(37 days)
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.
| Acceptance Criteria (Implied from Device Description & Predicate Equivalence) | Reported Device Performance |
|---|---|
| Safety: Device operates within applicable exposure limits for optical radiation. | "The Optovue Retinal OCT system emits near-infrared radiation from an SLD that is below all of the applicable exposure limits—including the guidelines for ophthalmic instrument exposure." (Safety analysis by Dr. Dave Sliney) |
| Effectiveness (Imaging & Measurement Capability): Capable of in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk as an aid in diagnosis and management of retinal diseases, comparable to or better than the predicate device. | - "RTVue has improvements in image acquisition speed and image resolution over its predecessor." (65 times faster scan speed due to Fourier Domain-OCT; higher image resolution due to broader spectral bandwidth). |
- "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).
§ 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.