(141 days)
No
The document describes image processing and quantitative analysis based on acquired data and comparison to normative databases, but does not mention the use of AI or ML algorithms.
No.
The core function of this device is imaging and diagnosis, not treatment. It aids in visualizing ocular structures, detecting, and managing diseases through diagnostic capabilities, and comparing measurements to normative databases.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The CIRRUS HD-OCT is indicated as a diagnostic device to aid in the detection and management of ocular diseases."
No
The device description explicitly states it is a "computerized instrument that acquires and analyzes crosssectional tomograms" and employs "non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images." This indicates the device includes hardware components for image acquisition (OCT scanner) in addition to software for analysis.
Based on the provided information, the CIRRUS™ HD-OCT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- CIRRUS HD-OCT Function: The CIRRUS HD-OCT is described as a "non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing... of anterior ocular structures." It uses non-invasive optical techniques to image structures within the eye.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It directly images the structures of the eye.
Therefore, the CIRRUS™ HD-OCT falls under the category of an imaging device used for in-vivo diagnosis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The CIRRUS HD-OCT is indicated 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
OBO
Device Description
The CIRRUSTM HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of anterior and posterior ocular structures (including cornea, retina, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this noninvasive optical technique. CIRRUS HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye).
The CIRRUS HD-OCT is offered in four models, Model 4000, 400, 5000 and 500. In the CIRRUS HD-OCT Models 4000 and 5000, the fundus camera is a line scanning ophthalmoscope. The CIRRUS HD-OCT Models 400 and 500 are similar to the Models 4000 and 5000 except that they provide the fundus image using the OCT scanner only.
The acquired imaging data can be analyzed to provide thickness and area measurements of regions of interest to the clinician. The system uses acquired data to determine the fovea location or the optic disc location. Measurements can then be oriented using the fovea and/or optic disc locations. The patient's results can be compared to subjects without disease for measurements of RNFL thickness, neuro-retinal rim area, average and vertical cup-to-disc area ratio, cup volume, macular thickness and ganglion cell plus inner plexiform layer thickness.
In addition to macular and optic disc cube scans, the CIRRUS HD-OCT also offers scans for OCT angiography imaging, a non-invasive approach with depth sectioning capability to visualize microvascular structures of the eye.
Anterior segment scans enable analysis of the anterior segment including Anterior Chamber Depth. Angle-to-Angle and automated measurement of the thickness of the cornea with the Pachymetry scan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical coherence tomography (OCT)
Anatomical Site
anterior ocular structures, posterior ocular structures, cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, choroid, anterior chamber, irido-corneal angles.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects.
Description of the test set, sample size, data source, and annotation protocol
Anterior Chamber and Pachymetry Scans:
A non-significant risk clinical study was conducted to determine the repeatability and reproducibility of the CIRRUS HD-OCT in measuring Central Corneal Thickness (CCT), Angle to Angle Distance (ATA). Anterior Chamber Depth (ACD), and Pachymetry. In addition, the comparability of these anterior segment measurements to corresponding measurements from the predicate Visante OCT was also evaluated.
The study evaluated subjects from three population groups. Group 1 consisted of 46 subjects with normal cornea. Group 2 included 40 subjects, who had previously undergone LASIK. Group 3 was made up of 45 subjects with corneal pathology. The subjects ranged in age from 25 to 69 years.
Anterior Chamber scans to measure CCT, ATA, ACD, and Pachymetry, as well as Pachymetry scans were taken in the Normal Cornea and Corneal Pathology groups. For the Post-LASIK group, only the Pachymetry scans, yielding nine measurement zones, were taken.
Visante OCT Anterior Segment Single scans were taken in the Normal Cornea and Corneal Pathology groups. Enhanced High Resolution Cornea scans were taken on subjects in the Post-LASIK group. Pachymetry scans were taken on each subject in each group.
The study inclusion criteria required adult males or females who were able and willing to make the required study visits, give consent and follow study instructions. In addition, inclusion criteria specific to the particular group was as follows:
- Normal Cornea group: Subjects with normal corneas.
- Corneal Pathology group: Subjects who had received a pathological diagnosis in the anterior segment that involved or affected the cornea. Such diagnoses could have included but was not limited to: keratoconus, pellucid marginal degeneration, corneal scarring, corneal degeneration, corneal dystrophy and corneal changes secondary to disease or surgery.
- Post-LASIK group: Subjects who had undergone uncomplicated LASIK surgery for either myopia or hyperopia within 2 - 24 weeks.
The study exclusion criteria included subjects with a history of leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis. The Normal Cornea and Post-LASIK groups also excluded subjects with blindness, low vision and/or severely diseased eyes whereas the Corneal Pathology group also excluded subjects with blindness or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images. The following exclusion criteria were applicable to their respective group:
Normal Cornea Group:
- Subjects who had undergone prior surgery or a procedure involving or affecting the cornea in the study eye.
- Presence of corneal pathology, either inflammatory or non-inflammatory, in the study eve.
Corneal Pathology Group: - Subjects with normal corneas in the study eye.
- Subjects who had undergone LASIK in the study eye.
- Blindness or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images.
Post-LASIK Group: - Subjects who had undergone prior refractive and corneal surgery, except LASIK, in the study eye.
- Subjects who had LASIK less than 2 weeks or more than 24 weeks prior to the day of data collection.
- Presence of corneal pathology, either inflammatory or non-inflammatory, in the study eve.
- History of complicated LASIK surgery necessitating re-treatment and enhancements.
The data was acquired and analyzed by a single operator on the Visante OCT and by three operators on three CIRRUS HD-OCT 4000 and three CIRRUS HD-OCT 5000 devices. Measurements were compared between CIRRUS HD-OCT 4000 and Visante OCT as well as between CIRRUS 5000 and Visante OCT. The first qualified Visante OCT scan was used for comparison with the first qualified CIRRUS 4000 and CIRRUS 5000 scan from any of the three devices.
Angle Study:
A non-significant risk clinical study was conducted to determine the repeatability and reproducibility of the CIRRUS HD-OCT instrument's measurements of Anterior Chamber Angle (ACA), Trabecular Iris Space Area (TISA), Angle Opening Distance (AOD) and Scleral Spur Angle (SSA). Another objective of the study was to evaluate the comparability of CIRRUS HD-OCT to Visante OCT.
Subjects were examined on three CIRRUS HD-OCT Model 4000 (CIRRUS 4000) and three CIRRUS HD-OCT Model 5000 (CIRRUS 5000) instruments by three operators; each operator was assigned to a specific CIRRUS 4000 and CIRRUS 5000 device. The operators acquired three measurements of three angle scans (HD Angle scans - Nasal; HD Angle scans - Temporal; Wide Angle to Angle scans) on each subject from the three CIRRUS devices. The Visante OCT Model 1000 was used by one operator only. The measurements taken on the CIRRUS were compared separately with the corresponding measurements taken on the Visante OCT.
The study enrolled 27 subjects ranging in age from 43 to 77 years: the mean was 62 vears. The study population consisted of glaucoma suspects and those with a diagnosis of glaucoma. The severity of the disease ranged from mild to severe. All enrolled subjects had a variety of angle configurations ranging from Grade II to Grade IV as assessed with gonioscopy by the Shaffer method of angle grading.
The study inclusion criteria required adult males or females who had been diagnosed with glaucoma of any severity and type or were glaucoma suspects and who were able and willing to make the required study visits, give consent and follow study instructions.
The study exclusion criteria included any condition that rendered the subject unable to fixate well enough to acquire the images and that the subject's study eye did not have any active infection of the anterior segment.
All images were reviewed by the operators that acquired them. Study measurements were generated by manual placement of software tools (Angle tool; TISA tool) for both CIRRUS and Visante OCT devices.
The data was taken on a total of 26 eyes for the Wide Angle-to-Angle scan and 27 eyes for the HD Angle scan measured by three operators on three CIRRUS 4000 and CIRRUS 5000 devices and by a single operator on Visante OCT. The first qualified CIRRUS scan from any of the three devices was used for comparison with the first qualified Visante OCT scan.
CIRRUS OCT Angiography:
In an additional study, a series of case studies comparing CIRRUS OCT angiography cube scans of 3x3 mm and 6x6 mm with fluorescein angiography images was completed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Anterior Chamber and Pachymetry Scans:
A non-significant risk clinical study was conducted to determine the repeatability and reproducibility of the CIRRUS HD-OCT in measuring Central Corneal Thickness (CCT), Angle to Angle Distance (ATA). Anterior Chamber Depth (ACD), and Pachymetry. In addition, the comparability of these anterior segment measurements to corresponding measurements from the predicate Visante OCT was also evaluated.
The study evaluated subjects from three population groups: 46 subjects with normal cornea, 40 subjects who had previously undergone LASIK, and 45 subjects with corneal pathology. The subjects ranged in age from 25 to 69 years.
The results of the repeatability and reproducibility analyses for CIRRUS HD-OCT Model 4000 and Model 5000 for all three groups are shown in Tables 1-6. Mean differences and 95% limits of agreement between CIRRUS HD-OCT Model 4000/5000 and Visante for CCT, ACD, ATA, and Pachymetry measurements are shown in Tables 7-9.
Angle Study:
A non-significant risk clinical study was conducted to determine the repeatability and reproducibility of the CIRRUS HD-OCT instrument's measurements of Anterior Chamber Angle (ACA), Trabecular Iris Space Area (TISA), Angle Opening Distance (AOD) and Scleral Spur Angle (SSA). Another objective of the study was to evaluate the comparability of CIRRUS HD-OCT to Visante OCT.
The study enrolled 27 subjects (26-27 eyes for different scans) ranging in age from 43 to 77 years (mean 62 years), comprising glaucoma suspects and diagnosed glaucoma patients.
Tables 10 and 11 show the repeatability and reproducibility analyses for CIRRUS 4000 and CIRRUS 5000, respectively. Table 12 shows the limits of agreement between CIRRUS 4000/5000 and Visante OCT.
CIRRUS OCT Angiography:
In an additional study, a series of case studies comparing CIRRUS OCT angiography cube scans of 3x3 mm and 6x6 mm with fluorescein angiography images was completed.
Key results: The findings demonstrate that the CIRRUS OCT Angiography in combination with OCT intensity-based information (B-scans and en face images) can give non-invasive threedimensional information regarding retinal microvasculature in a variety of retinal diseases. CIRRUS OCT Angiography is not intended as a substitute for fluorescein angiography. Vascular findings on fluorescein angiography may be absent, poorly defined, or variably defined on CIRRUS OCT Angiography. Additionally, leakage, staining, and pooling are not features of CIRRUS OCT Angiography.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See Tables 1-9 for Repeatability and Reproducibility: SD, Limit, CV%; Mean, SD, Difference, 95% CI for Mean Difference, 95% LOA for Mean Difference, p-value.
See Tables 10-12 for Repeatability and Reproducibility: Mean, SD, Limit, CV%; Difference Mean (SD), 95% CI for Mean Difference, p-value, 95% LoA for Mean Difference.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
Carl Zeiss Meditec Inc Ms. Mandy Ambrecht Staff Regulatory Affairs Specialist 5160 Hacienda Dr. Dublin, CA 94568
Re: K150977
Trade/Device Name: Cirrus HD-OCT with Software Version 8 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: July 24, 2015 Received: July 27, 2015
Dear Ms. Ambrecht:
This letter corrects our substantially equivalent letter of September 1, 2015.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
1
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150977
Device Name
CIRRUS HD-OCT with Software Version 8
Indications for Use (Describe)
The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior ocular structures. The device is indicated for visualizing anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The CIRRUS HD-OCT is indicated 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K)SUMMARY
5. 510(K)SUMMARY
510(k) SUMMARY (per 21 CFR §807.92)
Cirrus HD-OCT with Software Version 8
GENERAL INFORMATION
| Manufacturer: | Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, California 94568
(925) 557-4561 (phone)
(925) 557-4259 (fax)
Est. Reg. No. 2918630 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mandy Ambrecht
Staff Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, California 94568
(925) 557-4561 (phone)
(925) 557-4259 (fax) |
| Date Summary Prepared:
Date Summary Updated: | April 9, 2015
August 14, 2015 |
| Classification name: | Tomography, Optical Coherence; Ophthalmoscope |
| Classification: | Class II (acc. 21 CFR 886.1570) |
| Product Code: | OBO |
| Trade/Proprietary name: | CIRRUS™ HD-OCT |
| PREDICATE DEVICE | |
| Company:
Device: | Carl Zeiss Meditec, Inc.
Cirrus™ HD-OCT (K111157) |
| Company:
Device: | Carl Zeiss Meditec, Inc.
Visante OCT (K051789) |
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510(K)SUMMARY
INDICATIONS FOR USE
The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures. The device is indicated for visualizing and measuring anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT Angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid. The CIRRUS HD-OCT is indicated 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.
DEVICE DESCRIPTION
The CIRRUSTM HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of anterior and posterior ocular structures (including cornea, retina, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this noninvasive optical technique. CIRRUS HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye).
The CIRRUS HD-OCT is offered in four models, Model 4000, 400, 5000 and 500. In the CIRRUS HD-OCT Models 4000 and 5000, the fundus camera is a line scanning ophthalmoscope. The CIRRUS HD-OCT Models 400 and 500 are similar to the Models 4000 and 5000 except that they provide the fundus image using the OCT scanner only.
The acquired imaging data can be analyzed to provide thickness and area measurements of regions of interest to the clinician. The system uses acquired data to determine the fovea location or the optic disc location. Measurements can then be oriented using the fovea and/or optic disc locations. The patient's results can be compared to subjects without disease for measurements of RNFL thickness, neuro-retinal rim area, average and vertical cup-to-disc area ratio, cup volume, macular thickness and ganglion cell plus inner plexiform layer thickness.
In addition to macular and optic disc cube scans, the CIRRUS HD-OCT also offers scans for OCT angiography imaging, a non-invasive approach with depth sectioning capability to visualize microvascular structures of the eye.
Anterior segment scans enable analysis of the anterior segment including Anterior Chamber Depth. Angle-to-Angle and automated measurement of the thickness of the cornea with the Pachymetry scan.
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510(K)SUMMARY
NEW FEATURES
Models 5000 and 500: Two new CIRRUS HD-OCT Models (500 and 5000) provide incremental hardware and software improvements. The modifications include:
- The 15" color monitor was replaced with a 19" color monitor. ●
- . The DVD was eliminated and a second USB port on the operator's side was added.
- . The adjustable LCD internal fixation target was replaced with an LED based internal fixation target with nine fixed positions.
- The connections for a wired keyboard and a wired mouse, which were present in ● Models 400 and 4000 were removed, as the Models 500 and 5000 support a wireless keyboard and mouse.
- . The OCT camera /frame grabber combination was replaced with a combination that has the potential to acquire scans faster. Scans are acquired at 27,000 A-scans per second for all scan patterns on the Models 400, 500, 4000 and 5000 with the exception of a new scan pattern, referred to as OCT Angiography, that runs only on the Model 5000 at a higher speed, 68,000 A-scans per second.
- For the Model 500 only, the fundus image is generated using the faster speed of 68.000 ● A-scans per second and the power supply and computer were also replaced.
- DICOM compliant (OP) Ophthalmic Photography and (OPT) Ophthalmic ● Tomography data transfer is supported.
Anterior Segment External Lenses, New Scan Patterns, and Analysis Tools:
Two external Anterior Segment lenses were added to the ocular housing module:
- The external Anterior Chamber Lens, .
- The external Cornea Lens and ●
- A calibration kit for the Anterior Chamber Lens.
Hardware and software modifications were implemented on Models 500 and 5000 to enable the detection and identification of the external lenses. The Anterior Segment scans and analysis tools are as follows:
- Anterior Chamber Scan and Analysis: .
- o Anterior Chamber Scan The Anterior Chamber scan generates a wide field, speckle-reduced raster scan of the front of the eye at a depth of 5.8 mm with higher contrast and larger field of view than the Anterior Segment 5-Line Raster scan and the Wide Angle-to-Angle scan. This image provides an overall view of the anterior chamber and the configuration of bilateral irido-corneal angles in one glance.
- Chamber Tool The Chamber tool (aka Anterior Chamber Depth (ACD) tool) allows the user to measure four items: Corneal Central Thickness (CCT) in microns,
6
510(K)SUMMARY
Angle-to-Angle distance (ATA) in millimeters, Anterior Chamber Depth (ACD) in millimeters, and Lens Vault (LV) in microns. The tool also allows the user to place the arms and endpoints independently.
● Wide Angle-to-Angle Scan and Analysis:
- o The Wide Angle-to-Angle (ATA) scan generates a wide field, speckle-reduced raster scan with a depth of 2.9 mm. The scan simultaneously highlights both 0 and 180 degree irido-corneal angles.
- Irido-corneal (IC) Angle tool The irido-corneal angle tool is a trapezoid that can O be moved and adjusted to graphically display the angle opening distance (AOD), trabecular iris space area, and scleral spur (SSA) angle.
HD Angle Scan and Analysis: ●
- HD Angle Scan The HD Angle scan generates a speckle-reduced raster scan at a O depth of 2.9 mm. The scan highlights one irido-corneal angle.
- Angle Tool The Angle tool (aka Anterior Chamber tool or AC Angle tool) allows O the user to measure either a right or left angle via the use of an AC Left Angle tool and an AC Right Angle tool. In the Anterior Chamber Screen, both are available.
● HD Cornea Scan and Analysis:
- HD Cornea Scan The HD Cornea scan, generates a single high-definition scan o with a depth of 2.0 mm that has a wider field of view (9.0 mm in length) than the Anterior Segment 5-Line Raster. The Caliper tool is the only measurement tool offered with the HD Cornea scan.
- Caliper Tool The Caliper tool shows the distance measured between two points. о The Caliper tool is available for all anterior segment scans except Pachymetry. The Corneal Thickness (CT) measures the distance from the anterior surface of the cornea to the posterior surface of the cornea.
● Pachymetry Scan and Analysis:
- Pachymetry Scans.-The Pachymetry scan consists of 24 radial scan lines with a O scan depth of 2.0 mm that are used to generate a color-coded thickness map of the cornea. This scan requires the use of the external Cornea lens.
- Pachymetry Analysis Tools The Pachymetry analysis generates a two o dimensional thickness map from multiple B-scans acquired with the Pachymetry scan where the thickness is defined as the distance from a point on the anterior corneal surface to the closest point on the posterior corneal surface. The CIRRUS HD-OCT provides automated measurement of the thickness of the cornea in seventeen sectors.
Posterior Segment New Scan Patterns and Analyses:
- FastTracTM Retinal Tracking Technology - The CIRRUSTM HD-OCT uses multiple channels of concurrent imaging and proprietary algorithms to monitor and correct for the motion of the eye in real-time. The motion of the retina is observed at a high rate to
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510(K)SUMMARY
ensure higher efficiency in reducing the effects of motion., FastTrac ensures faster data acquisition by only re-scanning selective data that might be affected by motion. FastTrac also allows precise scanning at follow-up visits to acquire data at the same region of the eye. FastTrac Retinal Tracking is only available with Models 5000 and 4000 with a quad-core processor.
- Smart HD Scans: ●
- HD 1 Line 100x1 high-definition single line scan This scan generates a single O high definition scan at a depth of 2.0 mm by averaging 100 B-scans, each composed of 1024 A-scans. The scan can be positioned anywhere on the fundus image
- HD 21 Line: 21 high-definition scans This scan generates 21 high-definition O horizontal scan lines at a depth of 2.0 mm. The amount of B-scan averaging per line depends on the version of the instrument computer. The scan can be positioned anywhere on the fundus image.
- HD Cross: 10 high-definition scans; five horizontal and 5 vertical This scan o generates five horizontal and five vertical high-definition scan lines at a depth of 2.0 mm. The scan can be positioned anywhere on the fundus image.
- HD Radial: 12 high-definition radial scans This scan generates 12 high-O definition radial scan lines at a depth of 2.0. scan rotation, and line spacing are fixed. The scan can be positioned anywhere on the fundus image.
- Panomap Analysis: This is a wide field analysis that combines information from the macular thickness analysis, RNFL and ONH analysis and ganglion cell OU analysis into one report.
- . En Face Analysis: Automatically finds and displays retinal layers in existing 6x6 mm macular cube scans (512x128 or 200x200) and optic disc 200x200 scans. The user can visualize en face (c-scan), or partial en face, views of the same data. The user can choose any of the three surfaces as the basis for the partial en face images. A partial en face image is formed by the summation of image intensities based on one or more retinal contours.
- OCT Angiography: CIRRUS™ HD-OCT Angiography images are processed to ● provide detailed images of ocular blood flow without the use of intravenous dyes to visualize microvasculature structures of the eye. The flow data that is generated by processing OCT images has the same resolution and axial and transverse extent as the OCT intensity data, and therefore depth resolved flow images can be generated and displayed.
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510(K)SUMMARY
SUBSTANTIAL EQUIVALENCE
It is the opinion of Carl Zeiss Meditec, Incorporated that the CIRRUS HD-OCT with Software Version 8 is substantially equivalent to the Cirrus HD-OCT with RNFL, Macular, Optic Nerve Head and Ganglion Cell Normative Databases and the Visante OCT. The indications for use for the CIRRUS HD-OCT with Software Version 8 is similar to the indications for the predicate devices cited in this application. A technological comparison and clinical testing demonstrate that the CIRRUS HD-OCT with Software Version 8 is functionally equivalent to the predicate devices.
Evaluation performed on the CIRRUS HD-OCT with Software Version 8 supports the indications for use statement and demonstrates that the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness.
CLINICAL EVALUATION
Clinical data were collected and evaluated to support the indications for use statement for the CIRRUS HD-OCT with Software Version 8 and to demonstrate substantial equivalence to the Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative Databases with software version 6.0 and to the Visante OCT. These studies are summarized below.
Anterior Chamber and Pachymetry Scans
A non-significant risk clinical study was conducted to determine the repeatability and reproducibility of the CIRRUS HD-OCT in measuring Central Corneal Thickness (CCT), Angle to Angle Distance (ATA). Anterior Chamber Depth (ACD), and Pachymetry. In addition, the comparability of these anterior segment measurements to corresponding measurements from the predicate Visante OCT was also evaluated.
The study evaluated subjects from three population groups. Group 1 consisted of 46 subjects with normal cornea. Group 2 included 40 subjects, who had previously undergone LASIK. Group 3 was made up of 45 subjects with corneal pathology. The subjects ranged in age from 25 to 69 years.
Anterior Chamber scans to measure CCT, ATA, ACD, and Pachymetry, as well as Pachymetry scans were taken in the Normal Cornea and Corneal Pathology groups. For the Post-LASIK group, only the Pachymetry scans, yielding nine measurement zones, were taken.
Visante OCT Anterior Segment Single scans were taken in the Normal Cornea and Corneal Pathology groups. Enhanced High Resolution Cornea scans were taken on
9
subjects in the Post-LASIK group. Pachymetry scans were taken on each subject in each group.
The study inclusion criteria required adult males or females who were able and willing to make the required study visits, give consent and follow study instructions. In addition, inclusion criteria specific to the particular group was as follows:
- . Normal Cornea group: Subjects with normal corneas.
- . Corneal Pathology group: Subjects who had received a pathological diagnosis in the anterior segment that involved or affected the cornea. Such diagnoses could have included but was not limited to: keratoconus, pellucid marginal degeneration, corneal scarring, corneal degeneration, corneal dystrophy and corneal changes secondary to disease or surgery.
- . Post-LASIK group: Subjects who had undergone uncomplicated LASIK surgery for either myopia or hyperopia within 2 - 24 weeks.
The study exclusion criteria included subjects with a history of leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis. The Normal Cornea and Post-LASIK groups also excluded subjects with blindness, low vision and/or severely diseased eyes whereas the Corneal Pathology group also excluded subjects with blindness or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images. The following exclusion criteria were applicable to their respective group:
Normal Cornea Group:
- . Subjects who had undergone prior surgery or a procedure involving or affecting the cornea in the study eye.
- Presence of corneal pathology, either inflammatory or non-inflammatory, in . the study eve.
Corneal Pathology Group:
- Subjects with normal corneas in the study eye. .
- Subjects who had undergone LASIK in the study eye.
- Blindness or low vision rendering the subject unable to fixate to keep gaze ● still enough to acquire images.
Post-LASIK Group:
- . Subjects who had undergone prior refractive and corneal surgery, except LASIK, in the study eye.
- . Subjects who had LASIK less than 2 weeks or more than 24 weeks prior to the day of data collection.
- . Presence of corneal pathology, either inflammatory or non-inflammatory, in the study eve.
- . History of complicated LASIK surgery necessitating re-treatment and enhancements.
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The data was acquired and analyzed by a single operator on the Visante OCT and by three operators on three CIRRUS HD-OCT 4000 and three CIRRUS HD-OCT 5000 devices. Measurements were compared between CIRRUS HD-OCT 4000 and Visante OCT as well as between CIRRUS 5000 and Visante OCT. The first qualified Visante OCT scan was used for comparison with the first qualified CIRRUS 4000 and CIRRUS 5000 scan from any of the three devices.
The results of the repeatability and reproducibility analyses for the CIRRUS HD-OCT Model 4000 and Model 5000 Normal Cornea group, Corneal Pathology group and Post-LASIK group are shown in Tables 1-6.
Tables 7 and 8 show the mean difference in the CCT, ACD, ATA and Pachymetry measurements between CIRRUS HD-OCT Model 4000, Model 5000 and Visante for the Normal Cornea and Corneal Pathology groups. Table 9 shows the Pachymetry measurements on the Post-LASIK group.
| Normal Cornea Group | |||||||
|---|---|---|---|---|---|---|---|
| Scan Type | |||||||
| Parameter | Mean | Repeatability | Reproducibility | ||||
| SD | Limit | CV% | SD | Limit | CV% | ||
| Anterior Chamber | |||||||
| CCT | 543.8 | 8.806 | 24.657 | 1.619 | 9.514 | 26.639 | 1.750 |
| Angle to Angle | 12.309 | 0.187 | 0.523 | 1.517 | 0.265 | 0.741 | 2.150 |
| ACD | 2.880 | 0.066 | 0.185 | 2.291 | 0.068 | 0.191 | 2.366 |
| Pachymetry | |||||||
| Center | 528.8 | 3.359 | 9.405 | 0.635 | 3.719 | 10.414 | 0.703 |
| Inner Nasal | 552.7 | 3.113 | 8.716 | 0.563 | 3.646 | 10.208 | 0.660 |
| Inner Superior | 557.4 | 2.977 | 8.335 | 0.534 | 4.595 | 12.865 | 0.824 |
| Inner Inferior | 542.7 | 3.004 | 8.411 | 0.554 | 3.623 | 10.143 | 0.668 |
| Inner Temporal | 532.8 | 2.944 | 8.242 | 0.552 | 3.507 | 9.819 | 0.658 |
| Outer Nasal | 589.0 | 4.855 | 13.595 | 0.824 | 5.487 | 15.363 | 0.931 |
| Outer Superior | 601.3 | 4.432 | 12.410 | 0.737 | 6.800 | 19.041 | 1.131 |
| Outer Inferior | 576.2 | 3.793 | 10.622 | 0.658 | 4.958 | 13.882 | 0.860 |
| Outer Temporal | 555.1 | 3.553 | 9.947 | 0.640 | 4.209 | 11.786 | 0.758 |
Table 1. Repeatability and Reproducibility of CIRRUS 4000 Normal Cornea Group
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| Normal Cornea Group | ||||||||
|---|---|---|---|---|---|---|---|---|
| Scan Type | Parameter | Mean | Repeatability | Reproducibility | ||||
| SD | Limit | CV% | SD | Limit | CV% | |||
| Anterior Chamber | CCT | 549.5 | 9.749 | 27.297 | 1.774 | 11.897 | 33.311 | 2.165 |
| Angle to Angle | 12.030 | 0.171 | 0.479 | 1.423 | 0.300 | 0.840 | 2.494 | |
| ACD | 2.858 | 0.034 | 0.096 | 1.199 | 0.046 | 0.128 | 1.601 | |
| Pachymetry | ||||||||
| Center | 528.3 | 1.197 | 3.350 | 0.226 | 1.628 | 4.557 | 0.308 | |
| Inner Nasal | 552.8 | 2.674 | 7.486 | 0.484 | 3.218 | 9.011 | 0.582 | |
| Inner Superior | 557.9 | 3.399 | 9.518 | 0.609 | 4.261 | 11.930 | 0.764 | |
| Inner Inferior | 541.9 | 2.714 | 7.598 | 0.501 | 3.306 | 9.257 | 0.610 | |
| Inner Temporal | 532.5 | 1.870 | 5.237 | 0.351 | 2.085 | 5.837 | 0.392 | |
| Outer Nasal | 588.9 | 4.061 | 11.370 | 0.690 | 4.739 | 13.268 | 0.805 | |
| Outer Superior | 599.7 | 4.786 | 13.402 | 0.798 | 6.897 | 19.312 | 1.150 | |
| Outer Inferior | 572.4 | 3.511 | 9.830 | 0.613 | 5.326 | 14.912 | 0.930 | |
| Outer Temporal | 554.8 | 3.170 | 8.875 | 0.571 | 3.430 | 9.603 | 0.618 |
Table 2. Repeatability and Reproducibility of CIRRUS 5000
All statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance.
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and the residual variance.
Repeatability limit = 2.8 x Repeatability SD.
Reproducibility limit = 2.8 x Reproducibility SD.
Repeatability CV% = (Repeatability SD)/Intercept x 100%.
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| Corneal Pathology Group | |||||||
|---|---|---|---|---|---|---|---|
| Scan Type | |||||||
| Parameter | Mean | Repeatability | Reproducibility | ||||
| SD | Limit | CV% | SD | Limit | CV% | ||
| Anterior Chamber | |||||||
| CCT | 521.2 | 10.023 | 28.063 | 1.923 | 14.069 | 39.394 | 2.699 |
| Angle to Angle | 12.667 | 0.193 | 0.541 | 1.525 | 0.288 | 0.806 | 2.273 |
| ACD | 3.090 | 0.075 | 0.209 | 2.415 | 0.081 | 0.227 | 2.620 |
| Pachymetry | |||||||
| Center | 521.0 | 2.365 | 6.621 | 0.454 | 2.920 | 8.176 | 0.560 |
| Inner Nasal | 553.1 | 3.443 | 9.639 | 0.622 | 4.615 | 12.921 | 0.834 |
| Inner Superior | 558.1 | 4.771 | 13.359 | 0.855 | 5.387 | 15.084 | 0.965 |
| Inner Inferior | 534.9 | 4.134 | 11.576 | 0.773 | 4.290 | 12.012 | 0.802 |
| Inner Temporal | 527.8 | 3.475 | 9.731 | 0.658 | 3.598 | 10.073 | 0.682 |
| Outer Nasal | 594.2 | 4.237 | 11.863 | 0.713 | 5.442 | 15.239 | 0.916 |
| Outer Superior | 607.5 | 6.617 | 18.527 | 1.089 | 7.254 | 20.311 | 1.194 |
| Outer Inferior | 576.7 | 5.378 | 15.058 | 0.932 | 5.631 | 15.768 | 0.976 |
| Outer Temporal | 555.9 | 4.417 | 12.368 | 0.795 | 4.677 | 13.096 | 0.841 |
| All statistics are estimated from two-way random-effect ANOVA model with random effects |
Table 3. Repeatability and Reproducibility of CIRRUS 4000
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance.
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and the residual variance.
Repeatability limit = 2.8 x Repeatability SD.
Reproducibility limit = 2.8 x Reproducibility SD.
Repeatability CV% = (Repeatability SD)/Intercept x 100%.
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Table 4. Repeatability and Reproducibility of CIRRUS 5000 Corneal Pathology Group
| Repeatability | Reproducibility | ||||||
|---|---|---|---|---|---|---|---|
| Parameter | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Anterior Chamber Scan | |||||||
| CCT | 532.1 | 12.061 | 33.772 | 2.267 | 18.951 | 53.061 | 3.561 |
| Angle to Angle | 12.363 | 0.175 | 0.491 | 1.418 | 0.247 | 0.693 | 2.002 |
| ACD | 3.060 | 0.040 | 0.113 | 1.321 | 0.061 | 0.171 | 1.991 |
| Pachymetry Scan | |||||||
| Center | 521.0 | 2.739 | 7.670 | 0.526 | 2.788 | 7.807 | 0.535 |
| Inner Nasal | 553.4 | 3.928 | 11.000 | 0.710 | 4.394 | 12.303 | 0.794 |
| Inner Superior | 558.3 | 4.346 | 12.169 | 0.779 | 4.884 | 13.677 | 0.875 |
| Inner Inferior | 534.0 | 3.115 | 8.723 | 0.583 | 4.325 | 12.109 | 0.810 |
| Inner Temporal | 527.9 | 2.867 | 8.027 | 0.543 | 3.837 | 10.742 | 0.727 |
| Outer Nasal | 594.3 | 4.496 | 12.589 | 0.756 | 5.298 | 14.835 | 0.891 |
| Outer Superior | 606.5 | 5.534 | 15.495 | 0.912 | 6.185 | 17.319 | 1.020 |
| Outer Inferior | 572.5 | 4.233 | 11.851 | 0.739 | 8.945 | 25.046 | 1.563 |
| Outer Temporal | 556.2 | 3.821 | 10.699 | 0.687 | 4.792 | 13.418 | 0.862 |
| All statistics are estimated from two-way random effect ANOVA model with random effects |
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model.
Repeatability SD = Square root of the residual variance.
Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance.
Repeatability Limit = 2.8 x Repeatability SD.
Repeatability CV% = (Repeatability SD)/Intercept x 100%.
Reproducibility Limit = 2.8 x Reproducibility SD.
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510(K)SUMMARY
Table 5. Repeatability and Reproducibility of CIRRUS 4000 Post-LASIK Group
| ASIN Group |
|---|
| LI AVELL UL VUIV | ||||||||
|---|---|---|---|---|---|---|---|---|
| Scan Type | Repeatability | Reproducibility | ||||||
| Parameter | Mean | SD | Limit | CV% | SD | Limit | CV% | |
| Pachymetry | ||||||||
| Center | 465.5 | 1.793 | 5.022 | 0.385 | 2.000 | 5.601 | 0.430 | |
| Inner Nasal | 514.3 | 6.008 | 16.822 | 1.168 | 6.064 | 16.981 | 1.179 | |
| Inner Superior | 509.0 | 5.522 | 15.463 | 1.085 | 6.799 | 19.039 | 1.336 | |
| Inner Inferior | 501.2 | 4.976 | 13.934 | 0.993 | 6.434 | 18.016 | 1.284 | |
| Inner Temporal | 482.3 | 3.677 | 10.296 | 0.762 | 4.053 | 11.349 | 0.840 | |
| Outer Nasal | 583.6 | 8.052 | 22.546 | 1.380 | 8.175 | 22.890 | 1.401 | |
| Outer Superior | 583.2 | 7.965 | 22.302 | 1.366 | 10.257 | 28.719 | 1.759 | |
| Outer Inferior | 565.5 | 6.413 | 17.956 | 1.134 | 8.428 | 23.599 | 1.491 | |
| Outer Temporal | 530.9 | 5.973 | 16.725 | 1.125 | 6.424 | 17.986 | 1.210 | |
| All statistics are estimated from two-way random-effect ANOVA model with random effects | ||||||||
| operator/device, eye and interaction between operator/device and eye. | ||||||||
| Mean = Intercept of the ANOVA model | ||||||||
| Repeatability SD = Square root of the residual variance. | ||||||||
| Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and | ||||||||
| the residual variance. | ||||||||
| Repeatability limit = 2.8 x Repeatability SD. | ||||||||
| Reproducibility limit = 2.8 x Reproducibility SD. |
Repeatability CV% = (Repeatability SD)/Intercept x 100%.
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510(K)SUMMARY
Table 6. Repeatability and Reproducibility of CIRRUS 5000 Post-LASIK Group
| Scan Type | Repeatability | Reproducibility | ||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Mean | SD | Limit | CV% | SD | Limit | CV% | |
| Pachymetry | Center | 465.1 | 1.784 | 4.994 | 0.383 | 2.068 | 5.791 | 0.445 |
| Pachymetry | Inner Nasal | 514.8 | 6.912 | 19.355 | 1.343 | 6.912 | 19.355 | 1.343 |
| Pachymetry | Inner Superior | 508.8 | 4.785 | 13.398 | 0.940 | 5.749 | 16.098 | 1.130 |
| Pachymetry | Inner Inferior | 500.8 | 4.557 | 12.759 | 0.910 | 5.919 | 16.572 | 1.182 |
| Pachymetry | Inner Temporal | 481.8 | 4.657 | 13.040 | 0.967 | 4.657 | 13.040 | 0.967 |
| Pachymetry | Outer Nasal | 583.7 | 9.104 | 25.492 | 1.560 | 9.197 | 25.752 | 1.576 |
| Pachymetry | Outer Superior | 580.2 | 6.972 | 19.522 | 1.202 | 8.915 | 24.963 | 1.537 |
| Pachymetry | Outer Inferior | 560.4 | 5.560 | 15.568 | 0.992 | 9.557 | 26.760 | 1.705 |
| Pachymetry | Outer Temporal | 530.0 | 7.294 | 20.424 | 1.376 | 7.382 | 20.670 | 1.393 |
| All statistics are estimated from two-way random-effect ANOVA model with random effects |
All statistics are estimated from two-way random-effect ANOVA model with random effects
operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability SD = Square root of the residual variance.
Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance.
Repeatability Limit = 2.8 x Repeatability SD.
Repeatability CV% = (Repeatability SD)/Intercept x 100%.
Reproducibility Limit = 2.8 x Reproducibility SD.
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510(K)SUMMARY
| CIRRUS 4000, CIRRUS 5000 and Visante OCT - Normal Cornea Group | ||||||||
|---|---|---|---|---|---|---|---|---|
| Scan Type | ||||||||
| Parameter | N | Cirrus | ||||||
| Mean (SD) | Visante | |||||||
| Mean (SD) | Difference | |||||||
| Mean (SD) | 95% CI for | |||||||
| Mean | ||||||||
| Difference | p-value | 95% LOA | ||||||
| for Mean | ||||||||
| Difference | ||||||||
| Cirrus 4000 | ||||||||
| Anterior Chamber | ||||||||
| CCT | 46 | 547.2 (37.1) | 537.8 (33.8) | 9.4 (16.4) | 4.5, 14.2 | 4 Shaffer RN. Primary glaucomas. Gonioscopy, ophthalmoscopy,and perimetry. Trans Am. Acad Ophthalmol Otolaryngol. 1960;64:112-127. |
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CIRRUS 4000 and CIRRUS 5000, respectively. Table 12 shows the limits of agreement between CIRRUS 4000 and Visante OCT as well as between CIRRUS 5000 and Visante OCT.
| Table 10. Repeatability and Reproducibility of CIRRUS HD-OCT 4000 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Mean | SD | Repeatability | Reproducibility | ||||
| SD | Limit | CV% | SD | Limit | CV% | |||
| Wide Angle to Angle Scan | ||||||||
| TISA 500 Nasal | 0.147 | 0.020 | 0.056 | 13.590 | 0.032 | 0.088 | 21.484 | |
| TISA 750 Nasal | 0.267 | 0.032 | 0.091 | 12.153 | 0.045 | 0.125 | 16.772 | |
| AOD 500 Nasal | 0.433 | 0.057 | 0.159 | 13.161 | 0.080 | 0.225 | 18.549 | |
| AOD 750 Nasal | 0.577 | 0.077 | 0.215 | 13.289 | 0.086 | 0.240 | 14.831 | |
| SSA Nasal | 37.284 | 3.604 | 10.090 | 9.665 | 4.309 | 12.064 | 11.557 | |
| AC Angle Nasal | 35.965 | 4.128 | 11.559 | 11.479 | 4.626 | 12.953 | 12.862 | |
| TISA 500 Temporal | 0.150 | 0.025 | 0.070 | 16.738 | 0.036 | 0.100 | 23.973 | |
| TISA 750 Temporal | 0.271 | 0.027 | 0.075 | 9.854 | 0.044 | 0.122 | 16.032 | |
| AOD 500 Temporal | 0.443 | 0.069 | 0.193 | 15.544 | 0.093 | 0.260 | 20.961 | |
| AOD 750 Temporal | 0.589 | 0.060 | 0.168 | 10.173 | 0.095 | 0.266 | 16.115 | |
| SSA Temporal | 37.301 | 3.465 | 9.703 | 9.290 | 4.547 | 12.732 | 12.190 | |
| AC Angle Temporal | 36.050 | 3.916 | 10.965 | 10.863 | 4.585 | 12.839 | 12.719 | |
| HD Angle Scan | ||||||||
| TISA 500 Nasal | 0.162 | 0.018 | 0.051 | 11.350 | 0.024 | 0.067 | 14.745 | |
| TISA 750 Nasal | 0.293 | 0.025 | 0.071 | 8.669 | 0.036 | 0.102 | 12.404 | |
| AOD 500 Nasal | 0.474 | 0.057 | 0.159 | 11.986 | 0.068 | 0.191 | 14.371 | |
| AOD 750 Nasal | 0.652 | 0.061 | 0.171 | 9.345 | 0.082 | 0.230 | 12.589 | |
| SSA Nasal | 39.617 | 3.315 | 9.281 | 8.367 | 4.157 | 11.641 | 10.494 | |
| AC Angle Nasal | 38.550 | 3.049 | 8.536 | 7.908 | 3.544 | 9.924 | 9.194 | |
| TISA 500 Temporal | 0.156 | 0.017 | 0.049 | 11.101 | 0.022 | 0.062 | 14.114 | |
| TISA 750 Temporal | 0.267 | 0.021 | 0.060 | 8.009 | 0.027 | 0.077 | 10.285 | |
| AOD 500 Temporal | 0.460 | 0.054 | 0.151 | 11.738 | 0.070 | 0.196 | 15.197 | |
| AOD 750 Temporal | 0.586 | 0.057 | 0.158 | 9.656 | 0.079 | 0.220 | 13.410 | |
| SSA Temporal | 38.083 | 2.853 | 7.989 | 7.492 | 3.604 | 10.092 | 9.465 | |
| AC Angle Temporal | 36.878 | 2.333 | 6.534 | 6.327 | 3.401 | 9.522 | 9.221 |
Table 10. Repeatability and Reproducibility of CIRRUS HD-OCT 4000
All statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Reproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and the residual variance
Repeatability limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
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| Repeatability | Reproducibility | |||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Mean | SD | Limit | CV% | SD | Limit | CV% | |
| Wide Angle to Angle Scan | ||||||||
| TISA 500 Nasal | 0.151 | 0.025 | 0.071 | 16.801 | 0.030 | 0.083 | 19.614 | |
| TISA 750 Nasal | 0.263 | 0.028 | 0.080 | 10.827 | 0.037 | 0.103 | 14.053 | |
| AOD 500 Nasal | 0.439 | 0.075 | 0.209 | 17.012 | 0.081 | 0.226 | 18.365 | |
| AOD 750 Nasal | 0.570 | 0.055 | 0.153 | 9.598 | 0.084 | 0.236 | 14.783 | |
| SSA Nasal | 37.696 | 3.774 | 10.569 | 10.013 | 4.552 | 12.746 | 12.076 | |
| AC Angle Nasal | 36.165 | 3.427 | 9.595 | 9.475 | 4.861 | 13.612 | 13.442 | |
| TISA 500 Temporal | 0.150 | 0.027 | 0.076 | 18.169 | 0.032 | 0.090 | 21.368 | |
| TISA 750 Temporal | 0.275 | 0.041 | 0.115 | 14.946 | 0.045 | 0.126 | 16.353 | |
| AOD 500 Temporal | 0.445 | 0.080 | 0.223 | 17.893 | 0.090 | 0.252 | 20.243 | |
| AOD 750 Temporal | 0.586 | 0.076 | 0.213 | 12.972 | 0.085 | 0.237 | 14.434 | |
| SSA Temporal | 37.846 | 4.442 | 12.438 | 11.737 | 5.024 | 14.068 | 13.276 | |
| AC Angle Temporal | 35.951 | 3.725 | 10.430 | 10.361 | 5.184 | 14.514 | 14.418 | |
| HD Angle Scan | ||||||||
| TISA 500 Nasal | 0.158 | 0.017 | 0.048 | 10.764 | 0.022 | 0.061 | 13.786 | |
| TISA 750 Nasal | 0.281 | 0.023 | 0.065 | 8.305 | 0.034 | 0.095 | 12.085 | |
| AOD 500 Nasal | 0.461 | 0.053 | 0.148 | 11.496 | 0.066 | 0.185 | 14.332 | |
| AOD 750 Nasal | 0.621 | 0.054 | 0.151 | 8.699 | 0.075 | 0.211 | 12.162 | |
| SSA Nasal | 39.186 | 2.772 | 7.762 | 7.074 | 3.638 | 10.188 | 9.285 | |
| AC Angle Nasal | 38.282 | 2.517 | 7.048 | 6.575 | 3.433 | 9.612 | 8.968 | |
| TISA 500 Temporal | 0.161 | 0.020 | 0.057 | 12.685 | 0.026 | 0.072 | 16.033 | |
| TISA 750 Temporal | 0.270 | 0.028 | 0.078 | 10.319 | 0.032 | 0.090 | 11.950 | |
| AOD 500 Temporal | 0.475 | 0.064 | 0.179 | 13.415 | 0.075 | 0.209 | 15.699 | |
| AOD 750 Temporal | 0.576 | 0.062 | 0.173 | 10.750 | 0.072 | 0.202 | 12.534 | |
| SSA Temporal | 38.440 | 3.478 | 9.738 | 9.048 | 4.197 | 11.751 | 10.918 | |
| AC Angle Temporal | 37.209 | 2.868 | 8.031 | 7.708 | 3.630 | 10.164 | 9.756 |
Table 11. Repeatability and Reproducibility of CIRRUS HD-OCT 5000
All statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.
Mean = Intercept of the ANOVA model
Repeatability Limit = 2.8 x Repeatability SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance
Reproducibility Limit = 2.8 x Reproducibility SD
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Table 12. Limits of Agreement Between CIRRUS HD-OCT 4000, CIRRUS HD-OCT 5000 and Visante OCT
| AC Angle (deg) | N | CIRRUS Mean (SD) | Visante Mean (SD) | Difference Mean (SD) | 95% CI for Mean Difference | p-value | 95% LoA for Mean Difference |
|---|---|---|---|---|---|---|---|
| CIRRUS 4000 | |||||||
| Wide Angle to Angle Scan | |||||||
| Nasal | 26 | 36.944 (18.012) | 38.831 (18.272) | -1.887 (7.155) | -4.777, 1.003 | 0.191 | -16.196, 12.422 |
| Temporal | 26 | 37.258 (19.213) | 38.573 (18.385) | -1.315 (6.553) | -3.961, 1.332 | 0.316 | -14.420, 11.791 |
| HD Angle Scan | |||||||
| Nasal | 27 | 38.218 (17.344) | 39.974 (19.074) | -1.756 (8.038) | -4.936, 1.423 | 0.267 | -17.833, 14.320 |
| Temporal | 27 | 37.358 (20.609) | 36.767 (18.295) | 0.591 (6.181) | -1.854, 3.036 | 0.623 | -11.772, 12.954 |
| CIRRUS 5000 | |||||||
| Wide Angle to Angle Scan | |||||||
| Nasal | 26 | 36.054 (18.137) | 38.831 (18.272) | -2.777 (5.665) | -5.065, -0.488 | 0.019 | -14.107, 8.554 |
| Temporal | 26 | 35.255 (18.767) | 38.573 (18.385) | -3.318 (6.493) | -5.940, -0.695 | 0.015 | -16.304, 9.669 |
| HD Angle Scan | |||||||
| Nasal | 27 | 37.677 (17.408) | 39.974 (19.074) | -2.297 (8.411) | -5.625, 1.030 | 0.168 | -19.119, 14.525 |
| Temporal | 27 | 37.141 (19.649) | 36.767 (18.295) | 0.374 (5.934) | -1.974, 2.722 | 0.746 | -11.495, 12.243 |
| N is the number of eyes with measurements from both devices. | |||||||
| Difference = CIRRUS – Visante | |||||||
| 95% Confidence Interval ((CI) for mean difference is based on t-distribution _ n- |
Interval (CI) for mean difference is based on t-
value is based on paired t-test.
95% Limits of Agreement (LoA) = mean difference +/- 2 x difference SD
CIRRUS OCT Angiography
In an additional study, a series of case studies comparing CIRRUS OCT angiography cube scans of 3x3 mm and 6x6 mm with fluorescein angiography images was completed. The findings demonstrate that the CIRRUS OCT Angiography in combination with OCT intensity-based information (B-scans and en face images) can give non-invasive threedimensional information regarding retinal microvasculature in a variety of retinal diseases. CIRRUS OCT Angiography is not intended as a substitute for fluorescein angiography. Vascular findings on fluorescein angiography may be absent, poorly defined, or variably defined on CIRRUS OCT Angiography. Additionally, leakage, staining, and pooling are not features of CIRRUS OCT Angiography.
SUMMARY
As described in this 510(k) Summary, all testing deemed necessary was conducted on the CIRRUSTM HD-OCT with Software Version 8 to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.