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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 iVue with Normative Database is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The i Vue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

iVue with Normative Database (NDB) is a modification of its predicate device iVue (K091404) through the inclusion of the database collected with the iVue. The intent of use, system performance, majority of sub-assemblies, and key components of the iVue with NDB are all the same as iVue and RTVue with NDB.

iVue with NDB, based on the same Optical Coherence Tomography (OCT) technology that is used in the predicate device iVue (K091404) and RTVue with NDB (K101505), is a noninvasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue with NDB are designed and manufactured by Optovue, Inc.

The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K091404). The current submission is for a software modification through the addition of a normative database feature, similar to the NDB feature on the cleared predicate device RTV ue with NDB (K101505). With the addition of the normative database (NDB), the iVue can compare the measured data from the Retina Map scan, the Nerve Fiber scan, and the iWellness scan, to the normative database. The iVue/RTVue with Normative Database provide a comparison of the scanned measurements to a database of known normal subjects to provide a reference of where the patient's measurement stands in relation to the normative distribution. The iVue with normative database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and diseases. There is no hardware change from the 510(k) cleared iVue System (K091404). Additional scan patterns and acquisition of 3-D disc scan as ONH scan reference, optic disc analysis, and modification of the blood vessel extraction for the retina map scan are other software changes implemented in the current submission. These software changes are similar to features in the predicate RTVue device (K101505) and do not impact the safety and effectiveness of the system.

The device scans a patient's eye and uses a low coherence interferometer to measure the reflectivity of the retinal and corneal tissue. The cross sectional B-scan of the retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The patient will rest their head on the forehead and chin rest while the operator uses a joystick to align the device to the patient's eve. The computer has a graphic user interface for acquiring and analyzing the image.

iVue with NDB has similar scan patterns and analysis functions as the predicate device RTVue with NDB.

Here's a breakdown of the acceptance criteria and study information for the Optovue iVue NDB, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the repeatability and reproducibility of the iVue with NDB. While explicit "acceptance criteria" for performance are not directly stated in the traditional sense (e.g., a specific target for reproducibility SD), the study's goal is to show that the iVue's performance is "reasonably similar" and "substantially equivalent" to the predicate RTVue with NDB. The reported performance is captured in tables of repeatability and reproducibility, as well as comparison against the predicate device.

Implicit Acceptance Criteria (Performance should be "reasonably similar" and "substantially equivalent" to predicate):

2. Sample size used for the test set and the data provenance:

• Repeatability and Reproducibility Study:

  • Test Set Sample Size: 14 normal subjects, 13 patients with glaucoma, 13 patients with retina disease. Only one eye per subject was included.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study design indicates it was a "repeatability and reproducibility study... conducted with IRB approval," suggesting a prospective clinical study environment.

• Comparison to Predicate Device Study:

  • Test Set Sample Size:
    • GCC comparison: 21 subjects (normal group), 24 subjects (glaucoma group).
    • ONH (Disc Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • ONH (RNFL Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • Retina Map comparison: 21 subjects (normal group), 19 subjects (retina group).
    • iWellness (GCC Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • iWellness (Retina Parameters) comparison: 21 subjects (normal group), 16 subjects (retina group).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The comparison study implicitly uses data collected with the iVue and the predicate RTVue from the same or similar populations to assess equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document describes studies for repeatability and reproducibility of measurements and comparison against a predicate device. These types of studies typically do not involve experts establishing "ground truth" for diagnosis in the test set. Instead, the "ground truth" for these studies is the actual measurement obtained by the device (or predicate device) itself.
• The subjects are categorized as "normal," "glaucoma," or "retina disease," implying that these diagnoses were established clinically, presumably by ophthalmologists, but the document does not specify the number or qualifications of these diagnostic experts.

4. Adjudication method for the test set:

• No explicit adjudication method is mentioned for the test set in the context of establishing a diagnostic ground truth. The studies focus on device measurement precision and equivalence.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, 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 done, as this submission is for an Optical Coherence Tomography (OCT) system that provides quantitative measurements and a normative database comparison, not an AI-assisted diagnostic tool that human readers would interpret. The device itself performs the measurements and comparisons.

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

• Yes, the performance presented is standalone in the sense that the device's measurement repeatability, reproducibility, and comparison to a known database are evaluated directly. The iVue with NDB is an imaging device that provides quantitative data and a normative comparison; its output (color-coded percentile categories) is directly generated by the algorithm based on the acquired OCT images. Human operators acquire the images, but the measurement and comparison algorithms function independently.

7. The type of ground truth used:

• For Repeatability and Reproducibility studies: The "ground truth" is the device's own measurement. The studies assess how consistently the device produces these measurements under repeated conditions.
• For Comparison to Predicate Device studies: The "ground truth" for comparison is the measurement obtained by the predicate device (RTVue with NDB). The iVue with NDB's measurements are compared to the predicate's measurements to establish substantial equivalence.
• The normative database used by the device serves as a reference "ground truth" for defining "normal," "borderline," or "outside normal" ranges for patient measurements. The database was populated using data from "known normal subjects."

8. The sample size for the training set:

• The document states that the iVue normative database was established using a "nearly identical methodology as that of the predicate RTVue with NDB." It also mentions "the total number of normal subjects is also similar in the two normative databases."
• For the RTVue with NDB (predicate), which the iVue NDB is compared to, the previous 510(k) (K101505) would contain the detailed training set information. This document does not explicitly state the training set size for the iVue NDB itself, other than implying it's similar to the RTVue NDB. A previous submission for RTVue NDB (K101505) described collecting data from 300 normal subjects (as mentioned in other similar submissions).

9. How the ground truth for the training set was established:

• The "ground truth" for the normative database (which can be considered the training set for the "normal" ranges) was established by collecting data from "known normal subjects."
• Specific details mentioned:
  • "The iVue normative database collection was based on a similar study design, study protocol, and data collection method as those of predicate RTVue NDB data collection."
  • "The inclusion and exclusion criteria are identical in the two protocols."
  • Image quality review criteria were similar.
  • The database contains a "mixture of ethnicities, and have similar age, gender, and refractive error range coverage."
  • Regression models were employed to estimate normative limits, taking into account covariates such as age, signal strength, and optic disc size.
  • The comparison is displayed in color-coded percentile categories ('within normal', 'borderline', or 'outside normal') based on cut-off levels of 5% and 1%, which would have been derived from the statistical analysis of this normative database.

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The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and the other ocular structures of the anterior segment of the eve, including pachymetry and corneal power.

The already cleared (K071250) RTVue CA Module (CAM) is an instrument based on Fourier-Domain Optical Coherence Tomography (OCT) for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye with US FDA 510(k) clearance (K071250) in 2007. The RTVue CAM has been used in clinical practice for imaging the cornea, measuring corneal thickness, and visualizing the anterior segment angle. The RTVue CAM device uses the same Optical Coherence Tomography (OCT) technology that was previously cleared by FDA (K101505). The CAM adapter gives the user an option to use the RTVue device as previously approved for retina scans, or to use it for cornea and anterior eye scans. Aside from the CAM auxiliary attachment, the RTVue is virtually unchanged for the CAM use except the CAM software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina. The system scans a beam into patient's eye and uses a low coherence interferometer to measure the reflectivity of the ocular tissue. The cross-sectional ocular tissue structure is composed of sequence of A-scans. The RTVue has a traditional patient and instrumentinterface like most ophthalmic devices. The device is mounted on a motorized patient table. The patient will rest their head on the forehead and chin rest. The operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring, and displaying the acquired image. The RTVue image acquisition speed and image resolution remain the same when used in conjunction with CAM.

The provided document describes the RTVue CAM with Corneal Power Measurement device and its performance data to support substantial equivalence. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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