(326 days)
Not Found
No
The summary describes a device for imaging and measurement with a normative database for comparison, but there is no mention of AI or ML being used for image analysis, diagnosis, or any other function. The performance studies focus on comparability and repeatability, not on the performance of an AI/ML algorithm.
No
The device is described as an imaging and diagnostic device used to support the diagnosis and observation of eye diseases, not to treat them.
Yes
The 'Intended Use / Indications for Use' section explicitly states: "It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma."
No
The device description explicitly states it is a "non-contact, high resolution digital, tomographic and biomicroscopic imaging device" that merges fundus imaging and optical coherence tomography into a single device, indicating it includes significant hardware components for image acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CIRRUS photo is an in vivo imaging device. It directly images the structures of the eye (retina, cornea, etc.) within the living patient. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it is for "in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures... as well as imaging of anterior ocular structures." It also uses a normative database for comparison, but this is based on in vivo measurements, not in vitro analysis of samples.
Therefore, the CIRRUS photo falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CIRRUS photo (Models 600 and 800) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions.
These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea.
It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
Product codes (comma separated list FDA assigned to the subject device)
OBO, HKI
Device Description
The CIRRUS photo is a non-contact, high resolution digital, tomographic and biomicroscopic imaging device that merges fundus imaging and optical coherence tomography into a single device. To optimize the workflow, the system applies the same beam delivery system for imaging and scanning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography, Digital Camera (Fundus Imaging)
Anatomical Site
retina, surrounding parts of the eye, posterior ocular structures (retina, retinal nerve fiber layer, macula, optic disc), anterior ocular structures (cornea)
Indicated Patient Age Range
Not Found
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
NORMAL EYES STUDY
Sixty-three normal subjects were enrolled in a study to evaluate the equivalence of the means of 31 measurement parameters: retinal nerve fiber layer (RNFL) thickness (17 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the CIRRUS photo and Cirrus HD-OCT Model 4000. The study was divided into two phases. Thirty subjects were enrolled in Phase 1 that evaluated inter-operator variability. Three Optic Disc Cube 200x200 scans were taken on one eye and three Macular Cube 512x128 scans were taken on the fellow eye by each of the four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument. Thirty-three subjects were enrolled in Phase 2 that evaluated interdevice variability. Three Optic Disc Cube 200x200 scans were taken on one eye and three Macular Cube 512x128 scans were taken on the fellow eye from each of the four Cirrus HD-OCT Model 4000 instruments and each of the four CIRRUS photo instruments by one operator. Subjects could not participate in both phases.
DISEASED EYES STUDY
Seventy-three subjects with either macular disease or glaucoma were enrolled in a study to evaluate the equivalence of the means of 31 measurement parameters: retinal nerve fiber layer (RNFL) thickness (17 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the CIRRUS photo and Cirrus HD-OCT Model 4000. The study was divided into two study arms; study arm 1 enrolled subjects with retina disease and study arm 2 enrolled subjects with glaucoma. Each study arm had two phases; phase 1evaluated inter-device variability and phase 2 evaluated inter-operator variability. Subjects could not participate in both phases of the study.
Nineteen subjects with retinal disease were enrolled in the inter-device phase of the study. Three Macular Cube 512x128 scans were taken by one operator using four Cirrus HD-OCT Model 4000 and four CIRRUS photo instruments. Nineteen different subjects with retinal disease were enrolled in the inter-operator phase of the study. Three Macular Cube 512x128 scans were taken by four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument.
Seventeen subjects with glaucoma were enrolled in the inter-device phase of the study. Three Optic Disc Cube 200x200 scans were taken by one operator using four Cirrus HD-OCT Model 4000 and four CIRRUS photo instruments. Eighteen subjects with glaucoma were enrolled in the inter-operator phase of the study. Three Optic Disc Cube 200x200 scans were taken by four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Nonclinical and Clinical tests, including repeatability and reproducibility studies.
Sample Sizes:
- Normal Eyes Study: 63 normal subjects (30 in Phase 1 for inter-operator variability; 33 in Phase 2 for inter-device variability).
- Diseased Eyes Study: 73 subjects with macular disease or glaucoma (19 with retinal disease in inter-device phase; 19 with retinal disease in inter-operator phase; 17 with glaucoma in inter-device phase; 18 with glaucoma in inter-operator phase).
Key Results: - The mean values of the 31 thickness parameters (RNFL, ONH, Macular) were very similar for the CIRRUS photo and Cirrus HD-OCT Model 4000 devices.
- The studies support the incorporation of the normative databases established with the Cirrus HD-OCT Model 4000 instrument into the CIRRUS photo instrument with an adjustment based on regression analysis.
- CIRRUS photo showed good repeatability and reproducibility for both normal and diseased eyes.
Mean Difference (Normal Eyes - Inter-device phase, N=33):
- Average RNFL Thickness: 0.6 (SD 1.2), 95% CI (0.2, 1.0)
- Average Cup-to-Disc Ratio: -0.012 (SD 0.012), 95% CI (-0.016, -0.007)
- Central Subfield (Macular): 2.2 (SD 2.1), 95% CI (1.5, 3.0)
Mean Difference (Diseased Eyes - Inter-device phase, ONH N=17, Macular N=19):
- Average RNFL Thickness: 0.8 (SD 1.3), 95% CI (0.1, 1.4)
- Average Cup-to-Disc Ratio: -0.006 (SD 0.007), 95% CI (-.010, -.002)
- Central Subfield (Macular): 2.4 (SD 5.2), 95% CI (-0.1, 4.9)
Repeatability and Reproducibility (Normal Eyes):
- Average RNFL Thickness (µm): Repeatability SD = 1.4634, Reproducibility SD = 2.1899
- Central Subfield (Macular) (µm): Repeatability SD = 1.6398, Reproducibility SD = 2.7756
Repeatability and Reproducibility (Diseased Eyes):
- Average RNFL Thickness (µm): Repeatability SD = 1.4634, Reproducibility SD = 1.8796
- Central Subfield (Macular) (µm): Repeatability SD = 5.6224, Reproducibility SD = 7.6068
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Values for repeatability, reproducibility, mean differences, confidence intervals, and limits of agreement are provided.
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.
Carl Zeiss Meditec VISUCAM PRO NM Digital Camera (K052268), Carl Zeiss Meditec Cirrus HD-OCT Optical Coherence Tomographer with Retinal Nerve Fiber Layer (RNFL), Macular and Optic Nerve Head Normative Databases, Model 4000 (K083291; K111157), Carl Zeiss Meditec FF450 plus Fundus Camera (K011877), Topcon TRC-NW8F (K100207), Topcon 3D Optical Coherence Tomography 3D OCT-2000 (K092470).
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
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, 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
510(K) SUMMARY
JUN 1 8 2012
This 510(k) Summary information is being submitted in accordance with the requirements of 21 CFR 807.92(a).
SUBMITTER NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED
Applicant:
Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena 'Germany
Contact Person:
Judith A. Brimacombe, MA Director, Clinical/Regulatory Affairs Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 USA j.brimacombe@meditec.zeiss.com Tel: (925) 557-4616 Fax: (925) 557-4259
Summary Prepared:
June 14, 2012
Fundus Camera
NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME
Trade/Proprietary Name:
CIRRUS photo Models 600 and 800
Optical Coherence Tomography
Tomography, Optical coherence Camera, Ophthalmic, AC-powered
Common/Usual Name:
Classification Name:
Product Code and Class:
OBO - Class II HKI - Class II
Classification Number:
886.1570 886.1120
1
1
PREDICATE DEVICES
The CIRRUS photo (Models 600 and 800) is substantially equivalent to the Carl Zeiss Meditec VISUCAM PRO NM Digital Camera (K052268), the Carl Zeiss Meditec Cirrus HD-OCT Optical Coherence Tomographer with Retinal Nerve Fiber Layer (RNFL), Macular and Optic Nerve Head Normative Databases, Model 4000 (K083291; K111157), the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877), the Topcon TRC-NW8F (K100207), and the Topcon 3D Optical Coherence Tomography 3D OCT-2000 (K092470).
The CIRRUS photo is substantially equivalent to these cleared devices with regard to indications for use and technological characteristics.
DEVICE DESCRIPTION
The CIRRUS photo is a non-contact, high resolution digital, tomographic and biomicroscopic imaging device that merges fundus imaging and optical coherence tomography into a single device. To optimize the workflow, the system applies the same beam delivery system for imaging and scanning.
INDICATIONS FOR USE
The CIRRUS photo is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions.
These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea.
It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
2
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The CIRRUS photo has very similar indications for use and operating characteristics as the predicate devices. The CIRRUS photo combines into a single system the functionalities and indications for use from each of the predicate devices.
The fundus camera unit of the CIRRUS photo utilizes the same imaging properties and technology as the cleared VISUCAM PRO NM Digital Camera to record morphologic images of the human retina under mydriatic and non-mydriatic conditions, respectively. The spectral domain optical coherence tomographer SD-OCT Module is the same optical coherence tomography system as in the cleared Cirrus HD-OCT Optical Coherence Tomographer, Model 4000 (K083291; K111157). The CIRRUS photo includes the fluorescein angiography (FA), and indocyanine green angiography (ICGA) functionalities of the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877) and also contains filters for Fundus Autofluorescence. Filters for Fluorescein Angiography, ICG Angiography, and Fundus Autofluorescence are available in the Topcon TRC-NW8F (K100207). The Topcon 3D Optical Coherence Tornography 3D OCT-2000 (K092470), like the CIRRUS photo, incorporates a high resolution fundus camera with a Spectral Domain Optical Coherence Tomographer.
The CIRRUS photo is therefore substantially equivalent to the predicate devices. i.e., the Carl Zeiss Meditec VISUCAM PRO NM Digital Camera (K052268), the Carl Zeiss Meditec Cirrus HD-OCT, Model 4000 (K083291; K11157), the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877), the Topcon TRC-NW8F (K100207), and the Topcon 3D OCT-2000 (K092470).
BRIEF SUMMARY OF NONCLINICAL AND CLINICAL TESTS AND RESULTS
The CIRRUS photo has been designed and tested to the applicable standards for electrical and optical safety and verified to established specifications. In addition, the following clinical testing, which includes repeatability and reproducibility, was performed.
CLINICAL TESTING
Two prospective studies were conducted to determine comparability, repeatability and reproducibility of the measurement data between the CIRRUS photo and Cirrus HD-OCT Model 4000 instruments.
NORMAL EYES STUDY
Sixty-three normal subjects were enrolled in a study to evaluate the equivalence of the means of 31 measurement parameters: retinal nerve fiber layer (RNFL) thickness (17 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the CIRRUS photo and Cirrus HD-OCT Model 4000. The study was divided into two phases. Thirty subjects were enrolled in Phase 1 that evaluated inter-operator variability. Three Optic Disc Cube 200x200 scans were taken on one eye and three Macular Cube 512x128 scans were taken on the fellow eye by each of the four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument. Thirty-three subjects were enrolled in Phase 2 that evaluated interdevice variability. Three Optic Disc Cube 200x200 scans were taken on one eye and three
3
Macular Cube 512x128 scans were taken on the fellow eye from each of the four Cirrus HD-OCT Model 4000 instruments and each of the four CIRRUS photo instruments by one operator. Subjects could not participate in both phases.
DISEASED EYES STUDY
Seventy-three subjects with either macular disease or glaucoma were enrolled in a study to evaluate the equivalence of the means of 31 measurement parameters: retinal nerve fiber layer (RNFL) thickness (17 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the CIRRUS photo and Cirrus HD-OCT Model 4000. The study was divided into two study arms; study arm 1 enrolled subjects with retina disease and study arm 2 enrolled subjects with glaucoma. Each study arm had two phases; phase 1evaluated inter-device variability and phase 2 evaluated inter-operator variability. Subjects could not participate in both phases of the study.
Nineteen subjects with retinal disease were enrolled in the inter-device phase of the study. Three Macular Cube 512x128 scans were taken by one operator using four Cirrus HD-OCT Model 4000 and four CIRRUS photo instruments. Nineteen different subjects with retinal disease were enrolled in the inter-operator phase of the study. Three Macular Cube 512x128 scans were taken by four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument.
Seventeen subjects with glaucoma were enrolled in the inter-device phase of the study. Three Optic Disc Cube 200x200 scans were taken by one operator using four Cirrus HD-OCT Model 4000 and four CIRRUS photo instruments. Eighteen subjects with glaucoma were enrolled in the inter-operator phase of the study. Three Optic Disc Cube 200x200 scans were taken by four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument.
DATA ANALYSIS
For each of the two study devices and each measurement parameter, the mean of the available measurements was calculated for each study eye. The difference in each of the 31 measurement parameters between the CIRRUS photo and Cirrus HD-OCT Model 4000 were calculated for each study eye. The mean difference, the corresponding 95% confidence intervals, and 95% limits of agreement were calculated for each measurement parameter. As the inter-operator phase utilized only one device, only the results for the inter-device phase are presented in Tables 1 and 2 for the normal and diseased eye studies, respectively.
The mean values of the 31 thickness parameters were very similar for the two devices. The results of these two studies support the incorporation of the normative databases established with the Cirrus HD-OCT Model 4000 instrument into the CIRRUS photo instrument with an adjustment based on regression analysis.
Additionally, analysis of variance (ANOVA) with random effect models was used to evaluate the repeatability, inter-device variability and inter-operator variability of each measurement parameter for the CIRRUS photo. The repeatability standard deviation (SD) and limits for the CIRRUS photo are shown in Tables 3 and 4 for the normal and diseased eyes studies, respectively. Cirrus photo showed good repeatability and reproducibility for both normal and diseased eyes.
4
TABLE 1
MEAN DIFFERENCE IN RNFL, ONH AND MACULAR THICKNESS MEASUREMENTS BETWEEN CIRRUS PHOTO AND CIRRUS HD-OCT OPTICAL COHERENCE TOMOGRAPHER, MODEL 4000 (NORMAL EYES)
| | Cirrus 4000
Cirrus photo | | Difference | | 95% | 95% |
|------------------------------|-----------------------------|-----------------|------------------|--|-------------------------------------------------|------------------------|
| | Mean (SD) | Mean (SD) | Mean (SD) | | Confidence
Interval of
Mean
Difference | Limits of
Agreement |
| RNFL Parameter | N = 33 | N = 33 | N = 33 | | | |
| Average RNFL Thickness (µm) | 94.3 (9.7) | 93.7 (9.8) | 0.6 (1.2) | | (0.2, 1.0) | (-1.7, 2.9) |
| Temporal (µm) | 68.8 (13.1) | 68.4 (12.3) | 0.4 (1.9) | | (-0.3, 1.0) | (-3.3, 4.1) |
| Superior (µm) | 119.3 (12.2) | 121.0 (12.7) | -1.7 (2.4) | | (-2.5, -0.8) | (-6.3, 2.9) |
| Nasal (µm) | 69.8 (15.9) | 68.2 (16.8) | 1.6 (3.0) | | (0.6, 2.7) | (-4.3, 7.6) |
| Inferior (µm) | 119.4 (17.4) | 117.5 (16.8) | 1.9 (2.9) | | (0.9, 2.9) | (-3.7, 7.5) |
| Clock hour 9 (µm) | 53.3 (9.8) | 53.8 (8.9) | -0.5 (2.1) | | (-1.2, 0.3) | (-4.6, 3.6) |
| Clock hour 10 (µm) | 82.0 (18.7) | 83.8 (17.6) | -1.7 (3.1) | | (-2.8, -0.6) | (-7.9, 4.4) |
| Clock hour 11 (µm) | 134.8 (24.2) | 137.4 (23.5) | -2.6 (4.1) | | (-4.0, -1.2) | (-10.6, 5.4) |
| Clock hour 12 (µm) | 116.5 (20.8) | 117.1 (21.4) | -0.6 (4.5) | | (-2.2, 1.0) | (-9.3, 8.2) |
| Clock hour 1 (µm) | 106.5 (15.0) | 108.3 (15.8) | -1.8 (4.7) | | (-3.5, -0.1) | (-11.1, 7.5) |
| Clock hour 2 (µm) | 86.9 (21.3) | 83.5 (21.7) | 3.4 (3.9) | | (2.0, 4.8) | (-4.2, 10.9) |
| Clock hour 3 (µm) | 58.2 (12.3) | 56.1 (13.0) | 2.1 (3.5) | | (0.9, 3.4) | (-4.8, 9.0) |
| Clock hour 4 (µm) | 64.3 (18.1) | 64.8 (19.2) | -0.5 (3.8) | | (-1.8, 0.9) | (-8.0, 7.0) |
| Clock hour 5 (µm) | 93.0 (18.8) | 93.1 (18.9) | -0.2 (4.3) | | (-1.7, 1.4) | (-8.6, 8.2) |
| Clock hour 6 (µm) | 130.5 (31.2) | 130.3 (29.2) | 0.2 (5.6) | | (-1.7, 2.2) | (-10.7, 11.1) |
| Clock hour 7 (µm) | 134.8 (18.5) | 129.1 (17.7) | 5.7 (4.3) | | (4.2, 7.2) | (-2.7, 14.1) |
| Clock hour 8 (µm) | 71.0 (14.5) | 67.6 (14.1) | 3.4 (3.5) | | (2.2, 4.7) | (-3.4, 10.2) |
| ONH Parameters | N = 33 | N = 33 | N = 33 | | | |
| Average Cup-to-Disc Ratio | 0.455 (0.158) | 0.466 (0.154) | -0.012 (0.012) | | (-0.016, -0.007) | (-0.035, 0.011) |
| Vertical Cup-to-Disc Ratio | 0.430 (0.153) | 0.440 (0.152) | -0.010 (0.013) | | (-0.015, -0.005) | (-0.036, 0.016) |
| Disc Area (mm2) | 1.753 (0.294) | 1.822 (0.310) | -0.068 (0.034) | | (-0.081, -0.056) | (-0.135, -0.001) |
| Rim Area (mm2) | 1.317 (0.177) | 1.352 (0.186) | -0.034 (0.027) | | (-0.044, -0.025) | (-0.088, 0.019) |
| Cup Volume (mm3) | 0.1293 (0.1246) | 0.1382 (0.1309) | -0.0089 (0.0104) | | (-0.0126, -0.0052) | (-0.0292, 0.0114) |
| Macular Thickness Parameters | N = 33 | N = 33 | N = 33 | | | |
| Central Subfield (µm) | 265.0 (23.7) | 262.8 (23.4) | 2.2 (2.1) | | (1.5, 3.0) | (-1.8, 6.3) |
| Inner Temporal (µm) | 310.2 (13.7) | 308.6 (13.2) | 1.6 (2.5) | | (0.7, 2.5) | (-3.3, 6.6) |
| Inner Superior (µm) | 324.6 (14.8) | 323.6 (14.1) | 1.1 (3.1) | | (-0.0, 2.2) | (-5.1, 7.2) |
| Inner Nasal (µm) | 328.8 (15.4) | 326.6 (14.6) | 2.2 (3.0) | | (1.2, 3.3) | (-3.6, 8.1) |
| Inner Inferior (µm) | 320.7 (15.7) | 319.1 (14.9) | 1.6 (2.8) | | (0.6, 2.5) | (-3.9, 7.0) |
| Outer Temporal (µm) | 260.5 (13.6) | 261.0 (13.3) | -0.6 (1.9) | | (-1.2, 0.1) | (-4.3, 3.2) |
| Outer Superior (µm) | 279.7 (13.1) | 279.7 (12.7) | -0.0 (2.1) | | (-0.8, 0.7) | (-4.1, 4.0) |
| Outer Nasal (µm) | 299.4 (16.1) | 298.9 (15.2) | 0.5 (2.2) | | (-0.3, 1.3) | (-3.7, 4.7) |
| Outer Inferior (µm) | 266.2 (14.0) | 266.1 (13.4) | 0.2 (2.2) | | (-0.6, 0.9) | (-4.1, 4.4) |
For the inter-device phase of the study, 33 subjects were enrolled.
For each of the two study devices, the average of measurements from different units were calculated for each eye and this average was treated as the measurement for the corresponding eye.
Difference = Cirrus-4000 - Cirrus-photo.
95% Confidence Interval of Mean Difference = mean ± 1.96 ×SE. 95% Limits of Agreement = mean ± 1.96 ×SD.
5
TABLE 2
MEAN DIFFERENCE IN RNFL, ONH AND MACULAR THICKNESS MEASUREMENTS BETWEEN CIRRUS PHOTO AND CIRRUS HD-OCT OPTICAL COHERENCE TOMOGRAPHER, MODE + 4000 (DISEASED EYES)
| | Cirrus 4000
Mean (SD) | Cirrus photo
Mean (SD) | Difference
Mean (SD) | 95%
Confidence
Interval of
Mean
Difference | 95%
Limits of
Agreement |
|------------------------------|--------------------------|---------------------------|-------------------------|--------------------------------------------------------|-------------------------------|
| RNFL Parameter | N = 17 | N = 17 | N = 17 | | |
| Average RNFL Thickness (µm) | 63.8 (10.0) | 63.1 (9.6) | 0.8 (1.3) | (0.1, 1.4) | (-1.7, 3.2) |
| Temporal (µm) | 47.1 (8.3) | 48.1 (8.0) | -0.9 (1.7) | (-1.8, -0.1) | (-4.2, 2.4) |
| Superior (µm) | 78.5 (16.7) | 78.9 (17.7) | -0.3 (1.8) | (-1.3, 0.6) | (-3.9, 3.3) |
| Nasal (µm) | 58.7 (7.3) | 55.8 (5.8) | 2.9 (2.9) | (1.3, 4.4) | (-2.9, 8.6) |
| Inferior (µm) | 70.8 (18.1) | 69.4 (16.9) | 1.4 (2.3) | (0.2, 2.6) | (-3.1, 5.9) |
| Clock hour 9 (µm) | 41.6 (8.7) | 43.2 (8.8) | -1.6 (2.0) | (-2.6, -0.5) | (-5.6, 2.4) |
| Clock hour 10 (µm) | 52.4 (12.8) | 53.8 (14.2) | -1.3 (2.5) | (-2.6, -0.0) | (-6.3, 3.6) |
| Clock hour 11 (µm) | 78.9 (20.9) | 80.3 (21.5) | -1.4 (2.8) | (-2.9, 0.0) | (-7.0, 4.1) |
| Clock hour 12 (µm) | 81.4 (23.1) | 81.0 (24.6) | 0.4 (4.0) | (-1.7, 2.5) | (-7.5, 8.3) |
| Clock hour 1 (µm) | 75.3 (17.5) | 75.4 (17.8) | -0.1 (1.9) | (-1.1, 0.8) | (-3.8, 3.6) |
| Clock hour 2 (µm) | 66.5 (9.2) | 63.8 (9.3) | 2.7 (3.0) | (1.2, 4.2) | (-3.1, 8.5) |
| Clock hour 3 (µm) | 55.2 (10.0) | 51.1 (7.7) | 4.1 (3.9) | (2.1, 6.1) | (-3.5, 11.7) |
| Clock hour 4 (µm) | 54.4 (7.8) | 52.8 (6.7) | 1.6 (4.3) | (-0.5, 3.8) | (-6.7, 10.0) |
| Clock hour 5 (µm) | 64.7 (16.7) | 64.7 (17.4) | -0.1 (3.9) | (-2.0, 1.9) | (-7.6, 7.5) |
| Clock hour 6 (µm) | 75.3 (20.5) | 74.5 (18.6) | 0.8 (5.5) | (-2.0, 3.6) | (-9.9, 11.5) |
| Clock hour 7 (µm) | 72.6 (21.3) | 69.0 (18.8) | 3.5 (4.3) | (1.3, 5.8) | (-4.9, 12.0) |
| Clock hour 8 (µm) | 47.5 (10.2) | 47.4 (8.8) | 0.1 (2.8) | (-1.3, 1.6) | (-5.4, 5.7) |
| ONH Parameters | N = 17 | N = 17 | N = 17 | | |
| Average Cup-to-Disc Ratio | 0.732 (0.097) | 0.738 (0.093) | -0.006 (0.007) | (-.010, -.002) | (-.021, 0.008) |
| Vertical Cup-to-Disc Ratio | 0.736 (0.094) | 0.742 (0.088) | -0.006 (0.012) | (-.013, -.000) | (-.031, 0.018) |
| Disc Area (mm²) | 1.758 (0.489) | 1.853 (0.523) | -0.095 (0.045) | (-.118, -.072) | (-.184, -.006) |
| Rim Area (mm²) | 0.770 (0.216) | 0.795 (0.222) | -0.024 (0.016) | (-.032, -.016) | (-.055, 0.006) |
| Cup Volume (mm³) | 0.4105 (0.2230) | 0.4419 (0.2376) | -0.0315 (0.0181) | (-.0408, -.0222) | (-.0669, 0.0039) |
| Macular Thickness Parameters | N = 19 | N = 19 | N = 19 | | |
| Central Subfield (µm) | 343.8 (107.9) | 341.4 (108.8) | 2.4 (5.2) | (-0.1, 4.9) | (-7.9, 12.6) |
| Inner Temporal (µm) | 366.4 (92.7) | 365.0 (94.4) | 1.4 (9.3) | (-3.1, 5.9) | (-16.8, 19.6) |
| Inner Superior (µm) | 364.6 (86.3) | 364.7 (87.9) | -0.1 (5.4) | (-2.7, 2.5) | (-10.7, 10.5) |
| Inner Nasal (µm) | 366.1 (83.7) | 366.5 (85.3) | -0.4 (6.8) | (-3.6, 2.9) | (-13.6, 12.9) |
| Inner Inferior (µm) | 365.1 (85.7) | 365.1 (86.5) | -0.0 (5.1) | (-2.5, 2.4) | (-10.0, 10.0) |
| Outer Temporal (µm) | 283.7 (44.7) | 285.3 (45.6) | -1.6 (2.3) | (-2.7, -0.5) | (-6.0, 2.8) |
| Outer Superior (µm) | 299.6 (49.5) | 301.7 (50.0) | -2.1 (2.8) | (-3.5, -0.7) | (-7.7, 3.5) |
| Outer Nasal (µm) | 308.2 (45.7) | 310.0 (46.6) | -1.8 (2.6) | (-3.0, -0.5) | (-6.8, 3.3) |
| Outer Inferior (µm) | 285.7 (46.6) | 288.1 (48.5) | -2.4 (3.8) | (-4.2, -0.5) | (-9.9, 5.1) |
For the inter-device phase of the study, 17 glaucomatous eyes with retinal disease were enrolled. For each of the two study devices, the average of measurements from different units were calculated for each eye and this average was treated as the measurement for the corresponding eye.
Difference = Cirrus-4000 - Cirrus-photo.
95% Confidence Interval of Mean Difference = mean ± 1.96 ×SE. 95% Limits of Agreement = mean ± 1.96 ×SD.
6
TABLE 3.
CIRRUS PHOTO REPEATABILITY AND REPRODUCIBILITY IN MEASURING RNFL, ONH AND MACULAR THICKNESS (NORMAL EYES)
| Repeatability | Reproducibility | COV % | ||||
|---|---|---|---|---|---|---|
| SD | Limit | SD | Limit | Based on Repeatability | Based on Reproducibility | |
| RNFL Parameter | ||||||
| Average RNFL Thickness (µm) | 1.4634 | 4.0974 | 2.1899 | 6.1319 | 1.5660 | 2.3436 |
| Temporal (µm) | 3.1109 | 8.7106 | 3.4480 | 9.6544 | 4.6498 | 5.1536 |
| Superior (µm) | 4.0906 | 11.4538 | 5.2156 | 14.6038 | 3.4418 | 4.3884 |
| Nasal (µm) | 2.9302 | 8.2045 | 3.7041 | 10.3714 | 4.2513 | 5.3742 |
| Inferior (µm) | 3.4906 | 9.7737 | 4.8547 | 13.5930 | 2.9296 | 4.0744 |
| Clock hour 9 (µm) | 2.9861 | 8.3610 | 3.5083 | 9.8232 | 5.5946 | 6.5730 |
| Clock hour 10 (µm) | 4.2639 | 11.9388 | 4.6703 | 13.0768 | 5.2313 | 5.7299 |
| Clock hour 11 (µm) | 4.6518 | 13.0249 | 6.5183 | 18.2512 | 3.5278 | 4.9434 |
| Clock hour 12 (µm) | 6.6529 | 18.6281 | 7.7500 | 21.7000 | 5.6827 | 6.6198 |
| Clock hour 1 (µm) | 5.9988 | 16.7968 | 7.5104 | 21.0291 | 5.5767 | 6.9818 |
| Clock hour 2 (µm) | 5.1422 | 14.3981 | 6.4081 | 17.9426 | 6.0570 | 7.5481 |
| Clock hour 3 (µm) | 2.8467 | 7.9707 | 3.6839 | 10.3149 | 5.0520 | 6.5378 |
| Clock hour 4 (µm) | 3.4901 | 9.7722 | 4.2787 | 11.9803 | 5.3322 | 6.5371 |
| Clock hour 5 (µm) | 5.3422 | 14.9581 | 7.2244 | 20.2284 | 5.5214 | 7.4668 |
| Clock hour 6 (µm) | 5.9229 | 16.5841 | 8.1056 | 22.6956 | 4.4538 | 6.0951 |
| Clock hour 7 (µm) | 5.4060 | 15.1368 | 7.5886 | 21.2480 | 4.2341 | 5.9435 |
| Clock hour 8 (µm) | 3.8676 | 10.8293 | 4.9749 | 13.9296 | 5.8758 | 7.5580 |
| ONH Parameters | ||||||
| Cup Disc Ratio | 0.0236 | 0.0660 | 0.0245 | 0.0685 | 5.1582 | 5.3539 |
| Vertical CD Ratio | 0.0277 | 0.0774 | 0.0289 | 0.0809 | 6.3477 | 6.6278 |
| Disc Area (mm²) | 0.0888 | 0.2486 | 0.1009 | 0.2825 | 4.8833 | 5.5498 |
| Rim Area (mm²) | 0.0483 | 0.1352 | 0.0626 | 0.1752 | 3.5837 | 4.6455 |
| Cup Volume (mm³) | 0.0105 | 0.0294 | 0.0124 | 0.0349 | 7.5869 | 9.0060 |
| Macular Thickness Parameters | ||||||
| Central Subfield (µm) | 1.6398 | 4.5914 | 2.7756 | 7.7718 | 0.6308 | 1.0677 |
| Inner Temporal (µm) | 2.0716 | 5.8006 | 3.4834 | 9.7536 | 0.6683 | 1.1238 |
| Inner Superior (µm) | 2.1805 | 6.1054 | 3.4096 | 9.5470 | 0.6732 | 1.0527 |
| Inner Nasal (µm) | 2.1538 | 6.0307 | 3.1998 | 8.9594 | 0.6591 | 0.9792 |
| Inner Inferior (µm) | 2.0770 | 5.8156 | 3.2125 | 8.9951 | 0.6484 | 1.0029 |
| Outer Temporal (µm) | 1.7440 | 4.8833 | 2.8387 | 7.9483 | 0.6648 | 1.0820 |
| Outer Superior (µm) | 1.9601 | 5.4884 | 2.7409 | 7.6744 | 0.6997 | 0.9784 |
| Outer Nasal (µm) | 1.9932 | 5.5811 | 2.9532 | 8.2689 | 0.6662 | 0.9871 |
| Outer Inferior (µm) | 2.2541 | 6.3115 | 3.2616 | 9.1325 | 0.8427 | 1.2194 |
Repeatability SD is the standard deviations. Repeatability conditions. Repeatability Limit is the upper 95 % limit for the difference between repeated results under repeatability conditions. Per ISO 5725-6, Repeatability Limit = 2.8 x Repeatability SD. Reproducibility SD is the standard deviation under reproducibility conditions. It was estimated by the sum of repeatability variance and the variance components of operator "subjects, device and device *subjects. Reproducibility Limit is the upper 95 % limit for the difference between repeated results under reproducibility conditions. Reproducibility Limit = 2.8 × Reproducibility SD.
COV = Coefficient of variation = SD +Mean. ×100. SD is either Repeatability SD or Reproducibility SD.
7
TABLE 4
CIRRUS PHOTO REPEATABILITY AND REPRODUCIBILITY IN MEASURING RNFL, ONH AND MACULAR THICKNESS (DISEASED EYES)
| Repeatability | Reproducibility | COV % | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | Limit | SD | Limit | Based on | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Repeatability | Based on | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reproducibility | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RNFL Parameter | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Average RNFL Thickness (µm) | 1.4634 | 4.0976 | 1.8796 | 5.2629 | 2.2840 | 2.9336 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Temporal (µm) | 2.2956 | 6.4276 | 2.5546 | 7.1529 | 4.7043 | 5.2351 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Superior (µm) | 2.8264 | 7.9140 | 3.5281 | 9.8787 | 3.5930 | 4.4850 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Nasal (µm) | 2.8991 | 8.1176 | 3.9553 | 11.0748 | 4.9599 | 6.7668 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inferior (µm) | 2.5395 | 7.1106 | 2.9880 | 8.3664 | 3.6115 | 4.2493 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 9 (µm) | 2.4813 | 6.9476 | 2.8941 | 8.1034 | 5.5483 | 6.4713 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 10 (µm) | 3.4895 | 9.7705 | 3.9555 | 11.0755 | 6.4194 | 7.2768 | Clock hour 11 (µm) | 3.8494 | 10.7784 | 4.0928 | 11.4599 | 4.9950 | 5.3108 | Clock hour 12 (µm) | 4.4919 | 12.5774 | 5.7878 | 16.2060 | 5.4955 | 7.0809 | Clock hour 1 (µm) | 3.9406 | 11.0336 | 4.6576 | 13.0414 | 5.1041 | 6.0328 | Clock hour 2 (µm) | 3.4231 | 9.5848 | 3.9783 | 11.1394 | 5.1747 | 6.0140 | Clock hour 3 (µm) | 3.4882 | 9.7670 | 5.0632 | 14.1771 | 6.5627 | 9.5259 | Clock hour 4 (µm) | 3.8452 | 10.7666 | 4.7855 | 13.3993 | 6.8533 | 8.5291 | Clock hour 5 (µm) | 3.8818 | 10.8691 | 4.5783 | 12.8192 | 5.6594 | 6.6747 | Clock hour 6 (µm) | 3.9587 | 11.0845 | 4.3994 | 12.3182 | 5.3266 | 5.9195 | Clock hour 7 (µm) | 3.6302 | 10.1644 | 4.6261 | 12.9530 | 5.3360 | 6.7998 | Clock hour 8 (µm) | 2.5716 | 7.2005 | 3.0180 | 8.4503 | 5.4299 | 6.3724 | ONH Parameters | Cup Disc Ratio | 0.0276 | 0.0774 | 0.0278 | 0.0777 | 3.7279 | 3.7449 | Vertical CD Ratio | 0.0307 | 0.0860 | 0.0313 | 0.0877 | 4.0501 | 4.1308 | Disc Area (mm²) | 0.0584 | 0.1635 | 0.0624 | 0.1746 | 3.0618 | 3.2703 | Rim Area (mm²) | 0.0367 | 0.1027 | 0.0395 | 0.1106 | 4.5529 | 4.9033 | Cup Volume (mm³) | 0.0220 | 0.0615 | 0.0247 | 0.0692 | 4.8135 | 5.4138 | Macular Thickness Parameters | Central Subfield (µm) | 5.6224 | 15.7427 | 7.6068 | 21.2992 | 1.5989 | 2.1632 | Inner Temporal (µm) | 4.3574 | 12.2007 | 5.1083 | 14.3032 | 1.1857 | 1.3900 | Inner Superior (µm) | 4.5687 | 12.7923 | 5.3448 | 14.9653 | 1.2562 | 1.4696 | Inner Nasal (µm) | 4.1606 | 11.6498 | 6.3917 | 17.8968 | 1.1298 | 1.7356 | Inner Inferior (µm) | 5.4349 | 15.2178 | 5.7159 | 16.0046 | 1.5167 | 1.5951 | Outer Temporal (µm) | 2.9954 | 8.3870 | 3.3484 | 9.3755 | 1.0367 | 1.1588 | Outer Superior (µm) | 2.8585 | 8.0038 | 3.3155 | 9.2835 | 0.9475 | 1.0989 | Outer Nasal (µm) | 2.7562 | 7.7173 | 3.4669 | 9.7073 | 0.8862 | 1.1147 | Outer Inferior (µm) | 4.2730 | 11.9645 | 4.6956 | 13.1476 | 1.5132 | 1.6628 | |||||||||||||
| Clock hour 11 (µm) | 3.8494 | 10.7784 | 4.0928 | 11.4599 | 4.9950 | 5.3108 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 12 (µm) | 4.4919 | 12.5774 | 5.7878 | 16.2060 | 5.4955 | 7.0809 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 1 (µm) | 3.9406 | 11.0336 | 4.6576 | 13.0414 | 5.1041 | 6.0328 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 2 (µm) | 3.4231 | 9.5848 | 3.9783 | 11.1394 | 5.1747 | 6.0140 | Clock hour 3 (µm) | 3.4882 | 9.7670 | 5.0632 | 14.1771 | 6.5627 | 9.5259 | Clock hour 4 (µm) | 3.8452 | 10.7666 | 4.7855 | 13.3993 | 6.8533 | 8.5291 | Clock hour 5 (µm) | 3.8818 | 10.8691 | 4.5783 | 12.8192 | 5.6594 | 6.6747 | Clock hour 6 (µm) | 3.9587 | 11.0845 | 4.3994 | 12.3182 | 5.3266 | 5.9195 | Clock hour 7 (µm) | 3.6302 | 10.1644 | 4.6261 | 12.9530 | 5.3360 | 6.7998 | Clock hour 8 (µm) | 2.5716 | 7.2005 | 3.0180 | 8.4503 | 5.4299 | 6.3724 | ONH Parameters | Cup Disc Ratio | 0.0276 | 0.0774 | 0.0278 | 0.0777 | 3.7279 | 3.7449 | Vertical CD Ratio | 0.0307 | 0.0860 | 0.0313 | 0.0877 | 4.0501 | 4.1308 | Disc Area (mm²) | 0.0584 | 0.1635 | 0.0624 | 0.1746 | 3.0618 | 3.2703 | Rim Area (mm²) | 0.0367 | 0.1027 | 0.0395 | 0.1106 | 4.5529 | 4.9033 | Cup Volume (mm³) | 0.0220 | 0.0615 | 0.0247 | 0.0692 | 4.8135 | 5.4138 | Macular Thickness Parameters | Central Subfield (µm) | 5.6224 | 15.7427 | 7.6068 | 21.2992 | 1.5989 | 2.1632 | Inner Temporal (µm) | 4.3574 | 12.2007 | 5.1083 | 14.3032 | 1.1857 | 1.3900 | Inner Superior (µm) | 4.5687 | 12.7923 | 5.3448 | 14.9653 | 1.2562 | 1.4696 | Inner Nasal (µm) | 4.1606 | 11.6498 | 6.3917 | 17.8968 | 1.1298 | 1.7356 | Inner Inferior (µm) | 5.4349 | 15.2178 | 5.7159 | 16.0046 | 1.5167 | 1.5951 | Outer Temporal (µm) | 2.9954 | 8.3870 | 3.3484 | 9.3755 | 1.0367 | 1.1588 | Outer Superior (µm) | 2.8585 | 8.0038 | 3.3155 | 9.2835 | 0.9475 | 1.0989 | Outer Nasal (µm) | 2.7562 | 7.7173 | 3.4669 | 9.7073 | 0.8862 | 1.1147 | Outer Inferior (µm) | 4.2730 | 11.9645 | 4.6956 | 13.1476 | 1.5132 | 1.6628 | |||||||||||||||||||||||||||||||||||||||||
| Clock hour 3 (µm) | 3.4882 | 9.7670 | 5.0632 | 14.1771 | 6.5627 | 9.5259 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 4 (µm) | 3.8452 | 10.7666 | 4.7855 | 13.3993 | 6.8533 | 8.5291 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 5 (µm) | 3.8818 | 10.8691 | 4.5783 | 12.8192 | 5.6594 | 6.6747 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 6 (µm) | 3.9587 | 11.0845 | 4.3994 | 12.3182 | 5.3266 | 5.9195 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 7 (µm) | 3.6302 | 10.1644 | 4.6261 | 12.9530 | 5.3360 | 6.7998 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Clock hour 8 (µm) | 2.5716 | 7.2005 | 3.0180 | 8.4503 | 5.4299 | 6.3724 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ONH Parameters | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cup Disc Ratio | 0.0276 | 0.0774 | 0.0278 | 0.0777 | 3.7279 | 3.7449 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Vertical CD Ratio | 0.0307 | 0.0860 | 0.0313 | 0.0877 | 4.0501 | 4.1308 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Disc Area (mm²) | 0.0584 | 0.1635 | 0.0624 | 0.1746 | 3.0618 | 3.2703 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Rim Area (mm²) | 0.0367 | 0.1027 | 0.0395 | 0.1106 | 4.5529 | 4.9033 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cup Volume (mm³) | 0.0220 | 0.0615 | 0.0247 | 0.0692 | 4.8135 | 5.4138 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Macular Thickness Parameters | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Central Subfield (µm) | 5.6224 | 15.7427 | 7.6068 | 21.2992 | 1.5989 | 2.1632 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inner Temporal (µm) | 4.3574 | 12.2007 | 5.1083 | 14.3032 | 1.1857 | 1.3900 | Inner Superior (µm) | 4.5687 | 12.7923 | 5.3448 | 14.9653 | 1.2562 | 1.4696 | Inner Nasal (µm) | 4.1606 | 11.6498 | 6.3917 | 17.8968 | 1.1298 | 1.7356 | Inner Inferior (µm) | 5.4349 | 15.2178 | 5.7159 | 16.0046 | 1.5167 | 1.5951 | Outer Temporal (µm) | 2.9954 | 8.3870 | 3.3484 | 9.3755 | 1.0367 | 1.1588 | Outer Superior (µm) | 2.8585 | 8.0038 | 3.3155 | 9.2835 | 0.9475 | 1.0989 | Outer Nasal (µm) | 2.7562 | 7.7173 | 3.4669 | 9.7073 | 0.8862 | 1.1147 | Outer Inferior (µm) | 4.2730 | 11.9645 | 4.6956 | 13.1476 | 1.5132 | 1.6628 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inner Superior (µm) | 4.5687 | 12.7923 | 5.3448 | 14.9653 | 1.2562 | 1.4696 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inner Nasal (µm) | 4.1606 | 11.6498 | 6.3917 | 17.8968 | 1.1298 | 1.7356 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inner Inferior (µm) | 5.4349 | 15.2178 | 5.7159 | 16.0046 | 1.5167 | 1.5951 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Outer Temporal (µm) | 2.9954 | 8.3870 | 3.3484 | 9.3755 | 1.0367 | 1.1588 | Outer Superior (µm) | 2.8585 | 8.0038 | 3.3155 | 9.2835 | 0.9475 | 1.0989 | Outer Nasal (µm) | 2.7562 | 7.7173 | 3.4669 | 9.7073 | 0.8862 | 1.1147 | Outer Inferior (µm) | 4.2730 | 11.9645 | 4.6956 | 13.1476 | 1.5132 | 1.6628 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Outer Superior (µm) | 2.8585 | 8.0038 | 3.3155 | 9.2835 | 0.9475 | 1.0989 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Outer Nasal (µm) | 2.7562 | 7.7173 | 3.4669 | 9.7073 | 0.8862 | 1.1147 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Outer Inferior (µm) | 4.2730 | 11.9645 | 4.6956 | 13.1476 | 1.5132 | 1.6628 |
Repeatbility SD is the standard deviations. Repeatability conditions. Repeatability Limit is the upper 95 % limit for the difference between repeated results under repeatability conditions. Per ISO 5725-6, Repeatability Limit = 2.8 x Repeatability SD. Reproducibility SD is the standard deviation under reproducibility conditions. It was estimated by the sum of repeatability variance and the variance components of operator*subjects, device *subjects. Reproducibility Limit is the upper 95 % limit for the difference between reproducibility conditions. Reproducibility Limit = 2.8 x Reproducibility SD.
COV = Coefficient of variation = SD +Mean. x100. SD is either Repeatability SD or Reproducibility SD.
SUMMARY
As described in this 510(k) Summary, all testing deemed necessary was conducted on the CIRRUS photo to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 18 2012
Carl Zeiss Meditec, Inc. c/o Ms. Judith A. Brimacombe, M.A. Director, Clinical/Regulatory Affairs 5160 Hacienda Drive Dublin, CA 94568
Re: K112184
Trade/Device Name: Cirrus photo: Model 600 and 800 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: June 14, 2012 Received: June 15, 2012
Dear Ms. Brimacombe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Alexander
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Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K112184
Device Name(s): CIRRUS photo
Indications for Use:
The CIRRUS photo (Models 600 and 800) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions.
These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea.
It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S. C.
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510(k) Number K112184
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices