(57 days)
The Topcon 3D OCT-1 Maestro is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera 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.
The 3D OCT-1 Maestro 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.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects. The 3D OCT-1 Maestro is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
The Maestro is a non-contact, high-resolution, tomographic and bio-microscopic imaging system that merges OCT and fundus cameras into a single device. The technological characteristics of the OCT employed are similar to those of already 510(k)-cleared OCT products, such as Topcon's 3D OCT-2000 (K092470), in that it employs conventional spectral domain OCT with widely-used 840 nm light source. The technological characteristics of the fundus camera employed are also similar to those of already cleared fundus cameras, such as Topcon's TRC NW300 (K123460), in terms of field of view (FOV) and camera sensor resolution.
The Maestro captures an OCT image and a color fundus image sequentially. It can take anterior OCT images in addition to fundus OCT images. It also includes a reference database for fundus OCT. Captured images are transferred from the device to an off-the-shelf personal computer (PC) via LAN cable, where the dedicated software for this device is installed. The transferred data is then automatically processed with analysis functions such as the automatic retinal layers segmentation, the automatic thickness calculation with several grids, the optic disc analysis and comparison with a reference database of eyes free of ocular pathology, and is finally automatically saved to the PC.
Two software programs for installation on an off-the-shelf PC are provided with the device. The first PC software program, called "FastMap", captures the images from the device, analyzes them and enables viewing of the data. The second PC software program, called "OCT Viewer", can only analyze and view the data.
Accessories include the following: power cord; chin-rest paper sheet; LAN cable; chin-rest paper pins; external fixation target; dust cover; spare parts case; and stylus pen. An optional Anterior Segment Kit allows the user to activate the anterior segment imaging functionality of the Maestro device.
The Topcon 3D OCT-1 Maestro is a non-contact, high-resolution tomographic and biomicroscopic imaging device. The provided text outlines its performance data, primarily focusing on repeatability and reproducibility measurements for various ocular structures in different patient populations.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the repeatability and reproducibility of the measurements. Instead, it presents the calculated repeatability and reproducibility measurements (SD, Limit, CV%) for the Maestro device across different parameters and patient groups. The "acceptance criteria" appear to be implied by the presentation of these results, suggesting that the device's performance, as measured, is considered acceptable for demonstrating substantial equivalence to predicate devices.
However, based on the provided tables, here's a summary of the reported device performance:
| Measurement Type | Population | Scan Pattern | Typical Repeatability CV% (Range) | Typical Reproducibility CV% (Range) |
|---|---|---|---|---|
| Full Retinal Thickness | Normal Eyes | 12x9 3D Wide | 0.286% - 1.115% | 0.526% - 1.461% |
| 6x6 3D Macula | 0.305% - 0.684% | 0.498% - 1.025% | ||
| Retinal Disease Eyes | 12x9 3D Wide | 0.378% - 1.478% | 0.595% - 1.897% | |
| 6x6 3D Macula | 0.376% - 1.090% | 0.660% - 1.336% | ||
| Glaucoma Eyes | 12x9 3D Wide | 0.493% - 1.199% | 0.661% - 1.639% | |
| 6x6 3D Macula | 0.332% - 1.288% | 0.719% - 1.239% | ||
| Ganglion Cell + IPL | Normal Eyes | 12x9 3D Wide | 0.404% - 0.950% | 0.508% - 1.162% |
| 6x6 3D Macula | 0.364% - 1.044% | 0.557% - 1.148% | ||
| Retinal Disease Eyes | 12x9 3D Wide | 1.041% - 2.673% | 1.101% - 3.604% | |
| 6x6 3D Macula | 0.690% - 1.452% | 0.984% - 1.824% | ||
| Glaucoma Eyes | 12x9 3D Wide | 0.628% - 1.563% | 0.716% - 1.784% | |
| 6x6 3D Macula | 0.593% - 1.288% | 0.736% - 1.451% | ||
| Ganglion Cell Complex Thickness | Normal Eyes | 12x9 3D Wide | 0.470% - 0.821% | 0.645% - 1.056% |
| 6x6 3D Macula | 0.498% - 1.400% | 0.729% - 1.607% | ||
| Retinal Disease Eyes | 12x9 3D Wide | 1.112% - 3.213% | 1.112% - 3.232% | |
| 6x6 3D Macula | 0.485% - 1.093% | 0.601% - 1.093% | ||
| Glaucoma Eyes | 12x9 3D Wide | 0.638% - 1.189% | 0.687% - 1.240% | |
| 6x6 3D Macula | 0.508% - 1.131% | 0.678% - 1.265% | ||
| Retinal Nerve Fiber Layer (RNFL) - Average | Normal Eyes | 12x9 3D Wide | 1.318% | 1.517% |
| 6x6 3D Disc | 0.933% | 1.099% | ||
| Retinal Nerve Fiber Layer (RNFL) - Sectoral | Normal Eyes | 12x9 3D Wide | 2.461% - 16.711% | 3.040% - 18.538% |
| 6x6 3D Disc | 3.738% - 13.898% | 4.405% - 14.407% | ||
| Retinal Disease Eyes | 12x9 3D Wide | 1.594% - 8.143% | 1.888% - 8.675% | |
| 6x6 3D Disc | 1.084% - 5.725% | 1.480% - 7.387% | ||
| Glaucoma Eyes | 12x9 3D Wide | 1.970% - 8.261% | 2.097% - 8.299% | |
| 6x6 3D Disc | 1.929% - 6.480% | 1.933% - 7.074% | ||
| Optic Disc | Normal Eyes | 12x9 3D Wide | 3.520% - 6.600% | 4.233% - 7.967% |
| 6x6 3D Disc | 3.313% - 6.359% | 4.074% - 8.139% | ||
| Retinal Disease Eyes | 12x9 3D Wide | 3.858% - 8.404% | 4.981% - 20.586% | |
| 6x6 3D Disc | 2.855% - 5.627% | 3.438% - 11.024% | ||
| Glaucoma Eyes | 12x9 3D Wide | 3.179% - 14.274% | 3.811% - 17.103% | |
| 6x6 3D Disc | 1.852% - 5.813% | 1.959% - 7.201% |
The "Limit" values in the tables are calculated as 2.8 x SD, representing a range within which 95% of repeated measurements are expected to fall. The "CV%" is the Coefficient of Variation, indicating precision relative to the mean.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set (Clinical Studies for Repeatability and Reproducibility):
- Normal Subjects: 25 subjects for macula and optic disc measurements (full retinal thickness, ganglion cell + IPL, ganglion cell complex thickness, retinal nerve fiber layer, optic disc parameters). Explicitly stated in the tables (N=25).
- Subjects with Retinal Disease: 26 subjects for macula and optic disc measurements (full retinal thickness, ganglion cell + IPL, ganglion cell complex thickness, retinal nerve fiber layer, optic disc parameters). Explicitly stated in the tables (N=26).
- Subjects with Glaucoma: 25 subjects for macula and optic disc measurements (full retinal thickness, ganglion cell + IPL, ganglion cell complex thickness, retinal nerve fiber layer, optic disc parameters). Explicitly stated in the tables (N=25).
- Data Provenance: The document does not explicitly state the country of origin. The study is referred to as "clinical studies," but it's not specified if they were prospective or retrospective. Given that the manufacturer is Topcon Corporation of Japan, but the contact person is in the US, the studies could have been conducted in either or both regions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set in the context of the repeatability and reproducibility studies. The clinical studies were conducted to determine the agreement, repeatability, and reproducibility of measurement data, not for diagnostic accuracy against a ground truth.
However, it mentions: "Consistent with the labeling for the test and control devices, the clinical site was permitted to make manual adjustments to automated segmentation based on the clinician's judgment." This indicates that clinicians (likely ophthalmologists or optometrists) were involved in reviewing and potentially adjusting automated segmentation, but it doesn't define them as "ground truth" experts in the context of defining disease states or specific measurements for the purpose of validating the AI's accuracy against a known truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the context of establishing ground truth for the test set. The clinical studies focused on repeatability and reproducibility of quantitative measurements, rather than classification or diagnosis that would typically require an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance was not reported in this document. The clinical studies conducted were focused on the device's measurement precision (repeatability and reproducibility) and agreement with predicate devices rather than human-AI collaboration for diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The clinical studies described primarily assessed the precision of the device's measurements (which involve algorithms for segmentation and thickness calculation) rather than the standalone diagnostic performance of an AI algorithm. The device performs automatic retinal layer segmentation, automatic thickness calculation, and optic disc analysis. The phrase "the clinical site was permitted to make manual adjustments to automated segmentation based on the clinician's judgment" (page 6) suggests that the device's algorithms operate with potential human oversight, implying it's not strictly a standalone AI performance evaluation for diagnostic purposes. The data presented are for the device's ability to consistently provide these measurements.
7. The Type of Ground Truth Used
For the repeatability and reproducibility studies, the "ground truth" is not a diagnostic label (e.g., pathology, outcomes data). Instead, the studies assess the consistency of the device's quantitative measurements of ocular structures (e.g., retinal thickness, RNFL thickness) by comparing multiple measurements taken under similar or varied conditions. The reference database uses "known normal subjects" but this is for comparative analysis against a normal population rather than for establishing a "ground truth" for disease diagnosis in the test set.
8. The Sample Size for the Training Set
The document specifies a "Reference Database" was compiled using "399 subject eyes from normal study subjects." This database is for "quantitative comparison... to a database of known normal subjects," which functions as a normative reference rather than a training set for an AI/algorithm in the conventional sense (e.g., for classification tasks).
If parts of the device's functionality (like automatic segmentation) involve machine learning, the training set size for those specific algorithms is not provided in this document. The 399 normal subjects form a reference database, not explicitly an algorithm training set.
9. How the Ground Truth for the Training Set Was Established
For the "Reference Database" of 399 normal subjects:
- How it was established: The study collected measurements of various ocular structures from these normal eyes. The "normal" status of these subjects would have been established through clinical evaluation to ensure they were free of ocular pathology.
- Type of Ground Truth: The ground truth for this reference database is the consensus clinical determination that the subjects have "normal eyes" and the quantitative measurements derived from these normal eyes form the expected range for a healthy population. The document states it provides "quantitative comparison... to a database of known normal subjects." It also mentions "a reference database of eyes free of ocular pathology."
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2016
Topcon Corporation % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004
Re: K161509
Trade/Device Name: 3D OCT-1 Maestro Regulation Number: 21 CFR §886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: June 1, 2016 Received: June 1, 2016
Dear Mr. Kahan:
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.
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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 (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,
Denise L. Hampton -S
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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510(k) Number (if known) K161509
Device Name
3D OCT-1 Maestro
Indications for Use (Describe)
The Topcon 3D OCT-1 Maestro is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera 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.
The 3D OCT-1 Maestro 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.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects. The 3D OCT-1 Maestro is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY – K161509
Topcon Corporation's 3D OCT-1 Maestro
Submitter Information:
| Applicant: | Topcon Corporation75-1 Hasunuma-cho, Itabashi-kuTokyo, Japan 174-8580 |
|---|---|
| Phone: | (201) 599-5533 |
| Fax: | (201) 599-5248 |
| Contact Person: | Charles ReismanSenior Manager, Global R&DTopcon Medical Systems, Inc.111 Bauer DriveOakland, NJ 074361 (201) 599-5283 |
| Date Prepared: | July 25, 2016 |
| Subject Device: | |
| Device Name: | 3D OCT-1 Maestro |
| Common Name: | Optical Coherence Tomography |
| Classification Name: | Ophthalmoscope |
| Regulation: | Class II, 21 C.F.R. § 886.1570 |
| Product Code(s): | OBO, HKI |
| Predicate Device(s): |
Primary Predicate: Optovue's iVue with Normative Database (K121739) Topcon's TRC-NW300 Non-Mydriatic Retinal Camera (K123460) Secondary Predicate:
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Indications for Use:
The Topcon 3D OCT-1 Maestro is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera 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.
The 3D OCT-1 Maestro 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.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects. The 3D OCT-1 Maestro is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
Device Description:
The Maestro is a non-contact, high-resolution, tomographic and bio-microscopic imaging system that merges OCT and fundus cameras into a single device. The technological characteristics of the OCT employed are similar to those of already 510(k)-cleared OCT products, such as Topcon's 3D OCT-2000 (K092470), in that it employs conventional spectral domain OCT with widely-used 840 nm light source. The technological characteristics of the fundus camera employed are also similar to those of already cleared fundus cameras, such as Topcon's TRC NW300 (K123460), in terms of field of view (FOV) and camera sensor resolution.
The Maestro captures an OCT image and a color fundus image sequentially. It can take anterior OCT images in addition to fundus OCT images. It also includes a reference database for fundus OCT. Captured images are transferred from the device to an off-the-shelf personal computer (PC) via LAN cable, where the dedicated software for this device is installed. The transferred data is then automatically processed with analysis functions such as the automatic retinal layers segmentation, the automatic thickness calculation with several grids, the optic disc analysis and comparison with a reference database of eyes free of ocular pathology, and is finally automatically saved to the PC.
Two software programs for installation on an off-the-shelf PC are provided with the device. The first PC software program, called "FastMap", captures the images from the device, analyzes them and enables viewing of the data. The second PC software program, called "OCT Viewer", can only analyze and view the data.
Accessories include the following: power cord; chin-rest paper sheet; LAN cable; chin-rest paper pins; external fixation target; dust cover; spare parts case; and stylus pen. An optional Anterior Segment Kit allows the user to activate the anterior segment imaging functionality of the Maestro device.
Substantial Equivalence
The Maestro is substantially equivalent to the primary predicate device Optovue's iVue with Normative Database (iVue) cleared under K121739. The Maestro and the iVue with Normative Database have very similar indication for use statements with respect to the reference database and its ability to provide reference analyses. The Maestro and iVue are both OCT devices and each provide cross-sectional images of the fundus and measurement of posterior ocular structures. Both devices provide analysis functions for both retinal disease and glaucoma. Also, both are intended for use as a diagnostic device to aid in the detection and management of various ocular diseases.
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The Maestro and the iVue have similar technological characteristics with respect to the kind of OCT images they capture, the processing methods, and presentation of OCT information. The light source used by both devices is a spectral domain OCT (SD-OCT) using a superluminescent diode (SLD) with a center wavelength of 840 nm. The Maestro has a faster scan speed of 50,000 A-scans per second compared to 26,000 A-scans per second for the iVue. In addition, the Maestro has deeper A-scan depth of 2.6 mm (in tissue) at axial resolution of 6 micron (in tissue) and transverse resolution of 20 micron (in tissue) compared to A-scan depth of 2.0 to 2.3 mm at axial resolution of 5 micron and unspecified transverse resolution for the iVue. Both devices use the 3D Scan pattern and other similar scan patterns for posterior and Radial and Line-like scans for anterior. For the anterior segment feature, the Maestro provides only a visualization while the iVue also provides automated measurement of central corneal thickness.
In addition to the primary predicate device, Topcon's TRC-NW300 Non-Mydriatic Retinal Camera (NW300) (K123460) as a secondary predicate device for functionality. This secondary predicate device serves as a comparator device to the subject device since the scientific methodology and the device performance for the individual components have already been established. Comparative data between the subject and secondary predicate device will be provided in the device labeling.
Based on the intended use/indications for use and technological characteristics described above, the subject device is substantially equivalent to the primary predicate device.
Performance Data
Performance bench testing has been conducted on the Maestro to demonstrate substantial equivalence to the predicate devices. A list of testing conducted is as follows:
- Axial and Horizontal Resolutions
- . Trueness and Precision for Axial and Horizontal Directions
- . Testing to Consensus Standards for Ophthalmic Devices
- ISO 15004-1:2006 Ophthalmic instruments Fundamental requirements and test methods-Part 1: o General requirements applicable to all ophthalmic instruments
- ISO 10940: 2009 Ophthalmic instruments Fundus cameras o
- ISO 15004-2:2007 Ophthalmic Instruments Fundamental requirements and test methods Part 2: O Light hazard protection
- Electrical Safety ●
- o AAMI ANSI ES 60601-1:2005/A2:2010/(R)2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Third Edition)
- Electromagnetic Compatibility
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety O and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (Third Edition)
Biocompatibility of materials used in the patient contacting components were already evaluated and established in company's predicate device submissions.
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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 failure or latent flaw in the software could result in an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
Clinical Data
Topcon conducted clinical studies to determine agreement, repeatability and reproducibility of the measurement data between the Maestro device and the iVue with normative database. A comparative study between images of the Maestro and the TRC NW300 Non Mydriatic Retinal Camera was also conducted. These studies included data from 25 normal subjects with retinal disease, and 25 subjects with glaucoma. The studies included five main analysis, 2) an agreement analysis, 3) an agreement analysis, 3) a fundus photograph evaluation, 4) an anterior segment image evaluation, and 5) a B scan image quality evaluation.
A reference database study of the Maestro was also conducted.
Consistent with the labeling for the test and control devices, the clinical site was permitted to make manual adjustments to automated segmentation based on the clinician's judgment. The study device manual adjustment rates for macula scans ranged from approximately 0-5% for 6x6 macula and 10-15% for 12x9 wide scans. For RNFL thicknesses and optic disc parameters, the overall manual adjustment rates for the Maestro were 11-32% and 20-40% for 6x6 disc and 12x9 wide scans, respectively.
| Table 1: Full Retinal Thickness - Normal Eyes Repeatability and Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|
| Repeatability | Reproducibility | |||||||
| Device | ||||||||
| Measurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | ||||||||
| Central Fovea | 25 | 233.99 | 2.608 | 7.302 | 1.115 | 3.419 | 9.573 | 1.461 |
| Superior Parafoveal | 25 | 309.12 | 1.647 | 4.611 | 0.533 | 2.435 | 6.819 | 0.788 |
| Nasal Parafoveal | 25 | 309.72 | 1.470 | 4.116 | 0.475 | 2.595 | 7.266 | 0.838 |
| Inferior Parafoveal | 25 | 307.29 | 1.281 | 3.588 | 0.417 | 2.235 | 6.259 | 0.727 |
| Temporal Parafoveal | 25 | 296.65 | 1.417 | 3.968 | 0.478 | 2.294 | 6.424 | 0.773 |
| Superior Perifoveal | 25 | 268.84 | 1.442 | 4.039 | 0.536 | 2.140 | 5.991 | 0.796 |
| Nasal Perifoveal | 25 | 286.14 | 0.818 | 2.289 | 0.286 | 1.681 | 4.707 | 0.587 |
| Inferior Perifoveal | 25 | 257.54 | 1.059 | 2.965 | 0.411 | 1.356 | 3.796 | 0.526 |
| Temporal Perifoveal | 25 | 253.97 | 0.948 | 2.655 | 0.373 | 1.519 | 4.252 | 0.598 |
| Maestro 6x6 3D Macula | ||||||||
| Central Fovea | 25 | 231.18 | 1.581 | 4.428 | 0.684 | 2.370 | 6.637 | 1.025 |
| Superior Parafoveal | 25 | 310.61 | 1.649 | 4.619 | 0.531 | 2.616 | 7.324 | 0.842 |
| Nasal Parafoveal | 25 | 309.71 | 1.328 | 3.717 | 0.429 | 2.468 | 6.911 | 0.797 |
| Inferior Parafoveal | 25 | 307.78 | 1.244 | 3.484 | 0.404 | 2.112 | 5.913 | 0.686 |
| Temporal Parafoveal | 25 | 295.58 | 1.217 | 3.409 | 0.412 | 2.066 | 5.785 | 0.699 |
| Superior Perifoveal | 25 | 268.73 | 1.468 | 4.111 | 0.546 | 2.017 | 5.648 | 0.751 |
Precision Assessment:
Table 1: Full Retinal Thicknoss - Normal Eves Popoatability and Roproducibili
\DC - 026811/000013 - 8588672 v1
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| Repeatability | Reproducibility | |||||||
|---|---|---|---|---|---|---|---|---|
| DeviceMeasurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Nasal Perifoveal | 25 | 285.91 | 0.873 | 2.445 | 0.305 | 1.912 | 5.354 | 0.669 |
| Inferior Perifoveal | 25 | 258.27 | 1.285 | 3.599 | 0.498 | 2.143 | 6.002 | 0.830 |
| Temporal Perifoveal | 25 | 251.83 | 1.088 | 3.045 | 0.432 | 1.963 | 5.496 | 0.779 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
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Table 2: Full Retinal Thickness - Retinal Disease Eyes Repeatability and Reproducibility
| Repeatability | Reproducibility | |||||||
|---|---|---|---|---|---|---|---|---|
| Device | ||||||||
| Measurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | ||||||||
| Central Fovea | 26 | 250.15 | 3.697 | 10.351 | 1.478 | 4.745 | 13.285 | 1.897 |
| Superior Parafoveal | 26 | 317.62 | 1.561 | 4.371 | 0.492 | 2.371 | 6.639 | 0.747 |
| Nasal Parafoveal | 26 | 315.72 | 1.512 | 4.233 | 0.479 | 2.737 | 7.665 | 0.867 |
| Inferior Parafoveal | 26 | 313.43 | 2.060 | 5.769 | 0.657 | 2.983 | 8.351 | 0.952 |
| Temporal Parafoveal | 26 | 303.67 | 2.042 | 5.718 | 0.672 | 3.164 | 8.860 | 1.042 |
| Superior Perifoveal | 26 | 276.82 | 1.356 | 3.797 | 0.490 | 1.758 | 4.922 | 0.635 |
| Nasal Perifoveal | 26 | 288.87 | 1.093 | 3.059 | 0.378 | 1.719 | 4.812 | 0.595 |
| Inferior Perifoveal | 26 | 263.37 | 1.800 | 5.039 | 0.683 | 2.319 | 6.495 | 0.881 |
| Temporal Perifoveal | 26 | 261.82 | 1.950 | 5.459 | 0.745 | 2.279 | 6.382 | 0.871 |
| Maestro 6x6 3D Macula | ||||||||
| Central Fovea | 26 | 247.02 | 2.693 | 7.541 | 1.090 | 3.301 | 9.242 | 1.336 |
| Superior Parafoveal | 26 | 317.54 | 1.754 | 4.910 | 0.552 | 2.714 | 7.599 | 0.855 |
| Nasal Parafoveal | 26 | 315.98 | 1.515 | 4.241 | 0.479 | 2.575 | 7.210 | 0.815 |
| Inferior Parafoveal | 26 | 312.70 | 1.555 | 4.354 | 0.497 | 2.488 | 6.966 | 0.796 |
| Temporal Parafoveal | 26 | 301.80 | 1.484 | 4.156 | 0.492 | 2.704 | 7.570 | 0.896 |
| Superior Perifoveal | 26 | 276.60 | 1.531 | 4.286 | 0.553 | 2.365 | 6.621 | 0.855 |
| Nasal Perifoveal | 26 | 288.21 | 1.083 | 3.033 | 0.376 | 1.902 | 5.326 | 0.660 |
| Inferior Perifoveal | 26 | 263.98 | 1.697 | 4.751 | 0.643 | 2.177 | 6.095 | 0.825 |
| Temporal Perifoveal | 26 | 258.61 | 1.136 | 3.182 | 0.439 | 1.994 | 5.583 | 0.771 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{9}------------------------------------------------
| Table 3: Full Retinal Thickness - Glaucoma Eyes Repeatability and Reproducibility | ||
|---|---|---|
| Table 3: Full Retinal Thickness - Glaucoma Eyes Repeatability and Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|
| DeviceMeasurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | ||||||||
| Central Fovea | 25 | 243.09 | 2.914 | 8.159 | 1.199 | 3.985 | 11.158 | 1.639 |
| Superior Parafoveal | 25 | 304.59 | 1.921 | 5.380 | 0.631 | 2.727 | 7.635 | 0.895 |
| Nasal Parafoveal | 25 | 307.97 | 1.520 | 4.255 | 0.493 | 2.676 | 7.492 | 0.869 |
| Inferior Parafoveal | 25 | 299.65 | 2.012 | 5.633 | 0.671 | 2.723 | 7.624 | 0.909 |
| Temporal Parafoveal | 25 | 293.57 | 1.587 | 4.444 | 0.541 | 2.687 | 7.524 | 0.915 |
| Superior Perifoveal | 25 | 261.20 | 1.731 | 4.846 | 0.663 | 2.308 | 6.463 | 0.884 |
| Nasal Perifoveal | 25 | 276.95 | 1.393 | 3.901 | 0.503 | 1.831 | 5.127 | 0.661 |
| Inferior Perifoveal | 25 | 246.04 | 1.726 | 4.832 | 0.701 | 2.225 | 6.230 | 0.904 |
| Temporal Perifoveal | 25 | 247.98 | 1.685 | 4.718 | 0.679 | 2.229 | 6.241 | 0.899 |
| Maestro 6x6 3D Macula | ||||||||
| Central Fovea | 25 | 241.05 | 1.677 | 4.695 | 0.696 | 2.986 | 8.361 | 1.239 |
| Superior Parafoveal | 25 | 305.20 | 1.462 | 4.095 | 0.479 | 2.555 | 7.154 | 0.837 |
| Nasal Parafoveal | 25 | 307.46 | 1.245 | 3.487 | 0.405 | 2.791 | 7.815 | 0.908 |
| Inferior Parafoveal | 25 | 299.20 | 1.270 | 3.556 | 0.424 | 2.644 | 7.404 | 0.884 |
| Temporal Parafoveal | 25 | 292.57 | 1.222 | 3.421 | 0.418 | 2.636 | 7.380 | 0.901 |
| Superior Perifoveal | 25 | 261.20 | 1.379 | 3.860 | 0.528 | 2.142 | 5.998 | 0.820 |
| Nasal Perifoveal | 25 | 276.37 | 0.919 | 2.573 | 0.332 | 1.987 | 5.563 | 0.719 |
| Inferior Perifoveal | 25 | 246.18 | 1.492 | 4.177 | 0.606 | 2.298 | 6.433 | 0.933 |
| Temporal Perifoveal | 25 | 245.71 | 1.030 | 2.884 | 0.419 | 2.366 | 6.624 | 0.963 |
N = Number of subjects
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 limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{10}------------------------------------------------
Table 4: Ganglion Cell + IPL - Normal Eves Repeatability and Reproducibility
| Repeatability | Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Device | Measurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | Superior | 25 | 70.37 | 0.641 | 1.795 | 0.911 | 0.715 | 2.001 | 1.015 |
| Superior Nasal | 25 | 74.66 | 0.671 | 1.878 | 0.898 | 0.707 | 1.980 | 0.947 | |
| Superior Temporal | 25 | 71.46 | 0.590 | 1.651 | 0.825 | 0.831 | 2.326 | 1.162 | |
| Inferior | 25 | 68.11 | 0.634 | 1.776 | 0.931 | 0.663 | 1.856 | 0.973 | |
| Inferior Nasal | 25 | 73.59 | 0.699 | 1.957 | 0.950 | 0.768 | 2.150 | 1.043 | |
| Inferior Temporal | 25 | 73.12 | 0.553 | 1.550 | 0.757 | 0.708 | 1.983 | 0.968 | |
| Average | 25 | 71.89 | 0.291 | 0.814 | 0.404 | 0.365 | 1.023 | 0.508 | |
| Maestro 6x6 3D Macula | Superior | 25 | 70.48 | 0.736 | 2.060 | 1.044 | 0.809 | 2.266 | 1.148 |
| Superior Nasal | 25 | 74.62 | 0.394 | 1.102 | 0.528 | 0.548 | 1.535 | 0.735 | |
| Superior Temporal | 25 | 71.93 | 0.611 | 1.712 | 0.850 | 0.712 | 1.993 | 0.989 | |
| Inferior | 25 | 68.33 | 0.453 | 1.268 | 0.663 | 0.657 | 1.841 | 0.962 | |
| Inferior Nasal | 25 | 73.58 | 0.436 | 1.220 | 0.592 | 0.595 | 1.667 | 0.809 | |
| Inferior Temporal | 25 | 73.46 | 0.562 | 1.573 | 0.765 | 0.611 | 1.712 | 0.832 | |
| Average | 25 | 72.08 | 0.263 | 0.735 | 0.364 | 0.401 | 1.124 | 0.557 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{11}------------------------------------------------
| Table 5: Ganglion Cell + IPL - Retinal Disease Eyes Repeatability and Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|
| Repeatability | Reproducibility | |||||||
| Device | ||||||||
| Measurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | ||||||||
| Superior | 26 | 69.57 | 1.234 | 3.456 | 1.774 | 1.779 | 4.982 | 2.558 |
| Superior Nasal | 26 | 73.78 | 0.768 | 2.150 | 1.041 | 0.812 | 2.274 | 1.101 |
| Superior Temporal | 26 | 70.05 | 0.963 | 2.696 | 1.375 | 1.734 | 4.854 | 2.475 |
| Inferior | 26 | 65.84 | 1.760 | 4.928 | 2.673 | 1.826 | 5.113 | 2.774 |
| Inferior Nasal | 26 | 70.86 | 1.834 | 5.136 | 2.589 | 1.844 | 5.164 | 2.603 |
| Inferior Temporal | 26 | 70.39 | 1.427 | 3.995 | 2.027 | 2.537 | 7.103 | 3.604 |
| Average | 26 | 70.08 | 0.762 | 2.134 | 1.088 | 0.819 | 2.294 | 1.169 |
| Maestro 6x6 3D Macula | ||||||||
| Superior | 26 | 68.87 | 0.687 | 1.923 | 0.997 | 0.695 | 1.945 | 1.008 |
| Superior Nasal | 26 | 74.04 | 0.841 | 2.355 | 1.136 | 0.926 | 2.593 | 1.251 |
| Superior Temporal | 26 | 70.49 | 1.023 | 2.866 | 1.452 | 1.286 | 3.601 | 1.824 |
| Inferior | 26 | 66.77 | 0.810 | 2.268 | 1.213 | 0.940 | 2.633 | 1.408 |
| Inferior Nasal | 26 | 71.07 | 0.491 | 1.374 | 0.690 | 0.699 | 1.958 | 0.984 |
| Inferior Temporal | 26 | 71.37 | 0.993 | 2.782 | 1.392 | 1.078 | 3.017 | 1.510 |
0.375
Mean = Intercept of the ANOVA model
Average
Repeatability SD = Square root of the residual variance
26
70.45
Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance
1.049
0.532
0.465
1.302
0.660
Repeatability limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{12}------------------------------------------------
Table 6: Ganglion Cell + IPL - Glaucoma Eves Repeatability and Reproducibility
| Table 6: Ganglion Cell + IPL - Glaucoma Eyes Repeatability and Reproducibility | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Device | Measurement | N | Mean | Repeatability | Reproducibility | ||||
| SD | Limit | CV% | SD | Limit | CV% | ||||
| Maestro 12x9 3D Wide | |||||||||
| Superior | 25 | 63.55 | 0.884 | 2.476 | 1.392 | 1.011 | 2.832 | 1.591 | |
| Superior Nasal | 25 | 68.77 | 0.996 | 2.790 | 1.449 | 1.169 | 3.274 | 1.700 | |
| Superior Temporal | 25 | 63.93 | 0.883 | 2.472 | 1.381 | 0.908 | 2.542 | 1.420 | |
| Inferior | 25 | 59.61 | 0.932 | 2.608 | 1.563 | 1.063 | 2.977 | 1.784 | |
| Inferior Nasal | 25 | 66.07 | 0.868 | 2.432 | 1.315 | 0.980 | 2.743 | 1.483 | |
| Inferior Temporal | 25 | 63.34 | 0.902 | 2.526 | 1.424 | 0.935 | 2.618 | 1.476 | |
| Average | 25 | 64.22 | 0.403 | 1.129 | 0.628 | 0.460 | 1.288 | 0.716 | |
| Maestro 6x6 3D Macula | |||||||||
| Superior | 25 | 64.27 | 0.592 | 1.658 | 0.921 | 0.708 | 1.983 | 1.102 | |
| Superior Nasal | 25 | 69.54 | 0.480 | 1.345 | 0.691 | 0.559 | 1.566 | 0.804 | |
| Superior Temporal | 25 | 66.21 | 0.766 | 2.145 | 1.157 | 0.924 | 2.586 | 1.395 | |
| Inferior | 25 | 60.86 | 0.784 | 2.194 | 1.288 | 0.883 | 2.472 | 1.451 | |
| Inferior Nasal | 25 | 66.11 | 0.503 | 1.407 | 0.760 | 0.689 | 1.928 | 1.042 | |
| Inferior Temporal | 25 | 66.00 | 0.765 | 2.142 | 1.159 | 0.891 | 2.494 | 1.350 | |
| Average | 25 | 65.53 | 0.388 | 1.087 | 0.593 | 0.483 | 1.351 | 0.736 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{13}------------------------------------------------
Table 7: Ganglion Cell Complex Thickness - Normal Eyes Repeatability and Reproducibility
| Table 7: Ganglion Cell Complex Thickness - Normal Eyes Repeatability and Reproducibility | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Device | Measurement | N | Mean | Repeatability | Reproducibility | ||||
| SD | Limit | CV% | SD | Limit | CV% | ||||
| Maestro 12x9 3D Wide | |||||||||
| Superior | 25 | 106.36 | 0.731 | 2.046 | 0.687 | 0.872 | 2.441 | 0.819 | |
| Superior Nasal | 25 | 118.01 | 0.969 | 2.713 | 0.821 | 1.070 | 2.995 | 0.906 | |
| Superior Temporal | 25 | 94.11 | 0.595 | 1.665 | 0.632 | 0.755 | 2.115 | 0.803 | |
| Inferior | 25 | 106.27 | 0.746 | 2.087 | 0.702 | 1.007 | 2.820 | 0.948 | |
| Inferior Nasal | 25 | 120.43 | 0.887 | 2.483 | 0.736 | 1.272 | 3.562 | 1.056 | |
| Inferior Temporal | 25 | 97.48 | 0.640 | 1.791 | 0.656 | 0.821 | 2.299 | 0.842 | |
| Average | 25 | 107.11 | 0.504 | 1.411 | 0.470 | 0.691 | 1.936 | 0.645 | |
| Superior Average | 25 | 106.16 | 0.608 | 1.702 | 0.573 | 0.729 | 2.042 | 0.687 | |
| Inferior Average | 25 | 108.06 | 0.579 | 1.621 | 0.536 | 0.845 | 2.367 | 0.782 | |
| Maestro 6x6 3D Macula | |||||||||
| Superior | 25 | 106.95 | 1.497 | 4.192 | 1.400 | 1.719 | 4.813 | 1.607 | |
| Superior Nasal | 25 | 118.02 | 0.634 | 1.776 | 0.537 | 0.942 | 2.637 | 0.798 | |
| Superior Temporal | 25 | 93.78 | 0.711 | 1.992 | 0.759 | 0.924 | 2.587 | 0.985 | |
| Inferior | 25 | 107.29 | 0.681 | 1.908 | 0.635 | 1.137 | 3.184 | 1.060 | |
| Inferior Nasal | 25 | 121.27 | 0.687 | 1.925 | 0.567 | 0.901 | 2.522 | 0.743 | |
| Inferior Temporal | 25 | 97.09 | 0.682 | 1.909 | 0.702 | 0.979 | 2.741 | 1.008 | |
| Average | 25 | 107.43 | 0.535 | 1.497 | 0.498 | 0.783 | 2.193 | 0.729 | |
| Superior Average | 25 | 106.25 | 0.707 | 1.981 | 0.666 | 0.895 | 2.507 | 0.843 | |
| Inferior Average | 25 | 108.55 | 0.541 | 1.515 | 0.498 | 0.845 | 2.365 | 0.778 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{14}------------------------------------------------
Table 8: Ganglion Cell Complex Thickness - Retinal Disease Eyes Repeatability and Reproducibility
| Table 8: Ganglion Cell Complex Thickness - Retinal Disease Eyes Repeatability and Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|
| Repeatability | Reproducibility | |||||||
| DeviceMeasurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | ||||||||
| Superior | 26 | 108.98 | 1.462 | 4.095 | 1.342 | 2.295 | 6.425 | 2.106 |
| Superior Nasal | 26 | 120.00 | 0.926 | 2.593 | 0.772 | 0.985 | 2.758 | 0.821 |
| Superior Temporal | 26 | 94.96 | 1.024 | 2.867 | 1.078 | 1.262 | 3.534 | 1.329 |
| Inferior | 26 | 105.20 | 2.236 | 6.259 | 2.125 | 2.236 | 6.259 | 2.125 |
| Inferior Nasal | 26 | 116.09 | 3.729 | 10.442 | 3.213 | 3.752 | 10.506 | 3.232 |
| Inferior Temporal | 26 | 97.86 | 2.231 | 6.248 | 2.280 | 2.420 | 6.775 | 2.473 |
| Average | 26 | 107.20 | 1.192 | 3.337 | 1.112 | 1.192 | 3.337 | 1.112 |
| Superior Average | 26 | 107.98 | 0.756 | 2.118 | 0.700 | 1.157 | 3.240 | 1.072 |
| Inferior Average | 26 | 106.39 | 2.280 | 6.383 | 2.143 | 2.288 | 6.407 | 2.151 |
| Maestro 6x6 3D Macula | ||||||||
| Superior | 26 | 107.96 | 0.899 | 2.518 | 0.833 | 1.081 | 3.027 | 1.001 |
| Superior Nasal | 26 | 120.10 | 0.793 | 2.221 | 0.660 | 0.952 | 2.665 | 0.792 |
| Superior Temporal | 26 | 93.87 | 0.741 | 2.076 | 0.790 | 0.972 | 2.721 | 1.035 |
| Inferior | 26 | 106.13 | 1.160 | 3.248 | 1.093 | 1.160 | 3.248 | 1.093 |
| Inferior Nasal | 26 | 117.24 | 0.721 | 2.019 | 0.615 | 0.862 | 2.414 | 0.736 |
| Inferior Temporal | 26 | 95.85 | 0.780 | 2.184 | 0.814 | 0.901 | 2.524 | 0.940 |
| Average | 26 | 106.88 | 0.518 | 1.452 | 0.485 | 0.643 | 1.799 | 0.601 |
| Superior Average | 26 | 107.31 | 0.599 | 1.677 | 0.558 | 0.802 | 2.246 | 0.747 |
| Inferior Average | 26 | 106.41 | 0.612 | 1.712 | 0.575 | 0.686 | 1.920 | 0.644 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{15}------------------------------------------------
Table 9: Ganglion Cell Complex Thickness - Glaucoma Eyes Repeatability and Reproducibility
| Repeatability | Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| DeviceMeasurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% | |
| Maestro 12x9 3D Wide | |||||||||
| Superior | 25 | 95.85 | 1.053 | 2.947 | 1.098 | 1.188 | 3.327 | 1.240 | |
| Superior Nasal | 25 | 108.78 | 0.850 | 2.379 | 0.781 | 0.897 | 2.513 | 0.825 | |
| Superior Temporal | 25 | 85.28 | 1.014 | 2.840 | 1.189 | 1.033 | 2.893 | 1.211 | |
| Inferior | 25 | 91.59 | 1.037 | 2.903 | 1.132 | 1.071 | 2.998 | 1.169 | |
| Inferior Nasal | 25 | 105.43 | 0.777 | 2.175 | 0.737 | 0.974 | 2.728 | 0.924 | |
| Inferior Temporal | 25 | 85.08 | 0.756 | 2.116 | 0.888 | 0.818 | 2.289 | 0.961 | |
| Average | 25 | 95.34 | 0.608 | 1.703 | 0.638 | 0.655 | 1.833 | 0.687 | |
| Superior Average | 25 | 96.64 | 0.805 | 2.255 | 0.833 | 0.857 | 2.400 | 0.887 | |
| Inferior Average | 25 | 94.03 | 0.651 | 1.823 | 0.692 | 0.724 | 2.028 | 0.770 | |
| Maestro 6x6 3D Macula | |||||||||
| Superior | 25 | 96.85 | 0.700 | 1.960 | 0.723 | 0.908 | 2.542 | 0.937 | |
| Superior Nasal | 25 | 108.81 | 0.691 | 1.935 | 0.635 | 0.892 | 2.498 | 0.820 | |
| Superior Temporal | 25 | 84.93 | 0.597 | 1.671 | 0.703 | 0.809 | 2.264 | 0.952 | |
| Inferior | 25 | 92.15 | 1.042 | 2.917 | 1.131 | 1.166 | 3.264 | 1.265 | |
| Inferior Nasal | 25 | 105.99 | 0.706 | 1.977 | 0.666 | 0.914 | 2.558 | 0.862 | |
| Inferior Temporal | 25 | 84.51 | 0.742 | 2.079 | 0.878 | 0.939 | 2.629 | 1.111 | |
| Average | 25 | 95.59 | 0.486 | 1.360 | 0.508 | 0.648 | 1.814 | 0.678 | |
| Superior Average | 25 | 96.86 | 0.509 | 1.425 | 0.526 | 0.676 | 1.893 | 0.698 | |
| Inferior Average | 25 | 94.22 | 0.642 | 1.798 | 0.682 | 0.782 | 2.189 | 0.830 | |
| Device | Measurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | |||||||||
| Average | 25 | 105.30 | 1.388 | 3.887 | 1.318 | 1.598 | 4.474 | 1.517 | |
| Superior | 25 | 127.89 | 3.754 | 10.512 | 2.936 | 3.893 | 10.901 | 3.044 | |
| Nasal | 25 | 79.37 | 2.765 | 7.743 | 3.484 | 3.044 | 8.522 | 3.835 | |
| Inferior | 25 | 135.23 | 3.375 | 9.449 | 2.495 | 4.094 | 11.464 | 3.028 | |
| Temporal | 25 | 78.68 | 1.356 | 3.796 | 1.723 | 2.087 | 5.843 | 2.652 | |
| 12-hour - T | 25 | 65.26 | 1.606 | 4.496 | 2.461 | 1.984 | 5.554 | 3.040 | |
| 12-hour - TS | 25 | 93.36 | 2.636 | 7.381 | 2.824 | 3.024 | 8.467 | 3.239 | |
| 12-hour - ST | 25 | 138.21 | 4.533 | 12.691 | 3.280 | 4.933 | 13.812 | 3.569 | |
| 12-hour - S | 25 | 125.15 | 5.968 | 16.711 | 4.769 | 6.355 | 17.795 | 5.078 | |
| 12-hour - SN | 25 | 120.31 | 5.282 | 14.789 | 4.390 | 5.534 | 15.496 | 4.600 | |
| 12-hour - NS | 25 | 98.29 | 5.169 | 14.474 | 5.259 | 5.483 | 15.353 | 5.579 | |
| 12-hour - N | 25 | 62.75 | 2.490 | 6.972 | 3.968 | 3.514 | 9.840 | 5.600 | |
| 12-hour - NI | 25 | 77.11 | 4.042 | 11.318 | 5.242 | 4.072 | 11.402 | 5.281 | |
| 12-hour - IN | 25 | 113.67 | 5.013 | 14.035 | 4.410 | 5.880 | 16.463 | 5.173 | |
| 12-hour - I | 25 | 145.75 | 5.964 | 16.700 | 4.092 | 6.621 | 18.538 | 4.543 | |
| 12-hour - IT | 25 | 146.36 | 4.057 | 11.359 | 2.772 | 4.904 | 13.732 | 3.351 | |
| 12-hour - TI | 25 | 77.41 | 2.295 | 6.426 | 2.965 | 3.490 | 9.771 | 4.508 | |
| Maestro 6x6 3D Disc | |||||||||
| Average | 25 | 104.32 | 0.973 | 2.724 | 0.933 | 1.147 | 3.211 | 1.099 | |
| Superior | 25 | 128.41 | 2.627 | 7.356 | 2.046 | 2.917 | 8.167 | 2.272 | |
| Nasal | 25 | 78.14 | 2.007 | 5.619 | 2.569 | 2.302 | 6.445 | 2.946 | |
| Inferior | 25 | 135.51 | 2.003 | 5.610 | 1.478 | 2.503 | 7.008 | 1.847 | |
| Temporal | 25 | 75.22 | 1.335 | 3.738 | 1.775 | 1.859 | 5.206 | 2.471 | |
| 12-hour - T | 25 | 61.65 | 1.396 | 3.908 | 2.264 | 1.816 | 5.086 | 2.946 | |
| 12-hour - TS | 25 | 90.01 | 2.161 | 6.050 | 2.401 | 2.792 | 7.817 | 3.101 | |
| 12-hour - ST | 25 | 139.48 | 3.271 | 9.157 | 2.345 | 4.344 | 12.163 | 3.114 | |
| 12-hour - S | 25 | 125.52 | 4.964 | 13.898 | 3.954 | 5.145 | 14.407 | 4.099 | |
| 12-hour - SN | 25 | 120.20 | 4.160 | 11.647 | 3.461 | 4.294 | 12.024 | 3.573 | |
| 12-hour - NS | 25 | 97.39 | 3.622 | 10.143 | 3.720 | 4.295 | 12.025 | 4.410 | |
| 12-hour - N | 25 | 61.11 | 1.526 | 4.273 | 2.497 | 1.759 | 4.926 | 2.879 | |
| 12-hour - NI | 25 | 75.87 | 2.995 | 8.385 | 3.947 | 3.423 | 9.585 | 4.511 | |
| 12-hour - IN | 25 | 113.57 | 3.298 | 9.234 | 2.904 | 3.590 | 10.052 | 3.161 | |
| 12-hour - I | 25 | 147.83 | 3.633 | 10.172 | 2.457 | 4.388 | 12.287 | 2.968 | |
| 12-hour - IT | 25 | 145.02 | 3.980 | 11.144 | 2.745 | 4.366 | 12.224 | 3.010 | |
| 12-hour - TI | 25 | 73.98 | 2.212 | 6.194 | 2.990 | 3.259 | 9.125 | 4.405 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{16}------------------------------------------------
Table 10: Retinal Nerve Fiber Layer - Normal Eyes Repeatability and Reproducibility
{17}------------------------------------------------
| Repeatability | Reproducibility | |||||||
|---|---|---|---|---|---|---|---|---|
| DeviceMeasurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| T=Temporal; S=Superior; N=Nasal; I=InferiorAll statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interactionbetween operator/device and eye. | ||||||||
| N = Number of subjects | ||||||||
| 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% | ||||||||
| Reproducibility CV% = (Reproducibility SD)/Intercept x 100% |
{18}------------------------------------------------
Table 11: Retinal Nerve Fiber Layer - Retinal Disease Eyes Repeatability and Reproducibility
| Device | Measurement | N | Mean | SD | Repeatability | Reproducibility | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SD | Limit | CV% | SD | Limit | CV% | |||||
| Maestro 12x9 3D Wide | ||||||||||
| Average | 26 | 101.46 | 1.618 | 4.529 | 1.594 | 1.916 | 5.364 | 1.888 | ||
| Superior | 26 | 123.56 | 4.099 | 11.476 | 3.317 | 4.517 | 12.648 | 3.656 | ||
| Nasal | 26 | 76.76 | 3.346 | 9.370 | 4.359 | 3.948 | 11.055 | 5.143 | ||
| Inferior | 26 | 128.81 | 3.343 | 9.360 | 2.595 | 5.427 | 15.194 | 4.213 | ||
| Temporal | 26 | 76.73 | 1.708 | 4.783 | 2.226 | 2.166 | 6.064 | 2.823 | ||
| 12-hour - T | 26 | 67.02 | 1.942 | 5.438 | 2.898 | 2.510 | 7.028 | 3.745 | ||
| 12-hour - TS | 26 | 91.79 | 2.691 | 7.535 | 2.932 | 3.143 | 8.799 | 3.424 | ||
| 12-hour - ST | 26 | 133.09 | 4.608 | 12.901 | 3.462 | 5.515 | 15.443 | 4.144 | ||
| 12-hour - S | 26 | 122.77 | 6.633 | 18.572 | 5.403 | 7.191 | 20.135 | 5.857 | ||
| 12-hour - SN | 26 | 114.84 | 6.720 | 18.816 | 5.852 | 6.720 | 18.816 | 5.852 | ||
| 12-hour - NS | 26 | 91.74 | 6.559 | 18.365 | 7.150 | 6.839 | 19.149 | 7.455 | ||
| 12-hour - N | 26 | 64.72 | 3.133 | 8.772 | 4.840 | 3.512 | 9.833 | 5.426 | ||
| 12-hour - NI | 26 | 73.86 | 6.014 | 16.839 | 8.143 | 6.407 | 17.939 | 8.675 | ||
| 12-hour - IN | 26 | 111.63 | 5.625 | 15.749 | 5.039 | 9.004 | 25.210 | 8.066 | ||
| 12-hour - I | 26 | 146.30 | 5.483 | 15.353 | 3.748 | 6.994 | 19.583 | 4.781 | ||
| 12-hour - IT | 26 | 128.52 | 5.212 | 14.593 | 4.055 | 5.932 | 16.610 | 4.616 | ||
| 12-hour - TI | 26 | 71.39 | 2.549 | 7.136 | 3.570 | 2.791 | 7.815 | 3.910 | ||
| Maestro 6x6 3D Disc | ||||||||||
| Average | 26 | 101.72 | 1.102 | 3.086 | 1.084 | 1.505 | 4.214 | 1.480 | ||
| Superior | 26 | 125.25 | 2.512 | 7.034 | 2.006 | 2.609 | 7.305 | 2.083 | ||
| Nasal | 26 | 76.24 | 2.175 | 6.090 | 2.853 | 3.523 | 9.863 | 4.620 | ||
| Inferior | 26 | 131.15 | 2.293 | 6.419 | 1.748 | 2.830 | 7.924 | 2.158 | ||
| Temporal | 26 | 74.25 | 1.287 | 3.603 | 1.733 | 1.446 | 4.048 | 1.947 | ||
| 12-hour - T | 26 | 64.47 | 1.600 | 4.480 | 2.482 | 1.916 | 5.365 | 2.972 | ||
| 12-hour - TS | 26 | 89.31 | 2.218 | 6.210 | 2.483 | 2.644 | 7.404 | 2.961 | ||
| 12-hour - ST | 26 | 134.93 | 4.220 | 11.815 | 3.127 | 5.015 | 14.042 | 3.717 | ||
| 12-hour - S | 26 | 123.86 | 5.350 | 14.980 | 4.320 | 5.865 | 16.423 | 4.736 | ||
| 12-hour - SN | 26 | 116.90 | 3.694 | 10.343 | 3.160 | 4.234 | 11.854 | 3.622 | ||
| 12-hour - NS | 26 | 91.83 | 4.177 | 11.694 | 4.548 | 6.026 | 16.873 | 6.562 | ||
| 12-hour - N | 26 | 63.16 | 3.237 | 9.065 | 5.125 | 3.583 | 10.031 | 5.672 | ||
| 12-hour - NI | 26 | 73.70 | 4.219 | 11.814 | 5.725 | 5.444 | 15.242 | 7.387 | ||
| 12-hour - IN | 26 | 114.30 | 4.239 | 11.869 | 3.709 | 5.469 | 15.314 | 4.785 | ||
| 12-hour - I | 26 | 150.51 | 4.359 | 12.206 | 2.896 | 4.874 | 13.648 | 3.239 | ||
| 12-hour - IT | 26 | 128.61 | 3.770 | 10.556 | 2.932 | 4.834 | 13.535 | 3.759 | ||
| 12-hour - TI | 26 | 68.95 | 2.020 | 5.656 | 2.930 | 2.473 | 6.925 | 3.587 |
{19}------------------------------------------------
| Repeatability | Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| DeviceMeasurement | N | Mean | SD | SD | Limit | CV% | SD | Limit | CV% |
| T=Temporal; S=Superior; N=Nasal; I=InferiorAll statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interactionbetween operator/device and eye. | |||||||||
| N = Number of subjectsMean = Intercept of the ANOVA modelRepeatability SD = Square root of the residual varianceReproducibility SD = Square root of the sum of the operator/device variance, the interaction variance and the residual varianceRepeatability limit = 2.8 x Repeatability SDReproducibility limit = 2.8 x Reproducibility SDRepeatability CV% = (Repeatability SD)/Intercept x 100%Reproducibility CV% = (Reproducibility SD)/Intercept x 100% | |||||||||
| Table 12: Retinal Nerve Fiber Layer - Glaucoma Eyes Repeatability and Reproducibility | |||||||||
| DeviceMeasurement | N | Mean | SD | Repeatability | Reproducibility | ||||
| Limit | CV% | SD | Limit (Ratio) | CV% | |||||
| Maestro 12x9 3D Wide | |||||||||
| Average | 25 | 83.55 | 1.646 | 4.609 | 1.970 | 1.752 | 4.906 | 2.097 | |
| Superior | 25 | 97.32 | 3.814 | 10.679 | 3.919 | 3.948 | 11.055 | 4.057 | |
| Nasal | 25 | 70.63 | 3.805 | 10.653 | 5.387 | 4.036 | 11.301 | 5.715 | |
| Inferior | 25 | 102.90 | 3.271 | 9.160 | 3.179 | 3.402 | 9.526 | 3.306 | |
| Temporal | 25 | 63.29 | 1.370 | 3.837 | 2.165 | 1.941 | 5.434 | 3.066 | |
| 12-hour - T | 25 | 55.91 | 1.779 | 4.980 | 3.181 | 2.534 | 7.094 | 4.532 | |
| 12-hour - TS | 25 | 73.53 | 2.471 | 6.918 | 3.360 | 2.882 | 8.071 | 3.920 | |
| 12-hour - ST | 25 | 101.84 | 4.691 | 13.134 | 4.606 | 4.731 | 13.246 | 4.645 | |
| 12-hour - S | 25 | 99.85 | 6.176 | 17.294 | 6.185 | 7.648 | 21.415 | 7.659 | |
| 12-hour - SN | 25 | 90.18 | 5.725 | 16.031 | 6.349 | 5.828 | 16.318 | 6.463 | |
| 12-hour - NS | 25 | 80.96 | 6.688 | 18.727 | 8.261 | 6.719 | 18.813 | 8.299 | |
| 12-hour - N | 25 | 58.29 | 4.138 | 11.586 | 7.099 | 4.436 | 12.422 | 7.611 | |
| 12-hour - NI | 25 | 72.63 | 4.578 | 12.819 | 6.304 | 4.903 | 13.727 | 6.750 | |
| 12-hour - IN | 25 | 94.44 | 4.453 | 12.468 | 4.715 | 5.457 | 15.280 | 5.778 | |
| 12-hour - I | 25 | 117.00 | 6.214 | 17.400 | 5.311 | 6.214 | 17.400 | 5.311 | |
| 12-hour - IT | 25 | 97.27 | 4.222 | 11.822 | 4.341 | 4.684 | 13.114 | 4.815 | |
| 12-hour - TI | 25 | 60.46 | 2.243 | 6.280 | 3.709 | 2.530 | 7.083 | 4.184 | |
| Maestro 6x6 3D Disc | |||||||||
| Average | 25 | 83.70 | 1.615 | 4.521 | 1.929 | 1.618 | 4.530 | 1.933 | |
| Superior | 25 | 100.60 | 3.584 | 10.035 | 3.563 | 3.732 | 10.450 | 3.710 | |
| Nasal | 25 | 70.12 | 2.264 | 6.338 | 3.228 | 2.364 | 6.619 | 3.371 | |
| Inferior | 25 | 103.11 | 3.435 | 9.617 | 3.331 | 3.619 | 10.132 | 3.510 | |
| Temporal | 25 | 61.03 | 2.104 | 5.892 | 3.448 | 2.126 | 5.954 | 3.484 | |
| 12-hour - T | 25 | 53.80 | 2.642 | 7.397 | 4.911 | 2.740 | 7.671 | 5.092 | |
| 12-hour - TS | 25 | 72.04 | 3.961 | 11.090 | 5.498 | 3.961 | 11.090 | 5.498 | |
| 12-hour - ST | 25 | 103.27 | 4.067 | 11.386 | 3.938 | 5.553 | 15.548 | 5.377 | |
| 12-hour - S | 25 | 103.83 | 6.085 | 17.039 | 5.861 | 7.046 | 19.730 | 6.786 | |
| 12-hour - SN | 25 | 94.79 | 5.678 | 15.898 | 5.990 | 5.727 | 16.036 | 6.042 | |
| 12-hour - NS | 25 | 82.98 | 4.307 | 12.061 | 5.191 | 4.469 | 12.512 | 5.386 | |
| 12-hour - N | 25 | 55.65 | 2.670 | 7.477 | 4.798 | 2.734 | 7.656 | 4.913 | |
| 12-hour - NI | 25 | 71.73 | 3.964 | 11.099 | 5.527 | 4.035 | 11.297 | 5.625 | |
| 12-hour - IN | 25 | 94.94 | 6.152 | 17.226 | 6.480 | 6.716 | 18.805 | 7.074 | |
| 12-hour - I | 25 | 119.03 | 5.620 | 15.735 | 4.721 | 5.740 | 16.072 | 4.822 | |
| 12-hour - IT | 25 | 95.37 | 4.607 | 12.899 | 4.831 | 4.691 | 13.135 | 4.919 | |
| 12-hour - TI | 25 | 57.26 | 2.278 | 6.379 | 3.978 | 2.572 | 7.200 | 4.491 |
{20}------------------------------------------------
Table 12: Retinal Nerve Fiber Layer - Glaucoma Eyes Repeatability and Reproducibility
{21}------------------------------------------------
| Repeatability | Reproducibility | |||||||
|---|---|---|---|---|---|---|---|---|
| Device | ||||||||
| Measurement | N | Mean | SD | Limit | CV% | SD | Limit (Ratio) | CV% |
| T=Temporal; S=Superior; N=Nasal; I=Inferior | ||||||||
| All statistics are estimated from two-way random-effect ANOVA model with random effects operator/device, eye and interaction | ||||||||
| between operator/device and eye. | ||||||||
| N = Number of subjects | ||||||||
| 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% | ||||||||
| Reproducibility CV% = (Reproducibility SD)/Intercept x 100% |
{22}------------------------------------------------
| Table 13: Optic Disc - Normal Eyes Repeatability and Reproducibility | ||
|---|---|---|
| Table 13: Optic Disc - Normal Eyes Repeatability and Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|
| Repeatability | Reproducibility | |||||||
| Device | ||||||||
| Measurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | ||||||||
| C/D Vertical | 25 | 0.46 | 0.030 | 0.085 | 6.600 | 0.031 | 0.088 | 6.863 |
| C/D Area | 25 | 0.25 | 0.013 | 0.037 | 5.172 | 0.015 | 0.043 | 6.023 |
| Disc Area | 25 | 2.10 | 0.074 | 0.207 | 3.520 | 0.089 | 0.249 | 4.233 |
| Cup Area | 25 | 0.57 | 0.022 | 0.062 | 3.890 | 0.025 | 0.071 | 4.474 |
| Rim Area | 25 | 1.54 | 0.072 | 0.203 | 4.711 | 0.087 | 0.243 | 5.640 |
| Cup Volume | 25 | 0.10 | 0.006 | 0.016 | 5.322 | 0.007 | 0.020 | 7.014 |
| Rim Volume | 25 | 0.28 | 0.018 | 0.051 | 6.571 | 0.022 | 0.062 | 7.967 |
| Maestro 6x6 3D Disc | ||||||||
| C/D Vertical | 25 | 0.46 | 0.021 | 0.059 | 4.549 | 0.023 | 0.066 | 5.089 |
| C/D Area | 25 | 0.26 | 0.013 | 0.036 | 4.937 | 0.014 | 0.040 | 5.406 |
| Disc Area | 25 | 1.92 | 0.064 | 0.178 | 3.313 | 0.078 | 0.219 | 4.074 |
| Cup Area | 25 | 0.54 | 0.020 | 0.055 | 3.666 | 0.025 | 0.071 | 4.730 |
| Rim Area | 25 | 1.39 | 0.065 | 0.183 | 4.708 | 0.075 | 0.211 | 5.443 |
| Cup Volume | 25 | 0.10 | 0.005 | 0.014 | 4.747 | 0.007 | 0.020 | 6.759 |
| Rim Volume | 25 | 0.24 | 0.015 | 0.043 | 6.359 | 0.020 | 0.055 | 8.139 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{23}------------------------------------------------
Table 14: Optic Disc - Retinal Disease Eves Repeatability and Reproducibility
| Table 14: Optic Disc - Retinal Disease Eyes Repeatability and Reproducibility | Reproducibility | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Repeatability | |||||||||
| Device | Measurement | N | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Maestro 12x9 3D Wide | C/D Vertical | 26 | 0.47 | 0.025 | 0.071 | 5.377 | 0.030 | 0.085 | 6.430 |
| C/D Area | 26 | 0.26 | 0.019 | 0.054 | 7.387 | 0.020 | 0.057 | 7.789 | |
| Disc Area | 26 | 2.25 | 0.087 | 0.243 | 3.858 | 0.112 | 0.314 | 4.981 | |
| Cup Area | 26 | 0.61 | 0.041 | 0.115 | 6.728 | 0.043 | 0.121 | 7.080 | |
| Rim Area | 26 | 1.64 | 0.095 | 0.265 | 5.762 | 0.116 | 0.326 | 7.088 | |
| Cup Volume | 26 | 0.11 | 0.009 | 0.025 | 8.404 | 0.022 | 0.061 | 20.586 | |
| Rim Volume | 26 | 0.28 | 0.020 | 0.056 | 7.186 | 0.027 | 0.076 | 9.775 | |
| Maestro 6x6 3D Disc | C/D Vertical | 26 | 0.46 | 0.019 | 0.053 (0.439) | 4.117 | 0.021 | 0.058 (0.472) | 4.519 |
| C/D Area | 26 | 0.25 | 0.009 | 0.024 (0.469) | 3.400 | 0.010 | 0.029 (0.533) | 4.079 | |
| Disc Area | 26 | 2.07 | 0.065 | 0.183 (0.853) | 3.163 | 0.079 | 0.220 (0.754) | 3.803 | |
| Cup Area | 26 | 0.55 | 0.016 | 0.044 (0.441) | 2.855 | 0.019 | 0.053 (0.513) | 3.438 | |
| Rim Area | 26 | 1.52 | 0.062 | 0.172 (0.818) | 4.057 | 0.073 | 0.205 (0.732) | 4.817 | |
| Cup Volume | 26 | 0.10 | 0.005 | 0.014 (0.192) | 4.827 | 0.012 | 0.032 (0.420) | 11.024 | |
| Rim Volume | 26 | 0.26 | 0.015 | 0.041 (0.926) | 5.627 | 0.017 | 0.046 (0.949) | 6.419 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{24}------------------------------------------------
| Table 15: Optic Disc - Glaucoma Eyes Repeatability and Reproducibility | |||
|---|---|---|---|
| Table 15: Optic Disc - Glaucoma Eyes Repeatability and Reproducibility | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Device | Measurement | N | Repeatability | Reproducibility | |||||
| Mean | SD | Limit | CV% | SD | Limit | CV% | |||
| Maestro 12x9 3D Wide | |||||||||
| C/D Vertical | 25 | 0.77 | 0.031 | 0.086 | 4.030 | 0.032 | 0.090 | 4.185 | |
| C/D Area | 25 | 0.59 | 0.020 | 0.057 | 3.469 | 0.024 | 0.068 | 4.130 | |
| Disc Area | 25 | 2.35 | 0.075 | 0.209 | 3.179 | 0.089 | 0.251 | 3.811 | |
| Cup Area | 25 | 1.40 | 0.048 | 0.134 | 3.430 | 0.056 | 0.157 | 4.017 | |
| Rim Area | 25 | 0.95 | 0.064 | 0.179 | 6.722 | 0.080 | 0.225 | 8.449 | |
| Cup Volume | 25 | 0.41 | 0.058 | 0.164 | 14.274 | 0.070 | 0.196 | 17.103 | |
| Rim Volume | 25 | 0.12 | 0.011 | 0.030 | 8.953 | 0.014 | 0.038 | 11.152 | |
| Maestro 6x6 3D Disc | |||||||||
| C/D Vertical | 25 | 0.76 | 0.020 | 0.055 | 2.575 | 0.021 | 0.058 | 2.743 | |
| C/D Area | 25 | 0.59 | 0.011 | 0.031 | 1.852 | 0.012 | 0.032 | 1.959 | |
| Disc Area | 25 | 2.15 | 0.065 | 0.182 | 3.013 | 0.071 | 0.198 | 3.285 | |
| Cup Area | 25 | 1.28 | 0.045 | 0.125 | 3.485 | 0.048 | 0.134 | 3.755 | |
| Rim Area | 25 | 0.87 | 0.038 | 0.107 | 4.379 | 0.041 | 0.115 | 4.701 | |
| Cup Volume | 25 | 0.41 | 0.024 | 0.067 | 5.813 | 0.024 | 0.068 | 5.859 | |
| Rim Volume | 25 | 0.11 | 0.007 | 0.020 | 6.682 | 0.008 | 0.022 | 7.201 |
N = Number of subjects
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
Reproducibility limit = 2.8 x Reproducibility SD
Repeatability CV% = (Repeatability SD)/Intercept x 100%
{25}------------------------------------------------
Reference Database:
The reference database study included the assessment of 399 subject eyes from normal study subjects across a predefined range of ages and ethnicities. The study collected measurements of normal eyes for full retinal thickness, retinal nerve fiber layer thickness, ganglion cell layer thickness, ganglion cell complex and the optic disc in addition to small and large super pixel grid and TSNIT circle profile measurements. The reference limits at the 1°, 5°, 95° and 99°' percentile points were determined. The database age range is 18 – 88 years.
| Total(N=399) | |
|---|---|
| Age (years) | |
| n | 399 |
| Mean (SD) | 46.3 (16.3) |
| Median | 47.0 |
| Min, Max | 18, 88 |
| Age group, n (%) | |
| 18-30 years | 89 (22) |
| 31-40 years | 76 (19) |
| 41-50 years | 66 (17) |
| 51-60 years | 78 (20) |
| 61-70 years | 55 (14) |
| 70+ years | 35 (9) |
| Gender, n (%) | |
| Male | 173 (43) |
| Female | 226 (57) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 71 (18) |
| Not Hispanic and not Latino | 328 (82) |
| Race, n (%) | |
| White | 234 (59) |
| Black/African American | 81 (20) |
| American Indian/AlaskanNative | 4 (1) |
| Asian | 51 (13) |
| Native American/PacificIslander | 7 (2) |
| Other | 22 (6) |
Table 16: Reference Database Demographic Data
{26}------------------------------------------------
Substantial Equivalence Comparison Table
| Subject Device: | Primary Predicate: | Secondary Predicate Device: | |
|---|---|---|---|
| Topcon 3D OCT-1 Maestro | Optovue iVue (K121739) | Topcon TRC-NW300 (K123460) | |
| Indications forUse | The Topcon 3D OCT-1 Maestro is anon-contact, high resolutiontomographic and biomicroscopicimaging device that incorporates adigital camera for photographing,displaying and storing the data ofthe retina and surrounding parts ofthe eye to be examined underMydriatic and non-Mydriaticconditions.The 3D OCT-1 Maestro is indicatedfor in vivo viewing, axial crosssectional, and three-dimensionalimaging and measurement ofposterior ocular structures, includingretina, retinal nerve fiber layer,macula and optic disc as well asimaging of anterior ocular structures.It also includes a ReferenceDatabase for posterior ocularmeasurements which provide for thequantitative comparison of retinalnerve fiber layer, optic nerve head,and the macula in the human retinato a database of known normalsubjects. The 3D OCT-1 Maestro isindicated for use as a diagnosticdevice to aid in the diagnosis,documentation and management ofocular health and diseases in theadult population. | The iVue with Normative Databaseis an optical coherence tomographysystem intended for in vivo imaging,axial cross-sectional, three-dimensional imaging andmeasurement of anterior andposterior ocular structures. TheiVue is a non-contact, highresolution tomographic imagingdevice. It is intended for in vivoimaging, axial cross-sectional, andthree-dimensional imaging andmeasurement of anterior andposterior ocular structures, includingretina, retinal nerve fiber layer,ganglion cell complex (GCC), opticdisc, cornea, and anterior chamberof the eye. The iVue with NormativeDatabase is a quantitative tool forthe comparison of retina, retinalnerve fiber layer, ganglion cellcomplex, and optic discmeasurements to a database ofknown normal subjects. The iVuewith Normative Database isindicated for use as a device to aidin the diagnosis, documentation, andmanagement of ocular health anddiseases in the adult population. | The TRC-NW300 intended foruse in capturing images of theretina and the anterior segmentof the eye and presenting thedata to the eye care professional,without the use of a mydriatic. |
| Product Code | OBO, HKI | HLI | HKI |
| TechnologicalCharacteristics | OCT:Optical coherence tomography isemployed to obtain cross-sectionalimages of the fundus and theanterior segment of the eye.Fundus Camera:A Xenon flash and a CMOS cameraare employed to obtainfundus/anterior Color/digital Red-free images. | OCT:Optical coherence tomography isemployed to obtain cross-sectionalimages of the fundus and theanterior segment of the eye. | Fundus Camera:A Xenon flash and a CCDcamera are employed to obtainfundus/anterior Color images. |
| OCT | |||
| Light Source | Spectral domain OCT (SD-OCT)using a superluminescent diode(SLD) with center wavelength 840nm. | Spectral domain OCT (SD-OCT)using a superluminescent diode(SLD) with center wavelength 840nm. | N/A |
| Subject Device:Topcon 3D OCT-1 Maestro | Primary Predicate:Optovue iVue (K121739) | Secondary Predicate Device:Topcon TRC-NW300 (K123460) | |
| Analysis | For posterior:- Retinal layer segmentation- Thickness calculation- Optic disc analysisFor anterior:NA | For posterior:- Retinal layer segmentation- Thickness calculation- Optic disc analysisFor anterior:- Pachymetry measurement- Pachymetry map- Angle measurement | N/A |
| Fundus Camera | |||
| Observation | Light source- IR LEDCamera- CMOS camera | N/A | Light source- Halogen lampCamera- CCD camera |
{27}------------------------------------------------
Conclusion
As described in this 510(k) Summary, the performance testing deemed necessary was conducted and the resultant data support the substantial equivalence of the 3D OCT-1 Maestro to the primary predicate device Optovue's iVue with Normative Database (iVue) (K121739).
§ 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.