(268 days)
Not Found
No
The document mentions "automatic image analysis" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe the characteristics of an AI/ML model (training data, test data, specific performance metrics like AUC for classification). The analysis described appears to be based on traditional image processing techniques.
No
The device is described as an ophthalmic microscope and camera intended for examination and measurement, providing diagnostic information, not a direct therapeutic intervention.
Yes
The device is described as an ophthalmic microscope, optical pachymeter, and camera intended for the examination of the corneal endothelium and for the measurement of the thickness of the cornea. It captures images and analyzes information such as the number of endothelial cells, cell density, and cell area, which are used in medical procedures and observation, making it a diagnostic device.
No
The device description clearly states it is a "non-contact ophthalmic microscope, optical pachymeter, and camera," indicating it is a physical hardware device with integrated software for image capture and analysis.
Based on the provided information, the Nidek Specular Microscope CEM-530 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "examination of the corneal endothelium and for measurement of the thickness of the cornea." This is a direct examination of a living tissue within the body, not the analysis of samples taken from the body.
- Device Description: The description reinforces this by detailing how it captures images of the corneal endothelium and measures corneal thickness. It analyzes these images to provide information about cell characteristics, but this analysis is performed on images of the living tissue, not on a biological sample.
- Lack of Biological Sample Analysis: The core function of an IVD is to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. This device does not handle or analyze such samples.
While the device performs analysis of captured images, this analysis is of the in vivo (within the living body) images of the cornea, not in vitro (in glass, i.e., outside the body) analysis of biological samples.
Therefore, the Nidek Specular Microscope CEM-530 falls under the category of an ophthalmic diagnostic device used for direct examination and measurement of the eye, not an IVD.
N/A
Intended Use / Indications for Use
The Nidek Specular Microscope CEM-530 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, 21 CFR 886.1850
Device Description
The Nidek Specular Microscope CEM-530 provides non-contact, high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of the endothelium are used in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the the built-in thermal printer or captured images can be transferred to a filing system via LAN connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical
Anatomical Site
corneal endothelium, cornea
Indicated Patient Age Range
young (18-28 years of age) and adult (29-80 years of age)
Intended User / Care Setting
Not Found
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
A prospective clinical study was conducted to assess the agreement, accuracy and precision of the CEM-530 by comparing results across three machines/operators to those obtained with the predicate device, the Cellchek Plus. Three populations were studied: young (18-28 years of age) and adult (29-80 years of age) healthy subjects and pathologic adult eves (29-80 years of age).
A total of 74 eyes were evaluated (24 non-pathologic young eyes, 25 non-pathologic adult eves, and 25 pathologic adult eyes) for the assessment of device agreement and 62 evaluable eyes (20 non-pathologic young eyes, 22 non-pathologic adult eyes, and 20 pathologic adults eyes) for the assessment of device precision.
Additionally, analysis was completed on 24 images with and without corneal pathology using both the manual method and automated method of analysis on the same image.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Summary:
The performance testing conducted using the NIDEK Specular Microscope CEM-530 verified that the device operates as intended. The specifications to which the CEM-530 was verified to are substantially equivalent to the predicate devices and therefore, support a determination of substantial equivalence. The pachymetry functionality was evaluated in model eyes and the measurement accuracy of ± 10 microns was confirmed.
Additionally, the CEM-530 was subjected to electrical safety testing in accordance with IEC 60601-1, 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:
-
Study Type: Prospective clinical study
-
Sample Size:
- 74 eyes for assessment of device agreement (24 non-pathologic young eyes, 25 non-pathologic adult eyes, and 25 pathologic adult eyes)
- 62 evaluable eyes for assessment of device precision (20 non-pathologic young eyes, 22 non-pathologic adult eyes, and 20 pathologic adult eyes)
- 24 images with and without corneal pathology for automated vs. manual method analysis.
-
Key Results (Agreement):
- Differences were on the order of 3-5% of the overall mean value for endothelial cell density, coefficient of variation of endothelial cell area, and central corneal thickness measurements.
- Differences were approximately 15% of the overall mean for % hexagonality.
- All 95% Limits of Agreement (LOAs) included 0.
- For % hexagonality, measurements for CEM-530 were generally higher than Cellchek Plus.
- Correlation coefficients were generally high for endothelial cell density (0.9654) and central corneal thickness (0.8856), indicating strong linear relationships.
- Correlation coefficients were low for coefficient of variation of endothelial cell area (-0.0088) and % hexagonality (0.2036).
- Mean differences for Cell Density, Coefficient of Variation (CV), Hexagonality (HEX) and Number of Cells (NUM) for automated vs manual method:
- CD: 101.9 (53.76)
- CV: -7.4 (4.91)
- HEX: 11.3 (7.75)
- NUM: Not provided as mean difference, but average values of 173.3 (auto) vs 153.3 (manual)
- Correlation (R^2) for automated vs manual method:
- CD: 0.9918
- CV: 0.7523
- HEX: 0.2226
- NUM: 0.4306
-
Key Results (Precision):
- Repeatability for Nidek CEM-530 was notably better for central corneal thickness compared to the predicate device.
- The two devices had comparable repeatability for endothelial cell density, coefficient of variation of endothelial cell area, and % hexagonality.
- Repeatability SD (CEM-530): Endothelial Cell Density (75.5), Coefficient of Variation of Endothelial Cell Area (2.3), % Hexagonality (4.1), Central Corneal Thickness (3.3).
- Reproducibility SD (CEM-530): Endothelial Cell Density (113.2), Coefficient of Variation of Endothelial Cell Area (2.7), % Hexagonality (4.1), Central Corneal Thickness (5.8).
Conclusion:
The agreement and precision of the Nidek CEM-530 was found to be substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Agreement:
- Correlation Coefficient (R^2) for Endothelial Cell Density (0.9654), Coefficient of Variation Endothelial Cell Area (-0.0088), % Hexagonality (0.2036), Central Corneal Thickness (0.8856).
- Mean Difference, Mean Difference as a % of the CELLCHEK reading, 95% Limits of Agreement (LOA) for Endothelial Cell Density, Coefficient of Variation Endothelial Cell Area, % Hexagonality, Central Corneal Thickness.
- Precision:
- Repeatability SD, Repeatability SD as a % of the Mean, Repeatability Limit, Repeatability Ratio (CEM-530/CELLCHEK PLUS) for Endothelial Cell Density, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness.
- Reproducibility SD, Reproducibility SD as a % of the Mean, Reproducibility Limit, Reproducibility Ratio (CEM-530/CELLCHEK PLUS) for Endothelial Cell Density, Coefficient of Variation of Endothelial Cell Area, % Hexagonality, Central Corneal Thickness.
- Automated vs. Manual Method (Same Image):
- Mean Difference: CD (101.9), CV (-7.4), HEX (11.3).
- Mean difference as a % of the Manual reading: CD (4.94%), CV (-19.41%), HEX (20.98%), NUM (13.47%).
- Correlation (R^2): CD (0.9918), CV (0.7523), HEX (0.2226), NUM (0.4306).
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.
Konan Medical, Inc. Cellchek Plus (K120264)
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.
Not Found
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
510(k) Summary
This summary of the 510(k) premarket notification for the NIDEK Specular Microscope CEM-530 is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR S 807.92.
Date Prepared: November 27, 2013
SPONSER/ 510(k) OWNER/ MANUFACTURER
NIDEK Co., Ltd. 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Telephone: +81-533-67-8901 Facsimile: +81-533-67-6628 E mail: yoneji mizuno@nidek.co.jp Establishment Registration Number: 8030392
NOV 27 2013
CONTACT PERSON
Aron Shapiro Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9443 Facsimile: (978) 689-0020 E-mail: ashapiro@oraclinical.com
NAME OF DEVICE
Trade Name: CEM-530 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 DEVICE
Konan Medical, Inc. Cellchek Plus (K120264)
1
INDICATIONS FOR USE
The Nidek Specular Microscope CEM-530 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 DESCRIPTION
The Nidek Specular Microscope CEM-530 provides non-contact, high magnification image capture of the endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of the endothelium are used in intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection. In addition to the specular microscopy, the corneal thickness can be optically measured in a non-contact method. The CEM-530 has auto-tracking and auto-shooting functions. Results can be printed using the the built-in thermal printer or captured images can be transferred to a filing system via LAN connection.
SUBSTANTIAL EQUIVALENCE
The Specular Microscope CEM-530 is substantially equivalent to the Konan Medical, Inc. Cellchek Plus (K120264). The Specular Microscope CEM-530 has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicate device. Clinical performance data is provided which demonstrates that the CEM-530 is substantially equivalent to the Konan predicate device.
The CEM-530 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. Both the CEM-530 and the predicate device offer automatic capture features and manual capture modes. Both the CEM-530 and the predicate device have a built-in CCD camera. Slight differences in flash, illumination for focusing and fixation lamps were evaluated in terms of light safety and found to meet the requirements of ISO 15004-2.
Both the CEM-530 and the predicate device include an optical pachymeter with an accuracy of ± l 0 microns. 、
Regarding image analysis, both the CEM-530 and the predicate device offer automatic image analysis while the predicate device also offers manual analysis of images. Clinical performance data is provided which evaluates the precision and accuracy of the automatic analyses performed
2
by the CEM-530 compared to manual measurements performed with the predicate device. The clinical performance data demonstrates the substantial equivalence of the CEM-530 automatic measurement mode to the predicate device's manual mode.
Both the CEM-S30 and the predicate device comply with applicable electrical safety and light safety standards.
NON-CLINICAL PERFORMANCE SUMMARY
The performance testing conducted using the NIDEK Specular Microscope CEM-530 verified that the device operates as intended. The specifications to which the CEM-530 was verified to are substantially equivalent to the predicate devices and therefore, support a determination of substantial equivalence. The pachymetry functionality was evaluated in model eyes and the measurement accuracy of ± 10 microns was confirmed.
Additionally, the CEM-530 was subjected to electrical safety testing in accordance with IEC 60601-1, 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 CEM-530 by comparing results across three machines/operators to those obtained with the predicate device, the Cellchek Plus. Three populations were studied: young (18-28 years of age) and adult (29-80 years of age) healthy subjects and pathologic adult eves (29-80 years of age).
A total of 74 eyes were evaluated (24 non-pathologic young eyes, 25 non-pathologic adult eves, and 25 pathologic adult eyes) for the assessment of device agreement and 62 evaluable eyes (20 non-pathologic young eyes, 22 non-pathologic adult eyes, and 20 pathologic adults eyes) for the assessment of device precision.
All evaluable study eyes (74 eyes) were included in the assessment of device agreement. The differences were on the order of 3-5% of the overall mean value for endothelial cell density, coefficient of variation of endothelial cell area, and central corneal thickness measurements and approximately 15% of the overall mean for % hexagonality. All of the 95% Limits of Agreement (LOAs) included 0 and the majority was well centered around 0. However, for % hexagonality, the measurements for the CEM-530 device were generally higher than those from the Cellchek Plus machine. The correlation coefficients were generally high for the endothelial cell density and central corneal thickness measurements, indicative of strong linear relationships; but they were low for coefficient of variation of endothelial cell area and % hexagonality.
The mean differences for endothelial cell density are illustrated on the Bland Altman plot (Figure i. The greatest absolute differences between the two machines were seen at the extremes of the measurement range (Figure 2). The Deming regression line (Figure 3) showed good agreement between the devices. Table I provides a summary of the agreement data for all subjects.
3
Endothelial Cell Density Figure 1: Bland-Altman Plot- Observed Data-Endothelial Cell Density- All Subjects, Effectiveness Population
Image /page/3/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 3400, while the y-axis ranges from -700 to 700. There are three horizontal lines across the plot at approximately y = -400, y = -50, and y = 250. The data points are clustered between x = 2200 and x = 2800.
Figure 2: Device Difference by Cellchek Plus Value- Endothelial Cell Density- All Subjects, Effectiveness Population
Image /page/3/Figure/3 description: The image is a scatter plot with the title "Device Difference" on the y-axis and "CELLCHEY EL Value" on the x-axis. The x-axis ranges from 500 to 3500, while the y-axis ranges from -700 to 700. The data points are scattered, showing a negative correlation between the two variables. As the CELLCHEY EL Value increases, the Device Difference tends to decrease.
4
Image /page/4/Figure/0 description: The image is a scatter plot with two trend lines. The y-axis is labeled "CEM-520 Value" and ranges from 400 to 3600. There are two trend lines on the plot, one labeled "Deming Regression Line" and the other labeled "45 Degree Line."
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Figure 3: Deming Regression Plot- CEM-530 by Cellchek Plus- Endothelial Cell Density- All Subjects, Effectiveness Population
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5
Table 1: Four Corneal Specular Microscopic Variables Assessed with the Two Devices, All Configurations, All Subjects, Effectiveness Population
| | Endothelial Cell
Density | Coefficient of
Variation
Endothelial Cell
Area (CV) | Coefficient of
Variation
Endothelial Cell
Area
WITHOUT
Subject 001-3-
008 | %
Hexagonality | Central
Corneal
Thickness |
|-------------------------------------------------------------|-----------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------|---------------------------------|
| Nidek CEM-530 | | | | | |
| N | 74 | 74 | 73 | 74 | 74 |
| Mean | 2482.6 | 29.9 | 29.4 | 69.0 | 551.5 |
| (SD) | (436.55) | (7.21) | (5.86) | (5.19) | (40.7) |
| Median | 2574.0 | 28.0 | 28.0 | 69.0 | 551.0 |
| Min-Max | 731 - 3093 | 19 - 66 | 19 - 52 | 56 - 82 | 411 - 640 |
| Deming Regression
Intercept (95%
Confidence Interval) | 452.8 | 3278.7 | -42.2 | 55.3 | -4.2 |
| | (193.1, 712.5) | (-120246.9,
126804.3) | (-90.2, 5.8) | (38.0, 72.5) | (-120.5,
112.2) |
| Deming Regression
Slope
(95% Confidence
Interval) | 0.8 | -104.3 | 2.3 | 0.2 | 1.0 |
| | (0.7, 0.9) | (-4072.4, 3863.8) | (0.7, 3.8) | (-0.1, 0.5) | (0.8, 1.2) |
| Konan CELLCHEK XL (PLUS) | | | | | |
| N | 74 | 74 | 73 | 74 | 74 |
| Mean (SD) | 2553.1 | 31.2 | 31.4 | 59.3 | 565.2 |
| | (544.85) | (4.63) | (4.00) | (7.80) | (41.32) |
| Median | 2649.5 | 31.0 | 31.0 | 59.5 | 565.0 |
| Min- Max | 515 - 3472 | 11 - 40 | 22 - 40 | 40 - 75 | 474 - 685 |
| Device Comparisons | | | | | |
| Mean Difference (SD) | -70.5 | -1.3 | -2.1 | 9.7 | -13.8 |
| | (167.89) | (8.60) | (5.52) | (8.44) | (19.63) |
| Mean Difference (SD)
as a % of the
CELLCHEK reading | -0.42% | 0.77% | -6.07% | 18.19% | -2.38% |
| | (15.416%) | (61.409%) | (17.73%) | (17.464%) | (3.558%) |
| 95% Limits of
Agreement (LOA) | (-406.3, 265.2) | (-18.5, 15.9) | (-13.1, 9.0) | (-7.2, 26.5) | (-53.0,
25.5) |
| Correlation (R2) | 0.9654 | -0.0088 | 0.4247 | 0.2036 | 0.8856 |
6
Coefficient of Variation of Endothelial Cell Area
For the total population, the mean differences illustrated on the Bland Altman plot (Figure 4) were generally small. The flatness of the device difference plot (Figure 5) throughout the measurement range also illustrates good agreement between the devices, although an outlier is visible that had a low Cellchek Plus value and a very high Nidek CEM-530 value. This outlier caused a very poor fit on the Deming regression of Figure 6, but this greatly improved in Figure 7 when the regression lines were drawn with this subject excluded.
Image /page/6/Figure/2 description: This image is titled "Coefficient of Variation of Endothelial Cell Area". The image is labeled as "Figure 4: Bland-Altman Plot Observed Data- Coefficient of Variation Endothelial Cell Area- All Subjects, Effectiveness Population". The figure is likely a Bland-Altman plot, which is a scatter plot that is used to compare two methods of measurement.
Image /page/6/Figure/3 description: This image is a scatter plot with the x-axis labeled as "Mean" and the y-axis labeled as "Difference". The data points are scattered around the zero line, with some points above and some below. There are also two horizontal lines, one above and one below the zero line, which may represent the upper and lower limits of agreement.
7
Image /page/7/Figure/0 description: The image is a scatter plot titled "Endothelial Cell Area- All Subjects, Effectiveness Population". The y-axis is labeled "Device Difference" and ranges from -60 to 60. The x-axis is labeled "CELLCHEK XL Value" and ranges from 10 to 40. The data points are scattered across the plot, with a higher concentration between 25 and 35 on the x-axis and between -10 and 10 on the y-axis.
Figure 5: Device Difference by Cellchek Plus Value- Coefficient of Variation
Figure 6: Deming Regression Plot- CEM-530 by Cellchek Plus - Coefficient of Variation Endothelial Cell Area- All Subjects, Effectiveness Population, with Outlier ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Image /page/7/Figure/3 description: The image is a scatter plot with a regression line. The x-axis is labeled "CELLCHECK XL Value" and ranges from approximately 5 to 40. The y-axis is labeled "CEN-530 Value" and ranges from 0 to 100. The data points are scattered around the regression line, which has a positive slope.
8
Figure 7: Deming Regression Plot- CEM-530 by Cellchek Plus - Coefficient of Variation Endothelial Cell Area- All Subjects, Effectiveness Population, without Outlier
Image /page/8/Figure/1 description: This image is a scatter plot with two trend lines. The y-axis is labeled "CEM-536 Value" and ranges from -10 to 70. The x-axis is labeled "CELLCHECK XL Value" and ranges from 20 to 50. One trend line is labeled "Deming Regression Line" and the other is labeled "45 Degree Line".
Percent Hexagonality
While the LOAs included 0, the mean differences were on the order of approximately 15% of the mean for % hexagonality (Figure 8), more than for the other 3 variables. The lack of flatness of the device difference plot, Figure 9, also shows that the largest device differences are seen at the lower end of the scale. The Deming regression lines (Figure 10) show some agreement between the two devices.
9
Image /page/9/Figure/0 description: The image is a scatter plot titled "Effectiveness Population". The x-axis is labeled "Mean" and ranges from 52 to 80. The y-axis is labeled "Difference" and ranges from -40 to 40. There are three horizontal lines at approximately -15, 10, and 30, and the data points are scattered around the center of the plot.
Percent Hexagonality Figure 8: Bland-Altman Plot- Observed Data- % Hexagonality- All Subjects, Effectiveness Population
Figure 9: Device Difference by CELLCHEK XL (PLUS) Value- % Hexagonality- All Subjects, Effectiveness Population
Image /page/9/Figure/3 description: The image is a scatter plot with the title "Device Difference" on the y-axis and "CELLTHEK YL Value" on the x-axis. The x-axis ranges from 40 to 75, while the y-axis ranges from -40 to 40. The scatter plot shows a negative correlation between the two variables, with the points generally decreasing as the x-axis increases.
10
Image /page/10/Figure/0 description: This image is a scatter plot with two lines. The x-axis is labeled "CELLCHECK XL Value" and ranges from 40 to 80. The y-axis is labeled "CEM-530 Value" and ranges from 40 to 90. The scatter plot shows the relationship between the two variables, and the two lines represent the Deming Regression Line and the 45 Degree Line.
Figure 10: Deming Regression Plot- CEM-530 by CELLCHEK XL (PLUS)- % Hexagonality- All Subjects, Effectiveness Population
Central Corneal Thickness
The Bland Altman plot of Figure 11 shows that the LOAs include 0, indicating a lack of an overwhelmingly large systematic bias. The device differences plot (Figure 12) shows no notable effect of scale on agreement. The Deming regression lines (Figure 13) show an excellent fit.
11
Image /page/11/Figure/0 description: The image shows a Bland-Altman plot of observed data for central corneal thickness in an effectiveness population. The plot displays the difference between two measurements on the y-axis, ranging from approximately -80 to 120. There are three horizontal lines at approximately -50, -10, and 30, and data points are scattered around the middle line. The title of the plot is "Figure 11: Bland-Altman Plot- Observed Data- Central Corneal Thickness- All Subjects, Effectiveness Population".
Central Corneal Thickness Figure 11: Bland-Altman Plot- Observed Data- Central Corneal Thickness- All
Figure 12: Device Difference by Cellchek Plus Value- Central Corneal Thickness-All Subjects, Effectiveness Population
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Image /page/11/Figure/3 description: This image shows a scatter plot titled "All Subjects, Effectiveness Population". The y-axis is labeled "Device Difference" and ranges from -120 to 100. The x-axis is labeled "CELLCHEK XL Value" and ranges from 400 to 700. The data points are scattered across the plot, with a higher density between x values of 500 and 600 and y values between -40 and 20.
12
Figure 13: Deming Regression Plot- CEM-530 by Cellchek Plus - Central Corneal Thickness - All Subjects, Effectiveness Population
Image /page/12/Figure/1 description: The image is a scatter plot that compares two different values. The y-axis is labeled "DEM-520 Value" and ranges from 450 to 700. The x-axis is labeled "CELICHECK AL Value" and ranges from 450 to 570. There are two dotted lines on the plot, one labeled "Ceming Regression Line" and the other labeled "45 Degree Line".
Agreement of the measurements with the CEM-530 and the predicate device was found to be acceptable. Overall, within eye/subject variability was acceptable, and similar for both machines.
The precision of the two devices was assessed with repeatability and reproducibility measures: the first within a given subject and the second within and among configurations. Table 2 shows the repeatability and reproducibility data for each of the 4 variables in all subjects. Repeatability was notably better for the CEM-530 device for central corneal thickness. The two devices had comparable repeatability for the other endpoints.
| Variable | Nidek CEM-
530
N=62 | Konan
CELLCHEK
PLUS
N=62 |
|-----------------------------------------------|---------------------------|-----------------------------------|
| Endothelial Cell Density | | |
| Repeatability SD | 75.5 | 62.4 |
| Repeatability SD as a % of the Mean | 3.0% | 2.4% |
| Repeatability Limit | 211.5 | 174.8 |
| Repeatability Ratio (CEM-530/CELLCHEK PLUS) | 1.2102 | |
| Reproducibility SD | 113.2 | 95.2 |
| Reproducibility SD as a % of the Mean | 4.5% | 3.7% |
| Reproducibility Limit | 317.0 | 266.7 |
| Reproducibility Ratio (CEM-530/CELLCHEK PLUS) | 1.1887 | |
Table 2: Precision Analyses- All Subjects Effectiveness Population
13
| Coefficient of Variation of Endothelial Cell Area (CV) | ||
|---|---|---|
| Repeatability SD | 2.3 | 2.7 |
| Repeatability SD as a % of the Mean | 8.1% | 8.5% |
| Repeatability Limit | 6.6 | 7.5 |
| Repeatability Ratio (CEM-530/CELLCHEK PLUS) | 0.8746 | |
| Reproducibility SD | 2.7 | 2.7 |
| Reproducibility SD as a % of the Mean | 9.3% | 8.6% |
| Reproducibility Limit | 7.6 | 7.6 |
| Reproducibility Ratio (CEM-530/CELLCHEK PLUS) | 1.0016 | |
| % Hexagonality | ||
| Repeatability SD | 4.1 | 5.4 |
| Repeatability SD as a % of the Mean | 6.0% | 8.8% |
| Repeatability Limit | 11.4 | 15.0 |
| Repeatability Ratio (CEM-530/CELLCHEK PLUS) | 0.7586 | |
| Reproducibility SD | 4.1 | 5.4 |
| Reproducibility SD as a % of the Mean | 6.0% | 8.9% |
| Reproducibility Limit | 11.4 | 15.2 |
| Reproducibility Ratio (CEM-530/CELLCHEK PLUS) | 0.7466 | |
| Central Corneal Thickness | ||
| Repeatability SD | 3.3 | 12.5 |
| Repeatability SD as a % of the Mean | 0.6% | 2.2% |
| Repeatability Limit | 9.2 | 34.9 |
| Repeatability Ratio (CEM-530/CELLCHEK XL (PLUS)) | 0.2634 | |
| Reproducibility SD | 5.8 | 13.2 |
| Reproducibility SD as a % of the Mean | 1.1% | 2.3% |
| Reproducibility Limit | 16.3 | 37.0 |
.
ﻴ
.
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Additional analysis was completed on 24 images with and without corneal pathology using both the manual method and automated method of analysis on the same image. The images were then analyzed and generated the following results for CD (Cell Density), CV(Coefficient of Variation) and HEX(%Hexagonality)
| | CD
(Cell Density) | CV
(Coefficient of
Variation) | HEX
(Hexagonality) | NUM
(Number of Cells) |
|----------------------------------------------------|----------------------------------|-------------------------------------|------------------------------|--------------------------------|
| Mean | 2267.2 / 2165.3
Auto / Manual | 28.9 / 36.3
Auto / Manual | 68.7 / 57.4
Auto / Manual | 173.3 / 153.3
Auto / Manual |
| Mean Difference
(SD) | 101.9 (53.76) | -7.4(4.91) | 11.3(7.75) | |
| Mean difference
as a % of the
Manual reading | 4.94% | -19.41% | 20.98% | 13.47% |
| Correlation (R^2) | 0.9918 | 0.7523 | 0.2226 | 0.4306 |
| Deming Regression
Intercept | 127.7 | 5.0 | 50.3 | -334.1 |
| Deming Regression
Slope | 1.0 | 0.7 | 0.3 | 3.3 |
Table 3: Agreement Analysis on Same Image – Automated vs. Manual Method
Image /page/14/Figure/3 description: This image is labeled as "Figure 14: Deming Regression Plot - CEM-530 by Manual - Endothelial Cell Density (CD) - Same Image - All Subjects." The title indicates that the figure is a Deming Regression Plot. The plot is related to CEM-530 data obtained manually. The data is about endothelial cell density and includes all subjects from the same image.
Image /page/14/Figure/4 description: The image shows a scatter plot with two lines. The x-axis is labeled "Manual Value" and the y-axis is labeled "TEM-510 Value". There is a solid line labeled "Daring Regression Line" and a dashed line labeled "45 Degree Line". The scatter plot shows a positive correlation between the manual value and the TEM-510 value.
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Figure 15: Deming Regression Plot - CEM-530 by Manual - Coefficient of Variation of Endothelial Cell Area (CV) – Same Image – All Subjects
Image /page/15/Figure/1 description: The image is a scatter plot with two lines. The x-axis is labeled "Input Value" and ranges from 20 to 55. The y-axis is labeled "Output Value" and ranges from 22 to 60. There is a solid line labeled "Dasing Regression Line" and a dashed line labeled "45 Degree Line."
Figure 16: Deming Regression Plot - CEM-530 by Manual - % Hexagonality (HEX). - Same Image - All Subjects
Image /page/15/Figure/3 description: The image is a scatter plot with two lines. The x-axis is labeled "Manual Value" and ranges from 10 to 80. The y-axis is labeled "CEM.430 Value" and ranges from 40 to 80. There are two lines on the plot, one solid and one dashed, and several data points scattered around the lines.
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In summary, the agreement and precision of the Nidek CEM-530 was found to be substantially equivalent to the predicate device.
CONCLUSIONS
The Nidek Specular Microscope CEM-530 has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicate. The minor 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 Nidek Specular Microscope CEM-530 is as safe and effective as its predicate device, and thus, substantially equivalent.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 27, 2013
Nidek Co., Ltd. c/o Mr. Aron Shapiro Vice President 300 Brickstone Square Andover, MA 01810
Re: K130565
Trade/Device Name: Nidek Specular Microscope CEM-530 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: NQE Dated: October 17, 2013 Received: October 18, 2013
Dear Mr. Shapiro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boomed 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 commerce proc to may 20, 1977, Liv 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. Tournal controls provisions of the Act include requirements for annual registration, listing of I he general connous provisions and prohibitions against misbranding and ac vices, good manarataining prevates, as time, water 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), II your device is classified (500 above) a Existing major regulations affecting your device can be it may of Subject to adamonal conditions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Aron Shapiro
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/18/Picture/6 description: The image contains the text "Deborah L Falls -S". The text is written in a bold, sans-serif font. The word "Deborah" is on the left, followed by "L Falls" and then "-S" on the right. The text is slightly distorted, with some parts appearing blurred or pixelated.
for Malvina B. Evdelman, 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):
Device Name:_ Nidek Specular Microscope CEM-530
Indications For Use:
The Nidek Specular Microscope CEM-530 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR .
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Marsha L. Burke Nicholas -S 2013.12.03 15:14:38 -05'00'
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