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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:

• 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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The Cirrus™ HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative Databases is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.

The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The Cirrus normative databases are quantitative tools for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The Cirrus HD-OCT is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

The Cirrus™ HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of anterior and posterior ocular structures (including cornea, retina, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this noninvasive optical technique, Cirrus HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye).

The Cirrus HD-OCT is offered in two models, Model 4000 and Model 400. In the Cirrus HD-OCT Model 4000 instrument, the fundus camera is a line scanning ophthalmoscope. The Cirrus HD-OCT Model 400 is similar to the Model 4000 except that it provides the fundus image using the OCT scanner only.

The acquired imaging data can be analyzed to provide thickness and area measurements of regions of interest to the clinician. The system uses acquired data to determine the fovea location or the optic disc location. Measurements can then be oriented using the fovea and/or optic disc locations. The patient's results can be compared to subjects without disease for measurements of RNFL thickness, neuroretinal rim area, average and vertical cup-to-disc area ratio, cup volume, macular thickness and ganglion cell plus inner plexiform layer thickness.

Visit-to-visit comparison of images and measurements is available for the macula. Specifically, change in macular thickness, area and volume of Retinal Pigment Epithelium (RPE) elevations, area of sub-RPE illumination and distance of Sub-RPE illumination to the fovea. Change analysis of multiple visits, up to eight, can be performed for RNFL thickness, neuroretinal rim area, average and vertical cup-to-disc area ratio, cup volume, and macular thickness.

The provided document describes the predicate device and the clinical studies performed to support the substantial equivalence of the "Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative Databases" (Cirrus HD-OCT). The clinical evaluation focuses on demonstrating the device's measurement capabilities and the establishment of normative databases.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the overall device's performance against a gold standard for disease detection or management. Instead, the studies presented focus on the repeatability and reproducibility of various measurements performed by the device and the comparability of certain automated measurements to expert manual measurements from different imaging modalities.

The tables below summarize the specified repeatability and reproducibility limits (acceptance criteria as per ISO 5725-1 and ISO 5725-6, defined as the upper 95% limit for the difference between repeated results) and the reported performance (SD and limits).

Table 1. Repeatability and Reproducibility of Area of Sub-RPE Illumination (Automated Algorithm)

Table 2. Repeatability and Reproducibility of Closest Distance to Fovea (Automated Algorithm)

Table 3. Repeatability and Reproducibility of Area of Sub-RPE Illumination (Manually Edited)

Table 4. Repeatability and Reproducibility of Closest Distance to Fovea (Manually Edited)

Table 5. Repeatability and Reproducibility of Area of RPE Elevations

Table 6. Repeatability and Reproducibility of Volume of RPE Elevations

Table 7. Cirrus Repeatability and Reproducibility of GCA and ONH Parameters - Normal Subjects

Table 8. Repeatability and Visit-to-Visit Variability of ONH Parameters - Glaucomatous Subjects

Table 9. Repeatability of GCA Parameters - Glaucomatous Subjects

Summary of Studies Demonstrating Acceptance:

The studies listed above (Advanced RPE Analysis Study, measurements of Elevated RPE, Repeatability and Reproducibility studies) and the establishment of the normative databases serve as the proof that the device meets its intended use and demonstrates substantial equivalence. The "acceptance criteria" appear to be the demonstrated repeatability and reproducibility limits themselves, calculated according to ISO 5725-1 and ISO 5725-6 standards, or the statistical comparability (e.g., paired t-test showing no significant difference, good correlation R+) in the case of the RPE illumination comparison.

2. Sample Sizes used for the Test Set and Data Provenance:

• Advanced RPE Analysis Study (Areas of Increased Illumination):
  • Test Set Sample Size: 52 eyes from 52 subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it was a "non-significant risk clinical study" with "Four sites participated in the clinical data collection." The study was conducted on subjects evaluated for dry AMD with geographic atrophy. The study compares Cirrus HD-OCT automated measurements to FAF images (an existing, accepted modality). This implies a prospective data collection for this comparison.
• Advanced RPE Analysis Study (Measurements of Elevated RPE):
  • Test Set Sample Size: 70 eyes from 70 subjects were considered; the number included in final analysis is not explicitly stated but implies a similar number after qualification.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but "Three sites participated in the clinical data collection." Subjects were 50 years or older with dry age-related macular degeneration (AMD) with macular drusen. This implies a prospective data collection for this comparison.
• Measurements of Area of Increased Illumination Under the RPE Repeatability and Reproducibility:
  • Test Set Sample Size: Phase 1: 49 eyes of 37 subjects. Phase 2: 53 eyes of 39 subjects.
  • Data Provenance: "Single-site clinical study." The subjects had dry AMD with geographic atrophy. This suggests prospective data collection.
• Measurements of Elevated RPE Repeatability and Reproducibility:
  • Test Set Sample Size: Phase 1: 26 eyes of 23 subjects. Phase 2: 24 eyes of 21 subjects.
  • Data Provenance: "Single-site clinical study." The subjects had dry AMD with macular drusen. This suggests prospective data collection.
• Optic Nerve Head and Ganglion Cell Analysis Repeatability and Reproducibility (Normal Subjects):
  • Test Set Sample Size: 63 normal subjects.
  • Data Provenance: Not explicitly stated (e.g., multi-site, country). This suggests prospective data collection.
• Optic Nerve Head Parameters Repeatability and Visit-to-Visit Variability (Glaucomatous Subjects):
  • Test Set Sample Size: 55 glaucomatous subjects.
  • Data Provenance: Not explicitly stated (e.g., multi-site, country). This suggests prospective data collection.
• GCA Parameters Repeatability (Glaucomatous Subjects):
  • Test Set Sample Size: 119 subjects with glaucoma enrolled; 94 subjects with two qualified scans each were included in the analysis.
  • Data Provenance: "clinical study conducted at four sites." Not explicitly stated (e.g., country). This suggests prospective data collection.

3. Number of Experts used to Establish the Ground Truth for the Test Set and Qualifications:

• Advanced RPE Analysis Study (Areas of Increased Illumination): Ground truth was established by "expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images." The number and specific qualifications of these experts are not specified in the document.
• Advanced RPE Analysis Study (Measurements of Elevated RPE): Ground truth was established by "manually drawn by experts designated as drusen on color fundus photographs (CFPs)." The number and specific qualifications of these experts are not specified in the document.
• For repeatability and reproducibility studies, the ground truth is implicitly the repeated measurements themselves by the device, as the studies aim to quantify the variation within the device's measurements, not compare them against an external gold standard by human experts for classifications.

4. Adjudication Method:

• For the studies comparing automated measurements to expert manual measurements (e.g., Advanced RPE Analysis), the adjudication method is not explicitly stated. It mentions "expert manual measurements" and "manually drawn by experts," implying these were used as reference, but how inconsistencies between experts (if there were multiple) were resolved is not detailed.
• For the repeatability and reproducibility studies, adjudication doesn't apply in the traditional sense, as these studies focus on the intrinsic variation of the device's measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was described where human readers' performance with and without AI assistance was evaluated. The studies primarily focus on the device's measurement accuracy, repeatability, and reproducibility, and the establishment of normative databases. The comparison for RPE illumination detection was between the device's automated measurements and expert manual measurements from a different imaging modality, not an AI-assisted human vs. human-alone scenario.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, the comparability studies for Advanced RPE Analysis (Areas of Increased Illumination and Elevated RPE) assess the device's "automated measurements" (automated algorithm) against expert manual measurements from other imaging modalities. These can be considered standalone performance assessments of specific algorithms within the device.
• Similarly, all the repeatability and reproducibility studies for various parameters (GCA, ONH, RPE illumination, RPE elevations) assess the intrinsic performance of the device's measurement algorithms in a standalone manner, quantifying their consistency.

7. The Type of Ground Truth Used:

• Advanced RPE Analysis Study (Areas of Increased Illumination): Ground truth was "expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images." This is a form of expert consensus/manual delineation using another imaging modality.
• Advanced RPE Analysis Study (Measurements of Elevated RPE): Ground truth was "manually drawn by experts designated as drusen on color fundus photographs (CFPs)." This is also a form of expert consensus/manual delineation using another imaging modality.
• Normative Databases (RNFL, Macular, Optic Nerve Head, Ganglion Cell): The ground truth for these databases is implicitly the classification of subjects as "normal" based on clinical criteria (not specified in detail, but implied by the selection of normal subjects). The measurements are then statistically analyzed to establish reference values.
• For repeatability and reproducibility studies, the ground truth is the repeated measurements, not an external gold standard.

8. The Sample Size for the Training Set:

The document doesn't explicitly mention "training sets" as it would for a typical machine learning algorithm development (e.g., deep learning). The device is likely based on established image processing algorithms.

• The normative databases serve a similar function to a reference set, providing "normal" ranges for comparison in diagnosis.
  • Optic Nerve Head Normative Database: Derived from a "post-hoc analysis" of 282 eyes from 284 subjects (aged 19-84 years) included in a previous RNFL normative database (K083291).
  • Ganglion Cell Normative Database: Utilized the "same 282 subjects, aged 19-84 years that were deemed representative of a normal population" as the original macula normative database (K083291).

9. How the Ground Truth for the Training Set was Established:

• For the normative databases, the "ground truth" for inclusion was that the subjects were considered "normal." The document states the subjects (n=282) were "deemed representative of a normal population." However, the specific criteria or methods (e.g., expert clinical review, exclusion criteria) used to define and confirm these subjects as "normal" are not detailed in this summary. The data were collected from "seven sites."

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