(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.
§ 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.