(68 days)
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
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Safety | Meets safety requirements of IEC 60601-1 and IEC-60601-1-2 | Elliot lab Certification Testing (ref: R64363 Rev.3 and R63863 Rev. 4) |
| Stability | Meets stability requirements of IEC 60601-1 and IEC-60601-1-2 | Elliot lab Certification Testing (ref: R64363 Rev.3 and R63863 Rev. 4) |
| Equivalent Imaging Results | Delivers equivalent imaging results as the older generation RTVue line-scan cameras operating at ~27,000 A-lines per second | Bench test performed comparing RTVue XR with predicate device RTVue with NDB. |
Study Details:
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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."
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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.
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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.
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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.
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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).
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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.
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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.
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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.
§ 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.