(274 days)
No
The document describes the use of normative databases and statistical comparisons, but does not mention AI or ML algorithms for image analysis, diagnosis, or other functions.
No
The device is described as an ophthalmic diagnostic imaging device intended for viewing the posterior segment of the eye and aiding in the detection and management of various ocular diseases. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device." It further elaborates on its use "as an aid in the detection and management of various ocular diseases."
No
The device description explicitly states that the SPECTRALIS components include hardware such as a laser scanning camera mount with headrest, operation panel, power supply box, and host computer, in addition to the operation software.
Based on the provided information, the SPECTRALIS device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
- SPECTRALIS Function: The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device that directly images the posterior segment of the eye. It uses light-based technologies (OCT and cSLO) to visualize structures and perform measurements in vivo (within the living body).
- Specimen Requirement: IVDs require the examination of specimens derived from the human body. The SPECTRALIS does not analyze such specimens. It directly interacts with the eye itself.
Therefore, while the SPECTRALIS is a diagnostic device used to aid in the detection and management of ocular diseases, its mode of operation and the type of information it provides do not align with the definition of an In Vitro Diagnostic. It is an in vivo diagnostic imaging device.
N/A
Intended Use / Indications for Use
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging, crosssectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including age-related macular degeneration, macular edema, diabetic retinopathy, retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.
Product codes (comma separated list FDA assigned to the subject device)
OBO, MYC
Device Description
The SPECTRALIS HRA+OCT is a real-time imaging system of anterior and posterior segments of the human eye and for aiding in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma.
The device is a combination of optical coherence tomography (OCT) with confocal scanning laser ophthalmoscopy (cSLO). OCT imaging includes high-resolution cross-sectional imaging of ocular structures (e.g., retina, macula, optic nerve head); cSLO imaging includes high-resolution and dynamic infrared reflectance, blue reflectance, fluorescein angiography, indocyanine green angiography, and autofluorescence imaging. OCT images and cSLO images are acquired simultaneously and are viewed side-by-side on the computer screen. Images are acquired and stored using SPECTRALIS operation software, which runs on a standard personal computer. SPECTRALIS components include a laser scanning camera mount with headrest, operation panel, power supply box, operation software, and host computer. A MultiColor option is included to provide additional green reflectance imaging and a "composite color" image, which provides a different view of the features of the eye. This composite color image is not the same as fundus color photo. This submission includes Enhanced Depth Imaging (EDI) as an optional viewing mode that allows for better visualization of deep eye structures below the retina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Confocal Scanning Laser Ophthalmoscopy (cSLO)
Anatomical Site
posterior segment of the eye (including retina, macula, optic nerve head)
Indicated Patient Age Range
The reference databases cover an age range of 20 to 90 years.
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
RNFL Thickness Reference Database:
- Sample size: 330 eyes (167 right, 163 left) of 330 normal subjects (146 male, 184 female).
- Data source: Prospective, multi-center, observational study.
- Annotation protocol: RNFLT reference data was acquired and analyzed relative to the fovea-to-BMO-center axis, to ensure accurate and consistent positioning of the circle scans across eyes. First and fifth percentile reference limits for RNFLT were computed and age- and BMO area-adjusted.
BMO-MRW Reference Database:
- Sample size: 368 eyes (182 right, 186 left) of 368 normal subjects (165 male, 203 female).
- Data source: Prospective, multicenter, observational study.
- Annotation protocol: BMO-MRW reference data was acquired and analyzed relative to the fovea-to-BMO-center axis, to ensure accurate and consistent positioning of the BMO-MRW profiles across eyes. First and fifth percentile reference limits for BMO-MRW were computed and age- and BMO area-adjusted.
RNFLT and BMO-MRW measurement precision for use of the ONH-RC scan pattern:
- Sample size: 34 subjects enrolled, data of 32 subjects (16 healthy, 16 glaucomatous) included in analysis.
- Data source: Prospective, monocentric study.
- Annotation protocol: Three qualified individuals, each operating one of three Spectralis devices, performed measurements thrice at each device in baseline and follow-up mode. All acquired images were inspected by three experienced physicians for image quality (image quality index, missing scans, truncated scans, image defocus, floaters, pathologies and layer segmentation). Manual correction of fovea position was necessary in 11 of 288 APS definition activities (3.8%), and BMO position in 51 of 288 (17.7%).
RNFLT and BMO-MRW measurement agreement with the predicate device:
- Sample size: 48 subjects enrolled, data of 40 subjects (20 healthy, 20 glaucomatous) included in analysis.
- Data source: Prospective, monocentric study.
- Annotation protocol: All subjects were examined once with each device version (predicate with IR image-based FoDi and subject device with OCT-based APS) and underwent further supporting diagnostics. All acquired images were inspected by the investigator for image quality (image quality index, missing scans, truncated scans, image defocus, floaters, pathologies, scan center position alignment, and layer segmentation). Statistical analysis calculated mean of differences, min/max differences, standard deviation of differences, and 95% limits of agreement (LOA).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Studies (Precision and Agreement Studies for Normative Databases and Measurement Agreement)
RNFL Thickness Reference Database:
- Sample Size: 330 eyes (330 normal subjects)
- Key Results: Reference data for RNFL thickness along peri-papillary circle scans with 3.5 mm, 4.1 mm, and 4.7 mm diameter. Reference database is age-adjusted and BMO area-adjusted. Provides 1st and 5th percentile values for various sectors and global RNFLT.
BMO-MRW Reference Database:
- Sample Size: 368 eyes (368 normal subjects)
- Key Results: Reference data for BMO-MRW. Reference database is adjusted for age and BMO area. Provides 1st and 5th percentile values for various sectors and global BMO-MRW.
RNFLT and BMO-MRW measurement precision for use of the ONH-RC scan pattern:
- Study Type: Prospective, monocentric study to assess precision and agreement of ONH neuroretinal rim parameter and RNFL thickness measurements.
- Sample Size: 32 subjects (16 healthy, 16 glaucomatous)
- Key Results:
- Coefficients of variation and ANOVA analysis for BMO-MRW and RNFLT measurements were within specified ranges for the device.
- Manual correction of fovea APS position was necessary in 3.8% of activities (11 of 288).
- Manual correction of BMO APS position was necessary in 17.7% of activities (51 of 288).
- Mean and Maximum CV for Repeatability and Reproducibility were tabulated for BMO-MRW and 3.5 mm, 4.1 mm, 4.7 mm circle scans across baseline and follow-up modes, for normal and glaucoma groups. (See Tables 9-24 for detailed CV values).
- The results indicated good repeatability and reproducibility.
RNFLT and BMO-MRW measurement agreement with the predicate device:
- Study Type: Prospective, monocentric study to determine measurement agreement between the new OCT-based landmark definition (APS) and the predicate's IR image-based landmark definition (FoDi).
- Sample Size: 40 subjects (20 healthy, 20 glaucomatous)
- Key Results:
- Differences between the different RNFLT scans are overall small and within expected ranges and below predefined thresholds.
- Limits of Agreement (LOA) were calculated for RNFLT 3.5mm circle scan using APS compared with the manually positioned 12° circle scan pattern (predicate) for both normal and glaucoma subjects (See Tables 25-28 for detailed LOA values).
- It was concluded that results derived from the predicate software version 5.6 and the subject device software version 6.0 are considered to agree.
Overall Conclusion of Performance Studies: The performance data, including electrical safety, EMC, laser safety, software verification and validation, and clinical studies on normative databases, precision, and agreement, support the substantial equivalence determination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Precision and agreement metrics like Coefficient of Variation and Limits of Agreement were provided instead of diagnostic performance metrics like Sensitivity or Specificity.)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1570 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
Heidelberg Engineering Gmbh % Ms. Diane Horwitz Mandell Horwitz Consultants LLC 2995 Steven Martin Drive Fairfax, Virginia 22031
Re: K152205
Trade/Device Name: Spectralis Hra + Oct And Variants (e.g.s Below), Spectralis Fa+oct, Spectralis Icga+oct, Spectralis Oct Blue Peak, Spectralis Oct Ith Multicolor Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO. MYC. Dated: March 29, 2016 Received: March 30, 2016
Dear Ms. Horwitz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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)
Device Name
Spectralis HRA+OCT with RNFL and ONH Normative Database
Indications for Use (Describe)
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT BluePeak) and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including agerelated macular degeneration, macular edema, diabetic retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include normative databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal paraments, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summarv
Submitter I.
Heidelberg Engineering GmbH Max-Jarecki-Str. 8 69115 Heidelberg, Germany
Telephone: +49 / 6221 / 64 643 0 Fax: +49 / 6221 / 64 63 62
Contact Person: Dr. Christian Elm Date Summary Prepared: May 4, 2016
II. Device
Trade/Device Name: SPECTRALIS HRA+OCT and Variants Common/Usual Name: Retina Angiograph / Optical Coherence Tomograph Classification Name: Tomography, Optical Coherence (21 CFR 886.1570) Regulatory Class: II Product Code: OBO, MYC
III. Predicate Device
Heidelberg SPECTRALIS HRA+OCT, K101223, amended by K121993 Reference devices include other medical devices
- with wide field objective: Nidek Ophthalmoscope F-10, K072259 -
- with ultra-widefield objective: Optos 200 T, K111628 -
IV. Device Description
The SPECTRALIS HRA+OCT is a real-time imaging system of anterior and posterior segments of the human eye and for aiding in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma.
The device is a combination of optical coherence tomography (OCT) with confocal scanning laser ophthalmoscopy (cSLO). OCT imaging includes high-resolution cross-sectional imaging of ocular structures (e.g., retina, macula, optic nerve head); cSLO imaging includes high-resolution and dynamic infrared reflectance, blue reflectance, fluorescein angiography, indocyanine green angiography, and autofluorescence imaging. OCT images and cSLO images are acquired simultaneously and are viewed side-by-side on the computer screen. Images are acquired and stored using SPECTRALIS operation software, which runs on a standard personal computer. SPECTRALIS components include a laser scanning camera mount with headrest, operation panel, power supply box, operation software, and host computer. A MultiColor option is included to provide additional green reflectance imaging and a "composite color" image, which provides a different view of the features of the eye. This composite color image is not the same as fundus color photo. This submission includes Enhanced Depth Imaging (EDI) as an optional viewing mode that allows for better visualization of deep eye structures below the retina.
V. Intended Use/Indications for Use
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging, crosssectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography,
4
fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including age-related macular degeneration, macular edema, diabetic retinopathy, retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.
VI. Comparison of Technological Characteristics with the Predicate Device
The basic technological characteristics of the SPECTRALIS predicate, with software version 5.6, and the new device, with software version 6.0, remain the same. The new device has been updated in the following ways:
- . The new device includes a new reference database that includes optic nerve head (ONH) neuroretinal rim width measurements for the parameter BMO-MRW in addition to retinal nerve fiber layer (RNFL) thickness.
- . The method for locating the fovea and the optic disc center (FoDi) were modified to result in a more accurate definition of both locations with the revised imaging software. The FoDi method is based on an IR image of the fundus, the new, more accurate definition is called Anatomic Positioning System (APS) and is based on OCT images of the fundus. It uses the fovea and the BMO center as landmarks and aligns the image axis on the fovea-BMO center axis.
- . A new scan pattern called ONH-RC, which includes RNFL thickness measurements with three fixed diameter circles of 3.5, 4.1 and 4.7 mm diameter and 48 radial scans around the BMO center. The ONH-RC scan pattern measures the parameter BMO-MRW (BMO minimum rim width) with an image orientation based on APS information
- . An additional imaging function. Enhanced Depth Imaging (EDI), is added to enhance viewing the deep structures of the eve. EDI is available for standard OCT preset scan pattern only. It allows for standard segmentation of ILM and RNFL and retinal thickness measurement. Reference data are not available for EDI scans.
- . Two optional accessory lenses have been added to allow the user conveniently to view a greater proportion of the posterior eye in one view: the Wide Field Objective and the Ultra-Widefield Objective. Both objectives are used for SLO imaging only.
The differences between the predicate device and the subject device are shown in Table 1.
| | Predicate Device
(SPECTRALIS HRA+OCT)
K101223 and amended in
K121993 | Subject Device |
|--------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Optical image axis | Manually determined, FoDi
based, using IR images,
horizontally aligned | Semi-automatic aligned, APS
based, using OCT images
aligned along the fovea-BMO
center axis |
TABLE 1: COMPARISON OF CHANGED PRIMARILY CHARACTERISTICS
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| | Predicate Device
(SPECTRALIS HRA+OCT)
K101223 and amended in
K121993 | Subject Device |
|---------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement of RNFLT | Using 12° fixed degree circle
scan pattern | Using 3.5mm, 4.1mm and 4.7
mm fixed diameter circle scan
pattern |
| Measurement of ONH
neuroretinal rim width | Using 24 | Using 48 BMO-centered radial
scans |
| Reference database for ONH
neuroretinal rim with and RNFLT | Caucasian population, RNFLT
only | Population of different races and
ethnicities from Canada,
Germany, and US, representing
the population mix of the U.S.A.
RNFLT and BMO-MRW |
| EDI imaging | No | Yes |
| Scan angle options | 30° (standard lens) | 30° (standard lens),
55° (WFO) and 102° (UWF) |
TABLE 1: COMPARISON OF CHANGED PRIMARILY CHARACTERISTI
These differences were verified with clinical and bench testing and software verification and validation.
The standard hardware has not been modified compared to the predicate.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
The SPECTRALIS HRA+OCT has been tested according to IEC 60601-1 and IEC 60601-1-2 and was found to meet all requirements.
Laser Safetv
The system is a laser product of Class 1 according to 21 CFR §1040.10 and complies with IEC 60825-1.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction of or latent design flaw in the software could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would lead to minor injury.
A study in normal and glaucomatous human volunteers was conducted to assess precision and agreement of ONH neuroretinal rim parameter and RNFL thickness measurements. The coefficients of variation and the ANOVA analysis for the measured endpoints were within the specified range for this device.
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Clinical Studies
RNFL Thickness Reference Database
The RNFLT reference database includes 330 eyes (167 right eyes and 163 left eyes) of 330 normal subjects (146 male and 184 female) with mean age of 49.7 years (range 20 to 90 years) and of various racial and ethnic origins (non-Hispanic White: 218; Hispanic White: 45; Black or African American: 41; Asian: 23; American Indian / Alaska Native: 3). The racial and ethnic composition of the reference database is representative for the U.S. population. Subjects were enrolled in a prospective, multi-center, observational study. Included subjects had healthy eyes without prior intraocular surgery (except cataract surgery or Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve, no history of glaucoma, intraocular pressure ≤21 mmHg, best corrected visual acuity ≥0.5, refraction between +6 and -6 diopters, astigmatism ≤2 diopters, normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits, clinically normal appearance of optic disc with normal appearing neuroretinal rim with respect to color and shape.
RNFLT reference data was acquired and analyzed relative to the fovea-to-BMO-center axis, to ensure accurate and consistent positioning of the circle scans across eyes.
The first and fifth percentile reference limits for RNFLT were computed and age- and BMO areaadjusted, and used for comparison with the retinal nerve fiber layer thickness from an individual
The RNFLT reference database includes reference data for RNFL thickness along peri-papillary circle scans with 3.5 mm, 4.1 mm, and 4.7 mm diameter.
The reference database is limited by its sample size (330 subjects), the covered age range (20 to 90 years), the covered range of optic disc size (BMO area 1.0 to 3.4 mm+; 15 cases with BMO area >2.5 mm2), and the covered range of refraction (+6 to -6 diopters).
RNFL thickness in normal subjects decreases slightly with increasing age and with decreasing BMO area. To take this into account the reference database is age-adjusted and BMO areaadjusted based on multiple linear regression. As a result, the percentiles of the normal distribution used for the classification depend on the patient's age and the eye's BMO area.
Mean age and mean BMO area in the reference database are as follows:
- Mean age = 49.70 years -
- -Mean BMO area = 1.828 mm2
As an example for the effect of age and BMO area, the following Table 2 and Table 3 show the values of the 1st and the 5th percentiles of the average RNFLT (3.5 mm diameter circle) global and in the standard sectors, for a 45 years old subject with a large BMO area (2.5 mm2), and for a 65 years old subject with a small BMO area (1.5 mm2).
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| 1st percentile [µm] | 5th percentile [µm] | |
|---|---|---|
| Global | 82.5 | 88.8 |
| Temporal | 48.9 | 55.8 |
| Temporal superior | 86.1 | 100.5 |
| Temporal inferior | 115.3 | 127.5 |
| Nasal | 54.7 | 63.7 |
| Nasal superior | 71.4 | 87.8 |
| Nasal inferior | 66.5 | 82.2 |
TABLE 2: RNFLT (3.5 MM CIRCLE DIAMETER). AGE 45 YEARS. BMO AREA 2.5 MM2
TABLE 3: RNFLT (3.5 MM CIRCLE DIAMETER) AGE 65 YEARS, BMO AREA 1.5 MM4
| 1st percentile [µm] | 5th percentile [µm] | |
|---|---|---|
| Global | 72.2 | 78.5 |
| Temporal | 45.0 | 51.8 |
| Temporal superior | 72.4 | 86.7 |
| Temporal inferior | 99.6 | 111.8 |
| Nasal | 47.7 | 56.6 |
| Nasal superior | 42.4 | 68.8 |
| Nasal inferior | 51.0 | 66.7 |
BMO-MRW Reference Database
The BMO-MRW reference database includes 368 eyes (182 right eyes and 186 left eyes) of 368 normal subjects (165 male and 203 female) with mean age of 50.3 years (range 20 to 90 years) and of various racial and ethnic origins (non-Hispanic White: 246; Hispanic White: 47; Black or African American: 47; Asian: 25; American Indian / Alaska Native: 3). The racial and ethnic composition of the reference database is representative for the U.S. population. Subjects were enrolled in a prospective, multicenter, observational study. Included subjects had healthy eyes without prior intraocular surgery (except cataract surgery or Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve, no history of glaucoma, intraocular pressure ≤21 mmHg, best corrected visual acuity ≥0.5, refraction between +6 and -6 diopters, astigmatism ≤2 diopters, normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits, clinically normal appearance of optic disc with normal appearing neuroretinal rim with respect to color and shape.
BMO-MRW reference data was acquired and analyzed relative to the fovea-to-BMO-center axis, to ensure accurate and consistent positioning of the BMO-MRW profiles across eyes. The first and fifth percentile reference limits for BMO-MRW were computed and age- and BMO areaadjusted, and used for comparison with the BMO minimum rim width from an individual
The reference database is limited by its sample size (368 eyes of 368 subjects), the covered age range (20 to 90 years), the covered range of optic disc size (BMO area 1.0 to 3.4 mm²; 19 cases with BMO area >2.5 mm2), and the covered range of refraction (+6 to -6 diopters).
BMO-MRW decreases with increasing age and with increasing BMO area. To take this into account, the reference database is adjusted for age and BMO area in a multiple linear regression
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model. As a result, the percentiles of the normal distribution used for the classification depend on the patient's age and the eye's BMO area.
As an example for the effect of age and BMO area, the following Table 4 and Table 5 show the values of the 1st and the 5th percentiles of BMO-MRW for the global averages in the standard sectors, for a 45 years old subject with a small BMO area (1.5 mm²), and for a 65 years old subject with a large BMO (2.5 mm2).
| 1st percentile [um] | 5th percentile [um] | |
|---|---|---|
| Global | 231 | 268 |
| Temporal | 146 | 177 |
| Temporal superior | 194 | 237 |
| Temporal inferior | 227 | 268 |
| Nasal | 246 | 291 |
| Nasal superior | 227 | 277 |
| Nasal inferior | 268 | 316 |
TABLE 4: BMO-MRW, AGE 45 YEARS, BMO AREA 1.5 MM2
| 1st percentile [µm] | 5th percentile [µm] | |
|---|---|---|
| Global | 155 | 192 |
| Temporal | 94 | 124 |
| Temporal superior | 127 | 169 |
| Temporal inferior | 170 | 212 |
| Nasal | 146 | 192 |
| Nasal superior | 146 | 197 |
| Nasal inferior | 185 | 233 |
RNFLT and BMO-MRW measurement precision for use of the ONH-RC scan pattern In a prospective, monocentric study the clinical precision of BMO-MRW and RNFLT measurements have been determined for use of the ONH-RC scan pattern.
34 subjects were enrolled into the study. Data of 32 subjects was included in analysis. 16 subjects had healthy eyes (healthy eyes without prior intraocular surgery except cataract surgery or laser in-situ keratomileusis, and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve).
16 subjects had different stages of glaucomatous eyes (visual field mean deviation ranging from -0.5 to -25.8). All subjects' manifest spherical equivalent was between +6D and -6D, with astigmatism