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The RTVue XR OCT Avanti with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR OCT Avanti with Normative Database is also a quantitative tool for the comparison of retinal nerve fiber layer, and optic disk measurements in the human eve to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue XR OCT Avanti with AngioVue Software is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The RTVue XR OCT Avanti is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and measurement of the retinal nerve fiber layer and optic disc with micrometer range resolution as a tool and aid in the diagnosis and management of retinal disease. Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disc structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC and outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE.

The RTVue XR OCT Avanti is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image. The line-scan camera operates at approximately 70,000 A-lines per second.

The RTVue XR OCT Avanti offers three scan types: Retina, Glaucoma, and Cornea. For the cornea and anterior eye scans, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM auxiliary attachment (Cornea Anterior Module). 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.

With the normative database (NDB), the RTVue XR OCT Avanti can compare the measured data from the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to the normative database. The device will provide the analysis information to he used as a clinical reference to aid in the diagnosis and management of ocular diseases.

The RTVue XR OCT with AngioVue™ has an additional software module to aid in the visualization of vascular structures of the retina and choroid using a motion-contrast techniques without the need for intravenous dyes.

This document does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria in a quantitative manner as typically presented for AI/ML device submissions. This is a 510(k) summary for a medical device (RTVue XR OCT Avanti with AngioVue Software) filed in 2016, which predates the FDA's specific guidance for AI/ML medical devices.

The submission focuses heavily on demonstrating substantial equivalence to a predicate device (Optovue, Inc. RTVue XR OCT, K120238) rather than presenting a performance study with detailed acceptance criteria and corresponding results for the AngioVue software module.

However, based on the provided text, here's an attempt to answer your questions, highlighting the limitations of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the AngioVue software's performance in visualizing vascular structures. Instead, the performance is described qualitatively by comparing AngioVue scans with fluorescein angiography images.

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

The document states: "In case examples of a variety of retinal diseases, RTVue XR OCT Avanti with AngioVue Software cube scans were compared with fluorescein angiography images." This implies a qualitative comparison using a case series, rather than a formal, statistically powered test set with a specified sample size.

• Sample size: Not specified. The phrase "case examples" suggests a small, illustrative set of cases, not a statistically robust sample.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not specified in the document. The ground truth appears to be implicitly established by "fluorescein angiography images," which are a recognized clinical standard for vascular visualization. It's not stated whether these images were reviewed by experts for an adjudicated ground truth for the purpose of this submission.

4. Adjudication method for the test set

Not explicitly stated. The comparison was made against "fluorescein angiography images," which serve as a reference. There is no mention of a formal expert adjudication process (e.g., 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study is not mentioned in this document. The focus is on the device's capability to visualize structures, not on how its assistance improves human reader performance.

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

The "AngioVue software module" is described as providing "visualization of vascular structures." The performance discussed ("can give non-invasive three-dimensional information") refers to the output of the algorithm. Therefore, the visualization capability of the algorithm itself was assessed, but not against quantitative standalone performance metrics like sensitivity/specificity for detecting specific pathologies. The comparison to fluorescein angiography implies a standalone assessment of the image output.

7. The type of ground truth used

The ground truth used for comparison with the AngioVue images was fluorescein angiography images. This is an established clinical imaging modality for visualizing retinal and choroidal vasculature.

8. The 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 submissions of this era and type, where the software functionality is described as a "visualization aid" rather than a classification or diagnostic algorithm requiring extensive training data disclosures. The motion correction technology (MCT) is proprietary, and its development (which would involve data for "training" or optimization) is not detailed.

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

Since there is no mention of a training set, the method for establishing its ground truth is also not provided.

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The RTVue XR with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber laver, and optic disk measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue XR is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution. The RTVue XR OCT is based on the same Optical Coherence Tomography (OCT) technology used in its predicate device, RTVue with NDB OCT. The RTVue XR is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of Ascans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image. RTVue XR offers three scan types: Retina, Glaucoma, and Cornea. For the Cornea scan, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM (Cornea Anterior Module-cleared under K111505). The upgrade of the line scan camera is designed to provide faster image acquisition. The RTVue XR is an updated version of RTVue with NDB that operates at ~70,000 A-lines per second while the RTVue-100 operates at ~27,000 A-lines per second. The RTVue XR machines will be equipped with new line-scan cameras capable of operating at ~70,000 Alines per second while delivering equivalent imaging results as the older generation RTVue line-scan cameras operating at ~27,000 A-lines per second.

The provided 510(k) summary for the Optovue RTVue XR OCT describes a special 510(k) notice for an upgrade to an existing device (RTVue with NDB). The primary change is the inclusion of a new line scan camera for faster image acquisition.

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

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • The document mentions a "Bench test" for comparing the RTVue XR with the predicate device. However, it does not specify the sample size of the test set (e.g., number of images, number of patients) or the data provenance (e.g., country of origin, retrospective/prospective nature of the data) for this bench test. The focus of this submission is on hardware upgrade and the claim of "equivalent imaging results."

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

   • This information is not provided. The submission focuses on technical equivalence rather than a clinical performance study requiring expert ground truth for interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided. As there's no mention of a human-centric clinical study requiring ground truth establishment, adjudication methods are not discussed.

4. 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 or reported. This device is an imaging system, not an AI-assisted diagnostic tool for interpretation, and the submission's purpose (hardware upgrade) does not necessitate such a study.

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

   • No standalone algorithm performance study was done or reported. The RTVue XR is an imaging device, not an algorithm, and the submission focuses on its technical performance (image acquisition speed and equivalence).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the bench test, the ground truth would inherently be instrument specifications and image quality metrics for comparing the new camera's output to the predicate device's output. It is not expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This submission is for a hardware upgrade of an imaging device, not an AI/algorithm-driven device requiring a training set. The device itself uses a "Normative Database" for comparison, but details about its construction (sample size, ground truth, etc.) are outside the scope of this specific 510(k) for a camera upgrade.

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

   • Not applicable/Not mentioned. As a training set for an algorithm is not discussed, the establishment of its ground truth is also not. For the "Normative Database" mentioned in the Intended Use, the document states it's "a database of known normal subjects," implying a classification based on clinical normality, but further details are not provided in this submission.

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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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The RTVue with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as an aid in the diagnosis and management of retinal disease. The RTVue with Normative Database is also a quantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue is a computer controlled ophthalmic imaging and measurement system that employs optical coherence tomography to image and measure the posterior segment of the eye. The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K062552). Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disk structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL. GCC. the outer retinal thickness and total retinal thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE. The current submission is for a software modification to add a normative database. With the additional normative database (NDB), the RTVue can compare the measured data from the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to the normative database. The RTVue with Normative Database provides a statistical reference of the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to a database of known normal subjects. The RTVue with Normative Database will provide the analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular diseases.

1. Acceptance Criteria and Reported Device Performance:

The document describes a precision study to evaluate the RTVue with Normative Database. The acceptance criteria are implicitly demonstrated by presenting the repeatability and reproducibility standard deviations for various measurements. The "Performance Data" section outlines these results.
The acceptance criteria are not explicitly stated, however based on the precision study results for repeatability and reproducibility, the device performance is within acceptable limits for a medical device.

Table of Performance Results

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: A total of 36 subjects were used in the precision study. This included 4 normal subjects, 4 retina patients, and 4 glaucoma patients for each of the 3 RTVue devices used (12 subjects per device).
• Data Provenance: The data was collected at two clinical sites. The document implies a prospective nature as subjects were "enrolled in the study," and "data was carefully reviewed for completeness and quality." The country of origin is not explicitly stated but can be inferred as the United States given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: The ground truth for subject classification (normal, glaucoma, retina pathology) was established by the "Principal Investigator (PI) at each clinical site." The exact number of PIs is not specified but there were two clinical sites.
• Qualifications of Experts: The PIs diagnosed glaucoma and various retina pathologies. Their specific qualifications (e.g., "Radiologist with 10 years of experience") are not detailed beyond being a "Principal Investigator" responsible for diagnosis.

4. Adjudication Method:

The document mentions that all data was "carefully reviewed for completeness and quality in two levels," including a review of the CRF by the PI against inclusion/exclusion criteria, and a review of individual scans for image quality. There is no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) for establishing the diagnostic ground truth for patient classification. The PI at each site made the diagnosis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is described. The study focuses on the precision (repeatability and reproducibility) of the RTVue device itself, not on the improvement of human readers with AI assistance. The additional normative database (NDB) functions as a reference tool for comparison rather than a direct AI-assisted diagnostic aid for human readers in the context of this study.

6. Standalone Performance:

Yes, a standalone performance study was done. The precision study evaluates the RTVue device (algorithm only, in the sense of its measurement capabilities and normative database comparison) without human interpretation as the primary outcome. The results presented are the repeatability and reproducibility of the device's measurements.

7. Type of Ground Truth Used:

The ground truth used for classifying subjects into normal, glaucoma, or retina pathology groups was expert consensus (diagnosis by the Principal Investigator).

8. Sample Size for Training Set:

The "Normative Databases" section states that normative data was collected from 480 individuals (over 640 eyes) for the database. This acts as the "training set" for the normative database comparison feature of the device.

9. How Ground Truth for Training Set was Established:

The ground truth for the normative database was established by enrolling "known healthy eyes" from these 480 individuals. This implies that subjects were deemed healthy based on a medical evaluation, likely conducted by qualified medical professionals at the 11 clinical sites following an IRB approved protocol. The criteria for "healthy eyes" would have been part of this protocol, but are not explicitly detailed in the document.

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The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.

RTVue, based on the same Optical Coherence Tomography (OCT) technology that is using in the predicate device Humphrey® OCT3 (K012727), is a non-invasive diagnostic device for withing the ocular tissue structure with micrometer range resolution. A brochure of the OCT3 system is in appendices [1]

The RTVue, like its predicate device Humphrey® OCT3 (K012727), is a computer controlled ophthalmic imaging system. The device scan a beam into patient's eye and use a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of sequence of A-scans. It has a traditional patient and instrument interface 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. Operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquire and analysis image.

The RTVue has improvements in image acquisition speed and image resolution over its predecessor. RTVue uses non-mechanic moving part in the depth scan, a branch of OCT technology called Fourier Domain-OCT, so the scan speed improves about 65 times faster than the mechanical limited scan speed in previous devices. A detail description of the technology improvement from predicate device is published in Optics Express, May 2004 by Leitgeb et. al. Appendices [2, a].

The RTVue also uses the same light source SLD (super luminescent diode) as in its predicate device but with broader spectral bandwidth. The broad spectral bandwidth provides higher image resolution than a narrow one based on the Optical Coherence Tomography principle. A paper desertes the technology improvement from predicate device is published in Optics Express, May 2004 by Ko et. al. Appendices [2,6] and in American Journal of Ophthalmology, September 2004 by Wojtkowski et. al. Appendices [2. c]. Ocular pathologies imaged with the Fourier domain OCT and ultrahigh resolution light source also has been published in Investigative Ophthalmolgy & Visual Science , Spierban 2005 by Schmidt-Erfurtb et. al. Appendices [2,d] and in American Academy of Ophthy Implomy. October 2005 by Wojtkowski, et. al Appendices [2,e].

This document is a 510(k) Premarket Notification for the Optovue RTVue, an Optical Coherence Tomography (OCT) system. It focuses on demonstrating substantial equivalence to a predicate device, the Humphrey® OCT3.

NOTE: This 510(k) summary does not contain detailed acceptance criteria and a study proving the device meets specific numerical performance targets. Instead, it relies on demonstrating substantial equivalence and improvements over a predicate device by referencing published scientific papers and general safety assessments. The FDA's decision letter indicates clearance of the device based on this submission.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission, specific numerical acceptance criteria (e.g., target specificity, sensitivity, accuracy) for disease diagnosis are not explicitly defined in the document. The performance claims hinge on the RTVue's technological improvements over the predicate device and the general clinical effectiveness of OCT technology.

• "Ultrahigh-resolution OCT and standard resolution OCT exhibited comparable performance in differentiating thicker retinal layers, such as the retina nerve fiber, inner and outer plexiform, and inner and outer nuclear." (Ko et al., 2005, Journal of Ophthalmology). |
  | Basic Device Functionality: Accuracy tests, optical emission safety, electrical safety, electromagnetic compatibility, and software validation. | "The RTVue has had accuracy tests, optical emission safety analysis, electrical safety, electromagnetic compatibility test, and software validation tests." (No specific results provided, but stated as completed). |

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

• Test Set Sample Size: Not provided. The submission states "Clinic tests: Not Required" for the RTVue itself, as it relies on the predicate device's established clinical history and published studies using similar technology.
• Data Provenance: The document references several published scientific papers (e.g., in Optics Express, American Journal of Ophthalmology, Investigative Ophthalmology & Visual Science, SPIE Proceeding) that investigated Fourier Domain-OCT and ultrahigh-resolution OCT in general, as well as comparative studies between high-resolution and standard-resolution OCT. The provenance of the data in these external studies (e.g., country of origin, retrospective/prospective) is not detailed in this 510(k) summary.

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

• Number of Experts: Not applicable/Not specified. For the RTVue itself, no specific clinical "test set" with ground truth established by experts is described in this submission. The effectiveness claim is based on the general understanding of OCT technology and comparisons to published literature.
• Qualifications of Experts: Not specified for a dedicated test set for the RTVue. However, the safety analysis was completed by "an international recognized expert in the fild of optical radiation hazards and safety Dr. Dave Sliney." The scientific papers referenced would have involved clinical experts in ophthalmology.

4. Adjudication method for the test set:

• Not applicable/Not specified. As no specific clinical test set for the RTVue is detailed, no adjudication method is mentioned.

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. This submission is for an imaging device (OCT) and its improvements in image acquisition and resolution, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study related to "human readers improve with AI vs without AI assistance" is not relevant or described.

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

• No. This is not an algorithm submission; it's for an imaging device. The device provides images and measurements that clinicians (human-in-the-loop) use for diagnosis and management.

7. The type of ground truth used:

• Not explicitly defined as a dedicated "ground truth" for the RTVue's specific clinical validation within this document. The effectiveness claims are based on:
  • The established clinical utility of the predicate device (Humphrey® OCT3).
  • The inherent ability of OCT technology (especially high-resolution versions) to visualize ocular tissue structures, as demonstrated in numerous published clinical papers.
  • The conclusion from a comparative paper that "Ultrahigh-resolution OCT and standard resolution OCT exhibited comparable performance in differentiating thicker retinal layers," implying that the improved resolution does not degrade essential diagnostic information and may enhance it.

8. The sample size for the training set:

• Not applicable/Not provided. This is an imaging device, not an AI/machine learning algorithm requiring a "training set" in the conventional sense. The device's design and performance are based on optical physics and engineering, not pattern recognition trained on a dataset.

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

• Not applicable/Not provided. (See point 8).

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