CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope.

The graphical guidance tools, as displayed on the CALLISTO eye Panel PC or microscope eye piece, aid the surgeon to insert, align, position, and register an artificial lens. These tools are intended for anterior segment ophthalmic surgical procedures, including positioning and angular alignment of toric intraocular lenses, limbal relaxing incisions, and capsulorhexis. The system utilizes surgeon information for positioning of graphical guidance tools.

Device Description

CALLISTO eye is an assistance system that processes real-time video images that can be displayed on the CALLISTO eye panel PC for viewing by the surgeon and the surgical staff in the operating room. The same video images can be viewed by the surgeon through the evepiece of the OPMI LUMERA 700 surgical microscope. CALLISTO eve provides enhanced visualization and guidance tools to assist the surgeon during procedures such as limbal relaxing incisions, capsulorhexis, and alignment of toric intraocular lenses (IOL). All treatment templates are based on preoperative clinical data of a particular patient and defined by the surgeon prior to the surgery. These templates can be displayed on the CALLISTO eve panel PC and through the eyepiece of the OPMI LUMERA 700 surgical microscope.

CALLISTO eye consists of two product variants: CALLISTO eye BASIC and CALLISTO eye ASSISTANCE.

CALLISTO eve BASIC displays video images and patient data, stores patient data and video recordings, imports and exports patient data and exports videos and images after the surgery. This product variant also allows the remote control of the OPMI LUMERA 700 surgical microscope as well as data injection through the eyepiece via the Integrated Data Injection System (IDIS).

CALLISTO eye ASSISTANCE provides the graphical assistance tools to aid the surgeon during various ophthalmic procedures including limbal relaxing incisions (LRIs), capsulorhexis and toric IOL positioning. The assistance functions include Reference, Rhexis, Incision/LRI, Z-Align and K-track. These functions aid the surgeon in the opening of the capsulorhexis, making incisions and LRIs, aligning the toric intraocular lenses, and estimating a local corneal curvature during surgery.

For CALLISTO eye BASIC and ASSISTANCE, a database called OR database contains the patient data. The OR database is installed on the integrated PC. Documentation of videos and images can then be stored in this database as standard (SD) or high definition (HD) format.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for CALLISTO eye™ (K123464)

The provided documentation, a 510(k) Summary, describes the CALLISTO eye™ as an assistance system for ophthalmic surgeries. Crucially, this document does not explicitly state quantitative acceptance criteria in the typical format of a table with specific metrics and thresholds.

Instead, the submission for CALLISTO eye demonstrates substantial equivalence to a predicate device (TrueVision® 3D Visualization and Guidance System, K101861). The "acceptance criteria" and "performance demonstration" are framed in terms of meeting specifications and requirements, functional equivalence to the predicate, and not raising new safety or effectiveness concerns.

From the provided text, we can infer the following about the device's performance and the general approach to demonstrating its acceptability:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly tied to the functional equivalence and safety/effectiveness of the predicate device. Quantitative metrics for specific performance characteristics are not provided in this summary.

Acceptance Criterion (Inferred from 510(k) Summary)	Reported Device Performance (Summary Statements)
Functional Equivalence to Predicate Device: - Provide non-diagnostic video documentation and image capture for ophthalmic surgeries. - Allow remote control of the surgical microscope. - Display graphical guidance tools for surgeon assistance (insert, align, position, register artificial lens). - Intended for anterior segment ophthalmic surgical procedures (toric IOL positioning, limbal relaxing incisions, capsulorhexis). - Utilize surgeon information for positioning of graphical guidance tools.	"The fundamental technological characteristics of CALLISTO eye with software version 3.0 are similar to the predicate device... Both CALLISTO eye and TrueVision 3D Visualization and Guidance System are devices that work in conjunction with a surgical microscope to assist the surgeon during ophthalmic procedures." "Both are used in ophthalmic imaging applications and provide the means for capture, storage, or manipulation of image data and processing of patient information." "Both provide the surgical guidance templates and documentation of treatments to aid the surgeon during anterior segment ophthalmic surgical procedures." "All systems provide two dimensional graphical templates... to aid the surgeon during anterior segment ophthalmic surgical procedures, to make an incision, to perform a capsulorhexis, or to position a toric intraocular lens."
Meets Specifications and Requirements: - (Implicit) Compliance with design specifications for all functions/features.	"Verification and validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the CALLISTO eye." "All criteria for this testing were met and the results demonstrate that CALLISTO eye meets all performance specifications and requirements."
Meets Customer Requirements: - (Implicit) Device performs as expected for the end-user.	"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."
No New Questions of Safety or Effectiveness: - (Implicit) Any differences from the predicate device do not introduce new risks.	"The minor differences between CALLISTO eye and the predicate device do not raise any new questions of safety or effectiveness in comparison to the predicate device."

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

The 510(k) Summary does not specify a sample size for a "test set" in terms of patient data or clinical cases. The testing described is primarily "bench testing" focusing on software verification and system validation against internal specifications and customer requirements. It is not a clinical study involving a patient cohort for performance evaluation in the traditional sense of a diagnostic or therapeutic device.

The data provenance is not applicable here as a clinical test set with patient data is not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document describes internal verification and validation against specifications and customer requirements, not a study where experts established ground truth for a clinical dataset.

4. Adjudication Method

Not applicable. No clinical test set or expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention an MRMC comparative effectiveness study, nor does it discuss human readers or AI assistance in a comparative context. The device itself is an "assistance system" that aids the surgeon, but a study comparing human performance with and without this specific AI's assistance (or another AI) is not detailed.

6. Standalone Performance Study

Yes, in the context of "bench testing" and system validation. The document states: "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. All criteria for this testing were met and the results demonstrate that CALLISTO eye meets all performance specifications and requirements." This indicates that the algorithm/system was tested on its own to ensure it met its defined specifications.

7. Type of Ground Truth Used for the Test Set

The "ground truth" for the internal verification and validation of the CALLISTO eye was based on pre-defined specifications and requirements for the device's functions and features. For example, a graphical guidance tool designed to show a specific angle would be tested to ensure it correctly displays that angle as per its design specification.

8. Sample Size for the Training Set

Not applicable. The document does not describe the use of machine learning or AI models requiring a "training set" in the common sense of supervised learning with labeled data. The system uses "surgeon information for positioning of graphical guidance tools" and "preoperative clinical data of a particular patient" for its templates, implying a rule-based or data-driven display system rather than a machine learning model trained on a large dataset.

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

Not applicable. As no training set for a machine learning model is described, there's no information on how its ground truth would have been established. The system relies on surgeon input and pre-operative data, which forms the basis of the "templates" rather than being a training set for an AI to learn from.

Summary

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K123464

510(k) Premarket Notification CALLISTO eye™

SECTION 5.

MAR 0 5 2013

510(K) SUMMARY

510(K) SUMMARY

510(k) Summary

(per 21 CFR §807.92)

CALLISTO eye™

GENERAL INFORMATION

Manufacturer:	Carl Zeiss Meditec AGCarl Zeiss Strasse 22D-73447 Oberkochen, Germany+49 3641220-667 (phone)+49 3641220-756 (fax)Establishment Registration Number: 9615010
Contact Person:	Judith Brimacombe, M.A.Director, Clinical/Regulatory AffairsCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4616 (phone)(925) 557-4259 (fax)E-mail: j.brimacombe@meditec.zeiss.com
Date prepared:	February 28, 2013
Device	System, Image Management, OphthalmicOcular MarkerMicroscope, Surgical
Classification:	21 CFR 892.2050
Device Class:	II
Product Code:	NFJ HMR EPT
Common Name:	Picture Archiving and Communications SystemOphthalmic Surgical MarkerSurgical Microscope and Accessories
Trade/Proprietary Name:	CALLISTO eyeTM

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510(k) Premarket Notification CALLISTO eye™

SECTION 5.

PREDICATE DEVICE:

TrueVision Systems, Inc. Company: TrueVision® 3D Visualization and Guidance System Device: (K101861)

INDICATIONS FOR USE

CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope.

DEVICE DESCRIPTION

CALLISTO eye consists of two product variants: CALLISTO eye BASIC and CALLISTO eye ASSISTANCE.

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SECTION 5.

estimating a local corneal curvature during surgery.

For CALLISTO eye BASIC and ASSISTANCE, a database called OR database contains the patient data. The OR database is installed on the integrated PC. Documentation of videos and images can then be stored in this database as standard (SD) or high definition (HD) format.

SUBSTANTIAL EQUIVALENCE

The fundamental technological characteristics of CALLISTO eye with software version 3.0 are similar to the predicate device, TrueVision® 3D Visualization and Guidance System (K101861). Both CALLISTO eye and TrueVision 3D Visualization and Guidance System are devices that work in conjunction with a surgical microscope to assist the surgeon during ophthalmic procedures. Both are used in ophthalmic imaging applications and provide the means for capture, storage, or manipulation of image data and processing of patient information. Both provide the surgical guidance templates and documentation of treatments to aid the surgeon during anterior segment ophthalmic surgical procedures. All templates are set up prior to surgery and can be adjusted during the procedure.

CALLISTO eye and the predicate device consist of:

. a camera connected to a surgical microscope
. a computer providing the imaging application and the means to capture, store or manipulate images and video data as well as the methods for handling patient information
a flat panel display unit with a resolution of 1920 x 1080 pixels to display HD/SD . video content.

All systems provide two dimensional graphical templates, also known as assistance functions, to aid the surgeon during anterior segment ophthalmic surgical procedures, to make an incision, to perform a capsulorhexis, or to position a toric intraocular lens.

One minor difference between CALLISTO eye and predicate device is that the predicate device uses the application of a 3D HD flat panel screen and circular polarized glasses to display live or recorded videos images, whereas CALLISTO eye utilizes a standard 2D HD flat panel to display live or recorded videos and images. Furthermore, CALLISTO eye uses the touch screen as an user interface to omit additional keyboards and pointer devices in the OR setting.

CALLISTO eye and the predicate device serve the same principal purpose of clinical usage and provide a wide range of comparable functionality for their users.

It is the opinion of Carl Zeiss Meditec AG that CALLISTO eye with software version 3.0 is substantially equivalent to the predicate device, TrueVision 3D Visualization and Guidance System (K101861). The indications for use for CALLISTO eye are similar to the indications for use of the predicate device. The technological comparison demonstrates that CALLISTO

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510(k) Premarket Notification CALLISTO eye™

SECTION 5.

eve is functionally equivalent to the predicate device. The minor differences between CALLISTO eve and the predicate device do not raise any new questions of safety or effectiveness in comparison to the predicate device.

PERFORMANCE DATA

Verification and validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the CALLISTO eye. 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. All criteria for this testing were met and the results demonstrate that CALLISTO eye meets all performance specifications and requirements. 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.

SUMMARY

As described in this 510(k) Summary, all testing deemed necessary was conducted on CALLISTO eye to ensure that the device is as safe and effective as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows a partial view of a seal or logo, featuring the words "DEPARTMENT OF HEALTH & HUM" arranged vertically along the left side. To the right of the text, there are abstract shapes that appear to be stylized figures or symbols, possibly representing people. The image is in black and white, with the text and shapes rendered in a bold, clear font.

March 5, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Judith Brimacombe, M.A. Director, Clinical/Regulatory Affairs Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568

Re: K123464

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, HMR, EPT Dated: January 31, 2013 Received: February 1, 2013

Dear Ms. Brimacombe:

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

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Page 2 - Ms. Judith Brimacombe, M.A.

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.

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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kesia Y Alexander -S.

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

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Indications for Use

510(k) Number (if known): K123464

Device Name: CALLISTO eye™

Indications For Use:

CALLISTO eye is an assistance system that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The system allows the remote control of the surgical microscope.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K123464

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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).