(288 days)
No
The description mentions "computer-assisted cell counting and cell analysis capabilities" and an "automatic algorithm" for detecting cells and boundaries, but it also explicitly states the user can make corrections and that the manual method involves user identification. There is no mention of learning, training data for the algorithm itself (only for the performance study), or any terms typically associated with AI/ML like neural networks, deep learning, etc. The "automatic algorithm" appears to be a deterministic image processing algorithm rather than a learned model.
No
The device is used for examination and measurement, which are diagnostic functions, not therapeutic. It does not treat or cure any condition.
Yes
The device is intended for examination of the corneal endothelium and for measurement of the thickness of the cornea, which involves identifying and quantifying characteristics (cell density, coefficient of variation of cell area, percent hexagonality) that aid in diagnosis or understanding of a medical condition.
No
The device description explicitly mentions hardware components such as a non-contact ophthalmic microscope, optical pachymeter, camera, forehead rest, and chin rest. While it includes software for analysis, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope that examines the corneal endothelium and measures corneal thickness in situ (on the living patient). It does not involve the collection or analysis of specimens taken from the body.
- Intended Use: The intended use is for examination and measurement of the cornea, not for analyzing biological samples.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Konan Specular Microscope XVII, CellChek 20, 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.
Product codes (comma separated list FDA assigned to the subject device)
NQE
Device Description
The Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis program are included, and allow for analysis of the images of the cell distribution of the eye.
When photographing the corneal endothelium, the device performs the alignment and automatically focuses by capturing the reflected light from patient's eye with the camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, as well as computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory and can be preserved by using a printer.
Both the image of the corneal endothelium and the various computerized control functions are displayed on the touch screen monitor.
The parts of the device that come into contact with a patient are the forehead rest and the chin rest. Their material is acrylonitrile butadiene styrene (ABS), the same material used in reference device and one with proven biocompatibility.
The function of the software installed in the device is to calculate mainly the cell density, the coefficient of variation of cell area and the percent hexagonality. In the manual methods, Actual identification if the cells and cell boundaries is done by the (physician) user. In the automatic method, the software detects the cells and cell boundaries, however, the user is given the opportunity to make corrections. In use, the user interacts with the software by visually placing dots in the center of cells as or by tracing cell boundaries as they appear or on a screen or uses the automatic algorithm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Reflected light imaging (ophthalmic microscope)
Anatomical Site
Corneal endothelium, Cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Ophthalmic clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Sample Size: 80 subjects (55 females, 25 males)
Data Source: Patients from an ophthalmic clinic. Right eyes were primarily photographed; left eyes were photographed if the right could not be clearly photographed.
Annotation Protocol: Three analysts analyzed the examinees' images with each of the 6 methods of CellChek 20 (Center Method, Auto Center Method, Trace Method, Auto Trace Method, Flex Center Method, Auto Flex Center Method) and the Center Method of the reference device NONCON ROBO PACHY F&A.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective clinical study, Non-clinical testing.
Sample Size: 80 subjects for the clinical study.
Key Results:
- Non-Clinical Testing:
- Electrical safety testing per ANSI/AAMI ES 60601-1.
- Electromagnetic compatibility (EMC) testing per IEC 60601-1-2.
- Performance testing per ISO 15004-1.
- Optical radiation safety testing per ANSI Z80.36.
- Software validation testing per IEC 62304.
- Clinical Performance Testing (Agreement/Accuracy Analysis):
- Comparison between subject device (Konan Specular Microscope XVII, CellChek 20) and reference device (NONCON ROBO PACHY F&A) using Center Method:
- Cornea Measuring Area: Center Area (N=80)
- CD: Subject device average (SD) 2932.7 (527.83) vs reference device 2717.1 (486.74). Average difference (SD) 215.6 (151.15). R² = 0.9193.
- CV: Subject device average (SD) 34.0 (5.73) vs reference device 33.8 (5.12). Average difference (SD) 0.3 (3.85). R² = 0.5677.
- HEX: Subject device average (SD) 59.9 (7.05) vs reference device 58.1 (7.42). Average difference (SD) 1.8 (7.27). R² = 0.2460.
- Cornea Measuring Area: Peripheral Area (N=80)
- CD: Subject device average (SD) 2969.5 (507.65) vs reference device 2782.4 (464.10). Average difference (SD) 187.1 (144.61). R² = 0.9209.
- CV: Subject device average (SD) 34.4 (6.36) vs reference device 33.5 (5.25). Average difference (SD) 0.8 (4.57). R² = 0.4974.
- HEX: Subject device average (SD) 59.8 (6.00) vs reference device 58.8 (6.98). Average difference (SD) 1.0 (7.28). R² = 0.1439.
- Cornea Measuring Area: Center Area (N=80)
- Comparison between different analysis methods of the subject device (Center Method vs. Trace, Auto Trace, Auto Center, Flex Center, Auto Flex Center Methods) for Center Area (N=80):
- Very high correlations were observed across all variables (CD, CV, HEX) for Trace, Auto Trace, Auto Center, Flex Center, and Auto Flex Center methods when compared to the Center Method of the subject device. (R² values often >0.8 generally, with CD R² consistently near 0.99 for most comparisons.)
- Comparison between subject device (Konan Specular Microscope XVII, CellChek 20) and reference device (NONCON ROBO PACHY F&A) using Center Method:
- Precision Analysis (Repeatability and Reproducibility):
- Measured for CD, CV, and HEX for Center and Peripheral areas.
- For Center Method of subject device, repeatability and reproducibility were superior to the reference device.
- For Auto Trace, Auto Center, and Auto Flex Center methods of the subject device, repeatability and reproducibility were "very superior" to the reference device.
- For Trace Method and Flex Center Method of the subject device, repeatability and reproducibility were "partially superior to or equivalent with" the reference device.
Conclusion: The agreement, accuracy, and precision of the Konan Specular Microscope XVII, CellChek 20 demonstrates that it is substantially equivalent to the NONCON ROBO PACHY F&A. Based on the current results and K120264 studies, the subject device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include Corneal Endothelial Cell Density (CD), Coefficient of Variation (CV), and Hexagonality (HEX). The performance was assessed through:
- Average Difference (SD)
- Average Difference (SD) as a % of reference device reading
- 95% LOA (Limits of Agreement)
- Correlation (R²)
- Deming Regression Intercept (95% CI)
- Deming Regression Slope (95% CI)
- Repeatability SD and as a% of Average
- Repeatability limit
- Repeatability Ratio (CellChek 20/F&A)
- Reproducibility SD and as a% of Average
- Reproducibility limit
- Reproducibility Ratio (CellChek 20/F&A)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 26, 2020
Konan Medical, Inc. % Alan Donald President Matrix Medical Consulting Inc 8880 Rio San Diego Drive Suite 800 San Diego, California 92108
Re: K191558
Trade/Device Name: Konan Specular Microscope XVII Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: NQE Dated: February 12, 2020 Received: February 18, 2020
Dear Alan Donald:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elvin Ng Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| Indications for Use | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K191558 |
| Device Name | Konan Specular Microscope XVII |
| Indications for Use (Describe) | The Konan Specular Microscope XVII, CellChek 20, 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. |
| 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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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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510(k) Summary
4
The following 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
510(k) Summary
Submitter Information
| A. Company Name: | Konan Medical, Inc. |
|---|---|
| B. Company Address: | 10-29, Miyanishicho, Nishinomiya |
| Hyogo 662-0976, Japan | |
| C. Company Phone: | +81-798-36-3456 |
| D. Company facsimile: | +81-798-26-1028 |
| E. Contact Person: | Tatsuya Kasahara |
| F. Date Summary Prepared: | March 23, 2020 |
Device Identification
| A. Device Trade Name: | Konan Specular Microscope XVII, CellChek 20 |
|---|---|
| B. Common Name: | Specular Microscope |
| C. Classification Name(s): | AC-powered Slit Lamp Biomicroscope |
| D. Classification Regulation(s): | 886.1850 |
| E. Device Class: | Class 2 |
| F. Product Codes: | NQE |
| G. Advisory Panel: | Ophthalmic |
Identification of Predicate Device
The predicate device is the Konan Specular Microscope XIV, CellChek Plus, which was cleared by FDA under 510(k) number K120264 on April 11, 2012. In addition, the company has utilized the NONCON ROBO PACHY F&A, K062763, as a reference device.
5
Device Description
The Konan Specular Microscope XVII, CellChek 20, is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea. Cell counting and analysis program are included, and allow for analysis of the images of the cell distribution of the eye.
When photographing the corneal endothelium, the device performs the alignment and automatically focuses by capturing the reflected light from patient's eye with the camera. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, as well as computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory and can be preserved by using a printer.
Both the image of the corneal endothelium and the various computerized control functions are displayed on the touch screen monitor.
The parts of the device that come into contact with a patient are the forehead rest and the chin rest. Their material is acrylonitrile butadiene styrene (ABS), the same material used in reference device and one with proven biocompatibility.
The function of the software installed in the device is to calculate mainly the cell density, the coefficient of variation of cell area and the percent hexagonality. In the manual methods, Actual identification if the cells and cell boundaries is done by the (physician) user. In the automatic method, the software detects the cells and cell boundaries, however, the user is given the opportunity to make corrections. In use, the user interacts with the software by visually placing dots in the center of cells as or by tracing cell boundaries as they appear or on a screen or uses the automatic algorithm.
Indication for Use
The Konan Specular Microscope XVII, CellChek 20, 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.
6
Technological Characteristics
The Konan Specular Microscope XVII, CellChek 20, is technically equivalent to the Konan specular Microscope XIV, CellChek Plus. One of the principal design modifications for the device is that the mechanical unit used for alignment has changed. The mechanical unit of CellChek 20 has only three axes which work for X (right - left) - Y (up - down) - Z (forward - backward) alignment between the optics and a patient's eye. Therefore the patient needs to fixate on a peripheral target to obtain an image of endothelial cells at the peripheral position over the cornea. Another of the principal design modifications for the device is that the data analysis method has changed. The data analysis of CellChek 20 method consists of the Trace method with/without Auto-trace (which does not need to input parameter S, M, L or XL for analysis), the Center method with/without Auto-input (which uses the same algorithm as Auto-trace) and the Flex Center method with/without Auto-input (which uses the same algorithm as Auto-trace). A smaller CPU board (mother board) was implemented, and a new computer program was installed for the mechanical system and the data analysis system of CellChek 20.
| Comparative table between CellChek Plus and CellChek 20 | |||
|---|---|---|---|
| Model name | CellChek Plus | CellChek 20 | Comparison |
| 510(k) No. | K120264 | To Be Assigned by | |
| FDA | |||
| Device name | |||
| registered | Konan Specular | ||
| Microscope XIV | Konan Specular | ||
| Microscope XVII | |||
| Intended use | The device 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 | The device is a | ||
| non-contact | |||
| ophthalmic | |||
| microscope, optical | |||
| pachymeter, and | |||
| camera intended for | |||
| examination of the | |||
| corneal endothelium | |||
| and for measurement | |||
| of the thickness of | Same | ||
| cornea. | the cornea. | ||
| Composition | The device is | ||
| composed of the | |||
| optical unit, the | |||
| mechanical unit, the | |||
| electrical unit and the | |||
| display. | The device is | ||
| composed of the | |||
| optical unit, the | |||
| mechanical unit and | |||
| the power unit which | |||
| includes the electrical | |||
| unit and the display. | Different on expression. | ||
| No safety/effectiveness | |||
| concern. | |||
| Appearance | Image: Slit lamp | Image: Slit lamp | Different. |
| No safety/effectiveness | |||
| concern. | |||
| Size | 683(H) x 365(W) x | ||
| 451(D) mm | 451(H) x 310(W) x | ||
| 459(D) mm | Different. | ||
| No safety/effectiveness | |||
| concern. | |||
| Electric rating | Voltage: 100-230VAC | ||
| Frequency: 50/60Hz, | |||
| Power: 150VA | Voltage: | ||
| 100-240VAC | |||
| Frequency: 50/60Hz | |||
| Power: 100VA | Almost same | ||
| No safety/effectiveness | |||
| concern. | |||
| Class (Electrical | |||
| Safety) | Class I | ||
| Type B applied part | Class I | ||
| Type B applied part | Same | ||
| Operating | |||
| Principle | The photographing | ||
| the corneal | |||
| endothelium, the | |||
| device performs the | |||
| alignment and | |||
| automatically focuses | |||
| by capturing the | |||
| reflected light from the | |||
| patient's eye with the | |||
| camera. | The photographing | ||
| the corneal | |||
| endothelium, the | |||
| device performs the | |||
| alignment and | |||
| automatically | |||
| focuses by capturing | |||
| the reflected light | |||
| from the patient's eye | |||
| with the camera. | Different on axes. | ||
| No safety/effectiveness | |||
| concern. | |||
| The alignment is | |||
| performed by 5 axes | |||
| which are X (back and | |||
| forth), Y (right and | |||
| left), Z (up and down) | |||
| θX (horizontal turn) | |||
| and θY (vertical turn). | The alignment is | ||
| performed by 3 axes | |||
| which are X (back | |||
| and forth), Y (right | |||
| and left) and Z (up | |||
| and down). | |||
| Photographed | |||
| Area | 0.24 x 0.46 mm² | 0.25 x 0.55 mm² | Almost same. |
| No safety/effectiveness | |||
| concern. | |||
| Analysis | |||
| method | CellChek software: | ||
| Corner method | |||
| Auto trace method | |||
| Center method |
Flex Center method
---------- | CellChek software:
Trace method
Auto Trace method
Center method
Auto Center
method
F Center method
Auto F Center
method | Different (Algorithm of
Trace method, Center
method and F center
method has not
changed).
No safety/effectiveness
concern.
• Nomenclature was
changed "Corner
method" to "Trace
method" and "Flex
Center method" to
"F Center method".
• The Auto trace
method does not
need to input
parameter S, M, L
or XL for analysis.
• "Auto Center
method" and "Auto
F Center method"
were added. They
use the same |
| Materials of
Patient
Contacting
Parts | PTFE (forehead rest)
and ABS resin (chin
rest) | ABS resin (forehead
rest and chin rest) | algorithm of “Auto
Trace method” and
the center point of
the endothelial cell
is calculated as the
gravity point of the
endothelial cell by
“Auto Trace
method”.
Different.
No safety/effectiveness
concern.
Material of
forehead rest was
changed to the
same material of
chin rest. |
7
8
9
Summary of Testing
-
A. Non Clinical Testings
The following testing was performed on the Konan Specular Microscope XVII, CellChek 20: -
The CellChek 20 device was subjected to electrical safety testing in accordance with ANSI/AAMI ES 60601-1.
-
The CellChek 20 device was subjected to electromagnetic compatibility (EMC) testing in accordance with IEC 60601-1-2.
-
The CellChek 20 device was subjected to performance testing in accordance with ISO 15004-1.
-
The CellChek 20 device was subjected to optical radiation safety testing in accordance with ANSI Z80.36.
-
The CellChek 20 device was subjected to software validation testing in accordance with IEC 62304.
Performance Testing - Clinical
10
A prospective clinical study was conducted to assess the agreement, accuracy, and precision of the Konan Specular Microscope XVII, CellChek 20 by comparing the analytical results obtained with the NONCON ROBO PACHY F&A, a reference device, and also the predicate device for the Konan Specular Microscope XIV, CellChek Plus. This clinical performance testing includes the assessment of the agreement, accuracy, and precision of each of the 6 analysis methods, Trace Method, Auto Trace Method, Center Method, Auto Center Method, Flex Center Method, and Auto Flex Center Method of Konan Specular Microscope XVII, CellChek 20 by comparing with Center Method of NONCON ROBO PACHY F&A.
The examinees are all of the patients who came to the ophthalmic clinic, which has agreed to cooperate with this study, after the study start date. Some of the ophthalmic staffs basically photographed the right eyes of the examinees with Konan Specular Microscope XVII, CellChek 20 and NONCON ROBO PACHY F&A. However, when their right eyes could not be clearly photographed, the left eyes were photographed. Three analysts analyzed the examinees' images with each of the 6 methods, Center Method, Auto Center Method, Trace Method, Auto Trace Method, Flex Center Method, Auto Flex Center Method, of CellChek 20, and Center Method of F&A.
This study protocol pre-described criteria for the agreement limits is that the analysis result of each of the methods of CellChek 20 has a positive correlation with that of Center Method of F&A.
The mean (SD) age of the 80 subjects, whose breakdown was 55 females and 25 males, of this study was 65.6 (10.8) years.
No adverse events occurred in any examinees during this study. Additionally, no other safety issues of any kinds arose from the subject device and the reference device. The instruments of both of the devices were found to be safe and reliable in the assessment of corneal function.
The primary efficiency endpoints are the agreement and precision of the 3 variables, that is, Corneal Endothelial Cell Density, Coefficient of Variation, and Hexagonality (hereinafter mentioned as CD, CV, and HEX, respectively). The discussion on the results of this performance testing is shown as follows.
11
l. Agreement/Accuracy Analysis (Comparison between subject device and reference device)
-
- Cornea Measuring Area: Center Area
Analysis Method: Center Method of Subject Device and Reference Device
- Cornea Measuring Area: Center Area
Table 1 Three Corneal Specular Microscopic Variables Assessed with Center Method of Subject Device and Reference Device – Center area
| N=80 | CD (/mm²) | CV (%) | HEX (%) |
|---|---|---|---|
| NONCON ROBO PACHY F&A (Reference Device) | |||
| Average (SD) | 2717.1 (486.74) | 33.8 (5.12) | 58.1 (7.42) |
| Median | 2738.5 | 33.0 | 58.3 |
| Min - Max | 849 - 3937 | 25 - 56 | 37 - 77 |
| Konan Specular Microscope XVII, CellChek 20 (Subject Device) | |||
| Average (SD) | 2932.7 (527.83) | 34.0 (5.73) | 59.9 (7.05) |
| Median | 2915.9 | 33.2 | 59.9 |
| Min - Max | 816 - 4532 | 25 - 52 | 40 - 74 |
| Device Comparisons | |||
| Average Difference (SD) | 215.6 (151.15) | 0.3 (3.85) | 1.8 (7.27) |
| Average Difference (SD) as | |||
| a % of F&A reading | 7.94% (5.563%) | 0.74% (11.403%) | 3.08% (12.523%) |
| 95% LOA | (-86.7, 517.9) | (-7.5, 8.0) | (-12.8, 16.3) |
| Correlation (R²) | 0.9193 | 0.5677 | 0.2460 |
| Deming Regression | |||
| Intercept (95% CI) | 107.6 (105.8, 109.4) | 5.5 (3.6, 7.5) | 32.5 (30.6, 34.5) |
| Deming Regression Slope | |||
| (95% CI) | 1.0 (1.0, 1.0) | 0.8 (0.8, 0.9) | 0.5 (0.4, 0.5) |
Abbreviations: CD = corneal endothelial cell density; CI = confidence interval; CV = coefficient of
variation; HEX = hexagonality; LOA = limits of agreement; SD = standard deviation
The average differences were calculated as (Konan Specular Microscope XVII, CellChek 20) -
(NONCON ROBO PACHY F&A).
The average differences as a % of NONCON ROBO PACHY F&A reading were calculated by dividing the average differences with the averages of the reference device.
The 95% LOA's were calculated as the average differences +/- 2SD's.
12
a) CD
Corneal endothelial cell density as measured with the subject device had the average (SD) of 2932.7 (527.83) compared with those of 2717.1 (486.74) for the reference device. The average difference (SD) were 215.6 (151.15).
The Deming regression lines had the associated R2 value of 0.9193.
b)
Coefficient of Variation as measured with the subject device had the average (SD) of 34.0 (5.73) compared with those of 33.8 (5.12) for the reference device. The average difference (SD) were 0.3 (3.85).
The Deming regression lines had the associated R2 value of 0.5677.
c)
Percent of Hexagonality as measured with the subject device had the average (SD) of 59.9 (7.05) compared with those of 58.1 (7.42) for the reference device. The average difference (SD) were 1.8 (7.27).
The Deming regression lines had the associated R2 value of 0.2460.
2) Cornea Measuring Area: Peripheral Area
Analysis Method: Center Method of Subject Device and Reference Device
| Table 2 Three Corneal Specular Microscopic Variables Assessed with Center Method of Subject | ||||||
|---|---|---|---|---|---|---|
| Device and Reference Device – Peripheral Area |
| N=80 | CD (/mm²) | CV (%) | HEX (%) |
|---|---|---|---|
| NONCON ROBO PACHY F&A (Reference Device) | |||
| Average (SD) | 2782.4 (464.10) | 33.5 (5.25) | 58.8 (6.98) |
| Median | 2825.0 | 32.9 | 59.0 |
| Min – Max | 884 - 3802 | 23 - 55 | 34 - 76 |
| Konan Specular Microscope XVII, CellChek 20 (Subject Device) | |||
| Average (SD) | 2969.5 (507.65) | 34.4 (6.36) | 59.8 (6.00) |
| Median | 3007.5 | 33.7 | 59.9 |
| Min – Max | 904 - 4021 | 25 - 61 | 42 - 71 |
| Device Comparisons | |||
| Average Difference (SD) | 187.1 (144.61) | 0.8 (4.57) | 1.0 (7.28) |
| Average Difference (SD) as | |||
| a % of F&A reading | 6.72% (5.197%) | 2.46% (13.642%) | 1.67% (12.375%) |
13
510(k) Summary – Konan Specular Microscope XVII, CellChek 20
| 95% LOA | (-102.1, 476.3) | (-8.3, 10.0) | (-13.6, 15.5) |
|---|---|---|---|
| Correlation (R2) | 0.9209 | 0.4974 | 0.1439 |
| Deming Regression | |||
| Intercept (95% CI) | 48.8 (46.9, 50.8) | 5.7 (3.8, 7.6) | 40.6 (38.6, 42.6) |
| Deming Regression Slope | |||
| (95% CI) | 1.0 (1.0, 1.1) | 0.9 (0.8, 0.9) | 0.3 (0.3, 0.4) |
Abbreviations: CD = corneal endothelial cell density; CI = confidence interval; CV = coefficient of
variation; HEX = hexagonality; LOA = limits of agreement; SD = standard deviation
The average differences were calculated as (Konan Specular Microscope XVII, CellChek 20) -
(NONCON ROBO PACHY F&A).
The average differences as a % of NONCON ROBO PACHY F&A reading were calculated by dividing the average differences with the averages of the reference device.
The 95% LOA's were calculated as the average differences +/- 2SD's.
a) CD
Corneal endothelial cell density as measured with the subject device had the average (SD) of 2969.5 (507.65) compared with those of 2782.4 (464.10) for the reference device. The average difference (SD) were 187.1 (144.61).
The Deming regression lines had the associated R2 value of 0.9209.
b)
Coefficient of Variation as measured with the subject device had the average (SD) of 34.4 (6.36) compared with those of 33.5 (5.25) for the reference device. The average difference (SD) were 0.8 (4.57).
The Deming regression lines had the associated R2 value of 0.4974.
c) HEX
Percent of Hexagonality as measured with the subject device had the average (SD) of 59.8 (6.00) compared with those of 58.8 (6.98) for the reference device. The average difference (SD) were 1.0 (7.28).
The Deming regression lines had the associated R2 value of 0.1439.
14
- II. Agreement/Accuracy Analysis (Comparison between Center Method vs Trace Method, Auto Trance Method, Auto Center Method, Flex Center Method, and Auto Flex Center Method of Subject Device (Konan Specular Microscope XVII, CellChek 20))
- a) Corneal Measuring Area: Center Area Analysis Method: Center Method vs Trace Method of Subject Device
Table 3 Three Corneal Specular Microscopic Variables Assessed with Two Analysis Methods -Center Method vs Trace Method – Center Area
| N=80 | CD (/mm²) | CV (%) | HEX (%) |
|---|---|---|---|
| Center Method | |||
| Average (SD) | 2932.7 (527.83) | 34.0 (5.73) | 59.9 (7.05) |
| Median | 2915.9 | 33.2 | 59.9 |
| Min – Max | 816 - 4532 | 25 - 52 | 40 - 74 |
| Trace Method | |||
| Average (SD) | 2931.7 (531.31) | 29.5 (7.68) | 57.4 (7.78) |
| Median | 2897.5 | 28.5 | 58.4 |
| Min – Max | 820 - 4565 | 17 - 52 | 38 - 73 |
| Method Comparisons | |||
| Average Difference (SD) | -1.0 (28.00) | -4.5 (4.13) | -2.4 (3.39) |
| Average Difference (SD) as | |||
| a % of Center Method | |||
| reading | -0.03% (0.955%) | -13.34% (12.132%) | -4.06% (5.671%) |
| 95% LOA | (-57.0, 55.0) | (-12.8, 3.7) | (-9.2, 4.4) |
| Correlation (R2) | 0.9973 | 0.7215 | 0.8097 |
| Deming Regression | |||
| Intercept (95% CI) | -16.3 (-18.1, -14.5) | -9.2 (-11.3, -7.2) | -2.0 (-4.7, 0.7) |
| Deming Regression Slope | |||
| (95% CI) | 1.0 (1.0, 1.0) | 1.1 (1.1, 1.2) | 1.0 (0.9, 1.0) |
| Abbreviations: CD = corneal endothelial cell density; Cl = confidence interval; CV = coefficient of | |||
| variation; HEX = hexagonality; LOA = limits of agreement; SD = standard deviation |
The average differences were calculated as (Trace Method) - (Center Method).
The average differences as a % of Center Method reading were calculated by dividing the average differences with the averages of Center Method.
The 95% LOA's were calculated as the average differences +/- 2SD's.
15
(i) CD
Corneal endothelial cell density as measured with Trace Method had the average (SD) of 2931.7 (531.31) compared with those of 2932.7 (527.83) for Center Method. The average difference (SD) were -1.0 (28.00).
The Deming regression lines had the associated R2 value of 0.9973.
- CV (ii)
Corneal endothelial cell density as measured with Trace Method had the average (SD) of 29.5 (7.68) compared with those of 34.0 (5.73) for Center Method. The average difference (SD) were -4.5 (4.13).
The Deming regression lines had the associated R2 value of 0.7215.
- (iii) HEX
Corneal endothelial cell density as measured with Trace Method had the average (SD) of 57.4 (7.78) compared with 59.9 (7.05) for those of Center Method. The average difference (SD) were -2.4 (3.39).
The Deming regression lines had the associated R2 value of 0.8097.
b) Cornea Measuring Area: Center Area
Analysis Method: Center Method vs Auto Trance Method of Subject Device
Table 4 Three Corneal Specular Microscopic Variables Assessed with Two Analysis Methods -Center Method vs Auto Trance Method - Center Area
| N=80 | CD (/mm²) | CV (%) | HEX (%) |
|---|---|---|---|
| Center Method | |||
| Average (SD) | 2932.7 (527.83) | 34.0 (5.73) | 59.9 (7.05) |
| Median | 2915.9 | 33.2 | 59.9 |
| Min – Max | 816 - 4532 | 25 - 52 | 40 - 74 |
| Auto Trace Method | |||
| Average (SD) | 2756.1 (430.05) | 19.5 (4.34) | 59.5 (6.51) |
| Median | 2816.0 | 19.0 | 60.0 |
| Min – Max | 900 - 3475 | 11 - 35 | 38 - 73 |
| Device Comparisons | |||
| Average Difference (SD) | -176.6 (213.31) | -14.5 (3.77) | -0.3 (5.80) |
| Average Difference (SD) as | |||
| a % of Center Method | -6.02% (7.273%) | -42.67% (11.065%) | -0.58% (9.695%) |
16
510(k) Summary – Konan Specular Microscope XVII, CellChek 20
| reading | |||
|---|---|---|---|
| 95% LOA | (-603.3, 250.0) | (-22.1, -7.0) | (-12.0, 11.3) |
| Correlation (R2) | 0.8479 | 0.5682 | 0.4050 |
| Deming Regression Intercept (95% CI) | 555.8 (554.2, 557.4) | 0.1 (-1.5, 1.6) | 24.3 (22.1, 26.5) |
| Deming Regression Slope (95% CI) | 0.8 (0.7, 0.8) | 0.6 (0.5, 0.6) | 0.6 (0.6, 0.6) |
| Abbreviations: CD = corneal endothelial cell density; CI = confidence interval; CV = coefficient of variation; HEX = hexagonality; LOA = limits of agreement; SD = standard deviation | |||
| The average differences were calculated as (Auto Trace Method) - (Center Method). | |||
| The average differences as a % of Center Method reading were calculated by dividing the average differences with the averages of Center Method. | |||
| The 95% LOA's were calculated as the average differences +/- 2SD's. |
CD (i)
Corneal endothelial cell density as measured with Auto Trace Method had the average (SD) of 2756.1 (430.05) compared with those of 2932.7 (527.83) for Center Method. The average difference (SD) were -176.6 (213.31).
The Deming regression lines had the associated R2 value of 0.8479.
(ii) CV
Corneal endothelial cell density as measured with Auto Trace Method had the average (SD) of 19.5 (4.34) compared with those of 34.0 (5.73) for Center Method. The average difference (SD) were -14.5 (3.77).
The Deming regression lines had the associated R2 value of 0.5682.
- HEX (iii)
Corneal endothelial cell density as measured with Auto Trace Method had the average (SD) of 59.5 (6.51) compared with those of 59.9 (7.05) for Center Method. The average difference (SD) were -0.3 (5.80).
The Deming regression lines had the associated R2 value of 0.4050.
17
c) Cornea Measuring Area: Center Area
Analysis Method: Center Method vs Auto Center Method of Subject Device
Table 5 Three Corneal Specular Microscopic Variables Assessed with Two Analysis Method -Center Method vs Auto Center Method – Center Area
| N=80 | CD (/mm²) | CV (%) | HEX (%) |
|---|---|---|---|
| Center Method | |||
| Average (SD) | 2932.7 (527.83) | 34.0 (5.73) | 59.9 (7.05) |
| Median | 2915.9 | 33.2 | 59.9 |
| Min - Max | 816 - 4532 | 25 - 52 | 40 - 74 |
| Auto Center Method | |||
| Average (SD) | 2777.7 (433.55) | 34.3 (5.83) | 59.8 (6.96) |
| Median | 2828.0 | 34.5 | 60.0 |
| Min - Max | 921 - 3434 | 24 - 55 | 36 - 71 |
| Device Comparisons | |||
| Average Difference (SD) | -155.0 (210.98) | 0.3 (3.39) | -0.1 (4.67) |
| Average Difference (SD) as | |||
| a % of Center Method | |||
| reading | -5.29% (7.194%) | 0.75% (9.966%) | -0.16% (7.796%) |
| 95% LOA | (-577.0, 266.9) | (-6.5, 7.0) | (-9.4, 9.2) |
| Correlation (R2) | 0.8504 | 0.6854 | 0.6055 |
| Deming Regression | |||
| Intercept (95% CI) | 556.3 (554.7, 557.9) | 5.6 (3.9, 7.4) | 13.8 (11.4, 16.2) |
| Deming Regression Slope | |||
| (95% CI) | 0.8 (0.8, 0.8) | 0.8 (0.8, 0.9) | 0.8 (0.7, 0.8) |
The average differences as a % of Center Method reading were calculated by dividing the average differences with the averages of Center Method.
The 95% LOA's were calculated as the average differences +/- 2SD's.
18
CD (i)
Corneal endothelial cell density as measured with Auto Center Method had the average (SD) of 2777.7 (433.55) compared with those of 2932.7 (527.83) for Center Method. The average difference (SD) were -155.0 (210.98).
The Deming regression lines had the associated R2 value of 0.8504.
- CV (ii)
Corneal endothelial cell density as measured with Auto Center Method had the average (SD) of 34.3 (5.83) compared with those of 34.0 (5.73) for Center Method. The average difference (SD) were 0.3 (3.39).
The Deming regression lines had the associated R2 value of 0.6854.
- (iii) HEX
Corneal endothelial cell density as measured with Auto Center Method had the average (SD) of 59.8 (6.96) compared with those of 59.9 (7.05) for Center Method. The average difference (SD) were -0.1 (4.67).
The Deming regression lines had the associated R2 value of 0.6055.
d) Cornea Measuring Area: Center Area
Analysis Method: Center Method vs Flex Center Method of Subject Device
| Table 6 Three Corneal Specular Microscopic Variables Assessed with Two Analysis Method - | ||
|---|---|---|
| Center Method vs Flex Center Method – Center Area |
| N=80 | CD (/mm²) | CV (%) | HEX (%) |
|---|---|---|---|
| Center Method | |||
| Average (SD) | 2932.7 (527.83) | 34.0 (5.73) | 59.9 (7.05) |
| Median | 2915.9 | 33.2 | 59.9 |
| Min – Max | 816 - 4532 | 25 - 52 | 40 - 74 |
| Flex Center Method | |||
| Average (SD) | 2917.8 (531.26) | 36.0 (5.80) | 59.9 (5.91) |
| Median | 2899.2 | 35.0 | 60.2 |
| Min – Max | 822 - 4524 | 26 - 57 | 48 - 74 |
| Device Comparisons | |||
| Average Difference (SD) | -14.9 (28.88) | 2.0 (1.74) | 0.1 (3.47) |
| Average Difference (SD) as | |||
| a % of Center Method | -0.51% (0.985%) | 5.85% (5.106%) | 0.09% (5.798%) |
19
510(k) Summary – Konan Specular Microscope XVII, CellChek 20
| reading | |||
|---|---|---|---|
| 95% LOA | (-72.6, 42.9) | (-1.5, 5.5) | (-6.9, 7.0) |
| Correlation (R2) | 0.9971 | 0.9114 | 0.7587 |
| Deming Regression | |||
| Intercept (95% CI) | -29.6 (-31.4, -27.8) | 3.1 (1.3, 5.0) | 16.2 (13.9, 18.6) |
| Deming Regression Slope | |||
| (95% CI) | 1.0 (1.0, 1.0) | 1.0 (0.9, 1.0) | 0.7 (0.7, 0.8) |
| Abbreviations: CD = corneal endothelial cell density; CI = confidence interval; CV = coefficient of | |||
| variation; HEX = hexagonality; LOA = limits of agreement; SD = standard deviation | |||
| The average differences were calculated as (Flex Center Method) - (Center Method). |
The average differences as a % of Center Method reading were calculated by dividing the average differences with the averages of Center Method.
The 95% LOA's were calculated as the average differences +/- 2SD's.
CD (i)
Corneal endothelial cell density as measured with Flex Center Method had the average (SD) of 2917.8 (531.26) compared with those of 2932.7 (527.83) for Center Method. The average difference (SD) were -14.9 (28.88).
The Deming regression lines had the associated R2 value of 0.9971.
(ii) CV
Corneal endothelial cell density as measured with Flex Center Method had the average (SD) of 36.0 (5.80) compared with those of those of 34.0 (5.73) for Center Method. The average difference (SD) were 2.0 (1.74).
The Deming regression lines had the associated R2 value of 0.9114.
- HEX (iii)
Corneal endothelial cell density as measured with Flex Center Method had the average (SD) of 59.9 (5.91) compared with those of 59.9 (7.05) for Center Method. The average difference (SD) were 0.1 (3.47).
The Deming regression lines had the associated R2 value of 0.7587.
20
Cornea Measuring Area: Center Area e)
Analysis Method: Center Method vs Auto Flex Center Method of Subject Device
| Table 7 Three Corneal Specular Microscopic Variables Assessed with Two Analysis Method - | ||||
|---|---|---|---|---|
| Center Method vs Auto Flex Center Method – Center Area |
| N=80 | CD (/mm²) | CV (%) | HEX (%) |
|---|---|---|---|
| Center Method | |||
| Average (SD) | 2932.7 (527.83) | 34.0 (5.73) | 59.9 (7.05) |
| Median | 2915.9 | 33.2 | 59.9 |
| Min – Max | 816 - 4532 | 25 - 52 | 40 - 74 |
| Auto Flex Center Method | |||
| Average (SD) | 2760.8 (433.37) | 35.1 (5.84) | 59.6 (6.83) |
| Median | 2835.0 | 35.0 | 60.0 |
| Min – Max | 905 - 3415 | 24 - 58 | 38 - 70 |
| Device Comparisons | |||
| Average Difference (SD) | -172.0 (212.44) | 1.1 (3.60) | -0.3 (5.59) |
| Average Difference (SD) as | |||
| a % of Center Method | |||
| reading | -5.86% (7.244%) | 3.21% (10.586%) | -0.47% (9.342%) |
| 95% LOA | (-596.9, 252.9) | (-6.1, 8.3) | (-11.5, 10.9) |
| Correlation ( $R^2$ ) | 0.8480 | 0.6499 | 0.4564 |
| Deming Regression | |||
| Intercept (95% CI) | 543.5 (541.9, 545.0) | 7.2 (5.4, 8.9) | 20.4 (18.1, 22.7) |
| Deming Regression Slope | |||
| (95% CI) | 0.8 (0.8, 0.8) | 0.8 (0.8, 0.9) | 0.7 (0.6, 0.7) |
| Abbreviations: CD = corneal endothelial cell density; Cl = confidence interval; CV = coefficient of | |||
| variation; HEX = hexagonality; LOA = limits of agreement; SD = standard deviation | |||
| The average differences were calculated as (Auto Flex Center Method) - (Center Method). | |||
| The average differences as a % of Center Method reading were calculated by dividing the average |
differences with the averages of Center Method.
The 95% LOA's were calculated as the average differences +/- 2SD's.
21
CD (i)
Corneal endothelial cell density as measured with Auto Flex Center had the average (SD) of 2760.8 (433.37) compared with those of 2932.7 (527.83) for Center Method. The average difference (SD) were -172.0 (212.44).
The Deming regression lines had the associated R2 value of 0.8480.
- CV (ii)
Corneal endothelial cell density as measured with Auto Flex Center had the average (SD) of 35.1 (5.84) compared with those of 34.0 (5.73) for Center Method. The average difference (SD) were 1.1 (3.60).
The Deming regression lines had the associated R2 value of 0.6499.
- (iii) HEX
Corneal endothelial cell density as measured with Auto Flex Center had the average (SD) of 59.6 (6.83) compared with those of 59.9 (7.05) for Center Method. The average difference (SD) were -0.3 (5.59).
The Deming regression lines had the associated R2 value of 0.4564.
- III. Precision Analysis
- Cornea Measuring Area: Center Area 1)
Analysis Method: Center Method of Subject Device vs Center Method of Reference Device
Table 8 Precision Analyses for Center Method of Subject Device vs Center Method of Reference Device
- Center Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Center Method | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method |
|-----------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| CD | | |
| Repeatability SD | 9.1 | 9.8 |
| Repeatability SD as a% of the Average | 0.3% | 0.4% |
| Repeatability limit | 25.5 | 27.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.9286 | ----- |
| Reproducibility SD | 53.2 | 99.3 |
| Reproducibility SD as a% of the Average | 1.8% | 3.8% |
| Reproducibility limit | 149.0 | 278.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.5358 | ----- |
| CV | | |
| Repeatability SD | 0.4 | 0.6 |
22
| 310(k) Summary - Konan Specular Microscope XVII, CellChek 20 | ||
|---|---|---|
| Repeatability SD as a% of the Average | 1.2% | 1.8% |
| Repeatability limit | 1.1 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 0.6667 | ----- |
| Reproducibility SD | 0.9 | 3.2 |
| Reproducibility SD as a% of the Average | 2.7% | 9.1% |
| Reproducibility limit | 2.5 | 9.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2813 | ----- |
| HEX | ||
| Repeatability SD | 0.8 | 1.2 |
| Repeatability SD as a% of the Average | 1.3% | 2.1% |
| Repeatability limit | 2.2 | 3.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.6667 | ----- |
| Reproducibility SD | 1.3 | 2.2 |
| Reproducibility SD as a% of the Average | 2.2% | 3.8% |
| Reproducibility limit | 3.6 | 6.2 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.5909 | ----- |
510(k) Summary – Konan Specular Microscope XVII. CellChek 20
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
Cornea Measuring Area: Center Area 2)
Analysis Method: Trace Method of Subject Device vs Center Method of Reference Device
Table 9 Precision Analyses for Trace Method of Subject Device vs Center Method of Reference Device – Center Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Trace Method | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method |
|-----------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| CD | | |
| Repeatability SD | 12.1 | 9.8 |
| Repeatability SD as a% of the Average | 0.4% | 0.4% |
| Repeatability limit | 33.9 | 27.4 |
| Repeatability Ratio (CellChek 20/F&A) | 1.2347 | ------- |
| Reproducibility SD | 38.6 | 99.3 |
| Reproducibility SD as a% of the Average | 1.3% | 3.8% |
| Reproducibility limit | 108.1 | 278.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.3887 | ------- |
| CV | | |
23
| Repeatability SD | 0.9 | 0.6 |
|---|---|---|
| Repeatability SD as a% of the Average | 3.1% | 1.8% |
| Repeatability limit | 2.5 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 1.5000 | ----- |
| Reproducibility SD | 2.8 | 3.2 |
| Reproducibility SD as a% of the Average | 8.9% | 9.1% |
| Reproducibility limit | 7.8 | 9.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.8750 | ----- |
| HEX | ||
| Repeatability SD | 0.6 | 1.2 |
| Repeatability SD as a% of the Average | 1.0% | 2.1% |
| Repeatability limit | 1.7 | 3.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.5000 | ----- |
| Reproducibility SD | 1.7 | 2.2 |
| Reproducibility SD as a% of the Average | 3.0% | 3.8% |
| Reproducibility limit | 4.8 | 6.2 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.7727 | ----- |
510(k) Summary – Konan Specular Microscope XVII, CellChek 20
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
- Cornea Measuring Area: Center Area 3)
Analysis Method: Auto Trace Method of Subject Device vs Center Method of Reference Device
Table 10 Precision Analyses for Auto Trace Method of Subject Device vs Center Method of Reference Device – Center Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Auto Trace Method | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method |
|-----------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| CD | | |
| Repeatability SD | 0.0 | 9.8 |
| Repeatability SD as a% of the Average | 0.0% | 0.4% |
| Repeatability limit | 0.0 | 27.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 22.4 | 99.3 |
| Reproducibility SD as a% of the Average | 0.8% | 3.8% |
| Reproducibility limit | 62.7 | 278.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2256 | ----- |
24
| CV | ||
|---|---|---|
| Repeatability SD | 0.0 | 0.6 |
| Repeatability SD as a% of the Average | 0.0% | 1.8% |
| Repeatability limit | 0.0 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 0.7 | 3.2 |
| Reproducibility SD as a% of the Average | 3.6% | 9.1% |
| Reproducibility limit | 2.0 | 9.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2188 | ----- |
| HEX | ||
| Repeatability SD | 0.0 | 1.2 |
| Repeatability SD as a% of the Average | 0.0% | 2.1% |
| Repeatability limit | 0.0 | 3.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 1.4 | 2.2 |
| Reproducibility SD as a% of the Average | 2.4% | 3.8% |
| Reproducibility limit | 3.9 | 6.2 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.6364 | ----- |
N represents the total number of subjects in each eye population in the precision and agreement cohort with complete data (80 total images).
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
Cornea Measuring Area: Center Area 4)
Analysis Method: Auto Center Method of Subject Device vs Center Method of Reference Device
| Table 11 Precision Analyses for Auto Center Method of Subject Device vs Center Method of Reference | ||
|---|---|---|
| Device - Center Area | ||
| Variable | Konan Specular | |
| Microscope XVII, | ||
| CellChek 20 | ||
| (Subject Device) | ||
| Auto Center Method | NONCON ROBO | |
| PACHY F&A | ||
| (Reference Device) | ||
| Center Method | ||
| CD | ||
| Repeatability SD | 0.0 | 9.8 |
| Repeatability SD as a% of the Average | 0.0% | 0.4% |
| Repeatability limit | 0.0 | 27.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 21.0 | 99.3 |
| Reproducibility SD as a% of the Average | 0.8% | 3.8% |
| Reproducibility limit | 58.8 | 278.0 |
25
| Reproducibility Ratio (CellChek 20/F&A) | 0.2115 | ----- |
|---|---|---|
| CV | ----- | |
| Repeatability SD | 0.0 | 0.6 |
| Repeatability SD as a% of the Average | 0.0% | 1.8% |
| Repeatability limit | 0.0 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 1.0 | 3.2 |
| Reproducibility SD as a% of the Average | 2.9% | 9.1% |
| Reproducibility limit | 2.8 | 9.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.3125 | ----- |
| HEX | ----- | |
| Repeatability SD | 0.0 | 1.2 |
| Repeatability SD as a% of the Average | 0.0% | 2.1% |
| Repeatability limit | 0.0 | 3.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 1.5 | 2.2 |
| Reproducibility SD as a% of the Average | 2.5% | 3.8% |
| Reproducibility limit | 4.2 | 6.2 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.6818 | ----- |
510(k) Summary – Konan Specular Microscope XVII, CellChek 20
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
ર) Cornea Measuring Area: Center Area
Analysis Method: Flex Center Method of Subject Device vs Center Method of Reference Device
Table 12 Precision Analyses for Flex Center Method of Subject Device vs Center Method of Reference Device - Center Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Flex Center Method | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method |
|-----------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| CD | | |
| Repeatability SD | 12.2 | 9.8 |
| Repeatability SD as a% of the Average | 0.4% | 0.4% |
| Repeatability limit | 34.2 | 27.4 |
| Repeatability Ratio (CellChek 20/F&A) | 1.2449 | ----- |
| Reproducibility SD | 34.3 | 99.3 |
| Reproducibility SD as a% of the Average | 1.2% | 3.8% |
26
| Reproducibility limit | 96.0 | 278.0 |
|---|---|---|
| Reproducibility Ratio (CellChek 20/F&A) | 0.3454 | ----- |
| CV | ||
| Repeatability SD | 1.0 | 0.6 |
| Repeatability SD as a% of the Average | 2.8% | 1.8% |
| Repeatability limit | 2.8 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 1.6667 | ----- |
| Reproducibility SD | 1.3 | 3.2 |
| Reproducibility SD as a% of the Average | 3.6% | 9.1% |
| Reproducibility limit | 3.6 | 9.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.4063 | ----- |
| HEX | ||
| Repeatability SD | 1.4 | 1.2 |
| Repeatability SD as a% of the Average | 2.3% | 2.1% |
| Repeatability limit | 3.9 | 3.4 |
| Repeatability Ratio (CellChek 20/F&A) | 1.1667 | ----- |
| Reproducibility SD | 1.8 | 2.2 |
| Reproducibility SD as a% of the Average | 3.0% | 3.8% |
| Reproducibility limit | 5.0 | 6.2 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.8182 | ----- |
510(k) Summary – Konan Specular Microscope XVII. CellChek 20
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
-
- Cornea Measuring Area: Center Area
Analysis Method: Auto Flex Center Method of Subject Device vs Center Method of Reference Device
- Cornea Measuring Area: Center Area
Table 13 Precision Analyses for Auto Flex Center Method of Subject Device vs Center Method of Reference Device - Center Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Auto Flex Center Method | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method |
|---------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| CD | | |
| Repeatability SD | 0.0 | 9.8 |
| Repeatability SD as a% of the Average | 0.0% | 0.4% |
| Repeatability limit | 0.0 | 27.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ---- |
27
| 510(k) Summary - Konan Specular Microscope XVII, CellChek 20 | ||
|---|---|---|
| Reproducibility SD | 22.6 | 99.3 |
| Reproducibility SD as a% of the Average | 0.8% | 3.8% |
| Reproducibility limit | 63.3 | 278.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2276 | ----- |
| CV | ||
| Repeatability SD | 0.0 | 0.6 |
| Repeatability SD as a% of the Average | 0.0% | 1.8% |
| Repeatability limit | 0.0 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 0.9 | 3.2 |
| Reproducibility SD as a% of the Average | 2.6% | 9.1% |
| Reproducibility limit | 2.5 | 9.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2813 | ----- |
| HEX | ||
| Repeatability SD | 0.0 | 1.2 |
| Repeatability SD as a% of the Average | 0.0% | 2.1% |
| Repeatability limit | 0.0 | 3.4 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 1.4 | 2.2 |
| Reproducibility SD as a% of the Average | 2.4% | 3.8% |
| Reproducibility limit | 3.9 | 6.2 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.6364 | ----- |
510(k) Summary – Konan Specular Microscope XVII. CellChek 20
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
7) Cornea Measuring Area: Peripheral Area
Analysis Method: Center Method of Subject Device vs Center Method of Reference Device
Table 14 Precision Analyses for Center Method of Subject Device vs Center Method of Reference Device - Peripheral Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Center Method
N=80 | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method
N=80 |
|---------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| CD | | |
| Repeatability SD | 9.7 | 9.7 |
| Repeatability SD as a% of the Average | 0.3% | 0.3% |
28
| 510(k) Summary - Konan Specular Microscope XVII, CellChek 20 | ||
|---|---|---|
| Repeatability limit | 27.2 | 27.2 |
| Repeatability Ratio (CellChek 20/F&A) | 1.0000 | ----- |
| Reproducibility SD | 54.0 | 113.4 |
| Reproducibility SD as a% of the Average | 1.8% | 4.2% |
| Reproducibility limit | 151.2 | 317.5 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.4762 | ----- |
| CV | ||
| Repeatability SD | 0.9 | 0.6 |
| Repeatability SD as a% of the Average | 2.6% | 1.8% |
| Repeatability limit | 2.5 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 1.5000 | ----- |
| Reproducibility SD | 1.9 | 3.9 |
| Reproducibility SD as a% of the Average | 5.5% | 11.0% |
| Reproducibility limit | 5.3 | 10.9 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.4872 | ----- |
| HEX | ||
| Repeatability SD | 1.3 | 1.3 |
| Repeatability SD as a% of the Average | 2.2% | 2.2% |
| Repeatability limit | 3.6 | 3.6 |
| Repeatability Ratio (CellChek 20/F&A) | 1.0000 | ----- |
| Reproducibility SD | 1.7 | 2.5 |
| Reproducibility SD as a% of the Average | 2.9% | 4.3% |
| Reproducibility limit | 4.8 | 7.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.6800 | ----- |
510(k) Summary – Konan Specular Microscope XVII. CellChek 20
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
Cornea Measuring Area: Peripheral Area 8)
Analysis Method: Trace Method of Subject Device vs Center Method of Reference Device
Table 15 Precision Analyses for Trace Method of Subject Device vs Center Method of Reference Device – Peripheral Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Trace Method
N=80 | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method
N=80 |
|----------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| CD | | |
29
| Repeatability SD | 10.8 | 9.7 |
|---|---|---|
| Repeatability SD as a% of the Average | 0.4% | 0.3% |
| Repeatability limit | 30.2 | 27.2 |
| Repeatability Ratio (CellChek 20/F&A) | 1.1134 | ---- |
| Reproducibility SD | 43.9 | 113.4 |
| Reproducibility SD as a% of the Average | 1.5% | 4.2% |
| Reproducibility limit | 122.9 | 317.5 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.3871 | ---- |
| CV | ||
| Repeatability SD | 0.9 | 0.6 |
| Repeatability SD as a% of the Average | 3.0% | 1.8% |
| Repeatability limit | 2.5 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 1.5000 | ---- |
| Reproducibility SD | 3.0 | 3.9 |
| Reproducibility SD as a% of the Average | 9.3% | 11.0% |
| Reproducibility limit | 8.4 | 10.9 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.7692 | ---- |
| HEX | ||
| Repeatability SD | 0.6 | 1.3 |
| Repeatability SD as a% of the Average | 1.0% | 2.2% |
| Repeatability limit | 1.7 | 3.6 |
| Repeatability Ratio (CellChek 20/F&A) | 0.4615 | ---- |
| Reproducibility SD | 1.8 | 2.5 |
| Reproducibility SD as a% of the Average | 3.2% | 4.3% |
| Reproducibility limit | 5.0 | 7.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.7200 | ---- |
510(k) Summary – Konan Specular Microscope XVII. CellChek 20
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
- Cornea Measuring Area: Peripheral Area
Analysis Method: Auto Trace Method of Subject Device vs Center Method of Reference Device
Table 16 Precision Analyses for Auto Trace Method of Subject Device vs Center Method of Reference Device - Peripheral Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Auto Trace Method | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method
N=80 |
| ---------- | -------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------- |
|---|
30
| N=80 | ||
|---|---|---|
| CD | ||
| Repeatability SD | 0.0 | 9.7 |
| Repeatability SD as a% of the Average | 0.0% | 0.3% |
| Repeatability limit | 0.0 | 27.2 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 31.0 | 113.4 |
| Reproducibility SD as a% of the Average | 1.1% | 4.2% |
| Reproducibility limit | 86.8 | 317.5 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2734 | ----- |
| CV | ||
| Repeatability SD | 0.0 | 0.6 |
| Repeatability SD as a% of the Average | 0.0% | 1.8% |
| Repeatability limit | 0.0 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 1.1 | 3.9 |
| Reproducibility SD as a% of the Average | 5.4% | 11.0% |
| Reproducibility limit | 3.1 | 10.9 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2821 | ----- |
| HEX | ||
| Repeatability SD | 0.0 | 1.3 |
| Repeatability SD as a% of the Average | 0.0% | 2.2% |
| Repeatability limit | 0.0 | 3.6 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 3.2 | 2.5 |
| Reproducibility SD as a% of the Average | 5.5% | 4.3% |
| Reproducibility limit | 9.0 | 7.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 1.2800 | ----- |
N represents the total number of subjects in each eye population in the precision and agreement cohort with complete data (80 total images).
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
- Cornea Measuring Area: Peripheral Area
Analysis Method: Auto Center Method of Subject Device vs Center Method of Reference Device
Table 17 Precision Analyses for Auto Center Method of Subject Device vs Center Method of Reference Device – Peripheral Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20 | NONCON ROBO
PACHY F&A
(Reference Device) |
| ---------- | --------------------------------------------------- | ------------------------------------------------ |
|---|
31
| 510(k) Summary - Konan Specular Microscope XVII. CellChek 20 |
|---|
| 510(k) Summary - Konan Specular Microscope XVII, CellChek 20 | ||
|---|---|---|
| (Subject Device) | ||
| Auto Center Method | ||
| N=80 | Center Method | |
| N=80 | ||
| CD | ||
| Repeatability SD | 0.0 | 9.7 |
| Repeatability SD as a% of the Average | 0.0% | 0.3% |
| Repeatability limit | 0.0 | 27.2 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | |
| Reproducibility SD | 27.7 | 113.4 |
| Reproducibility SD as a% of the Average | 1.0% | 4.2% |
| Reproducibility limit | 77.6 | 317.5 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2443 | |
| CV | ||
| Repeatability SD | 0.0 | 0.6 |
| Repeatability SD as a% of the Average | 0.0% | 1.8% |
| Repeatability limit | 0.0 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | |
| Reproducibility SD | 1.1 | 3.9 |
| Reproducibility SD as a% of the Average | 3.2% | 11.0% |
| Reproducibility limit | 3.1 | 10.9 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2821 | |
| HEX | ||
| Repeatability SD | 0.0 | 1.3 |
| Repeatability SD as a% of the Average | 0.0% | 2.2% |
| Repeatability limit | 0.0 | 3.6 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | |
| Reproducibility SD | 1.5 | 2.5 |
| Reproducibility SD as a% of the Average | 2.5% | 4.3% |
| Reproducibility limit | 4.2 | 7.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.6000 |
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
- Cornea Measuring Area: Peripheral Area
Analysis Method: Flex Center Method of Subject Device vs Center Method of Reference Device
Table 18 Precision Analyses for Flex Center Method of Subject Device vs Center Method of
Reference Device - Peripheral Area
| Variable | Konan Specular | NONCON ROBO |
|---|---|---|
| ---------- | ---------------- | ------------- |
32
| 510(k) Summary – Konan Specular Microscope XVII, CellChek 20 | ||
|---|---|---|
| Microscope XVII, | ||
| CellChek 20 | ||
| (Subject Device) | ||
| Flex Center Method | ||
| N=80 | PACHY F&A | |
| (Reference Device) | ||
| Center Method | ||
| N=80 | ||
| CD | ||
| Repeatability SD | 13.2 | 9.7 |
| Repeatability SD as a% of the Average | 0.4% | 0.3% |
| Repeatability limit | 37.0 | 27.2 |
| Repeatability Ratio (CellChek 20/F&A) | 1.3608 | ------ |
| Reproducibility SD | 57.7 | 113.4 |
| Reproducibility SD as a% of the Average | 2.0% | 4.2% |
| Reproducibility limit | 161.6 | 317.5 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.5088 | ------ |
| CV | ||
| Repeatability SD | 0.9 | 0.6 |
| Repeatability SD as a% of the Average | 2.5% | 1.8% |
| Repeatability limit | 2.5 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 1.5000 | ------ |
| Reproducibility SD | 1.2 | 3.9 |
| Reproducibility SD as a% of the Average | 3.4% | 11.0% |
| Reproducibility limit | 3.4 | 10.9 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.3077 | ------ |
| HEX | ||
| Repeatability SD | 1.3 | 1.3 |
| Repeatability SD as a% of the Average | 2.2% | 2.2% |
| Repeatability limit | 3.6 | 3.6 |
| Repeatability Ratio (CellChek 20/F&A) | 1.0000 | ------ |
| Reproducibility SD | 1.4 | 2.5 |
| Reproducibility SD as a% of the Average | 2.4% | 4.3% |
| Reproducibility limit | 3.9 | 7.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.5600 | ------ |
N represents the total number of subjects in each eye population in the precision and agreement cohort with complete data (80 total images).
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
12) Cornea Measuring Area: Peripheral Area
Analysis Method: Auto Flex Center Method of Subject Device vs Center Method of Reference Device
33
Table 19 Precision Analyses for Auto Flex Center Method of Subject Device vs Center Method of
Reference Device - Peripheral Area
| Variable | Konan Specular
Microscope XVII,
CellChek 20
(Subject Device)
Auto Flex Center Method
N=80 | NONCON ROBO
PACHY F&A
(Reference Device)
Center Method
N=80 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| CD | | |
| Repeatability SD | 0.0 | 9.7 |
| Repeatability SD as a% of the Average | 0.0% | 0.3% |
| Repeatability limit | 0.0 | 27.2 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 28.1 | 113.4 |
| Reproducibility SD as a% of the Average | 1.0% | 4.2% |
| Reproducibility limit | 78.7 | 317.5 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.2478 | ----- |
| CV | | |
| Repeatability SD | 0.0 | 0.6 |
| Repeatability SD as a% of the Average | 0.0% | 1.8% |
| Repeatability limit | 0.0 | 1.7 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 1.2 | 3.9 |
| Reproducibility SD as a% of the Average | 3.4% | 11.0% |
| Reproducibility limit | 3.4 | 10.9 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.3077 | ----- |
| HEX | | |
| Repeatability SD | 0.0 | 1.3 |
| Repeatability SD as a% of the Average | 0.0% | 2.2% |
| Repeatability limit | 0.0 | 3.6 |
| Repeatability Ratio (CellChek 20/F&A) | 0.0000 | ----- |
| Reproducibility SD | 1.4 | 2.5 |
| Reproducibility SD as a% of the Average | 2.4% | 4.3% |
| Reproducibility limit | 3.9 | 7.0 |
| Reproducibility Ratio (CellChek 20/F&A) | 0.5600 | ----- |
N represents the total number of subjects in each eye population in the precision and agreement cohort with complete data (80 total images).
The repeatability limit was 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 sum of the variance components of operator + device, operator + device x subject interaction, and residual within subject.
34
Conclusion
- Agreement/Accuracy Analysis -
As shown in Table 14, regardless of the difference of the corneal measuring areas, that is, center area and peripheral area, all of the variables, CD, CV, and HEX, measured by Center Method of Konan Specular Microscope XVII, CellChek 20 showed very high correlations with those by Center Method of NONCON ROBO PACHY F&A.
As shown in Table 15, as for Konan Specular Microscope XVII, CellChek 20, all of the variables measured by Trace Method, Auto Trace Method, Auto Center Method, Flex Center Method, and Auto Flex Center Method showed very high correlations with those by Center Method, respectively.
- = Precision Analysis
As for all of the measured variables, CD, CV, and HEX, the repeatability and reproducibility measured by Center Method of Konan Specular Microscope XVII, CellChek 20 were superior to those measured by Center Method of NONCON ROBO PACHY F&A.
As for Auto Trace Method, Auto Center Method, and Auto Flex Center Method of Konan Specular Microscope XVII, CellChek 20, their repeatability and reproducibility of all of the variables were very superior to those by Center Method of NONCON ROBO PACHY F&A.
Additionally, the repeatability and reproducibility of Trace Method and Flex Center Meth of Konan Specular Microscope XVII, CellChek 20 were partially superior to or equivalent with those by Center Method of NONCON ROBO PACHY F&A.
From the above, the agreement, accuracy, and precision of the Konan Specular Microscope XVII, CellChek 20 demonstrates that it is substantially equivalent to the NONCON ROBO PACHY F&A. Please note that in the above studies we compared agreement, accuracy, and precision between the subject device and the reference device NONCON ROBO PACHY F&A cleared under K062763. However, in K120264 submission we demonstrated substantial equivalence between Konan Specular Microscope XIV, CellChek Plus (predicate to the subject device) and NONCON ROBO PACHY F&A (reference device). Therefore, based on the current results and K120264 studies we conclude substantial equivalence in the clinical performance of the subject device to the predicate.
35
Table 14 Agreement between Konan Specular Microscope XVII, CellChek 20 and
| Measuring Position | Variables | Correlation |
|---|---|---|
| Center | CD | Strong Positive Correlation |
| CV | Strong Positive Correlation | |
| HEX | Strong Positive Correlation | |
| Peripheral | CD | Strong Positive Correlation |
| CV | Strong Positive Correlation | |
| HEX | Week Positive Correlation |
NONCON ROBO PACHY F&A
Table 15 Agreement between Center Method and Other Methods of
| Analysis Method | Variables | Correlation |
|---|---|---|
| Trace | CD | Strong Positive Correlation |
| CV | Strong Positive Correlation | |
| HEX | Strong Positive Correlation | |
| Auto Trace | CD | Strong Positive Correlation |
| CV | Strong Positive Correlation | |
| HEX | Positive Correlation | |
| Auto Center | CD | Strong Positive Correlation |
| CV | Strong Positive Correlation | |
| HEX | Strong Positive Correlation | |
| Flex Center | CD | Strong Positive Correlation |
| CV | Strong Positive Correlation | |
| HEX | Strong Positive Correlation | |
| Auto Flex Center | CD | Strong Positive Correlation |
| CV | Strong Positive Correlation | |
| HEX | Positive Correlation |
Konan Specular Microscope XVII, CellChek 20
Conclusions Drawn from Studies
The conclusion drawn from the non-clinical and the clinical testing data demonstrates that the Konan Specular Microscope XVII, CellChek 20, is substantially equivalent to the predicate device, the Konan Specular Microscope XIV, CellChek Plus.