The EM-4000 Specular Microscope is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

Device Description

The Tomey EM-4000 Specular Microscope is a non-contact ophthalmic microscope and camera intended for corneal endothelium imaging. Its operating principle is based on the Specular optical principle. This device is used for imaging the corneal endothelium. The EM-4000 analyzes and displays data such as cell number, cell density, coefficient of variation and percent hexagonality. When photographing the corneal endothelium, the equipment performs the alignment and automatically focuses by capturing the reflected light from the patient's eye with the CCD camera. Infrared LEDs are used as the light source for the alignment. Operation with the iovstick also makes it possible to focus manually. The green LED light radiates to the cornea, and the endothelium image is captured with the CCD camera by the reflected light from the cornea. The endothelium images are stored in internal memory.

Furthermore, the EM-4000 is able to measure the central corneal thickness. The corneal endothelium is photographed first followed by measuring the central corneal thickness. The infrared LED light for measurement of corneal thickness radiates to the cornea through the objective lens for photographing the cornea, and the central corneal thickness can be calculated by measuring the distance on the optical line sensor between the reflected light from front surface and back surface of cornea.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document:

The document describes the Tomey EM-4000 Specular Microscope, a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. The study aims to demonstrate substantial equivalence to a predicate device, the Konan Medical, Inc. Cellchek XL (K120264).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in this document for all parameters beyond pachymetry. Instead, the study aims to show "agreement, accuracy and precision" with the predicate device, demonstrating substantial equivalence. For pachymetry, a specific accuracy is mentioned.

Acceptance Criteria	Reported Device Performance (Tomey EM-4000 vs. Konan Cellchek XL)
Pachymetry Accuracy (non-clinical)	± 10 microns (Confirmed in non-clinical performance summary)
Endothelial Cell Density (CD) Agreement	Mean difference for CD: -6.49% (SD 5.648%). 95% LOA: (-413.6, 74.2). Correlation (R): 0.9634.
Coefficient of Variation (CV) Agreement	Mean difference for CV: 1.65% (SD 11.304%). Correlation (R): 0.6226.
Percent Hexagonality (HEX) Agreement	Mean difference for % HEX: 0.70% (SD 15.091%). Correlation (R): 0.5549.
Central Corneal Thickness (CCT) Agreement	Mean difference for CCT: -3.11% (SD 3.995%). Correlation (R): 0.8561.
Precision (Repeatability & Reproducibility)	For all variables (CD, CV, HEX, CCT), the Tomey EM-4000 showed slightly less variability compared to the Konan Cellchek XL (e.g., lower Repeatability and Reproducibility SDs, and Repeatability/Reproducibility Ratios < 1). This indicates better or equivalent precision.
Electrical Safety	Complies with ANSI/AAMI ES60601-1.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2.
Optical Radiation Safety	Complies with ISO 15004-1 and ISO 15004-2.
Overall Substantial Equivalence to Predicate	The study concluded that the Tomey EM-4000 (core method) and the Konan CellChek XL (center method) were substantially equivalent for the parameters measured in terms of agreement and precision.

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

Test Set Sample Size:
- Agreement portion (specular microscope variables): 67 subjects
- Agreement portion (Central Corneal Thickness - CCT): 68 subjects
- Precision portion: 44 subjects
Data Provenance: The study was a prospective clinical study. The country of origin is not explicitly stated, but the manufacturer is Tomey Corporation from Japan, and the contact person is in Andover, MA, USA, suggesting it could be a multi-site or US-based study, but this is not confirmed.

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

The document mentions that the clinical study results for the device measurements using the Core Method of analysis were based upon the use of a "reading center." However, it does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). This information is missing from the provided text.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It mentions a "reading center" was used for the "Core Method of analysis." This implies that images were processed and analyzed, likely by trained readers or technicians at this center, to derive the measurements (CD, CV, %HEX). The comparison is then made between the Tomey EM-4000's results and those derived from the predicate device by this reading center. It's not clear if there was a multi-reader consensus process or a single reader approach for the predicate device's "ground truth" derived by the reading center.

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

No, an MRMC comparative effectiveness study was not done.
This study is comparing a new device (Tomey EM-4000) to a predicate device (Konan CellChek XL) to demonstrate substantial equivalence based on their direct measurements of corneal parameters. It is not an AI-assisted human reader study; rather, it is a direct device-to-device comparison. Therefore, there's no reported effect size on how human readers improve with AI assistance.

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

The study primarily evaluates the standalone performance of the Tomey EM-4000 as a diagnostic device by comparing its measurements to those obtained from a predicate device. Both devices are instruments that perform measurements directly. The document states, "The EM-4000 analyzes and displays data such as cell number, cell density, coefficient of variation and percent hexagonality." This implies autonomous algorithmic processing of the captured images without continuous human intervention during the measurement process, although human setup/operation is expected. The "Core Method of analysis" mentioned for the reading center likely refers to the standard analytical algorithms used for both devices' outputs. So, yes, it's essentially a standalone device performance comparison.

7. The Type of Ground Truth Used

The "ground truth" in this study is the measurements obtained from the predicate device, the Konan CellChek XL. The objective is to demonstrate that the Tomey EM-4000 produces measurements that are in agreement with and precise relative to the established predicate device, thus establishing substantial equivalence. It is not pathology, outcomes data, or an independent expert consensus on the true biological value, but rather a comparative truth against a legally marketed device.

8. The Sample Size for the Training Set

The document does not provide information on a training set for the EM-4000. This is typical for a device validation study where the algorithm is presumably already developed and "trained" (if machine learning is involved) prior to clinical evaluation. The clinical study described here functions as a validation/test set to demonstrate comparative performance.

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

As no training set information is provided, there is no information on how its ground truth was established.

Summary

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January 19, 2018

Tomey Corporation % Ryan Bouchard, Official Correspondent Ora, Inc. 300 Brickstone Square Andover, MA 01810

Re: K171313

Trade/Device Name: EM-4000 Specular Microscope Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: NOE Dated: December 17, 2017 Received: December 19, 2017

Dear Ryan Bouchard:

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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.

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 -S

for Malvina 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)

K171313

Device Name EM-4000 Specular Microscopy

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)

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510(k) Summary

This summary of the 510(k) premarket notification for the Tomey EM-4000 Specular Microscope is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

Date Prepared: January 12, 2018

SPONSER/ 510(k) OWNER/ MANUFACTURER

Tomey Corporation 2-11-33 Noritakeshinmachi Nishi-ku, Nagoya 451-0051 JAPAN

CONTACT PERSON

Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9574 Facsimile: (978) 689-0020 E-mail: rbouchard@oraclinical.com

NAME OF DEVICE

Trade Name: EM-4000 Specular Microscope Common Name: Specular Microscope

DEVICE CLASSIFICATION/FDA REVIEWING BRANCH

The Ophthalmic Branch has classified AC Powered Slit Lamp Biomicroscopes as Class II devices pursuant to 21 C.F.R. §886.1850.

PRODUCT CODE: CLASSIFICATION / CFR TITLE

NQE, 21 CFR 886.1850

PREDICATE DEVICES Konan Medical, Inc. Cellchek XL (K120264)

INDICATIONS FOR USE

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PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Tomey EM-4000 Specular Microscope is substantially equivalent to the Konan Medical, Inc. Cellchek XL (K120264). The Tomey EM-4000 Specular Microscope has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicate device. The Tomey EM-4000 Specular Microscope and the predicate device are both non-contact ophthalmic microscopes, optical pachymeters, and cameras intended for examination of the corneal endothelium and for measurement of the thickness of the cornea.

The EM-4000 and the Konan Cellchek XL both utilize the general specular optical principle for imaging endothelial cells and performing pachymetry. The two devices use different light sources for measurement and focusing. However, compliance with ISO 15004-2 is documented. The EM-4000 uses a green LED for measurement and an infrared LED for focusing while the predicate device uses a Xe tube flash lamp for measurement and halogen lamp for focusing.

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Both devices measure cell number, cell density, coefficient of variation and percent hexagonality. The clinical performance data demonstrates the substantial equivalence of the EM-4000 to the Konan predicate device. Both the EM-4000 and the Konan Cellchek XL include an optical pachymeter with an accuracy of + 10 microns. Bench testing comparing the EM-4000 pachymetry functionality to the predicate device is provided. The non-clinical and clinical performance data demonstrated the substantial equivalence of the pachymetry measurements. For the measurements assessed, the Tomey EM-4000 Specular Microscope and predicate device results were found to be substantially equivalent.

NON-CLINICAL PERFORMANCE SUMMARY

The performance testing conducted using the EM-4000 verified that the device operates as intended. The pachymetry functionality was evaluated and the measurement accuracy of + 10 microns was confirmed.

Additionally, the EM-4000 was subjected to electrical safety testing in accordance with ANSI/AAMI ES60601-1, electromagnetic compatibility (EMC) testing in accordance with IEC 60601-1-2, and optical radiation safety testing in accordance with ISO 15004-1 and ISO 15004-2.

CLINICAL PERFORMANCE SUMMARY

A prospective clinical study was conducted to assess the agreement, accuracy and precision of the EM-4000 by comparing results across three machines/operators to those obtained with the predicate device, the Konan Cellchek XL. Three populations were studied: young (18-28 years of age) and adult (29-80 vears of age) healthy subjects and pathologic adult eves (29-80 vears of age).

There were 70 subjects enrolled in the study: 25 in the non-pathologic voung eye population, 23 in the non-pathologic adult eye population, and 22 in the pathologic adult eye population. Of those, 67 were included in the effectiveness population for the agreement portion of the study for the specular microscope variables. For the central corneal thickness (CCT) variable, 68 subjects were included in the effectiveness population.

Of the 70 enrolled subjects, 44 were included in the population for the precision portion of the study: 14 in the non-pathologic young eye population, 15 in the non-pathologic adult eye population, and 15 in the pathologic adult eye population.

The agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with predicate device measurements of

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Percent Hexagonality <45, Coefficient of Variation >0.40, or Cell Density <1900. Agreement and variability of the analysis methods is not known for eyes with parameters beyond these values.

The clinical study results for the device measurements using the Core Method of analysis were based upon the use of a reading center

Endothelial Cell Density

For the Core Method, the mean difference for endothelial cell density (CD) was -6.49%. . The mean differences for endothelial cell density are illustrated on the Bland Altman plot (Figure 1). Plots of the device differences by the CellChek XL value are presented (Figure 2). The Deming regression lines showed an associated correlation value of 0.9634 (Figure 3). Table 1 provides a summary of the agreement data for all subjects with the Core Method.

Figure 1 Bland-Altman Plot - Observed Data - Endothelial Cell Density (CD) -Core Method- All Subjects - Effectiveness Population

Image /page/6/Figure/5 description: This image is a scatter plot with the title missing. The x-axis is labeled "Mean" and ranges from 600 to 3600. The y-axis is labeled "Difference" and ranges from -1000 to 400. There are three horizontal lines on the plot, one red and two green, and the data points are clustered in the middle of the plot.

Note: The red line is the mean and the green lines are the Limits of Agreement (LOAs). The differences are calculated as (Tomey EM-4000) - (Konan CellChek XL).

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Device Difference by Konan CellChek XL Value – Endothelial Cell Figure 2 Density (CD) – Core Method-All Subjects – Effectiveness Population

Image /page/7/Figure/1 description: This image is a scatter plot with the title "Konan CELLCHEK XL Value" on the x-axis and "Device Difference" on the y-axis. The x-axis ranges from 600 to 3600, while the y-axis ranges from -1000 to 400. The data points are clustered between x values of 2000 and 3400, and y values of -500 to 100.

The differences are calculated as (Tomey EM-4000) - (Konan CellChek XL).

Deming Regression Plot – Tomey EM-4000 by Konan CellChek XL – Figure 3 Endothelial Cell Density (CD) - Core Method - All Subjects - Effectiveness Population

Image /page/7/Figure/4 description: This image is a scatter plot that compares Tomey Value and Konan CELLCHEK XL. The x-axis represents Konan CELLCHEK XL, ranging from 600 to 3600, while the y-axis represents Tomey Value, ranging from 400 to 3600. The plot includes a Deming Regression Line and a 45 Degree Line, which are used to analyze the relationship between the two variables. The data points are clustered along the lines, indicating a positive correlation between Tomey Value and Konan CELLCHEK XL.

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	CD	CV	% HEX	CCT
Tomey Specular Microscope EM-4000
N	67	67	67	68
Mean (SD)	2504.6(443.68)	31.8 (3.83)	60.3 (6.54)	542.1 (41.88)
Median	2604.0	31.0	60.0	543.5
Min-Max	650-3161	24-42	41-77	416 - 644
Konan CellChek XL
N	67	67	67	67
Mean (SD)	2674.3(454.08)	31.5 (4.18)	60.8 (8.61)	559.9 (42.25)
Median	2778.0	32.0	60.0	560.5
Min- Max	990-3472	21-40	33-80	441 - 677
Device Comparisons
Mean Difference (SD)	-169.7(121.95)	0.3 (3.49)	-0.4 (7.38)	-17.8 (22.57)
Mean Difference (SD) as a	-6.49%(5.648%)	1.65%(11.304%)	0.70%(15.091%)	-3.11%(3.995%)
95% LOA	(-413.6, 74.2)	(-6.7, 7.3)	(-15.2, 14.3)	(-62.9, 27.4)
Correlation (R)	0.9634	0.6226	0.5549	0.8561
DemingRegressionIntercept (95% CI)	-106.1(-387.7, 175.4)	4.4 (-4.0, 12.8)	22.9 (2.5, 43.3)	66.9(-3.8, 137.6)
Deming Regression Slope(95% CI)	1.0 (0.9, 1.1)	0.9 (0.6, 1.1)	0.6 (0.3, 0.9)	1.0 (0.9, 1.1)

Core Method: Corneal Specular Microscopic Variables Assessed with Table 1 the Two Devices – All Configurations – All Subjects – Effectiveness Population

Abbreviations: CD = endothelial cell density; CI = confidence interval; CV = coefficient of variation of endothelial cell area; HEX = hexagonality; LOA = limits of agreement; SD = standard deviation

For subjects in the Precision and Agreements from the first acceptable images from each machine within the same configuration are used for the agreement analyses.

The mean differences are calculated as (Tomey Specular Microscope EM-4000) - (Konan CellChek XL).

The mean differences as a % of the CellChek reading are calculated for each subject first and then summarized.

Coefficient of Variation (CV) of Endothelial Cell Area

For the Core Method, for all configurations and all subjects, the Tomey EM-4000 mean (SD) difference, as illustrated on the Bland Altman plots (Figure 4) was 1.65% (SD 11.304%). Plots of the device difference by the CellChek XL value are presented in (Figure 5). The Deming regression lines showed an associated value of 0.6226 (Figure 6).

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Bland-Altman Plot – Observed Data – Coefficient of Variation Figure 4 Endothelial Cell Area (CV) - Core Method - All Subjects - Effectiveness Population

Image /page/9/Figure/1 description: This image is a scatter plot with the title 'Difference' on the y-axis and 'Mean' on the x-axis. The x-axis ranges from 20 to 48, while the y-axis ranges from -10 to 25. There are two horizontal green lines at approximately y=7 and y=-7, and a horizontal red line at y=0. The scatter plot contains numerous blue data points.

Note: The red line is the mean and the green lines are the Limits of Agreement (LOAs). The differences are calculated as (Tomey EM-4000) - (Konan CellChek XL).

Device Difference by Konan CellChek XL Value - Coefficient of Figure 5 Variation Endothelial Cell Area (CV) - Core Method - All Subjects - Effectiveness Population

Image /page/9/Figure/4 description: This image is a scatter plot with the title "Device Difference" on the y-axis and "Konan CELLCHEK XL Value" on the x-axis. The x-axis ranges from 20 to 44, while the y-axis ranges from -10 to 25. The data points are scattered across the plot, showing the relationship between the two variables. Most of the data points are between 24 and 40 on the x axis.

The differences are calculated as (Tomey EM-4000) - (Konan CellChek XL).

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Deming Regression Plot - Tomey EM-4000 by Konan CellChek XL -Figure 6 Coefficient of Variation Endothelial Cell Area (CV) - Core Method - All Subjects -Effectiveness Population

Image /page/10/Figure/1 description: This image is a scatter plot that compares Tomey values to Konan CELLCHEK XL values. The x-axis represents the Konan CELLCHEK XL values, ranging from 10 to 60, while the y-axis represents the Tomey values, ranging from 10 to 70. The plot includes a Deming Regression Line and a 45 Degree Line, which are used to analyze the relationship between the two sets of values. The data points are clustered between 25 and 40 on the x-axis and 25 and 45 on the y-axis.

Percent Hexagonality

For the Core Method, for all configurations and all subjects, the Tomey EM-4000 mean (SD) % HEX compared to the CellChek XL was 0.70% (SD 15.091%). Bland Altman plots with data as a percentage of the mean are presented in Figure 7. Plots of the device difference by the CellChek XL value are presented in Figure 8. The Deming regression lines showed an associated correlation value of 0.5549 (Figure 9).

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Figure 7 Bland-Altman Plot – Observed Data – % Hexagonality (HEX) – Core Method - All Subjects - Effectiveness Population

Image /page/11/Figure/1 description: The image is a scatter plot with two axes labeled "Mean" and "Difference". The x-axis, "Mean", ranges from 30 to 80, while the y-axis, "Difference", ranges from -50 to 30. A red horizontal line is at y=0, and two green horizontal lines are at approximately y=14 and y=-14. The scatter plot shows a cluster of points mostly between x=50 and x=70, with a few outliers.

Note: The red line is the mean and the green lines are the Limits of Agreement (LOAs). The differences are calculated as (Tomey EM-4000) - (Konan CellChek XL).

Device Difference by CellChek XL Value – % Hexagonality – Core Figure 8 Method - All Subjects - Effectiveness Population

Image /page/11/Figure/4 description: This image is a scatter plot with the x-axis labeled "Konan CELLCHEK XL Value" ranging from 30 to 90, and the y-axis labeled "Device Difference" ranging from -50 to 30. The data points are clustered, showing a negative correlation between the two variables. As the Konan CELLCHEK XL Value increases, the Device Difference tends to decrease.

The differences are calculated as (Tomey EM-4000) - (Konan CellChek XL).

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Deming Regression Plot - Tomey EM-4000 by Konan CellChek XL -Figure 9 % Hexagonality (HEX) - Core Method - All Subjects - Effectiveness Population

Image /page/12/Figure/1 description: This image is a scatter plot comparing "Tomey Value" and "Konan CELLCHEK XL". The x-axis represents "Konan CELLCHEK XL" with values ranging from 30 to 90, while the y-axis represents "Tomey Value" with values ranging from 10 to 110. The plot includes two lines: a blue line labeled "Deming Regression Line" and a red dashed line labeled "45 Degree Line", along with scattered blue points representing the data.

Central Corneal Thickness

For the Core Method, for all configurations and all subjects, the Tomey EM-4000 mean (SD) CCT compared to the CellChek XL was -3.11% (SD 3.995%). Bland Altman plots with data as a percentage of the mean are presented in Figure 10. Plots of the device difference by the CellChek XL value are presented in Figure 11. The Deming regression lines showed an associated correlation value of 0.8561 (Figure 12).

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Bland-Altman Plot -- Observable Data -- Central Corneal Thickness (CCT) --Figure 10 Core Method – All Subjects – Effectiveness Population

Image /page/13/Figure/1 description: This image is a scatter plot with the title "Difference" on the y-axis and "Mean" on the x-axis. The x-axis ranges from 400 to 700, while the y-axis ranges from -70 to 50. There are three horizontal lines on the plot at approximately -65, -18, and 28.

Note: The red line is the mean and the green lines are the LOAs. The differences are calculated as (Tomey EM-4000) – (Konan CellChek XL)

Device Difference by CellCheck XL Value – Central Corneal Thickness (CCT) Figure 11 - Core Method - All Subject - Effectiveness Population.

Image /page/13/Figure/4 description: This image is a scatter plot with the title "Device Difference" on the y-axis and "Konan CELLCHEK XL Value" on the x-axis. The x-axis ranges from 400 to 750, while the y-axis ranges from -70 to 40. The scatter plot shows a cluster of blue points, indicating the relationship between the two variables. The points are concentrated between x values of 500 and 600.

The differences are calculated as (Tomey EM-4000) - (Konan CellChek XL)

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Figure 12 Deming Regression Plot – Tomey EM-4000 by Konan CellChek XL – Central Corneal Thickness (CCT) – Core Method – All Subjects – Effectiveness Population

Image /page/14/Figure/1 description: This image is a scatter plot comparing Tomey Value and Konan CELLCHEK XL. The x-axis represents Konan CELLCHEK XL, ranging from 400 to 750, while the y-axis represents Tomey Value, also ranging from 400 to 750. The plot includes a Deming Regression Line and a 45 Degree Line, providing a visual comparison between the two measurement methods.

Table 2 Core Method: Precision Analyses - All Subjects - Effectiveness Population

Variable	Tomey EM-4000N=44	Konan CellChekN=44
Endothelial Cell Density
Repeatability SD	49.9	65.9
Repeatability SD as a % of the Mean	2.0%	2.5%
Repeatability Limit	139.6	184.4
Repeatability Ratio (TOMEY EM-4000/Konan CellChek XL)	0.7570	--
Reproducibility SD	54.6	72.7
Reproducibility SD as a % of the Mean	2.2%	2.8%
Reproducibility Limit	152.9	203.4
Reproducibility Ratio (TOMEY EM-4000/Konan CellChek XL)	0.7514	--
Variable	Tomey EM-4000N=44	Konan CellChekN=44
Coefficient of Variation of Endothelial CellArea (CV)
Repeatability SD	2.0	2.2
Repeatability SD as a % of the Mean	6.1%	7.1%
Repeatability Limit	5.5	6.1
Repeatability Ratio (TOMEY EM-4000/Konan CellChek XL)	0.8925	---
Reproducibility SD	2.1	2.3
Reproducibility SD as a % of the Mean	6.5%	7.4%
Reproducibility Limit	5.8	6.4
Reproducibility Ratio (TOMEY EM-4000/Konan CellChek XL)	0.9062	---
% Hexagonality
Repeatability SD	3.6	4.3
Repeatability SD as a % of the Mean	5.9%	6.8%
Repeatability Limit	10.1	11.9
Repeatability Ratio (TOMEY EM-4000/Konan CellChek XL)	0.8449	---
Reproducibility SD	4.0	4.3
Reproducibility SD as a % of the Mean	6.5%	6.9%
Reproducibility Limit	11.2	12.0
Reproducibility Ratio (TOMEY EM-4000/Konan CellChek XL)	0.9271	---
Central Corneal Thickness (CCT)
Repeatability SD	5.9	17.7
Repeatability SD as a % of the Mean	1.1%	3.1%
Repeatability Limit	16.4	49.7
Repeatability Ratio (TOMEY EM-4000/Konan CellChek XL)	0.3298	---
Reproducibility SD	7.6	26.6
Reproducibility SD as a % of the Mean	1.4%	4.7%
Reproducibility Limit	21.4	74.4
Reproducibility Ratio (TOMEY EM-4000/Konan CellChek XL)	0.2874	---

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Abbreviations: SD = standard deviation

N represents the total number of subjects in each eye population in the precision and agreement cohort. If any variance component was negative, it was reported as 0. The repeatability limit is 2.8 times the repeatability standard deviation, which is the square root of the residual within subject variance component. The reproducibility limit is 2.8 times the reproducibility standard deviation, which is the square root of the variance components of operator+device, operator+device x subject interaction, and residual within subject.

Overall, within eye/subject variability results were reasonably similar for both machines for the parameters measured, as seen in Table 2. The precision of the two devices was assessed with repeatability and reproducibility measures: the first within a given subject and the second

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within and among configurations. With regard to overall precision, using the core method, the largest component of variation was the subject to subject variation. The EM-4000 machine was slightly less variable than the CellChek XL machine for all variables: CD, CV, %HEX and CCT.

In summary, for the parameters measured the agreement and precision results of the Tomey EM-4000 core method and the Konan CellChek XL center method were found to be substantially equivalent.

CONCLUSIONS

The Tomey EM-4000 has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicate. The differences between the subject device and the predicate device have been assessed in a human clinical trial which found agreement, accuracy and precision between the two devices. Therefore, the Tomey EM-4000 and the predicate device were determined to be substantially equivalent.

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.