(286 days)
The Nidek Optical Coherence Tomography RS-3000 including scanning laser ophthalmoscope function with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
- the retina, retinal nerve fiber layer, and optic disc, and
- . the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter),
as an aid in the diagnosis and management of adults having or suspected of having ocular disease.
The Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX. is an ophthalmic instrument to observe and analyze the fundus, and the shape or the lesion of the retina in a non-contact and non-invasive manner. In addition, the anterior segment adapter attached over the objective lens of the main body enables non-invasive and noncontact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle. The image filing software NAVIS-EX permits management and various diagnoses of captured images. When the personal computer (PC) with the NAVIS-EX installed is connected to the RS-3000 through a cable, the image data acquired by the RS-3000 is transmitted. The software offers the functions such as filing, external 1/F, image processing.
Here's a breakdown of the acceptance criteria and study detailed in the provided text:
Acceptance Criteria and Device Performance for Nidek Optical Coherence Tomography RS-3000
The Nidek Optical Coherence Tomography RS-3000 with Image Filing Software NAVIS-EX was evaluated against the predicate device, Optovue RTVue, for its agreement, precision, and image quality. The study aimed to demonstrate substantial equivalence by showing that the RS-3000 performs as well as the predicate device(s) and does not introduce any new safety risks.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the RS-3000 are implicitly defined by demonstrating agreement and comparable precision with the predicate device (Optovue RTVue) across various ocular measurements, and by meeting recognized consensus standards. While explicit numerical acceptance thresholds aren't provided in the summary for the agreement portion, the conclusion states that the RS-3000 "showed agreement with the RTVue" for many measurements, implying meeting an acceptable level of concordance. For precision, the comparison is made by stating whether the RS-3000's repeatability and reproducibility limits were "smaller than or similar to" or "larger than" the RTVue's.
Key Performance Metrics based on the Clinical Summary:
| Metric / Feature | Acceptance Criteria (Implicit) | Reported Device Performance (RS-3000 vs. RTVue) |
|---|---|---|
| Agreement | Demonstrate agreement with predicate device (RTVue). | Total Retinal Thickness: - Normal: RS-3000 16.2-19.0 µm greater in 4/9 segments; other segments showed agreement. - Retinal Disease: All 9 segments showed agreement. Inner Retinal Thickness: - Normal: RS-3000 10.6-20.0 µm less in 3/8 segments; other segments showed agreement. - Retinal Disease: All 8 segments showed agreement. Outer Retinal Thickness: - Normal: RS-3000 14.7-34.3 µm greater in all 9 segments. - Retinal Disease: All but 1 segment showed agreement; RS-3000 21.3 µm greater in one segment. RNFL Thickness: - Normal/Glaucoma: Both groups showed agreement in all 4 quadrants and total mean. Optic Disc Analysis: - Normal/Glaucoma: Both groups showed agreement in all 4 parameters (C/D horizontal, C/D vertical, Disc area, Cup area). Central Corneal Thickness: - Normal: RS-3000 13.4 µm higher. - Corneal Disease: No significant differences. |
| Precision (Repeatability & Reproducibility) | Demonstrate comparable precision to predicate device (RTVue). | Total Retinal Thickness: - Normal: RS-3000 limits (2.8-7.393 µm) smaller than/similar to RTVue (6.313-17.746 µm). - Retinal Disease: RS-3000 repeatability (6.049-32.453 µm) larger than/similar to RTVue (5.522-17.511 µm); reproducibility mixed. Inner Retinal Thickness: - Normal: RS-3000 limits (1.476-5.442 µm) smaller than/similar to RTVue (3.461-11.843 µm). - Retinal Disease: RS-3000 limits (5.176-14.162 µm) smaller than/similar to RTVue (6.433-20.9 µm). Outer Retinal Thickness: - Normal: RS-3000 limits (2.425-5.032 µm) smaller than RTVue (7.961-12.531 µm). - Retinal Disease: RS-3000 repeatability (4.961-23.653 µm) smaller than/similar to RTVue (7.865-20.293 µm); reproducibility smaller in some segments. RNFL Thickness: - Normal: RS-3000 limits (6.682-21.575 µm) larger than RTVue (3.508-14.148 µm). - Glaucoma: RS-3000 repeatability (11.122-32.506 µm) larger than RTVue (3.67-10.291 µm); reproducibility mixed. Optic Disc Analysis: - Normal: RS-3000 repeatability larger for C/D horizontal, disc area, cup area, smaller for C/D vertical. Reproducibility similar except disc area larger. - Glaucoma: RS-3000 repeatability smaller for C/D horizontal, larger for disc area, similar for C/D vertical/cup area. Reproducibility generally smaller or mixed. Central Corneal Thickness: - Normal/Corneal Disease: RS-3000 limits larger than RTVue. |
| Anterior Chamber Angle OCT Image Quality | Demonstrate comparable image quality to predicate device (RTVue). | RS-3000 unacceptable scan rate (40.7%) for anterior chamber scans was significantly higher than RTVue (2.2%), largely due to "poor patient cooperation." Despite this, the clinical summary states: "The quality of the Anterior Chamber Angle OCT image was comparable to the predicate device." This implies that when an acceptable image was acquired, its quality was comparable. |
| SLO Image Quality (RS-3000 Only) | Assess quality of SLO images. | Quality assessment of SLO images was obtained by a Reading Center. No direct comparison to predicate is feasible as the predicate does not have this feature. (Specific results not detailed in this summary). |
| Registration Function (RS-3000 Only) | Assess the functionality of the registration feature. | The registration function was assessed. Unacceptable scan rates for RS-3000 with follow-up on (which uses registration) were notably higher than with follow-up off, often due to "not aligning with baseline." (Specific performance metrics not detailed in this summary). |
| Safety | No adverse events. | Zero adverse events occurred during the clinical study. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 89 subjects were enrolled to provide:
- At least 80 evaluable eyes for agreement measurements.
- At least 48 evaluable eyes for precision and registration measurements.
- 20 study eyes per eye group for agreement assessment.
- The first 12 study eyes that completed the study from each eye population within the agreement assessment cohort were used for precision assessment.
- Data Provenance: The study was a prospective clinical study conducted at one clinical site located in the United States.
- Eye Groups:
- Normal Eyes
- Eyes with Retinal Disease
- Eyes with Glaucoma
- Eyes with Corneal Disease (specifically for Central Corneal Thickness and Anterior Chamber measurements)
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish ground truth or their qualifications. However, it mentions that for the Device Capability Assessment, the quality of the SLO image was "assessed by a Reading Center." This suggests that qualified professionals from a reading center were involved in evaluating image quality, but their specific number and qualifications are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (like 2+1, 3+1, none) for establishing ground truth or evaluating disagreements among measurements or interpretations. The comparison for agreement and precision is primarily statistical between the RS-3000 and the RTVue.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. This study focuses on device-to-device comparison and precision rather than human-in-the-loop performance.
6. Standalone Performance (Algorithm Only)
The study primarily evaluates the performance of the Nidek Optical Coherence Tomography RS-3000 as a diagnostic imaging device, comparing its measurements and image quality to a predicate device. It is not an "algorithm-only" or "standalone" performance study in the sense of an AI algorithm making diagnoses without human intervention. The device produces images and measurements, which are then used by clinicians ("as an aid in the diagnosis and management of adults having or suspected of having ocular disease").
7. Type of Ground Truth Used
The ground truth for this device involved comparative measurements against a legally marketed predicate device (Optovue RTVue) for agreement and precision, as well as an assessment of image quality by a Reading Center. There is no mention of pathology or long-term outcomes data being used as ground truth in this summary.
8. Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This is typical for a 510(k) submission for an imaging device where the primary evaluation is about measurement accuracy, precision, and image quality compared to a predicate, rather than an AI/ML algorithm that requires a distinct training and test set with ground truth labels.
9. How Ground Truth for the Training Set was Established
Since no training set is mentioned or implied for an AI/ML algorithm, there is no information provided on how ground truth for a training set was established.
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1. 510(K) SUMMARY
Date Prepared: March 14, 2013
MAR 1 4 2013
・・
1
SPONSOR/510(K) OWNER/ MANUFACTURER
Nidek Co., Ltd. 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Telephone: +81-533-67-8901 Facsimile: +81-533-67-6628 Email: yoneji_mizuno@nidek.co.jp Establishment Registration Number: 8030392
OFFICIAL CONTACT PERSON
Lena Sattler Orasi Consulting, LLC. 1667 Ridgewood Rd. Wadsworth, OH 44281 Telephone: (440) 554-3706 Facsimile: (866) 904-4315 E-mail: lena@orasiconsulting.com
COMMON/USUAL NAME
Optical Coherence Tomography
PROPRIETARY OR TRADE NAMES
RS-3000
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K12/622
K121622 510{k) Summary
CLASSIFICATION INFORMATION
Classification Name: Medical Specialty: Device Class: Classification Panel: Product Codes:
Ophthalmoscope, A-C Powered Ophthalmic II Ophthalmic Device Panel ово
PRODUCT CODE: CLASSIFICATION / CFR TITLE
·OBO:
Class II § 21 CFR 886.1570
LEGALLY MARKETED PREDICATE DEVICE
Trade/Device Name: RTVue with Normative Database Applicant: Optovue 510{k} Premarket Notification number: K101505 Classification: Class II FDA Product Code: HLI Establishment Registration number: 3005950902 Trade/Device Name: RTVue CAM with Corneal Power Measurement Applicant: Optovue 510(k) Premarket Notification number: K11505 Classification: Class II FDA Product Code: OBO, MMQ Establishment Registration number: 3005950902 Trade/Device Name: Cirrus HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Database Applicant: Carl Zeiss 510(k) Premarket Notification number: K083291 Classification: Class II FDA Product Code: HLI Establishment Registration number: 2918630
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K121622 510{k) Summary
GENERAL DEVICE DESCRIPTION
The Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX. is an ophthalmic instrument to observe and analyze the fundus, and the shape or the lesion of the retina in a non-contact and non-invasive manner. In addition, the anterior segment adapter attached over the objective lens of the main body enables non-invasive and noncontact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle. The image filing software NAVIS-EX permits management and various diagnoses of captured images. When the personal computer (PC) with the NAVIS-EX installed is connected to the RS-3000 through a cable, the image data acquired by the RS-3000 is transmitted. The software offers the functions such as filing, external 1/F, image processing.
INDICATIONS FOR USE - RS-3000
The Nidek Optical Coherence Tomography RS-3000 including scanning laser ophthalmoscope function with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
- the retina, retinal nerve fiber layer, and optic disc, and
- . the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter),
as an aid in the diagnosis and management of adults having or suspected of having ocular disease.
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K121622 510(k) Summary
DEVICE DESCRIPTION
Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX, is an ophthalmic instrument to observe and analyze the fundus, and the shape or the lesion of the retina in a non-contact and non-invasive manner. In addition, the anterior segment adapter attached over the objective lens of the main body enables non-invasive and noncontact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle.
By using confocal laser scanning ophthalmoscopy with a 785nm near-infrared light source, the fundus image (hereinafter referred to as SLO image) is obtained; and by optical coherence tomography with an 880 nm infrared light, the cross-sectional image of the fundus (hereinafter referred to as OCT image) is obtained. '
The images captured using the RS-3000 allow observation of the fundus, and the shape, structure, and lesion of the patient's retina. In addition, the anterior segment adapter attached over the objective lens of the main body of the RS-3000 enables non-invasive and non-contact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle. The RS-3000 system is comprised of the following components: Main body, PC, PC monitor, Image Filing Software NAVIS-EX and isolation transformer. The NAVIS-EX software permits the management of various analyses of the captured images.
The image filing software NAVIS-EX permits management and various diagnoses of captured images. When the personal computer (PC) with the NAVIS-EX installed is connected to the RS-3000 through a cable, the image data acquired by the RS-3000 is transmitted. The software offers functions such as filing, external I/F, and Image processing. ﻟﻤﻤﻠﻜﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
SUBSTANTIAL EQUIVALENCE
The Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX, is similar in technological characteristics, performance and has the same intended use as the predicate device(s). Any differences in technological characteristics between the Nidek Optical Coherence Tomography RS-3000 with Image Filing Software NAVIS-EX and the predicate device do not raise any new questions of safety or effectiveness. Thus, the RS-3000 with Image Filing Software NAVIS-EX is substantially equivalent to the predicate device(s).
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KI21622
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K121622 510(k) Summary
COMPARISON TABLE OF TECHNOLOGICAL CHARACTERISTICS
| Substantial Equivalence Comparison Table: RTVue | ||
|---|---|---|
| Feature | RS-3000 with NAVIS-EX | RTVue, CA |
| Manufacturer | NIDEK | Optovue |
| 510(k) Number | K121622 | K101505 |
| Classification | 886.1570 | 886.1570 |
| Product Code | OBO | HLI |
| Intended Use | ||
| The Nidek Optical CoherenceTomography RS-3000 includingscanning laser ophthalmoscopefunction with Image FilingSoftware NAVIS-EX is a non-contact system for imaging thefundus and for axial crosssectional imaging of ocularstructures. It is indicated for invivo imaging and measurementof:• the retina, retinal nerve fiberlayer, and optic disc, and• the anterior chamber andcornea (when used with theoptional auxiliary anteriorchamber adapter),as an aid in the diagnosis andmanagement of adults having orsuspected of having oculardisease. | The RTVue with NormativeDatabase is an opticalcoherence tomography systemindicated for the in vivoimaging and measurement ofthe retina, retinal nerve fiberlayer, and optic disk as an aidin the diagnosis andmanagement of retinal disease.The RTVue with Normativedatabase is also a quantitativetool for the comparison ofretina, retinal nerve fiber layer,and optic disc measurementsin the human eye to a databaseof known normal subjects. It isintended for use as a diagnosticdevice to aid in the detectionand management of oculardisease. | |
| Performance Features | ||
| Measurement principle | ||
| Imaging of theFundus/AnteriorSegment | Confocal scanning laserophthalmoscopy for RS-3000 | Near IR observation |
| Tomographic Imagingof theFundus/AnteriorSegment | Spectral Domain OCT | Spectral Domain OCT |
| Scan rate (in OCT Imagecapture) | 53,000 A-Scan/s | 26,000 A-Scan/s |
| Light source wavelength | ||
| Imaging of theFundus/AnteriorSegment | 785 nm (Diode laser) for RS-3000, | 735 nm (LED) |
| Tomographic Imagingof theFundus/AnteriorSegment | 880 nm (SLD) | 840 nm (SLD) |
| Imaging of the Fundus | 25 µm (in the X and Y directions)for RS-3000(SLO) | 25 µm (in the X and Ydirections) |
| Tomographic Imagingof the Fundus | 20 µm (in the X and Ydirections), 7 µm (in the Zdirection) | 15 µm (in the X and Ydirections), 5 µm (in the Zdirection) |
| Imaging of theAnterior Segment | 50 µm (in the X and Y directions)for RS-3000(SLO) | 70 µm (in the X and Ydirections) |
| Tomographic Imagingof the AnteriorSegment | 20 µm (in the X and Ydirections), 7 µm (in the Zdirection) | 15 µm (in the X and Ydirections), 5 µm (in the Zdirection) |
| Minimum pupildiameter required | φ2.5 mm | φ2.5mm |
| Focus range | -15 D to +10 D | -15 D to +20 D |
| Field of view | ||
| Imaging of the Fundus | 40°× 30 °for RS-3000, | 32°×22° |
| Tomographic Imagingof the Fundus | Scan width:3 mm to 9 mmScan depth:2.1 mm | Scan width:2 mm to 12 mmScan depth:2 mm to 2.3 mm |
| Imaging of theAnterior Segment | 14 mm×12 mm | 5.75mm×4.3mm / 12mm×8mm |
| Tomographic Imagingof the AnteriorSegment | Scan width:2 mm to 8 mmScan depth:2.1 mm | Scan width:1 mm to 3 mm/ 2 mm to 6 mmScan depth:1.96 mm / 2.3 mm |
| Measurement and Analysis | ||
| 3D Volume Rendering | Yes | Yes |
| Retinal Thicknessmeasurement (Total/Innerlayer) | Yes | Yes |
| RNFL Thicknessmeasurement | Yes | Yes |
| Optic Disc analysis | Yes | Yes |
| Pachymetry | Yes | Yes |
| Angle analysis | Yes | Yes |
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K12/622
K121622 510(k) Summary
| Substantial Equivalence Comparison Table: Cirrus HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Database | ||
|---|---|---|
| Feature | RS-3000 with NAVIS-EX | Cirrus HD-OCT |
| Manufacturer | NIDEK | Carl Zeiss |
| 510(k) Number | K121622 | K083291 |
| Classification | 886.1570 | 886.1570 |
| Product Code | OBO | OBO |
| Intended Use | ||
| The Nidek Optical Coherence TomographyRS-3000 including scanning laserophthalmoscope function with Image FilingSoftware NAVIS-EX is a non-contact systemfor imaging the fundus and for axial crosssectional imaging of ocular structures. It isindicated for in vivo imaging andmeasurement of:the retina, retinal nerve fiber layer, and optic disc, and the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter), as an aid in the diagnosis and managementof adults having or suspected of havingocular disease. | The Cirrus™ HD-OCT is a non-contact, highresolution tomographic and biomicroscopicimaging device. It is indicated for in-vivoviewing, axial cross-sectional, and threedimensional imaging and measurement ofanterior and posterior ocular structures,including cornea, retina, retinal fiber layer,macula, and optic disc. The Cirrus HD-OCTwith Retinal Nerve Fiber Layer (RNFL) andMacular Normative Database is aquantitative tool for the comparison ofretinal nerve fiber layer and the macula inthe human retina to a database of knownnormal subjects. It is intended for use as adiagnostic device to aid in the detection andmanagement of ocular diseases including,but not limited to, macular holes, cystoidmacular edema, diabetic retinopathy, age-related macular degeneration, andglaucoma. | |
| Performance Features | ||
| Measurementprinciple | Confocal scanning laser ophthalmoscopy | Confocal scanning laser ophthalmoscopy |
| Light sourcewavelength | 785 nm (Diode laser) | 750 nm (SLD) |
| Optical power | 320μW | <1.5mW |
| Frame rate | 10fps | >20Hz |
| Field of view | 40°x 30° | 36°× 30° |
| Lateral resolution | 25 μm | 25 μm |
| Focus adjustmentrange | -15D to +10D | -20D to +20D |
| Detector type | APD | Line CCD |
| External fixation lamp | Provided | Provided |
| Anterior segmentimaging | Yes | Yes |
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NON-CLINICAL PERFORMANCE SUMMARY
See Appendix 10 and Appendix 11 for supporting documentation regarding non-clinical performance testing.
The Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX, was evaluated according to the requirements of FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 62304, IEC 62366, ISO 15004-1, and ISO15004-2) and were found to meet the requirements of the applicable parts.
Bench testing of the repeatability and reproducibility of thickness measurement using the RS-3000 on a model eye was performed by multiple operators. Analysis of measurement errors in each result maintains sufficient accuracy with the device requirement specification of ± 5% accuracy of thickness measurements. As a result of this testing, the RS-3000 was found to maintain sufficient accuracy and to meet requirement specifications.
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K12/622
CLINICAL SUMMARY
A prospective clinical study was conducted at one clinical site located in the United States. A total of 89 subjects were enrolled to provide at least 80 evaluable eyes for the agreement measurements and at least 48 evaluable eyes for the precision and registration i measurements.
The specific objectives of the study were to:
- a. assess the agreement of the measurements of Total Retinal Thickness [ILM-RPE], Inner Retinal Thickness [ILM-IPL/INL], Outer Retinal Thickness [IPL/INL-RPE], Retinal Nerve Fiber Layer (RNFL) Thickness, Optic Disc Analysis and Central Corneal Thickness between the Nidek OCT RS-3000 and the Optovue RTVue1 predicate device;
- b. compare the quality of the Anterior Chamber Angle OCT image between the Nidek RS-3000 and the Optovue RTVue predicate device;
- c. assess the precision of the Nidek RS-3000 and the Optovue RTVue with respect to the measurements of Total Retinal Thickness [ILM-RPE], G Chart [NFL+GCL+IPL] Thickness (RS-3000 only), Inner Retinal Thickness [ILM-IPL/INL], Outer Retinal Thickness [IPL/INL-RPE], RNFL Thickness, Optic Disc Analysis and Central Corneal Thickness;
- d. compare the precision of the Nidek RS-3000 to the precision of the Optovue RTVue;
- e. obtain a quality assessment of the SLO image of the RS-3000; and
- assess the registration function of the RS-3000. ﺖ
The subject eye groups consisted of the following four groups: (1) Normal Eyes; (2) Eyes with Retinal Disease; (3) Eyes with Glaucoma and (4) Eyes with Corneal Disease (including eyes having undergone keratorefractive surgery). All study eyes were evaluated for the agreement and device capability assessments of this study. The first 12 eyes that had completed the study of each of the four study eye populations enrolled were evaluated for the precision assessment of the study. The first 12 eyes of the normal, retinal disease and glaucoma study eye groups that had completed the study were evaluated for the registration assessment. If both eyes of a subject were eligible for the study, one eye was selected randomly for evaluation. Both eyes of the normal eye study group must have met all normal eligibility criteria to participate in the study. The order of device testing was randomized.
Three Nidek RS-3000 devices and three Optovue RTVue devices were used. Each RS-3000 device was paired with one RTVue device for a total of three RS-3000/RTVue device pairs. Each of the three device pairs was designated one, and only one, operator for a total of three operator and device pairs for the precision and registration scans acquired for this study. Each operator and device pair was considered one configuration for a total of three
' The RTVue OCT is 510(k) cleared by the U.S. Food and Drug Administration and is commercially distributed in the United States; K101505.
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specific operator/device configurations. Study eyes evaluated for precision and registration assessments were equally distributed among the three operator/device configurations.
Agreement Assessment: Twenty study eyes from each eye group that completed the study were included in the agreement assessment. The first acceptable RS-3000 scan with follow-up off and the first acceptable RTVue scan were designated as the agreement scans. Scans were acquired to capture the clinical data points for each of the agreement primary clinical endpoints.
Precision Assessment: The first 12 study eyes that completed the study from each eye population within the agreement assessment cohort were designated for the precision assessment. Each operator/device configuration tested four of the 12 study eyes for each eye group. Three measurements from each device were taken of each eye. This is a nested design with three configurations, four eyes per configuration and three measurements per device per eye. All three RS-3000 and RTVve scans had the registration feature disabled (follow-up off). Scans were acquired to capture the clinical data points for each of the precision primary clinical endpoints.
RS-3000 Registration Assessment: The same three specific operator/device configurations used in the precision assessment were used for the registration assessment of the RS-3000. The same 12 study eyes from each eye group for the precision assessment (excluding the corneal disease group as the RS-3000 does not have a registration feature associated with the pachymetry measurement) were designated for the registration assessment. The third acceptable scan obtained in the precision assessment was designated as the "baseline" scan. Three additional scans with the registration feature enabled (follow-up on) were acquired following the baseline scan. Scans were acquired to capture the clinical data points for each of the registration primary clinical endpoints.
Device Capability Assessment: All study eyes from each subject group were included for the SLO Quality Assessment. Utilizing the single scan acquired for the agreement assessment with the RS-3000 (only), the quality of the SLO image for each study eve was assessed by a Reading Center.
Safety Assessment: Safety endpoints were defined as any adverse events identified during the clinical study. There were zero adverse events that occurred during this clinical study.
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| Clinical Endpoints: | ||
|---|---|---|
| Data points | RS-3000andRTVue | RS-3000only | Agreement | Precision | Registration [RS-3000 only] | |
|---|---|---|---|---|---|---|
| Total RetinalThickness | 9 segments | X | X | X | X | |
| Inner RetinalThickness | RS-3000: 8segmentsRTVue: 9segments | X | X | X | X | |
| Outer RetinalThickness | 9 segments | X | X | X | X | |
| RNFL | TSNI | X | X | X | X | |
| G Chart | 8 segments | X | X | X | X | X |
| Optic DiscAnalysis | C/D Ratio, DiscArea, Cup Area | X | X | X | X | |
| Pachymetry | Central CornealThickness | X | X | |||
| AnteriorChamber Image | ImageAssessment | X | X | |||
| SLO Image | ImageAssessment | X |
Scan Patterns and Scan Parameters:
| RS-3000 Scan Pattern :Parameter | RTVue Scan Pattern : Parameter | |
|---|---|---|
| Total Retinal Thickness | Macular Map : 6 x 6mm | EMM5 Scan: 6 x 6mm |
| Inner Retinal Thickness | ||
| Outer Retinal Thickness | ||
| G Chart | Image: [scan] | |
| SLO Image | ||
| RNFL | Disc Map :4.5 x 4.5mm | ONH Scan + 3D Disc Map : RadialScans 3.45mm Circular Scans |
| Optic Disc Analysis | ||
| Pachymetry | Corneal Radial : 6 x 6mm | Cam-L Pachymetry: 6mm Radial Scanswith Circle |
| Anterior Chamber Image | ACA Line : 4mm | CS-HD Angle : 4mm |
:
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Acceptability of Scans:
Study technicians were instructed to acquire the minimum number of "acceptable" required scans for agreement and precision analysis as dictated in the clinical study protocol. Reasons for not accepting a scan included: Poor SSI (Signal Strength Index), Poor Patient Cooperation, Device Malfunction, Ocular Obstruction, Eye Blink, Eye Movement and Scan Pattern Cut Off and Other.
For the Total Retinal Thickness scans, there are 7.1%, 32.2% and 4.7% unacceptable scans for RS-3000 with follow-up off, RS-3000 with follow-up on and RTVue, respectively. The most common reasons for unacceptable scans are scan pattern (5.6%, RS-3000 with followup off), others (22.6%, RS-3000 with follow-up on), and eye blink and other (1.9% each, RTVue). Twenty-four of the 26 other reasons for RS-3000 with follow-up on were indicated as not aligning with baseline. The Inner and Outer Retinal Thickness scans had very similar unacceptable rates.
For the G-chart scans, there are 7.1% and 22.9% unacceptable scans for RS-3000 with follow-up off and on, respectively. The most common reasons for unacceptable scans are scan pattern (5.1%, RS-3000 with follow-up off) and others (16.2%, RS-3000 with followup on). Sixteen of the 17 other reasons for RS-3000 with follow-up on were indicated as not aligning with baseline.
For the RNFL and Optic Disc scans, there are 14.2%, 29.4% and 5.6% unacceptable scans for RS-3000 with follow-up off, RS-3000 with follow-up on and RTVue, respectively. The most common reasons for unacceptable scans are scan pattern (5%, RS-3000 with followup off) and others (16:8%, RS-3000 with follow-up on and 3.7%, RTVue). Eighteen of the 20 other reasons for RS-3000 with follow-up on were indicated as not aligning with baseline.
For the Central Corneal Thickness scans, there are 27.7% and 4.6% unacceptable scans for RS-3000 and RTVue, respectively. The most common reasons for unacceptable scans are scan pattern (4.1%, RS-3000), and poor SSI (1.9%, RTVue).
For the Anterior Chamber scans, there are 40.7% and 2.2% unacceptable scans for RS-3000 and RTVue, respectively. The most common reasons for unacceptable scans are poor patient cooperation (26%, RS-3000), and poor SSI and eye blink (1.1% each, RTVue).
The RS-3000 unacceptable scan rates were:
- lower in the normal group than the retinal group in retinal thickness scans (6% and . 9.4% for follow-up off, and 20.4% and 40.9% for follow-up on),
- lower in the normal group than the glaucoma group in G-chart scans (2.5% and . 10.3% for follow-up off, and 20.4% and 25% for follow-up on),
- lower in the normal group than the retinal group in RNFL scans (13% and 14.8% for . follow-up off", and 20.4% and 37.3% for follow-up on),
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- lower in the normal group than the glaucoma group and the corneal group in Central Corneal Thickness scans (23%, 32.6% and 26.2%, respectively), and
- . similar among the four eye groups (from 37.1% to 44.7%) in Anterior Chamber scans.
Agreement Results:
Total Retinal Thickness
Limit of agreement analysis of the total retinal thickness is summarized in tables 1 through 4 below. For the normal subjects, the RS-3000 measured an average of 16.2, 19.0, 17.8, and 18.4μm greater than the RTVue in four segments (nasal 2, temporal 2, superior 2 and inferior 2, respectively). For the retinal group, all nine segments showed agreement between the two devices.
Inner Retinal Thickness
Limit of agreement analysis of the inner retinal thickness is summarized n tables 1 through 4 below. For the normal subjects, the RS-3000 measured an average of 20.0, 10.6, and 14.3um less than the RTVue in three segments (temporal 1, superior 1, and inferior 1. respectively). For the retinal group, all eight segments showed agreement between the two devices.
Outer Retinal Thickness
Limit of agreement analysis of the total retinal thickness is summarized in tables 1 through 4 below. For the normal subjects, the RS-3000 measured an average of 14.7 to 34.3um greater than the RTVue in all nine segments. For the retinal group, all but 1 segment showed agreement between the two devices. The RS-3000 measured an average of 21.3um greater than the RTVue in the temporal segment 1.
Retinal Nerve Fiber Laver Thickness
Limit of agreement analysis of the retinal nerve fiber layer is summarized in tables 1 through 4 below. For all subjects, in both the normal and glaucoma study groups, the RS-3000 showed agreement with the RTVue in all four quadrants and in the total mean.
Optic Disc Analysis
Limit of agreement analysis of the optic disc analysis is summarized in tables 1 through 4 below. For all subjects, in both the normal and glaucoma study groups, the RS-3000 showed agreement with the RTVue in all four parameters analyzed, C/D horizontal, C/D vertical, Disc area and Cup area.
Central Corneal Thickness
The RS-3000 measured an average of 13.4um higher than the RTVue for the measurement of central corneal thickness for the normal study group. In the corneal group, no significant differences in the measurement of central corneal thickness were found between the two devices.
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K121622 510{k) Summary
| n | RS-3000Mean (SD) | RTVueMean (SD) | DifferenceMean (SD) | 95% CI forMeanDifference | 95% LOAfor MeanDifference | |
|---|---|---|---|---|---|---|
| Total Retinal Thickness (µm) | ||||||
| Nasal 1 | 20 | 307.9 (19.4) | 299.7 (22.0) | 8.2 (9.4) | 3.8, 12.6 | -10.5, 26.9 |
| Nasal 2 | 20 | 338.2 (19.2) | 322.0 (19.2) | 16.2 (6.1) | 13.3, 19.0 | 3.9, 28.4 |
| Center | 20 | 266.9 (22.9) | 266.8 (21.9) | 0.1 (7.9) | -3.6, 3.8 | -15.6, 15.8 |
| Temporal 1 | 20 | 282.3 (17.0) | 280.0 (18.0) | 2.4 (11.9) | -3.2, 7.9 | -21.4, 26.1 |
| Temporal 2 | 20 | 322.6 (16.0) | 303.6 (18.8) | 19.0 (9.3) | 14.6, 23.3 | 0.4, 37.5 |
| Superior 1 | 20 | 295.6 (19.8) | 282.3 (19.6) | 13.4 (9.1) | 9.1, 17.6 | -4.8, 31.5 |
| Superior 2 | 20 | 336.0 (19.3) | 318.2 (17.3) | 17.8 (7.2) | 14.4, 21.2 | 3.3, 32.3 |
| Inferior 1 | 20 | 284.4 (16.6) | 283.7 (18.0) | 0.7 (8.0) | -3.1, 4.5 | -15.4, 16.8 |
| Inferior 2 | 20 | 333.6 (17.4) | 315.2 (17.2) | 18.4 (8.2) | 14.5, 22.3 | 1.9, 34.9 |
| Inner Retinal Thickness (µm) | ||||||
| Nasal 1 | 20 | 111.5 (10.5) | 120.1 (12.2) | -8.7 (8.9) | -12.8, -4.5 | -26.4, 9.1 |
| Nasal 2 | 20 | 112.3 (8.4) | 130.6 (13.6) | -18.3 (11.5) | -23.7, -12.9 | -41.2, 4.6 |
| Temporal 1 | 20 | 86.6 (8.5) | 106.6 (8.4) | -20.0 (5.9) | -22.8, -17.2 | -31.9, -8.1 |
| Temporal 2 | 20 | 102.4 (6.1) | 114.1 (10.3) | -11.7 (8.3) | -15.5, -7.8 | -28.2, 4.9 |
| Superior 1 | 20 | 97.5 (9.6) | 108.0 (8.4) | -10.6 (4.9) | -12.9, -8.2 | -20.4, -0.7 |
| Superior 2 | 20 | 114.2 (9.3) | 127.2 (12.3) | -13.0 (12.0) | -18.6, -7.4 | -37.0, 11.0 |
| Inferior 1 | 20 | 97.0 (8.3) | 111.3 (9.4) | -14.3 (6.5) | -17.4, -11.2 | -27.4, -1.2 |
| Inferior 2 | 20 | 115.1 (8.5) | 125.8 (10.3) | -10.8 (7.6) | -14.3, -7.2 | -26.0, 4.5 |
| Outer Retinal Thickness (µm) | ||||||
| Nasal 1 | 20 | 195.8 (11.6) | 179.6 (13.8) | 16.3 (7.0) | 13.0, 19.5 | 2.2, 30.3 |
| Nasal 2 | 20 | 225.4 (12.5) | 191.2 (15.1) | 34.3 (9.7) | 29.7, 38.8 | 14.8, 53.7 |
| Center | 20 | 218.4 (15.3) | 185.2 (11.7) | 33.2 (7.0) | 29.9, 36.5 | 19.2, 47.2 |
| Temporal 1 | 20 | 195.5 (10.5) | 173.3 (12.6) | 22.2 (7.8) | 18.5, 25.8 | 6.5, 37.8 |
| Temporal 2 | 20 | 219.7 (11.0) | 189.5 (14.0) | 30.2 (8.6) | 26.1, 34.2 | 12.9, 47.4 |
| Superior 1 | 20 | 197.5 (11.7) | 174.1 (13.5) | 23.5 (8.6) | 19.4, 27.5 | 6.3, 40.6 |
| Superior 2 | 20 | 221.0 (12.5) | 191.0 (16.4) | 30.1 (11.9) | 24.5, 35.6 | 6.2, 53.9 |
| Inferior 1 | 20 | 186.9 (10.7) | 172.2 (11.4) | 14.7 (4.3) | 12.7, 16.7 | 6.2, 23.2 |
| Inferior 2 | 20 | 218.0 (12.4) | 189.8 (14.0) | 28.2 (7.1) | 24.9, 31.5 | -14.0, 42.4 |
| Retinal Nerve Fiber Layer Thickness (µm) | ||||||
| Superior | 20 | 125.5 (16.5) | 116.8 (12.6) | 8.7 (10.7) | 3.7, 13.7 | -12.7, 30.1 |
| Temporal | 20 | 63.2 (11.3) | 76.4 (8.5) | -13.2 (9.1) | -17.5, -9.0 | -31.4, 5.0 |
| Inferior | 20 | 128.0 (14.3) | 127.4 (11.7) | 0.5 (7.1) | -2.8, 3.8 | -13.7, 14.7 |
Table 1: Mean Difference in Retinal Thickness, RNFL, Optic Disc and Central Corneal Thickness Between RS-3000 and RTVue . Subjects With Normal Eyes .
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| n | RS-3000Mean (SD) | RTVueMean (SD) | DifferenceMean (SD)1 | 95% CI forMeanDifference2 | 95% LOAfor MeanDifference3 | |
|---|---|---|---|---|---|---|
| Nasal | 20 | 84.1 (11.9) | 81.1 (8.7) | 3.0 (8.6) | -1.0, 7.0 | -14.2, 20.2 |
| Total Mean | 20 | 101.0 (10.3) | 100.4 (7.8) | 0.5 (4.6) | -1.6, 2.7 | -8.6, 9.7 |
| Optic Disc | ||||||
| C/DHorizontal | 19 | 0.542 (0.148) | 0.687 (0.205) | -0.176(0.124) | -0.236, -0.116 | -0.425,0.072 |
| C/D Vertical | 19 | 0.495 (0.128) | 0.585 (0.166) | -0.111(0.071) | -0.145, -0.077 | -0.253,0.031 |
| Disc Area(mm^2) | 20 | 2.134 (0.396) | 1.849 (0.339) | 0.285 (0.290) | 0.150, 0.420 | -0.294,0.864 |
| Cup Area(mm^2) | 19 | 0.643 (0.383) | 0.712 (0.515) | -0.106(0.248) | -0.225,0.014 | -0.601,0.389 |
| Central Corneal Thickness (µm) | ||||||
| 20 | 543.2 (28.5) | 529.8 (29.2) | 13.4 (6.6) | 10.3, 16.4 | 0.2, 26.5 | |
| n | RS-3000Mean (SD) | RTVueMean (SD) | DifferenceMean (SD) ¹ | 95% CI forMeanDifference² | 95% LOAfor MeanDifference³ | |
| Total Retinal Thickness (µm) | ||||||
| Nasal 1 | 20 | 309.2 (31.9) | 296.8 (36.1) | 12.4 (18.7) | 3.6, 21.2 | -25.1, 49.9 |
| Nasal 2 | 20 | 327.8 (48.1) | 317.4 (47.8) | 10.4 (12.7) | 4.4, 16.4 | -15.1, 35.9 |
| Center | 20 | 280.1 (76.0) | 277.0 (70.1) | 3.1 (14.8) | -3.8, 10.0 | -26.6, 32.8 |
| Temporal 1 | 20 | 275.0 (19.9) | 269.5 (24.6) | 5.6 (9.6) | 1.0, 10.1 | -13.7, 24.8 |
| Temporal 2 | 20 | 308.9 (46.2) | 290.3 (45.3) | 18.6 (9.4) | 14.1, 23.0 | -0.3, 37.4 |
| Superior 1 | 20 | 290.6 (28.3) | 279.8 (31.9) | 10.8 (9.0) | 6.5, 15.0 | -7.2, 28.7 |
| Superior 2 | 20 | 323.0 (47.2) | 309.2 (46.2) | 13.8 (10.2) | 9.0, 18.6 | -6.6, 34.2 |
| Inferior 1 | 20 | 287.4 (30.7) | 284.1 (37.3) | 3.3 (10.3) | -1.5, 8.1 | -17.2, 23.8 |
| Inferior 2 | 20 | 327.9 (48.1) | 315.0 (52.0) | 13.0 (8.1) | 9.1, 16.8 | -3.3, 29.2 |
| Inner Retinal Thickness (µm) | ||||||
| Nasal 1 | 20 | 114.8 (20.9) | 115.6 (19.5) | -0.9 (14.7) | -7.7, 6.0 | -30.2, 28.5 |
| Nasal 2 | 20 | 110.7 (31.3) | 124.6 (26.9) | -14.0 (18.1) | -22.4, -5.5 | -50.1, 22.2 |
| Temporal 1 | 20 | 86.4 (12.0) | 102.9 (13.3) | -16.5 (9.3) | -20.8, -12.1 | -35.0, 2.1 |
| Temporal 2 | 20 | 103.6 (19.0) | 109.6 (20.1) | -6.0 (13.8) | -12.4, 0.4 | -33.5, 21.5 |
| Superior 1 | 20 | 100.2 (18.1) | 107.0 (16.3) | -6.9 (8.2) | -10.7, -3.0 | -23.2, 9.5 |
| Superior 2 | 20 | 111.5 (27.1) | 119.6 (21.4) | -8.2 (15.4) | -15.3, -1.0 | -38.9, 22.6 |
| Inferior 1 | 20 | 100.8 (21.2) | 109.3 (13.9) | -8.5 (14.0) | -15.0, -1.9 | -36.5, 19.6 |
| Inferior 2 | 20 | 120.0 (21.6) | 120.6 (21.7) | -0.6 (15.2) | -7.7, 6.6 | -31.0, 29.9 |
| Outer Retinal Thickness (µm) | ||||||
| Nasal 1 | 20 | 194.0 (15.3) | 181.2 (20.7) | 12.8 (16.6) | 5.0, 20.5 | -20.5, 46.0 |
| Nasal 2 | 20 | 216.8 (25.1) | 192.7 (25.3) | 24.1 (19.4) | 15.0, 33.2 | -14.6, 62.8 |
| Center | 20 | 210.9 (41.0) | 190.6 (53.5) | 20.4 (23.9) | 9.2, 31.5 | -27.4, 68.1 |
| Temporal 1 | 20 | 188.0 (13.9) | 166.7 (13.0) | 21.3 (9.5) | 16.9, 25.7 | 2.4, 40.2 |
| Temporal 2 | 20 | 204.8 (32.5) | 180.7 (27.9) | 24.1 (13.9) | 17.6, 30.6 | -3.7, 51.9 |
| Superior 1 | 20 | 189.8 (14.5) | 172.7 (16.9) | 17.2 (11.6) | 11.7, 22.6 | -6.0, 40.3 |
| Superior 2 | 20 | 210.9 (28.1) | 189.6 (28.8) | 21.4 (19.0) | 12.5, 30.2 | -16.7, 59.4 |
| Inferior 1 | 20 | 185.9 (11.5) | 174.9 (25.6) | 11.0 (16.5) | 3.3, 18.7 | -22.1, 44.1 |
| Inferior 2 | 20 | 207.3 (28.9) | 194.3 (34.9) | 13.0 (14.9) | 6.0, 19.9 | -16.8, 42.7 |
Data included are the first accepted scans from RS-3000 with follow-up off and the first accepted scans from RTVue.
1 Difference = RS-3000 - RTVue
2 95% confidence interval for mean difference based on t-distribution
3 95% limits of agreement = mean difference +/- 2 x difference SD
Program: LOA.sas (11DEC2012 20:56:34)
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K121622 510(k) Summary
Table 2: Mean Difference in Retinal Thickness Between RS-3000 and RTVue Subjects With Retinal Disease
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| ﺘ | RS-3000Mean (SD) | RTVueMean (SD) | DifferenceMean (SD) ! Difference2 Difference3 | 95% Cl for 95% LOAMean | for Mean | ||
|---|---|---|---|---|---|---|---|
| Data included are the first accepted scans from RS-3000 with follow-up off and the first |
accepted scans from RTVue.
1 Difference = RS-3000 - RTVue
2 95% confidence interval for mean difference based on t-distribution 3 95% limits of agreement = mean difference +/- 2 x difference SD
95 % limits of agreement = mean difference +/- 2 x difference
Program: LOA.sas (11DEC2012 20:56:34)
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K12/622
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| RS-3000Mean (SD) | RTVueMean (SD) | DifferenceMean (SD)1 | 95% CI forMean Difference2 | 95% LOAfor Mean Difference3 | ||
|---|---|---|---|---|---|---|
| n | ||||||
| Retinal Nerve Fiber Layer Thickness (µm) | ||||||
| Superior | 20 | 90.9 (26.0) | 86.3 (19.4) | 4.5 (9.3) | 0.2, 8.9 | -14.0, 23.1 |
| Temporal | 20 | 53.1 (14.0) | 65.8 (13.6) | -12.8 (9.7) | -17.3, -8.2 | -32.2, 6.6 |
| Inferior | 20 | 85.9 (27.4) | 91.4 (24.3) | -5.5 (8.3) | -9.4, -1.6 | -22.0, 11.0 |
| Nasal | 20 | 70.0 (22.8) | 66.1 (10.2) | 3.9 (18.3) | -4.7, 12.5 | -32.8, 40.6 |
| Total Mean | 20 | 75.7 (16.1) | 77.4 (13.5) | -1.8 (6.0) | -4.6, 1.1 | -13.8, 10.3 |
| Optic Disc | ||||||
| C/D Horizontal | 20 | 0.783 (0.130) | 0.917 (0.129) | -0.134(0.117) | -0.189, -0.079 | -0.368,0.100 |
| C/D Vertical | 20 | 0.762 (0.119) | 0.834 (0.133) | -0.073(0.065) | -0.103, -0.042 | -0.202,0.057 |
| Disc Area (mm^2) | 20 | 2.195 (0.385) | 2.028 (0.362) | 0.167 (0.332) | 0.012, 0.322 | -0.497,0.831 |
| Cup Area (mm^2) | 20 | 1.305 (0.443) | 1.434 (0.539) | -0.130(0.394) | -0.314,0.055 | -0.917,0.658 |
Table 3: Mean Difference in RNFL and Optic Disc Between RS-3000 and RTVue Subjects With Glaucoma
Data included are the first accepted scans from RS-3000 with follow-up off and the first accepted scans from RTVue.
1 Difference = RS-3000 - RTVue
2 95% confidence interval for mean difference based on t-distribution 3 95% limits of agreement = mean difference +/- 2 x difference SD
Program: LOA.sas (11DEC2012 20:56:34)
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Table 4: Mean Difference in Central Corneal Thickness Between RS-3000 and RTVue Subjects With Corneal Disease
| n | RS-3000Mean (SD) | RTVueMean (SD) | DifferenceMean (SD)1 | 95% CI forMeanDifference2 | 95% LOAfor MeanDifference3 |
|---|---|---|---|---|---|
| Central Corneal Thickness (μm) | |||||
| 20 | 520.8 (63.8) | 508.1 (63.2) | 12.8 (8.0) | 9.0, 16.5 | -3.2, 28.7 |
Data included are the first accepted scans from RS-3000 with follow-up off and the first accepted scans from RTVue.
1 Difference = RS-3000 ~ RTVue
2 95% confidence interval for mean difference based on t-distribution
3 95% limits of agreement = mean difference +/- 2 x difference SD
Program: LOA.sas (11DEC2012 20:56:34)
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Precision Results:
Total Retinal Thickness
Repeatability and reproducibility of the total retinal thickness are summarized in tables 5 through 11 below.
For the normal group, the repeatability limits (range: 2.8 to 7.393μm) and the reproducibility limits (range: 2.8 to 7.393µm) of RS-3000 with follow-up off tended to be smaller than or similar to that of the RTVue (the repeatability limits and the reproducibility limits of RTVue have the same range: 6.313 to 17.746um). The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.761 to 6.55um).
For the retinal group, the repeatability limits of RS-3000 with follow-up off (range: 6.049 to 32.453um) tended to be larger than or similar to that of the RTVue (range: 5.522 to 17.511um). However, there was no clear pattern in the reproducibility limits between the two study devices (range: 6.049 to 32.453um for RS-3000 Off, 6.031 to 17.511um for RTVue). The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 4.62 to 27.403um).
Inner Retinal Thickness
Repeatability and reproducibility of the inner retinal thickness are summarized in tables 5 through 11 below.
For the normal group, the repeatability limits (range: 1.476 to 5.442um) and the reproducibility limits (range: 1.476 to 5.442µm) of RS-3000 with follow-up off tended to be smaller than or similar to that of the RTVue (repeatability limit range: 3.461 to 10.601um; reproductbility limit range: 3.461 to 11.843um). The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.034 to 5.280um).
For the retinal group, the repeatability limits (range: 5.176 to 14.162µm) and the reproducibility limits (range: 5.176 to 14.162µm) of RS-3000 with follow-up off tended to be smaller than or similar to that of the RTVue (repeatability limit range: 6.433 to 18.397μm; reproducibility limit range: 8.056 to 20.9um). The repeatability limits and the reproducibility limits of RS-3000 with follow-up off tended to be larger or similar to that of the RS-3000 with follow-up on (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 3.365 to 18.026pm).
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Outer Retinal Thickness
Repeatability and reproducibility of the outer retinal thickness are summarized in tables 5 through 11 below
For the normal group, the repeatability limits (range: 2.425 to 4.174 m) and the reproducibility limits (range: 2.425 to 5.032µm) of RS-3000 with follow-up off tended to be smaller than that of the RTVue (the repeatability limits and the reproducibility limits of RTVue have the same range: 7.961 to 12.531µm) in all segments. The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 2.139 to 4.252um}.
For the retinal group, the repeatability limits of RS-3000 with follow-up off frange: 4.961 to 23.653μm) tended to be smaller than or similar to that of the RTVue (range: 7.865 to 20.293μm). The reproducibility limits of RS-3000 with follow-up off (range: 4.961 to 25.459µm) tended to be smaller in the superior and inferior segments than that of RTVue (range: 7.865 to 20.293μm), and there was no clear pattern in the other segments. The repeatability limits and the reproducibility limits of RS-3000 with follow-up off tended to be larger than or similar to that of the RS-3000 with follow-up on (repeatability range: 3.30 to 16.755μm and reproducibility range: 3.30 to 23.312μm).
G Chart
Repeatability and reproducibility of the G-chart thickness are summarized in table 5 through 11 below.
For the normal group, the repeatability and reproducibility limits were similar in all but 2 segments between the 2 settings of RS-3000 (repeatability limit range: 1.807 to 6.209um for the off setting and 1.807 to 4.501um for the on setting; the reproducibility limits had the same range as the repeatability limits). The repeatability limits of the 2 inferior/temporal segments were greater in the off setting than the on setting.
For the glaucoma group, the repeatability and reproducibility limits of the off setting tended to be greater than or similar to that of the on setting (repeatability limit range: 3.333 to 16.858µm for the off setting and 1.924 to 19.281 um for the on setting; reproducibility limit range: 6.616 to 28.245 um for the off setting and 1.924 to 29.736um for the on setting).
Retinal Nerve Fiber Laver
Repeatability and reproducibility of the retinal nerve fiber layer thickness are summarized in tables 5 through 11 below.
For the normal group, the repeatability limits (range: 6.682 to 20.661um) and the reproducibility limits (range: 6.682 to 21.575um) of RS-3000 with follow-up off tended to be larger than that of the RTVue (the repeatability limit range: 3.508 to 8.516um; the reproducibility limit range: 3.508 to 14.148µm). The repeatability limits and the reproducibility limits were similar between the two settings of RS-3000 (the repeatability limits and the reproducibility limits of RS-3000 On have the same range: 8.043 to 16.413um)
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For the glaucoma group, the repeatability limits of RS-3000 with follow-up off (range: 11.122 to 32.506um) tended to be larger than that of the RTVue (range: 3.67 to 10.291 um). The repeatability limits of the off setting were greater than or similar to the on setting (range: 7.525 to 20.766um). However, there is no clear pattern in the reproducibility limits between the RS-3000 with follow-up off (range: 15.591 to 46.568um) and RTVue (range: 6.533 to 26.092um). The reproducibility limits were similar between the two settings of RS-3000 (range of the on setting: 10.139 to 52.57um).
Optic Disc Analysis
Repeatability and reproducibility of the optic disc are summarized in tables 5 through 11 below.
For the normal group, the repeatability limits of RS-3000 with follow-up off (range: 0.058 to 0.478µm) tended to be larger in C/D horizontal, disc area and cup area, and smaller in C/D vertical than that of the RTVue (range: 0.073 to 0.196um). The reproducibility limits were similar between RS-3000 with follow-up off (range: 0.241 to 1.029µm) and RTVue (range: 0.238 to 1.039um), except for disc area in which the RS-3000 with follow-up off tended to be larger. The repeatability limits {range of on setting: 0.065 to 0.388μm) and the reproducibility limits {range of on setting: 0.211 to 1.092µm) were similar between the two settings of RS-3000, except for C/D horizontal in which the repeatability limit of the off setting tended to be larger than that of the on setting.
For the glaucoma group, the repeatability limits of RS-3000 with follow-up off (range: 0.087 to 0.318um) tended to be smaller in C/D horizontal and larger in disc area than that of the RTVue (range: 0.117 to 0.413µm). The two devices had similar repeatability limits in C/D vertical and cup area. The reproducibility limits of RS-3000 with follow-up off (range: 0.087 to 0.775um) tended to be smaller in C/D horizontal, C/D vertical and cup area, and larger in disc area than that of RTVue (range: 0.186 to 0.455um). The repeatability and reproducibility limits of the off setting were smaller than or similar to the on setting {repeatability limit range: 0.132 to 0.422um; reproducibility limit range: 0.132 to 0.918um).
Central Corneal Thickness
The repeatability limits of RS-3000 were larger than that of the RTVue in both the normal (8.15µm and 3.024um, respectively) and corneal groups (18.933um and 3.199um, respectively). The reproducibility limit of RS-3000 was larger than that of the RTVue in the normal group (31.336um and 3.024µm, respectively), but similar between the two devices in the corneal group (57.874µm and 53.963um, respectively).
{22}------------------------------------------------
Table 5: RS-3000 with Follow-up Off: Repeatability and Reproducibility in Measuring Retinal Thickness, G-Chart Thickness, RNFL, Optic Disc and Central Corneal Thickness Subjects With Normal Eyes
| Repeatability | Reproducibility | CV% | |||||
|---|---|---|---|---|---|---|---|
| n | SD | Limit | SD | Limit | Based onRepeatability | Based onReproducibility | |
| Total Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 1.642 | 4.596 | 1.642 | 4.596 | 0.531 | 0.531 |
| Nasal 2 | 12 | 1.537 | 4.302 | 1.537 | 4.302 | 0.450 | 0.450 |
| Center | 12 | 2.641 | 7.393 | 2.641 | 7.393 | 0.992 | 0.992 |
| Temporal 1 | 12 | 2.115 | 5.921 | 2.115 | 5.921 | 0.746 | 0.746 |
| Temporal 2 | 12 | 1.000 | 2.800 | 1.000 | 2.800 | 0.309 | 0.309 |
| Superior 1 | 12 | 1.354 | 3.791 | 1.354 | 3.791 | 0.459 | 0.459 |
| Superior 2 | 12 | 1.518 | 4.252 | 1.518 | 4.252 | 0.448 | 0.448 |
| Inferior 1 | 12 | 2.230 | 6.244 | 2.230 | 6.244 | 0.781 | 0.781 |
| Inferior 2 | 12 | 1.344 | 3.762 | 1.344 | 3.762 | 0.401 | 0.401 |
| Inner Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 0.898 | 2.513 | 0.898 | 2.513 | 0.798 | 0.798 |
| Nasal 2 | 12 | 1.700 | 4.759 | 1.700 | 4.759 | 1.481 | 1.481 |
| Temporal 1 | 12 | 1.394 | 3.905 | 1.394 | 3.905 | 1.599 | 1.599 |
| Temporal 2 | 12 | 1.179 | 3.300 | 1.179 | 3.300 | 1.150 | 1.150 |
| Superior 1 | 12 | 0.527 | 1.476 | 0.527 | 1.476 | 0.540 | 0.540 |
| Superior 2 | 12 | 1.564 | 4.378 | 1.564 | 4.378 | 1.341 | 1.341 |
| Inferior 1 | 12 | 1.179 | 3.300 | 1.179 | 3.300 | 1.211 | 1.211 |
| Inferior 2 | 12 | 1.944 | 5.442 | 1.944 | 5.442 | 1.681 | 1.681 |
| Outer Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 1.130 | 3.165 | 1.130 | 3.165 | 0.577 | 0.577 |
| Nasal 2 | 12 | 0.898 | 2.513 | 0.898 | 2.513 | 0.397 | 0.397 |
| Center | 12 | 1.434 | 4.015 | 1.434 | 4.015 | 0.655 | 0.655 |
| Temporal 1 | 12 | 0.866 | 2.425 | 0.866 | 2.425 | 0.442 | 0.442 |
| Temporal 2 | 12 | 1.054 | 2.952 | 1.054 | 2.952 | 0.478 | 0.478 |
| Superior 1 | 12 | 0.866 | 2.425 | 0.866 | 2.425 | 0.440 | 0.440 |
| Superior 2 | 12 | 1.027 | 2.877 | 1.027 | 2.877 | 0.464 | 0.464 |
| Inferior 1 | 12 | 1.106 | 3.096 | 1.797 | 5.032 | 0.589 | 0.957 |
| Inferior 2 | 12 | 1.491 | 4.174 | 1.491 | 4.174 | 0.681 | 0.681 |
| G Chart Thickness (µm) | |||||||
| Superior/Nasal 1 | 12 | 0.646 | 1.807 | 0.646 | 1.807 | 0.598 | 0.598 |
| Repeatability | Reproducibility | CV% | |||||
| n | SD | Limit | SD | Limit | Based on Repeatability | Based on Reproducibility | |
| Superior/Nasal 2 | 12 | 1.958 | 5.482 | 1.958 | 5.482 | 1.673 | 1.673 |
| Superior/Temporal 1 | 12 | 0.957 | 2.681 | 0.957 | 2.681 | 1.085 | 1.085 |
| Superior/Temporal 2 | 12 | 1.555 | 4.353 | 1.555 | 4.353 | 1.432 | 1.432 |
| Inferior/Nasal 1 | 12 | 0.898 | 2.513 | 0.898 | 2.513 | 0.836 | 0.836 |
| Inferior/Nasal 2 | 12 | 1.667 | 4.667 | 1.667 | 4.667 | 1.449 | 1.449 |
| Inferior/Temporal 1 | 12 | 1.528 | 4.277 | 1.528 | 4.277 | 1.676 | 1.676 |
| Inferior/Temporal 2 | 12 | 2.217 | 6.209 | 2.217 | 6.209 | 2.034 | 2.034 |
| Retinal Nerve Fiber Layer Thickness (µm) | |||||||
| Superior | 12 | 7.379 | 20.661 | 7.379 | 20.661 | 5.746 | 5.746 |
| Temporal | 12 | 4.381 | 12.267 | 4.381 | 12.267 | 7.070 | 7.070 |
| Inferior | 12 | 4.014 | 11.239 | 4.014 | 11.239 | 3.055 | 3.055 |
| Nasal | 12 | 6.593 | 18.461 | 7.705 | 21.575 | 8.063 | 9.422 |
| Total Mean | 12 | 2.386 | 6.682 | 2.386 | 6.682 | 2.347 | 2.347 |
| Optic Disc | |||||||
| C/D Horizontal | 12 | 0.050 | 0.141 | 0.123 | 0.344 | 9.302 | 22.701 |
| C/D Vertical | 12 | 0.021 | 0.058 | 0.086 | 0.241 | 4.184 | 17.325 |
| Disc Area (mm^2) | 12 | 0.171 | 0.478 | 0.365 | 1.023 | 7.598 | 16.251 |
| Cup Area (mm^2) | 12 | 0.055 | 0.155 | 0.368 | 1.029 | 8.112 | 53.949 |
| Central Corneal Thickness (µm) | |||||||
| 12 | 2.911 | 8.150 | 11.191 | 31.336 | 0.529 | 2.035 | |
| n | Repeatability | Reproducibility | CV% | ||||
| SD | Limit | SD | Limit | Based on Repeatability | Based on Reproducibility | ||
| Total Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 1.787 | 5.005 | 1.787 | 5.005 | 0.578 | 0.578 |
| Nasal 2 | 12 | 1.434 | 4.014 | 1.434 | 4.014 | 0.420 | 0.420 |
| Center | 12 | 2.339 | 6.550 | 2.339 | 6.550 | 0.872 | 0.872 |
| Temporal 1 | 12 | 1.658 | 4.643 | 1.658 | 4.643 | 0.583 | 0.583 |
| Temporal 2 | 12 | 1.641 | 4.596 | 1.641 | 4.596 | 0.507 | 0.507 |
| Superior 1 | 12 | 1.143 | 3.199 | 1.143 | 3.199 | 0.388 | 0.388 |
| Superior 2 | 12 | 1.354 | 3.791 | 1.354 | 3.791 | 0.400 | 0.400 |
| Inferior 1 | 12 | 1.764 | 4.939 | 1.764 | 4.939 | 0.615 | 0.615 |
| Inferior 2 | 12 | 0.986 | 2.761 | 0.986 | 2.761 | 0.294 | 0.294 |
| Inner Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 0.727 | 2.034 | 0.727 | 2.034 | 0.643 | 0.643 |
| Nasal 2 | 12 | 1.886 | 5.280 | 1.886 | 5.280 | 1.634 | 1.634 |
| Temporal 1 | 12 | 1.054 | 2.952 | 1.054 | 2.952 | 1.205 | 1.205 |
| Temporal 2 | 12 | 1.106 | 3.096 | 1.106 | 3.096 | 1.077 | 1.077 |
| Superior 1 | 12 | 0.745 | 2.087 | 0.745 | 2.087 | 0.763 | 0.763 |
| Superior 2 | 12 | 1.344 | 3.763 | 1.344 | 3.763 | 1.148 | 1.148 |
| Inferior 1 | 12 | 0.913 | 2.556 | 0.913 | 2.556 | 0.935 | 0.935 |
| Inferior 2 | 12 | 1.333 | 3.733 | 1.333 | 3.733 | 1.160 | 1.160 |
| Outer Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 1.518 | 4.252 | 1.518 | 4.252 | 0.776 | 0.776 |
| Nasal 2 | 12 | 0.943 | 2.640 | 0.943 | 2.640 | 0.418 | 0.418 |
| Center | 12 | 1.225 | 3.429 | 1.225 | 3.429 | 0.558 | 0.558 |
| Temporal 1 | 12 | 0.882 | 2.469 | 0.882 | 2.469 | 0.449 | 0.449 |
| Temporal 2 | 12 | 1.093 | 3.060 | 1.093 | 3.060 | 0.495 | 0.495 |
| Superior 1 | 12 | 0.764 | 2.139 | 0.764 | 2.139 | 0.388 | 0.388 |
| Superior 2 | 12 | 1.080 | 3.024 | 1.080 | 3.024 | 0.488 | 0.488 |
| Inferior 1 | 12 | 1.202 | 3.365 | 1.202 | 3.365 | 0.637 | 0.637 |
| Inferior 2 | 12 | 1.118 | 3.130 | 1.118 | 3.130 | 0.510 | 0.510 |
| G Chart Thickness (µm) | |||||||
| Superior/Nasal 1 | 12 | 0.646 | 1.807 | 0.646 | 1.807 | 0.596 | 0.596 |
| n | Repeatability | Reproducibility | CV% | ||||
| SD | Limit | SD | Limit | Based onRepeatability | Based onReproducibility | ||
| Superior/Nasal 2 | 12 | 1.581 | 4.427 | 1.581 | 4.427 | 1.343 | 1.343 |
| Superior/Temporal 1 | 12 | 1.000 | 2.800 | 1.000 | 2.800 | 1.130 | 1.130 |
| Superior/Temporal 2 | 12 | 1.118 | 3.130 | 1.118 | 3.130 | 1.023 | 1.023 |
| Inferior/Nasal 1 | 12 | 0.799 | 2.238 | 0.799 | 2.238 | 0.743 | 0.743 |
| Inferior/Nasal 2 | 12 | 1.607 | 4.501 | 1.607 | 4.501 | 1.400 | 1.400 |
| Inferior/Temporal 1 | 12 | 0.882 | 2.469 | 0.882 | 2.469 | 0.963 | 0.963 |
| Inferior/Temporal 2 | 12 | 1.213 | 3.397 | 1.213 | 3.397 | 1.119 | 1.119 |
| Retinal Nerve Fiber Layer Thickness ( $\mu$ m) | |||||||
| Superior | 12 | 5.862 | 16.413 | 5.862 | 16.413 | 4.578 | 4.578 |
| Temporal | 12 | 3.508 | 9.822 | 3.508 | 9.822 | 5.529 | 5.529 |
| Inferior | 12 | 4.696 | 13.150 | 4.696 | 13.150 | 3.604 | 3.604 |
| Nasal | 12 | 5.006 | 14.017 | 5.006 | 14.017 | 6.268 | 6.268 |
| Total Mean | 12 | 2.872 | 8.043 | 2.872 | 8.043 | 2.835 | 2.835 |
| Optic Disc | |||||||
| C/D Horizontal | 12 | 0.035 | 0.097 | 0.096 | 0.270 | 6.674 | 18.511 |
| C/D Vertical | 12 | 0.023 | 0.065 | 0.075 | 0.211 | 4.738 | 15.328 |
| Disc Area (mm^2) | 12 | 0.138 | 0.388 | 0.390 | 1.092 | 6.220 | 17.527 |
| Cup Area (mm^2) | 12 | 0.059 | 0.164 | 0.322 | 0.902 | 9.151 | 50.283 |
| Repeatability | Reproducibility | CV% | |||||
| n | SD | Limit | SD | Limit | Based onRepeatability | Based onReproducibility | |
| Total Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 10.127 | 28.356 | 10.127 | 28.356 | 3.233 | 3.233 |
| Nasal 2 | 12 | 7.145 | 20.007 | 7.145 | 20.007 | 2.144 | 2.144 |
| Center | 12 | 4.106 | 11.497 | 4.106 | 11.497 | 1.391 | 1.391 |
| Temporal 1 | 12 | 11.590 | 32.453 | 11.590 | 32.453 | 4.151 | 4.151 |
| Temporal 2 | 12 | 2.708 | 7.583 | 2.708 | 7.583 | 0.846 | 0.846 |
| Superior 1 | 12 | 2.160 | 6.049 | 2.160 | 6.049 | 0.732 | 0.732 |
| Superior 2 | 12 | 3.232 | 9.049 | 3.232 | 9.049 | 0.957 | 0.957 |
| Inferior 1 | 12 | 2.698 | 7.554 | 2.698 | 7.554 | 0.940 | 0.940 |
| Inferior 2 | 12 | 3.253 | 9.109 | 3.253 | 9.109 | 0.977 | 0.977 |
| Inner Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 5.058 | 14.162 | 5.058 | 14.162 | 4.331 | 4.331 |
| Nasal 2 | 12 | 4.857 | 13.598 | 4.857 | 13.598 | 4.303 | 4.303 |
| Temporal 1 | 12 | 3.375 | 9.449 | 3.375 | 9.449 | 3.757 | 3.757 |
| Temporal 2 | 12 | 3.041 | 8.516 | 3.041 | 8.516 | 2.807 | 2.807 |
| Superior 1 | 12 | 2.021 | 5.658 | 2.021 | 5.658 | 1.934 | 1.934 |
| Superior 2 | 12 | 3.460 | 9.688 | 3.460 | 9.688 | 2.949 | 2.949 |
| Inferior 1 | 12 | 1.849 | 5.176 | 1.849 | 5.176 | 1.823 | 1.823 |
| Inferior 2 | 12 | 2.934 | 8.217 | 2.934 | 8.217 | 2.392 | 2.392 |
| Outer Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 7.165 | 20.061 | 7.165 | 20.061 | 3.657 | 3.657 |
| Nasal 2 | 12 | 7.057 | 19.760 | 9.093 | 25.459 | 3.209 | 4.134 |
| Center | 12 | 4.113 | 11.517 | 4.113 | 11.517 | 1.843 | 1.843 |
| Temporal 1 | 12 | 8.448 | 23.653 | 8.448 | 23.653 | 4.470 | 4.470 |
| Temporal 2 | 12 | 4.010 | 11.229 | 4.010 | 11.229 | 1.898 | 1.898 |
| Superior 1 | 12 | 1.772 | 4.961 | 1.772 | 4.961 | 0.933 | 0.933 |
| Superior 2 | 12 | 2.949 | 8.256 | 2.949 | 8.256 | 1.343 | 1.343 |
| Inferior 1 | 12 | 1.871 | 5.239 | 1.871 | 5.239 | 1.011 | 1.011 |
| Inferior 2 | 12 | 3.167 | 8.867 | 3.167 | 8.867 | 1.510 | 1.510 |
{23}------------------------------------------------
K12/622
K121622 510(k) Summary
All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance
CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD
Repeatability limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Program: RR.sas (11DEC2012 20:58:33)
{24}------------------------------------------------
Table 6: RS-3000 with Follow-up On: Repeatability and Reproducibility in Measuring Retinal Thickness, G-Chart Thickness, RNFL and Optic Disc Subjects With Normal Eyes
{25}------------------------------------------------
K12/622
K121622 510{k) Summary
All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes Repeatability SD = Square root of the residual variance
Repeatability SD = Square root of the residual variance
Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance
CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the
repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Program: RR.sas (11DEC2012 20:58:33)
{26}------------------------------------------------
.
Table 7: RS-3000 with Follow-up Off: Repeatability and Reproducibility in Measuring Retinal Thickness Subjects With Retinal Disease
{27}------------------------------------------------
| Repeatability | Reproducibility | CV% | |||||
|---|---|---|---|---|---|---|---|
| n | SD | Limit | SD | Limit | Based onRepeatability | Based onReproducibility | |
| All statistics are estimated from a nested ANOVA model with random effectsoperator/device and eyes within operator/device using all accepted scans.n = Number of eyes | |||||||
| n | Repeatability | Reproducibility | CV% | ||||
| SD | Limit | SD | Limit | Based onRepeatability | Based onReproducibility | ||
| Total Retinal Thickness (um) | |||||||
| Nasal 1 | 12 | 5.984 | 16.755 | 5.984 | 16.755 | 1.907 | 1.907 |
| Nasal 2 | 12 | 8.033 | 22.492 | 8.033 | 22.492 | 2.399 | 2.399 |
| Center | 12 | 5.250 | 14.699 | 5.250 | 14.699 | 1.767 | 1.767 |
| Temporal 1 | 12 | 9.787 | 27.403 | 9.787 | 27.403 | 3.508 | 3.508 |
| Temporal 2 | 12 | 2.774 | 7.767 | 2.774 | 7.767 | 0.868 | 0.868 |
| Superior 1 | 12 | 1.650 | 4.620 | 1.650 | 4.620 | 0.558 | 0.558 |
| Superior 2 | 12 | 2.455 | 6.874 | 2.455 | 6.874 | 0.722 | 0.722 |
| Inferior 1 | 12 | 2.533 | 7.093 | 2.533 | 7.093 | 0.882 | 0.882 |
| Inferior 2 | 12 | 2.088 | 5.847 | 2.088 | 5.847 | 0.632 | 0.632 |
| Inner Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 1.202 | 3.365 | 1.202 | 3.365 | 1.031 | 1.031 |
| Nasal 2 | 12 | 6.438 | 18.026 | 6.438 | 18.026 | 5.654 | 5.654 |
| Temporal 1 | 12 | 4.580 | 12.823 | 4.580 | 12.823 | 5.122 | 5.122 |
| Temporal 2 | 12 | 2.764 | 7.739 | 2.764 | 7.739 | 2.555 | 2.555 |
| Superior 1 | 12 | 1.667 | 4.667 | 1.667 | 4.667 | 1.583 | 1.583 |
| Superior 2 | 12 | 1.443 | 4.042 | 1.443 | 4.042 | 1.217 | 1.217 |
| Inferior 1 | 12 | 2.211 | 6.191 | 2.211 | 6.191 | 2.168 | 2.168 |
| Inferior 2 | 12 | 1.555 | 4.353 | 1.555 | 4.353 | 1.284 | 1.284 |
| Outer Retinal Thickness (µm) | |||||||
| Nasal 1 | 12 | 5.984 | 16.755 | 8.326 | 23.312 | 3.040 | 4.230 |
| Nasal 2 | 12 | 4.890 | 13.693 | 5.412 | 15.153 | 2.218 | 2.455 |
| Center | 12 | 3.136 | 8.780 | 3.136 | 8.780 | 1.405 | 1.405 |
| Temporal 1 | 12 | 5.354 | 14.992 | 5.354 | 14.992 | 2.834 | 2.834 |
| Temporal 2 | 12 | 3.100 | 8.681 | 3.100 | 8.681 | 1.469 | 1.469 |
| Superior 1 | 12 | 1.247 | 3.492 | 1.247 | 3.492 | 0.657 | 0.657 |
| Superior 2 | 12 | 2.603 | 7.290 | 2.603 | 7.290 | 1.180 | 1.180 |
| Inferior 1 | 12 | 1.179 | 3.300 | 1.179 | 3.300 | 0.638 | 0.638 |
| Inferior 2 | 12 | 2.345 | 6.567 | 2.345 | 6.567 | 1.122 | 1.122 |
.
residual variance CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Program: RR.sas (11DEC2012 20:58:33)
{28}------------------------------------------------
K72/622
Table 8: RS-3000 with Follow-up On: Repeatability and Reproducibility in Measuring Retinal Thickness Subjects With Retinal Disease
{29}------------------------------------------------
30
All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes Repeatability SD = Square root of the residual variance Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Program: RR.sas (11DEC2012 20:58:33)
{30}------------------------------------------------
Table 9: RS-3000 with Follow-up Off: Repeatability and Reproducibility in Measuring G-Chart Thickness, RNFL and Optic Disc Subjects With Glaucoma
| Repeatability | Reproducibility | CV% | |||||
|---|---|---|---|---|---|---|---|
| n | SD | Limit | SD | Limit | Based onRepeatability | Based onReproducibility | |
| G Chart Thickness (µm) | |||||||
| Superior/Nasal 1 | 12 | 1.258 | 3.523 | 10.088 | 28.245 | 1.456 | 11.673 |
| Superior/Nasal 2 | 12 | 2.517 | 7.047 | 2.517 | 7.047 | 2.609 | 2.609 |
| Superior/Temporal 1 | 12 | 1.787 | 5.004 | 2.912 | 8.153 | 2.567 | 4.181 |
| Superior/Temporal 2 | 12 | 2.363 | 6.616 | 2.363 | 6.616 | 2.681 | 2.681 |
| Inferior/Nasal 1 | 12 | 1.190 | 3.333 | 9.991 | 27.974 | 1.480 | 12.419 |
| Inferior/Nasal 2 | 12 | 4.916 | 13.765 | 6.738 | 18.867 | 5.251 | 7.198 |
| Inferior/Tempora11 | 12 | 2.718 | 7.611 | 5.130 | 14.365 | 4.079 | 7.699 |
| Inferior/Tempora12 | 12 | 6.021 | 16.858 | 6.021 | 16.858 | 6.972 | 6.972 |
| Retinal Nerve Fiber Layer Thickness (µm) | |||||||
| Superior | 12 | 5.568 | 15.591 | 5.568 | 15.591 | 6.629 | 6.629 |
| Temporal | 12 | 4.964 | 13.899 | 5.781 | 16.185 | 9.405 | 10.953 |
| Inferior | 12 | 6.039 | 16.910 | 6.039 | 16.910 | 7.531 | 7.531 |
| Nasal | 12 | 11.609 | 32.506 | 16.631 | 46.568 | 17.769 | 25.456 |
| Total Mean | 12 | 3.972 | 11.122 | 6.370 | 17.837 | 5.586 | 8.958 |
| Optic Disc | |||||||
| C/D Horizontal | 12 | 0.056 | 0.158 | 0.056 | 0.158 | 6.925 | 6.925 |
| C/D Vertical | 12 | 0.031 | 0.087 | 0.031 | 0.087 | 4.039 | 4.039 |
| Disc Area (mm^2) | 12 | 0.096 | 0.269 | 0.277 | 0.775 | 4.505 | 12.971 |
| Cup Area (mm^2) | 12 | 0.114 | 0.318 | 0.114 | 0.318 | 8.409 | 8.409 |
.
{31}------------------------------------------------
K12/622
32
All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes Repeatability SD = Square root of the residual variance Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance
CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD
Repeatability limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Program: RR.sas (11DEC2012 20:58:33)
{32}------------------------------------------------
33
Table 10: RS-3000 with Follow-up On: Repeatability and Reproducibility in Measuring G-Chart Thickness, RNFL and Optic Disc Subjects With Glaucoma
| Repeatability | Reproducibility | CV% | |||||
|---|---|---|---|---|---|---|---|
| n | SD | Limit | SD | Limit | Based on Repeatability | Based on Reproducibility | |
| G Chart Thickness (µm) | |||||||
| Superior/Nasal 1 | 12 | 1.624 | 4.549 | 10.121 | 28.338 | 1.868 | 11.640 |
| Superior/Nasal 2 | 12 | 6.886 | 19.281 | 8.994 | 25.183 | 6.999 | 9.141 |
| Superior/Temporal 1 | 12 | 1.691 | 4.736 | 1.691 | 4.736 | 2.423 | 2.423 |
| Superior/Temporal 2 | 12 | 2.427 | 6.795 | 2.427 | 6.795 | 2.739 | 2.739 |
| Inferior/Nasal 1 | 12 | 1.225 | 3.429 | 10.620 | 29.736 | 1.508 | 13.080 |
| Inferior/Nasal 2 | 12 | 4.173 | 11.685 | 6.041 | 16.916 | 4.429 | 6.412 |
| Inferior/Temporal 11 | 12 | 0.687 | 1.924 | 0.687 | 1.924 | 1.015 | 1.015 |
| Inferior/Temporal 12 | 12 | 3.902 | 10.924 | 3.902 | 10.924 | 4.526 | 4.526 |
| Retinal Nerve Fiber Layer Thickness (µm) | |||||||
| Superior | 12 | 7.416 | 20.766 | 7.416 | 20.766 | 9.020 | 9.020 |
| Temporal | 12 | 3.621 | 10.139 | 3.621 | 10.139 | 7.386 | 7.386 |
| Inferior | 12 | 6.654 | 18.632 | 7.337 | 20.543 | 8.648 | 9.535 |
| Nasal | 12 | 5.972 | 16.722 | 18.775 | 52.570 | 9.534 | 29.973 |
| Total Mean | 12 | 2.687 | 7.525 | 6.364 | 17.820 | 3.934 | 9.318 |
| Optic Disc | |||||||
| C/D Horizontal | 12 | 0.047 | 0.132 | 0.047 | 0.132 | 5.849 | 5.849 |
| C/D Vertical | 12 | 0.055 | 0.155 | 0.055 | 0.155 | 7.142 | 7.142 |
| Disc Area (mm^2) | 12 | 0.149 | 0.417 | 0.328 | 0.918 | 7.136 | 15.717 |
| Cup Area (mm^2) | 12 | 0.151 | 0.422 | 0.151 | 0.422 | 11.323 | 11.323 |
{33}------------------------------------------------
K12/622
K121622 510(k) Summary
All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eyes Repeatability SD = Square root of the residual variance Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD
Reproducibility limit = 2.8 x Reproducibility SD
Program: RR.sas (11DEC2012 20:58:33)
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K12/622
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Table 11: RS-3000 with Follow-up Off: Repeatability and Reproducibility in Measuring Central Corneal Thickness Subjects With Corneal Disease
| Repeatability | Reproducibility | CV% | |||||
|---|---|---|---|---|---|---|---|
| n | SD | Limit | SD | Limit | Based onRepeatability | Based onReproducibility | |
| Central Corneal Thickness (μm) | 12 | 6.762 | 18.933 | 20.669 | 57.874 | 1.283 | 3.922 |
All statistics are estimated from a nested ANOVA model with random effects operator/device and eyes within operator/device using all accepted scans. n = Number of eves Repeatability SD = Square root of the residual variance Reproducibility SD = Square root of the sum of the operator/device variance and the residual variance CV% = Coefficient of variation in % = SD/Intercept x 100%, SD is either the repeatability SD or the reproducibility SD Repeatability limit = 2.8 x Repeatability SD Reproducibility limit = 2.8 x Reproducibility SD
Program: RR.sas (11DEC2012 20:58:33)
CONCLUSIONS
In summary, Nidek Co., Ltd., is of the opinion that the Nidek Optical Coherence Tomography RS-3000, with Image Filing Software NAVIS-EX, does not introduce any new potential safety risks, are as effective, and perform as well as the predicate device(s).
WARNING: Clinical studies indicate that measurements of retinal layer thickness for central corneal thickness] performed by the RS-3000 sometimes differs from those of OCT devices made by other manufacturers, due to differences in segmentation software. Measurements made on different devices are not interchangeable.
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Image /page/35/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake entwined around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nidek Co., Ltd. % Ms. Lena Sattler Orasi Consulting, LLC. 1667 Ridgewood Rd. Wadsworth, OH 44281
Re: K121622 Trade/Device Name: RS-3000 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope, AC Powered Regulatory Class: Class II Product Code: OBO Dated: March 4, 2013 Received: March 7, 2013
Dear Ms. Sattler:
This letter corrects our substantially equivalent letter of March 14, 2013.
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 (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.
MAR 1 5 2013
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 (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
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Deborah Liftalls -S
for Malvina B. Eydelman, M.D. Director Division of Opthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT: RS-3000
510(k) Number (if known): K121622
Device Name: RS-3000
Indications for Use:
The Nidek Optical Coherence Tomography RS-3000 including scanning laser ophthalmoscope function with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
-
. the retina, retinal nerve fiber layer, and optic disc, and
AND/OR -
. the anterior chamber and cornea (when used with the optional auxiliary anterior chamber adapter),
as an aid in the diagnosis and management of adults having or suspected of having ocular disease.
Prescription Use _ X __ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Charles Chiang 2013.03 1413.56:57 -04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K121622
§ 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.