The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:

Lens thickness
Corneal curvature and thickness
Axial length
Anterior chamber depth
Pupil diameter
White-to-white distance (WTW)

For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.

The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

Device Description

The IOLMaster 700 device is a computerized biometry device consisting of an OCT system, a Keratometer system, and a camera for the purposes of:

measuring distances within the human eye along the visual axis (e.g. axial length, lens thickness, anterior chamber depth),
measuring the corneal surface with a keratometer,
measuring distances at the front of the eye with a camera (e.g. white-to-white distance).

The IOLMaster 700 is used for visualization and measurement of ocular structures mainly required for the preparation of cataract surgeries to calculate the refractive power of the intraocular lens (IOL) to be implanted. The IOLMaster 700 device includes a swept source frequency domain optical coherence tomography (OCT) module capable of acquiring tomograms of the eye. The axial measurements are based on those tomograms.

The IOLMaster 700 device is operated via multi touch monitor and alternatively with computer mouse and keyboard. A joystick on the measuring head is used for manual alignment of the device to the patient's eye.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the IOLMaster 700 device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria (e.g., "AL difference must be less than 0.05 mm"). Instead, it focuses on demonstrating comparability to predicate devices and showing good repeatability and reproducibility. The "Limits of Agreement" from the Bland-Altman analysis (which is implied by the report of mean difference and limits of agreement) can be considered as the implicit acceptance ranges for comparability.

Measured Parameter	IOLMaster 700 vs. IOLMaster 500 (Mean Difference (SD))	Limits of Agreement (Lower, Upper)	IOLMaster 700 vs. Lenstar LS 900 (Mean Difference (SD))	Limits of Agreement (Lower, Upper)	IOLMaster 700 Repeatability (SD)	IOLMaster 700 Repeatability (%CV)
Biometry Mode
Axial Length (AL) [mm]	0.004 (0.025)	-0.045, 0.053	N/A	N/A	0.009	0.037%
Anterior Chamber Depth (ACD) [mm]	0.017 (0.121)	-0.221, 0.254	N/A	N/A	0.010	0.314%
Lens Thickness (LT) [mm]	N/A	N/A	0.020 (0.120)	-0.246, 0.256	0.019	0.410%
Central Corneal Thickness (CCT) [µm]	N/A	N/A	0.116 (4.492)	-8.688, 8.920	2.271	0.414%
Keratometry Mode
R1, Radius in Flat Meridian [mm]	0.001 (0.044)	-0.086, 0.087	N/A	N/A	0.026	0.334%
R2, Radius in Steep Meridian [mm]	-0.002 (0.046)	-0.093, 0.088	N/A	N/A	0.024	0.316%
Spherical Equivalent (SE) [D]	-0.001 (0.190)	-0.374, 0.371	N/A	N/A	0.100	0.231%
Cylinder (Cyl) [D]	0.013 (0.318)	-0.610, 0.636	N/A	N/A	0.191	20.449%
Axis (A) [°]	1.407 (11.388)	-20.91, 23.73	N/A	N/A	5.633	6.93%
WTW Mode
White-to-White (WTW) [mm]	-0.125 (0.167)	-0.452, 0.203	N/A	N/A	0.090	0.755%

Acceptance Criteria Implied: The study's conclusion that "The results of the IOLMaster 700 measurements are comparable to those of the predicate devices" and that it "demonstrated good repeatability and reproducibility for all parameters" indicates that the observed differences and variability fall within clinically acceptable ranges, deeming the device substantially equivalent. The p-values for paired t-tests (Table 2) consistently being above 0.05 (except for WTW) further support comparable means, although differences in variability exist.

2. Sample Size and Data Provenance

Test Set Sample Size: A total of 120 eyes were enrolled in the study. Only one eye of each subject was designated as the study eye.
Data Provenance: The study was a prospective non-significant risk clinical study conducted at three sites. The document does not specify the countries/regions of these sites, but it is a US FDA submission, implying compliance with US regulations.

3. Number of Experts and Qualifications for Ground Truth for Test Set

The document does not mention the use of experts to establish ground truth for the test set. The study directly compares the IOLMaster 700 measurements against the measurements obtained by the predicate devices (IOLMaster 500 and Lenstar LS 900) as the reference for comparability. For repeatability and reproducibility, the device's own measurements are compared against each other.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the context of expert review for ground truth, as ground truth was not established by experts. For data quality during analysis, "scans were reviewed using the same quality criteria as described in the User Manual, Software Description." The specific criteria included issues like incorrect caliper placement, blurred images, closed eyelids, and distorted reflections.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on device biometry measurement accuracy, comparability to predicate devices, and repeatability/reproducibility, not on human reader performance with or without AI assistance. The device is a biometer, not an AI-assisted diagnostic tool for interpretation.

6. Standalone Performance Study

Yes, a standalone study was performed in the sense that the IOLMaster 700's own measurements were evaluated for repeatability and reproducibility, independent of human interpretation or "human-in-the-loop" performance. The device is intended to provide objective biometric measurements. The comparison to predicate devices also serves as a standalone performance assessment against established benchmarks.

7. Type of Ground Truth Used

The "ground truth" for the comparative study was the measurements obtained from the predicate devices:

IOLMaster 500 (for AL, ACD, R1, R2, SE, Cyl, A, WTW)
Lenstar LS 900 (for LT, CCT)

For repeatability and reproducibility, the device's own repeated measurements served as the basis for assessing consistency.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI development. This device is a measurement instrument based on optical principles, not a machine learning model that requires a separate training data set for its core functionality of measurement.

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

As there is no mention of a training set for an algorithm, this question is not applicable based on the provided document. The device's measurement algorithms are likely based on physical principles (e.g., optical coherence tomography) rather than being trained on a large dataset with established ground truth in the AI/ML sense.

Summary

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

July 10, 2015

Carl Zeiss Meditec. Inc. Ms. Christine Dunbar Ophthalmic Systems Manager, Regulatory Submissions 5160 Hacienda Drive Dublin, California 94568

Re: K143275 Trade/Device Name: IOLMaster 700 Regulation Number: 21 CFR 886.1850 Regulation Name: Ac-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: June 4, 2015 Received: June 5, 2015

Dear Ms. Dunbar:

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.

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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" (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 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.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman 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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Section 1: Indications for Use - IOLMaster 700

510(k) Number (if known):

Device Name(s): IOLMaster 700

Indications for Use:

Lens thickness
Corneal curvature and thickness ●
Axial length ●
Anterior chamber depth ●
Pupil diameter
. White-to-white distance (WTW)

For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.

The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 ______ of________________________________________________________________________________________________________________________________________________________________

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Section 2: 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.

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

Submitter:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-5207745 Jena Germany
Contact Person:	Christine Dunbar, PMPManager, Regulatory SubmissionsCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568christine.dunbar@zeiss.comTel: (925) 560-5139Fax: (925) 557-4259

Date Prepared: June 29, 2015

Name of device, including trade name and classification name

1.	Trade/Proprietary Name:	a. IOLMaster 700
2.	Common/Usual Name:	a. Biometer
3.	Classification Name:	a. AC-powered, biomicroscope
4.	Product Code and Class:	a. HJO - Class II
5.	Classification Number:	a. 21 CFR 886.1850

Predicate Devices

The IOLMaster 700 is similar in function and application and is used in the preparation phase of cataract surgery as the following predicate devices:

. the IOLMaster 500 (K122418) - the primary predicate as it has the most similar intended use and characteristics,
the Lenstar LS 900 (K082891) is an additional (secondary) predicate to support the two new ● measurements featured on the IOLMaster 700,
additionally, the IOLMaster 500 as part of the ZEISS Cataract Suite markerless (K141068) ● for the Reference Imaging feature.

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Carl Zeiss Meditec Premarket Notification 510(k)

The Visante OCT (K051789) is provided as a reference device to support the OCT function of the IOLMaster 700.
The IOLMaster 700 provides similar basic measurement features as the primary predicate. IOLMaster 500 (K122418). Additionally, the IOLMaster 700 measures the corneal thickness and lens thickness which is similar to the Lenstar LS 900 (K082891) manufactured by Haag- Streit. All three devices are intended to provide measurements of the human eye and provide IOL power calculations to aid the physician prior to cataract surgery.

A comparison of the features, indications for use, and technological characteristics of the IOLMaster 700 is intended to establish substantial equivalence to the previously cleared predicate devices, the IOLMaster 500 and the Lenstar LS 900.

Device Description

The IOLMaster 700 device is a computerized biometry device consisting of an OCT system, a Keratometer system, and a camera for the purposes of:

measuring distances within the human eye along the visual axis (e.g. axial length, lens ● thickness, anterior chamber depth),
measuring the corneal surface with a keratometer, .
measuring distances at the front of the eye with a camera (e.g. white-to-white distance).

Indications for Use

The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination in the appropriate power and type of intraocular lens.

The IOLMaster 700 measures:

Lens thickness ●
Corneal curvature and thickness
Axial length
. Anterior chamber depth

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ELECarl Zeiss Meditec Premarket Notification 510(k)

Pupil diameter ●
. White-to-white distance (WTW)

For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain twodimensional images of ocular structures of the anterior and posterior segments of the eye.

The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

Comparison of Technological Characteristics

The comparison of the technological characteristics to the predicates is as follows:

IOLMaster 700:

The IOLMaster 700 is a new biometry device providing the same basic measuring features as the IOLMaster 500 and in addition, measures central corneal thickness and lens thickness. It also includes the Reference Image functionality for use in the ZEISS Cataract Suite markerless workflow.

The IOLMaster 700 contains a swept source frequency domain optical coherence tomography (OCT) module that uses a tunable laser [1055 nm]. It is based on an interference optical method known as partial coherence interferometry (PCI). Multiple A-scans provide B-scans that are displayed as cross-sectional images of the human eye and are used to obtain axial measurements: corneal thickness, anterior chamber depth, lens thickness, and axial length. Corneal curvature and white-to-white measurements use the same technology as the IOLMaster 500.

IOLMaster 500 (K122418):

The IOLMaster 700 provides similar basic measurement features as the primary predicate, IOLMaster 500 (K122418). Both devices are combined biometry instruments used to take measurements of the human eve. It provides measurements of the following eve parameters: axial length, corneal curvature, anterior chamber depth, and white-to-white distance is similar to the measurements from the IOLMaster 700. The axial length measurement is based on partial coherence interferometry (PCI) A-scans as it is in the IOLMaster 700. The IOLMaster 500 uses a multimode laser diode [780 nm] to realize time domain interferometry (dual beam principle).

Anterior chamber depth measurements are based on a slit lamp module, whereas the IOLMaster 700 extracts anterior chamber depth from OCT scans similar to the Lenstar LS 900 (K082891) system. Corneal curvature is measured by a telecentric keratometry. White-to-white is obtained using a camera.

Lenstar LS 900 (K082891):

The IOLMaster 700 measures the corneal thickness and lens thickness which is similar to the Lenstar LS 900 (K082891) manufactured by Haag-Streit. Both devices generate A-scans. The technology used by the Lenstar LS 900 includes super luminescence diode [820 nm] as the laser source, A-scans based on Optical Low-Coherence Reflectometry (OLCR, principle of OCT) and a distance dependent

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keratometer.

Like the IOLMaster 700, the Lenstar LS 900 is used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL for implantation after cataract removal.

Visante OCT (K051789):

The reference device, Visante OCT and the IOLMaster 700 OCT both acquire and visualize crosssectional tomograms of the anterior eye segment using optical coherence tomography (OCT).

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Table 1 Summary of Comparison between IOLMaster 700 and IOLMaster 500

Feature or Function	IOLMASTER 700SUBJECT DEVICE	IOLMASTER 500PRIMARY PREDICATE- K122418
Indications for Use	The IOLMaster 700 is intended forbiometric measurements andvisualization of ocular structures. Themeasurements and visualization assistin the determination of theappropriate power and type ofintraocular lens. The IOLMaster 700measures:• Lens thickness• Corneal curvatureand thickness• Axial length• Anterior chamber depth• Pupil diameter• White-to-whitedistance (WTW)For visualization, the IOLMaster 700employs optical coherencetomography (OCT) to obtain two-dimensional images of ocularstructures of the anterior andposterior segments of the eye.The Reference Image functionality isintended for use as a preoperative andpostoperative image capture tool.	The IOLMaster is intended for thebiometric determination of ocularmeasurements of axial length,anterior chamber depth, cornealradius, white-to-white (WTW), andfor the measurement of pupil sizeand deviation of the visual axisfrom the center of the pupil. Forpatients who are candidates forintraocular lens (IOL) implantation,the device also performscalculations to assist physicians indetermining the appropriate IOLpower and type for implantation.This device is intended for use byphysicians and eye-care professionalsand may only be used under thesupervision of a physicianAdditional IOLMaster 500Predicate - K141068IOLMaster 500 Indications for Useremains unchanged from K122418.
Reference Image	Included feature (software license)Green LEDs for green lightillumination for image capturing ofscleral vessels with internal camera.	Option Reference Image Featurecleared under K141068.Green LEDs for green lightillumination for image capturing ofscleral vessels with internal camera.
Principles of Operation	Optical coherence tomography(OCT) - Generation of B-Scans	Partial coherence interferometry(PCI) - Generation of A-Scans.
	LED spot projection	LED spot projection
		Slit Lamp Illumination
	Image capture	Image capture
	Image processing	Image processing
Feature or Function	IOLMASTER 700SUBJECT DEVICE	IOLMASTER 500PRIMARY PREDICATE- K122418
Cross-sectional ImagingTechnology	Swept source laser [1055 nm],frequency domain optical coherenceinterferometry (OCT principle),acquires 2000 A-scans /second,Two orthogonal scan units. MultipleA-scans provide a B-scan (2DImaging).	Multimode laser diode [780 nm],Time domain interferometry (dualbeam principle),
Fixation Light	LED [660 nm]	LED [590 nm]
Keratometry	Telecentric keratometry = distanceindependentLight spot projection (infraredLEDs)	Telecentric keratometry = distanceindependentLight spot projection (infraredLEDs)
AL (mm):	Swept source laser [1055 nm],Spectral domain interferometry(OCT principle),Multiple A-scans provide a B-scan(2D image).	Multimode laser diode [780 nm],Time domain interferometry (dualbeam principle),Measurement can be imported fromultrasound system.
ACD (mm):	Swept source laser [1055 nm],Spectral domain interferometry(OCT principle),Multiple A-scans provide a B-scan(2D image).	Slit lamp principle
CCT, LT (mm):	Swept source laser [1055 nm],Spectral domain interferometry(OCT principle).Multiple A-scans provide a B-scan(2D image).	Not available.
WTW, Pupil diameter(mm):	Infrared LEDs illumination andimage capturing of the eye withinternal camera.	Infrared LEDs illumination andimage capturing of the eye withinternal camera.
Computational formulas	Haigis Suite(includes Haigis,Haigis-L and Haigis-T)Hoffer QHolladay 2SRK®/T	Haigis,Haigis-LHofferQHolladay 1Holladay 2SRK®/T
Feature or Function	IOLMASTER 700SUBJECT DEVICE	IOLMASTER 500PRIMARY PREDICATE- K122418
		SRK® IIPhakic implantsCorneal K's correction (for eyesafter refractive surgery)
Ultrasound linkOption “Sonolink”	Not available	Available

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ZEISS Carl Zeiss Meditec Premarket Notification 510(k)

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Premarket Notification 510(k)

Performance Data

Biocompatibility:

The IOLMaster 700 has two patient-contact components; the patient chin rest and the forehead rest. Biocompatibility testing was conducted according to ISO 10993-1:2009 Biological evaluation of medical devices. The material tested was compliant with the requirements in ISO10993-1:2009.

Electrical Safety and EMC:

Electrical safety and electromagnetic compatibility (EMC) for the IOLMaster 700 was evaluated. Conformance to standards for electrical safety (IEC 60601-1:2007), electromagnetic compatibility (IEC 60601-1-2:2007) and other recognized standards was demonstrated.

Optical radiation safety:

Optical radiation safety of the IOLMaster 700 was evaluated. Conformance to light hazard protection for ophthalmic instruments (ISO 15004-2:2007) and safety of laser products (IEC 60825-1:2007) was demonstrated.

Software Verification and Validation Testing:

The IOLMaster 700 was tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005.

Clinical Studies:

Description of Study:

A non-significant risk clinical study was conducted at three sites to determine comparability of the measurements obtained from the IOLMaster 700 and the IOLMaster 500 and Lenstar LS 900, and to

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determine the repeatability and reproducibility of the measurements of the IOLMaster 700.

A total of 120 eyes were enrolled to determine the comparability of the following parameters: axial length (AL), anterior chamber depth (ACD), central corneal thickness (CCT), lens thickness (LT), white-to-white (WTW) and keratometry [Radii R1 and R2, Cylinder (Cyl), Spherical Equivalent (SE), Axis (A)]. Only one eye of each subject was designed as the study eye.

The subjects with cataracts enrolled in the study ranged in age from 37 to 89 years; the mean was 68 years. The severity of the cataract density was determined by the clinical investigator and included mild (Grade 1, 83%), moderate (Grade 2, 15%) and severe (Grade 3, 2%). The study population included 54 males and 66 females (45%, 55%, respectively).

The study inclusion criteria required adult males or females who had been diagnosed with a cataract graded to be at least grade 1 and who were willing to participate in the study examination and measurements and give consent.

The study exclusion criteria included:

Patients who were not capable of understanding the instructions of the investigator or to give ● their consent or who were unable to sit upright in front of the devices, with injuries to the forehead or chin;
Patients with an inability to keep fixation as well as those who had eccentric fixation, nervous ● disposition, poor patient cooperation or those with tremor, nystagmus, or shortage of breath;
Patients with insufficient corneal reflection for a keratometry or ACD measurement, i.e. due to serious tear film problems on the study eve or who had existing corneal abnormalities. e.e. corneal scars, keratoconus, degenerative diseases, active inflammation in the study eye:
Patients who did not remove their hard or soft contact lens within the required time period prior ● to undergoing study measurements or who had partial or complete covering of the cornea by eyelid or eyelid closure;
Patients with previous refractive or other corneal surgery on the study eyes or implantation of a . phakic intraocular lens in the study eye;
. Patients with morphological changes in the retinal anatomy in fovea region, e.g. vitreous hemorrhage, acute retinal detachment in the study eye.

Data Collection

The study employed three IOLMaster 700 devices, three IOLMaster 500 devices, and three Lenstar LS 900 devices; each of the three sites possessed one IOLMaster 700, one IOLMaster 500 and one Lenstar LS 900 for the duration of the study.

Subjects were examined with the three study devices in one session wherein the operators attempted to take five measurements with the IOLMaster 700 and one measurement with the IOLMaster 500 as well as the Lenstar LS 900 on each study eye.

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Data Analysis

Prior to data analysis, scans were reviewed using the same quality criteria as described in the User Manual, Software Description. Specifically, the reviewers used the following criteria:

Incorrect caliper placement by artifacts in B-scans (interfaces not detected correctly by the ● algorithm due to poor segmentation or floaters or other artifacts in the vitreous / anterior chamber)
Blurred WTW image (scleral image not visible) ●
Closed eyelid in any image ●
Distorted or missing reflections in keratometry image (incomplete number of spots reflected ● from cornea or blurred reflections due to shading caused by eye lashes, eye lid or poor tear film)

For the agreement comparison, only the first acceptable IOLMaster 700 measurement out of five was u s e d to analyze the difference between the IOLMaster 700 and the comparison device.

For analyzing keratometry, the resulting parameters spherical equivalent (SE) and cylinder (CYL) were calculated based on the existing values R1 [mm] and R2 [mm].

For each of the parameters AL. ACD. R1, R2. A. SE and CYL, the difference in measurement between IOLMaster 700 and IOLMaster 500 was calculated for each eye by subtracting the value of IOLMaster 500 from the value of IOLMaster 700.

Repeatability standard deviation (SD) was estimated by the square-root of the estimated variance due to measurement error based on the random effect ANOVA model. The repeatability limit (or repeatability) was estimated by the 95% confidence limit of the difference between two repeated measurements (Formula 1).The reproducibility SD was estimated by the square-root of sum of variance due to measurement error and variance due to study site.

The reproducibility limit (or reproducibility) was estimated by Formula 2:

1. Repeatability SD is the standard deviation under repeatability conditions. Per ISO 5725-1 and ISO 5725-6, Repeatability Limit = 2.8 × Repeatability SD. Repeated COV [%] = Coefficient of Variation = Repeatability SD = Mean. (x 100). The mean was the estimated general mean in the random ANOVA model for the R&R calculation.
1. Reproducibility SD is the standard deviation calculated for the difference between individual measurement using different operators and instruments. Per ISO 5725-1 and ISO 5725-6, Reproducibility Limit = 2.8 × Reproducibility SD.

The Coefficient of Variability (COV) was calculated by the standard deviation from repeatability and reproducibility and the mean of all used measurements.

As the Axis measurement in IOLMaster 700 serves only for the alignment of toric IOLs, only eyes with corneal astigmatism of 0.75 D and higher were analyzed.

Table 1 summarizes the descriptive statistics for differences between the IOLMaster 700 and the comparison devices (IOLMaster 500 and Lenstar LS 900).

The values from each instrument used in the calculation of those differences are shown in Table 2

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(Descriptive Statistics Summary for Difference), and Table 3 (Mean Difference Between Devices with Limits of Agreement).

In Tables 1-3, the first acceptable measurement for each subject was considered for comparison of the IOLMaster 700 and comparison devices (IOLMaster 500 and Lenstar LS 900).

	Table 1: Descriptive Statistics Summary - IOLMaster 700 and Comparison Devices
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	IOLMaster 700				IOLMaster 500
	n	Mean (SD)	Median	Min,Max	n	Mean (SD)	Median	Min,Max
Biometry mode
AL [mm]	113	23.636(1.820)	23.260	20.49,34.56	113	23.632(1.811)	23.250	20.53,34.54
ACD [mm]	113	3.061(0.415)	3.080	2.03,4.12	113	3.044(0.402)	3.020	2.09,4.08
Keratometry mode
R1, Radius in FlatMeridian [mm]	113	7.784(0.250)	7.780	7.10,8.80	113	7.783(0.252)	7.780	7.12,8.78
R2, Radius in SteepMeridian [mm]	113	7.610(0.238)	7.610	6.99,8.18	113	7.613(0.238)	7.610	6.99,8.15
SE [D]	113	43.175(1.326)	43.170	39.36,47.13	113	43.176(1.329)	43.122	39.32,47.06
Cyl [D]	113	0.969(0.627)	0.870	0.00,3.39	113	0.956(0.663)	0.856	0.00,3.24
A [°]	59	90.63(68.224)	96	0,187	59	89.22(67.078)	89	-2,188
WTW mode
WTW [mm]	97	11.889(0.407)	12.00	10.9,12.9	97	12.024(0.429)	12.00	11.0,13.0
	IOLMaster 700				Lenstar LS 900
	n	Mean (SD)	Median	Min,Max	n	Mean (SD)	Median	Min,Max
Biometry mode
LT [mm]	112	4.643(0.411)	4.665	3.70,5.60	112	4.623(0.417)	4.630	3.70,5.62
CCT [µm]	112	549.27(36.368)	548.5	430,655	112	549.15(35.411)	550.0	435,653
The value "-2" for Minimum axis of the IOLMaster 500 is due to the performed conversion for comparison.

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Biometry mode

LT [mm]

CCT [µm]

Difference between IOLMaster 700 and IOLMaster 500
	N	Mean (SD)	Median	Min, Max	p-valueT-test for pairedsamples
Biometry mode
AL [mm]	113	0.004(0.025)	0.000	-0.06, 0.09	0.074
ACD [mm]	113	0.017(0.121)	-0.010	-0.30, 0.38	0.149
Keratometry mode
R1, Radius in FlatMeridian [mm]	113	0.001(0.044)	0.000	-0.14, 0.25	0.949
R2, Radius in SteepMeridian [mm]	113	-0.002(0.046)	0.000	-0.16, 0.13	0.598
SE [D]	113	-0.001(0.190)	0.000	-0.92, 0.62	0.937
Cyl [D]	113	0.013(0.318)	-0.008	-0.88, 0.87	0.659
A [°]	59	1.407(11.388)	0	-35, 32	0.347
WTW mode
WTW [mm]	97	-0.125(0.167)	-0.10	-0.8, 0.4	<0.001
Difference between IOLMaster 700 and Lenstar LS 900
	N	Mean (SD)	Median	Min, Max	p-valueT-test for pairedsamples

0.000

-1.0

-0.32, 0.67

-9, 13

0.079

0.785

Table 2: Descriptive Statistics Summary - Difference between IOLMaster 700 and Comparison Devices

The difference for each subject between the two devices = IOLMaster 700 - comparison device.

0.020

(0.120) 0.116

(4.492)

112

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Image /page/14/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. Below the wordmark is a curved shape, also in blue, that suggests a lens or optical element. The overall design is clean and modern, reflecting the company's focus on precision and technology.

Carl Zeiss Meditec Premarket Notification 510(k)

Table 3: Mean Difference Between Devices (with Limits of Agreement)

Difference between IOLMaster 700 and IOLMaster 500
	N	IOLMaster 700Mean (SD)	IOLMaster 500Mean (SD)	DifferenceMean (SD)(95% CI)	LowerLimit ofAgreement	Upper LimitofAgreement
Biometry mode
AL [mm]	113	23.636 (1.820)	23.632 (1.811)	0.004 (0.025)(0.000, 0.009)	-0.045	0.053
ACD [mm]	113	3.061 (0.415)	3.044 (0.402)	0.017 (0.121)(-0.006, 0.039)	-0.221	0.254
Keratometry mode
R1, Radius inFlat Meridian[mm]	113	7.784 (0.250)	7.783 (0.252)	0.001 (0.044)(-0.008, 0.009)	-0.086	0.087
R2, Radius inSteep Meridian[mm]	113	7.610 (0.238)	7.613 (0.238)	-0.002 (0.046)(-0.011, 0.006)	-0.093	0.088
SE [D]	113	43.175 (1.326)	43.176 (1.329)	-0.001 (0.190)(-0.037, 0.034)	-0.374	0.371
Cyl [D]	113	0.969 (0.627)	0.956 (0.663)	0.013 (0.318)(-0.046, 0.072)	-0.610	0.636
A [°]	59	90.63 (68.224)	89.22 (67.078)	1.407 (11.3883)(-1.561; 4.375)	-20.91	23.73
WTW mode
WTW [mm]	97	11.889 (0.407)	12.024 (0.429)	-0.125 (0.167)(-0.158, -0.091)	-0.452	0.203
Difference between IOLMaster 700 and Lenstar LS 900
	N	IOLMaster 700Mean (SD)(95% CI)	Lenstar LS 900Mean (SD)(95% CI)	DifferenceMean (SD)(95% CI)	LowerLimit ofAgreement	Upper LimitofAgreement
Biometry mode
LT [mm]	112	4.643 (0.411)	4.623 (0.417)	0.020 (0.120)(-0.002, 0.043)	-0.246	0.256
CCT [µm]	112	549.27(36.368)	549.15(35.411)	0.116 (4.492)(-0.725, 0.957)	-8.688	8.920
The difference for each subject between the two devices = IOLMaster 700 - comparison device.

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Image /page/15/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. Below the wordmark, there is a curved, white shape that resembles a lens or a stylized representation of light. The overall design is clean and modern, conveying a sense of precision and technological expertise.

Carl Zeiss Meditec Premarket Notification 510(k)

Additionally, analysis of variance (ANOVA) with random effect models was used to evaluate the repeatability and reproducibility of each measurement parameter for the IOLMaster 700. Table 4 below summarizes the standard deviation and percent coefficient of variation for ANOVA components due to repeated measurements, different devices or study site, and the total of these two components. It should be noted that the information for operator effect was not collected.

			Between-Replicates		Between-Site/Device		Total(Overall)
Parameter	N	Mean	(SD, %CV)		(SD, %CV)		(SD, %CV)
Biometry mode
AL [mm]	117	23.605	0.009	0.037%	0.318	1.346%	0.318	1.346%
ACD [mm]	117	3.053	0.010	0.314%	0.057	1.853%	0.057	1.879%
CCT [µm]	117	548.598	2.271	0.414%	2.844	0.518%	3.640	0.663%
LT [mm]	117	4.661	0.019	0.410%	0.000	0.000%	0.019	0.410%
Keratometry mode
R1 [mm]	109	7.784	0.026	0.334%	0.032	0.411%	0.041	0.530%
R2 [mm]	109	7.617	0.024	0.316%	0.044	0.580%	0.050	0.661%
SE [D]	109	43.159	0.100	0.231%	0.232	0.537%	0.252	0.585%
Cyl [D]	109	0.934	0.191	20.449%	0.000	0.000%	0.191	20.449%
A [°]	59	81.249	5.633	6.93%	0.000	0.000%	5.633	6.93%
WTW mode
WTW [mm]	115	11.928	0.090	0.755%	0.018	0.155%	0.092	0.771%
Axis analysis includes study eyes with corneal cylinder power > 0.75 D only.

Table 4: IOLMaster 700 Variation Components

The table above shows the variance components for effect due to site/device and effect due to replicates and the corresponding repeatability and reproducibility as well as an overall SD and COV value.

Summary

The results of the IOLMaster 700 measurements are comparable to those of the predicate devices, IOLMaster 500 and Lenstar LS 900. In comparison with the predicate biometry devices, the IOLMaster 700 demonstrated good repeatability and reproducibility for all parameters.

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.