(111 days)
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.
| Feature/Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Visualization of vascular structures | Aid in visualization of vascular structures of the retina and choroid. | "The images demonstrate that the RTVue XR OCT Avanti angiography in combination with OCT intensity-based information can give non-invasive three-dimensional information regarding retinal microvasculature in the retina and choroid." (Qualitative claim, no specific metrics provided). |
| Artifact reduction (Motion Correction) | Minimize potential artifacts caused by blinks and eye motion. | "AngioVue image processing can employ a proprietary motion correction technology (MCT) to reduce potential artifacts caused by blinks and eye motion during scan acquisition." "The MCT performs motion correction based on minimization of the overall difference between the two scan volumes acquired during OCT angiography image capture." (Qualitative claim, no specific metrics provided for reduction percentage). |
| Safety and Effectiveness | As safe and effective as the predicate device (RTVue XR OCT). | "All testing deemed necessary was conducted and the results demonstrated that the RTVue XR OCT Avanti with AngioVue Software is as safe and as effective as the predicate device for the intended use." "Testing, risk analysis and image comparison to fluorescein angiography also confirmed that no new questions of safety or effectiveness were identified." |
| Equivalence to Predicate | Substantially equivalent in design, features, performance, etc. | "Based upon no significant differences between the proposed device and the predicate device, the RTVue XR OCT Avanti with AngioVue Software is substantially equivalent in design, features, performance, fundamental scientific technology, and is appropriate for the proposed indications for use." |
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.
§ 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.