The ZEISS Cataract Suite markerless workflow uses a preoperative image capture tool from the IOLMaster 500 that permits visualization and guidance during cataract surgery using CALLISTO eye. The ZEISS Cataract Suite markerless utilizes an ophthalmic surgical microscope and the following medical devices:

IOLMaster 500: The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.

CALLISTO eye: 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 position of graphical guidance tools.

Device Description

The markerless toric IOL alignment workflow provided with the ZEISS Cataract Suite markerless is a series of medical devices integrated into one workflow for use by a cataract surgeon. The workflow comprises an optical biometric device with green LED image capture from the IOLMaster 500 (K122418) with an optional accessory (Option Reference Image). The captured image is transferred to a cataract surgery assistance system, the CALLISTO eye (K123464), which operates in conjunction with ophthalmic surgical microscopes. Integrated or external data injection systems (IDIS or EDIS) are capable of displaying the graphical templates of the CALLISTO eye in the right ocular of the ophthalmic surgical microscopes.

AI/ML Overview

The provided text describes the regulatory clearance of the ZEISS Cataract Suite markerless, which is a system comprising the IOLMaster 500, CALLISTO eye, and ophthalmic surgical microscopes, intended to aid in cataract surgery, particularly for toric IOL alignment.

However, the document is a 510(k) summary for regulatory clearance and does not contain the detailed study information as requested. It focuses on demonstrating substantial equivalence to a predicate device and outlines general software and safety testing, but lacks specific performance data, acceptance criteria, study methodologies, or ground truth establishment details.

Therefore, I cannot fulfill all the requested information. Below is what can be inferred or explicitly stated from the provided text, and where information is missing.

Missing Information Disclaimer:

The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and statistical analysis as would be found in a clinical trial report. As such, much of the requested information (e.g., specific acceptance criteria values, reported device performance metrics against those criteria, sample sizes for test/training sets, details of ground truth establishment, expert qualifications, adjudication methods, MRMC study results, or standalone algorithm performance) is not present in this document.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document primarily asserts "safe and effective with respect to their Indications for Use" based on software verification/validation and safety testing, and comparison to a predicate device. Specific quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) and corresponding performance metrics are not detailed.	Not specified in the document. No quantitative performance metrics are provided against any specific acceptance criteria. The document states "software verification and validation, safety testing and bench testing" were conducted.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the document.
Data Provenance: Not specified. The document mentions "appropriate bench testing" and software testing. It does not indicate the nature, origin, or type (retrospective/prospective) of any clinical data used for performance evaluation, if any.

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)

Number of Experts: Not specified in the document.
Qualifications of Experts: Not specified in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not specified 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

MRMC Study: Not specified in the document. The document describes the CALLISTO eye as an "assistance system" and states its graphical tools "aid the surgeon." However, it does not provide details of any MRMC study comparing surgeon performance with and without the system, nor an effect size.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: The document does not describe a standalone performance study of the algorithm (e.g., a specific "AI" component's accuracy without a human surgeon's input beyond providing the initial images). The system is presented as an "assistance system" for human surgeons.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not specified in the document. The document focuses on software verification and validation, and safety testing, which typically involve testing against predefined specifications or known correct outputs, rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Sample Size for Training Set: Not specified in the document. It's unclear if machine learning models requiring training sets were central to the "AI" component, but even if so, no such details are provided.

9. How the ground truth for the training set was established

Ground Truth Establishment for Training Set: Not specified in the document.

Summary of what is known from the document:

Device: ZEISS Cataract Suite markerless, comprising IOLMaster 500, CALLISTO eye, and ophthalmic surgical microscopes.
Purpose: Markerless toric IOL alignment workflow, visualization, and guidance during cataract surgery.
Regulatory Basis: Substantial equivalence to predicate device (TrueVision 3D Visualization and Guidance System K101861).
Testing Mentioned: Software testing (according to FDA Guidance for Software in Medical Devices and IEC 62304:2006), electromagnetic compatibility, safety testing, and "appropriate bench testing."
Conclusion: The device is deemed "safe and effective with respect to their Indications for Use" based on the mentioned testing and comparison to the predicate.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

December 19, 2014

Carl Zeiss Meditec, Inc. Ms. Sarah Harrington, M.S., MBA Staff Regulatory Specialist 5160 Hacienda Drive Dublin, CA 94568

Re: K141068

Trade/Device Name: Zeiss Cataract Suite markerless Regulation Number: 21 CFR 886.1850 Regulation Name: Biomicroscope, Slit-Lamp, AC-powered Regulatory Class: Class II Product Code: HJO, NFJ, HMR, EPT, HRM Dated: July 29, 2014 Received: July 30, 2014

Dear Ms. Harrington:

This letter corrects our substantially equivalent letter of September 9, 2014.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

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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1.0 INDICATIONS FOR USE - ZEISS CATARACT SUITE MARKERLESS

510(k) Number (if known):

ZEISS Cataract Suite markerless Device Name(s):

Indications for Use:

IOLMaster 500

The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.

This device is intended for use by physicians and eye-care professionals and may only be used under supervision of a physician.

CALLISTO eve

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 position of graphical guidance tools.

Prescription Use	X
(Part 21 CFR 801 Subpart D)
	AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page

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2.0 510(K) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

Submitter's name, address, telephone number, contact person, and date summary prepared:

1. Applicant:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-5207745 JenaGermany
2. Contact Person:	Sarah Harrington, MS, MBAStaff Regulatory SpecialistCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568sarah.harrington@zeiss.comTel: (925) 560-5134Fax: (925) 557-4259

Name of device, including trade name and classification name

1.	Trade/Proprietary Name:	a. IOLMaster / IOLMaster 500b. CALLISTO eyec. Opthalmic Surgical Microscopes
2.	Common/Usual Name:	a. Biometerb. Picture Archiving and Communication Systemc. Ophthalmic Surgical Microscope and accessories
3.	Classification Name:	a. AC-powered slit lamp biomicroscopeb. System, Image management, Ophthalmic;Ocular Marker; Surgical Microscopec. Surgical Microscope, operating & accessories,AC-powered, ophthalmic
4.	Product Code and Class:	a. HJO - Class IIb. NFJ, HMR, EPT– Class IIc. HRM - Class I
5.	Classification Number:	a. 21 CFR 886.1850b. 21 CFR 892.2050c. 21 CFR 878.4700

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Predicate Device

The ZEISS Cataract Suite markerless is similar in function and application in cataract surgery to the predicate device, the TrueVision 3D Visualization and Guidance System (K101861). The visualization system displays real-time images during ophthalmic surgery on a flat-panel digital display device positioned for live video image viewing by the surgeon in the operating room.

Device Description

Indications for Use

IOLMaster 500

This device is intended for use by physicians and eye-care professionals and may only be used under supervision of a physician.

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Indications for Use (cont.)

CALLISTO eye

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 svstem utilizes surgeon information for position of graphical guidance tools.

Comparison of Technological Characteristics

The ZEISS Cataract Suite markerless and the predicate device, the TrueVision 3D Visualization and Guidance System (K101861) share similar functional features and operating characteristics. The TrueVision system captures an image of the eye that is displayed by the 3D Visualization and Guidance System. As with the CALLISTO eye, the TrueVision 3D Visualization and Guidance System provides graphical templates and overlays that are viewed via an ophthalmic surgical microscope to aid the surgeon during cataract surgery.

Performance Data

The IOLMaster 500 and CALLISTO eye software were tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005. The software testing also followed the Carl Zeiss Meditec internal software development procedure that is in compliance with the IEC 62304:2006 - Medical device software - Software life cycle processes.

Electromagnetic compatibility and safety testing was conducted along with appropriate bench testing to verify changes to the devices.

Conclusion

Based on the software verification and validation, safety testing and bench testing as well as the comparison to the predicate devices, the ZEISS Cataract Suite markerless as well as the contributing devices are safe and effective with respect to their Indications for Use.

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.