functions	SWVersion 3.0	SWVersion 3.2	SWVersion 3.5	SWVersion 3.6
As cleared in premarket notification	K123464	K141844	K141068
Eye tracking	X		X	X
NewExport of OCT data to connectedPACS system (FORUM)				X
UpdatedControl of the RESCAN 700 (OCTCamera) connected to the OPMILUMERA 700		X		X
Visualization of optical coherencetomography (OCT) data		X		X
Capture and review of OCT data(images and B-scans)		X		X
Support of 1-Line, 2-Line (OCT cube)and 5-Line OCT data		X		X
NewXY-tracking support for ScanLocation Marker (for OCT viewsbased on vessels)				X
NewSupport for 2.9 mm and 5.8 mm scandepths				X
NewAutomatic combination of scan lengthand scan depth (user configurable).				X
UpdatedCombined full screen mode formicroscope live video and OCT liveview				X
Ocular overlays provided for theexternal data injection system (EDIS)to display information in the eyepieceof the microscope (OPMI LUMERA,OPMI Lumera i and OPMI Lumera T)			X	X
NewIcon-based ocular overlays to visualizethe provided information (“Cockpits”)in the data injections system of theconnected microscope				X
Import / Export of patient treatmentdata to a USB storage device	X	X	X	X
CALLISTO eye Functions	SWVersion3.0	SWVersion3.2	SWVersion3.5	SWVersion3.6
As cleared in premarket notification	K123464	K141844	K141068
Import / Export of patient treatmentdata to connected PACS system(FORUM)			x	x
NewImport of patient treatment data usingWLAN				x
NewUSB recording: Surgerydocumentation can be recorded inparallel to a USB hard drive				x

Table 1 presents the functions offered by the previous and proposed CALLISTO eye.

{6}------------------------------------------------

{7}------------------------------------------------

Table 5.1: CALLISTO eye Functions by Software Version

RISK MANAGEMENT

Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by design means, protection measures and user instructions. To confirm that the measures are effective and that the product meets its intended uses, verification of requirements and standards was performed as well as validation of the clinical workflow. Carl Zeiss Meditec adheres to recognized and established industry practice and relevant international standards where indicated.

PERFORMANCE DATA & SUMMARY OF VERIFICATION AND VALIDATION ACTIVITY (21 CFR §807.92(B))

Verification and validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the CALLISTO eye Software. A portion of software verification may be considered "bench testing". Each function and/or feature was tested by means of the appropriate test case or test specification. The system verification test report provides the test cases, expected results for each test case and the actual results obtained.

Software verification activities completed were divided into three phases:

. Tests accompanying development (including code inspections)
Integration test phase stabilization phase ●
System verification

Validation was also conducted for CALLISTO eye according to the Validation Plan to ensure that the device meets the customer's requirements with respect to performance. The objectives defined in the validation plan were achieved according to the validation results.

{8}------------------------------------------------

Verification and validation activities were successfully completed and prove that CALLISTO eye Software, version 3.6, meets the stipulated requirements and performs as intended.

FDA Recognized Standards
Identification	Description
ISO 14971: 2007	Medical Devices – Application of RiskManagement to Medical Devices
IEC 62366-1:2015	Medical devices – Application ofusability engineering to medical devices
IEC 62304:2015	Medical device software - Software lifecycle processes
NEMA PS 3.1-3.20	Digital Imaging and Communications inMedicine (DICOM)

CALLISTO eye Software, version 3.6, conforms to the applicable FDA recognized and international IEC and ISO standards with regards to performance and safety:

Table 2: FDA Recognized Standards

TECHNOLOGICAL CHARACTERISTICS (21 CFR 5807.92(a)(6)) AND SUBSTANTIAL EQUIVALENCE (21 CFR §807.92(a)(3))

It is the opinion of Carl Zeiss Meditec AG that the proposed device, CALLISTO eye Software, version 3.6, is substantially equivalent to CALLISTO eye, as described in premarket notification K123464, K141068 and K141844, with regards to indications for use. Both the proposed product, CALLISTO eye Software, version 3.6, and the predicate devices as cleared in premarket notifications K123464, K141068, and K141844 provide non-diagnostic video documentation and image capture for ophthalmic surgeries and allow remote control of the surgical microscope.

Both the proposed product, CALLISTO eye Software, version 3.6, and the predicate device, CALLISTO eye as described in K123464 inject (displays) information such as light level, zoom and recording into the right ocular; the proposed device uses "Cockpits", an icon-based ocular overlays to visualize the provided information in the data injections system of the connected microscope.

Both the proposed product, CALLISTO eye Software, version 3.6, and the predicate device, CALLISTO eye as described in K141068, provides a variety of assistance functions to assist the surgeon with implanting intraocular lenses (IOL), particularly toric intraocular lenses.

Both the proposed product, CALLISTO eye Software, version 3.6, and the predicate device, CALLISTO eye as described in K141068, allows patient and treatment data to be imported from the IOLMaster Model 500 and is compatible with the IOLMaster 700; the proposed device also allows IOLMaster patient and treatment data to be imported using WLAN.

{9}------------------------------------------------

CALLISTO eye Software, version 3.6, and the predicate device, CALLISTO eye version 3.2, as employed in the RESCAN 700 (K141844), can visualize OCT data taken by the OCT Camera RESCAN 700. Specifically, both systems can display 1-Line, 2-Line (OCT-Cube), and 5-Line OCT scans, record videos and images of live OCT scans. Both devices offered XY tracking; the proposed device also offers Z tracking.

SUMMARY (21 CFR §807.92(b)(3))

The modifications to the CALLISTO eye Software, version 3.6, consolidate the functions cleared under the previous premarket notifications K123464 (CALLISTO eye 3.0) and K141068 (Zeiss Cataract Suite markerless with CALLISTO eye 3.5) as well as under K141844 (RESCAN 700).

The modifications to the subject device does not raise new issues of safety or effectiveness. Therefore, ZEISS believes that the subject device, CALLISTO eye Software, version 3.6, is substantially equivalent to the predicate devices, CALLISTO eye software version 3.0 (K123464), ZEISS Cataract Suite markerless with CALLISTO eye software version 3.5 (K141068), and RESCAN 700 with CALLISTO eye software version 3.2 (K141844).

Regulation Number and Section

§ 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).