(83 days)
The RTVue with Software 5.0 is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal 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 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 current submission, RTVue with Software 5.0, is for minor software modifications, such as such as scan name changes, scan length limits, marking and labeling conventions, and improved data acquisition/archiving speeds.
The provided document (K100861) is a 510(k) summary for a software modification (RTVue with Software 5.0) to an existing device (RTVue). The submission is a Special 510(k), which indicates that it's for minor changes that don't raise new questions of safety or effectiveness. As such, it relies on substantial equivalence to the predicate device and does not typically contain acceptance criteria or detailed study results for device performance validation in the way a traditional 510(k) for a novel device would.
Therefore, much of the requested information cannot be extracted from this specific document. The document explicitly states: "The RTVue with Software 5.0 is a modification to RTVue. ... The minor differences in the RTVue with Software 5.0 do not raise any new questions of safety or effectiveness. Thus, the RTVue with Software 5.0 is substantially equivalent to its predicate devices." This implies that the performance characteristics and acceptance criteria were established and met by the predicate device (RTVue).
Here's a breakdown based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided special 510(k) summary. For a special 510(k), the focus is on demonstrating that the modification does not alter the fundamental safety and effectiveness profile already established for the predicate device. Therefore, new acceptance criteria or performance studies are generally not required to be submitted in the summary.
2. Sample size used for the test set and the data provenance
This information is not present in the provided special 510(k) summary. Given that it's a special 510(k) for minor software modifications, new clinical or performance studies with test sets are not typically conducted or summarized if the change is non-impactful to clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the provided special 510(k) summary.
4. Adjudication method for the test set
This information is not present in the provided special 510(k) summary.
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
This information is not present in the provided special 510(k) summary. The device description does not indicate AI functionality or reader assistance, focusing on imaging and measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided special 510(k) summary. The device is described as an "optical coherence tomography system" involving "in vivo imaging and measurement," implying it's a diagnostic tool where a human interprets the output. There is no mention of an algorithm acting as a standalone diagnostic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided special 510(k) summary.
8. The sample size for the training set
This information is not present in the provided special 510(k) summary. The document does not describe the use of machine learning or algorithms that would require a "training set" in the conventional sense of AI.
9. How the ground truth for the training set was established
This information is not present in the provided special 510(k) summary.
Conclusion regarding the Special 510(k) (K100861):
This document describes a Special 510(k) submission for minor software modifications to an existing device. Such submissions typically don't include new performance data or acceptance criteria because the changes are considered not to affect the fundamental safety and effectiveness already established by the predicate device. Therefore, a detailed study proving the device meets acceptance criteria, with specific metrics, sample sizes, expert qualifications, and ground truth methodologies, is not part of this type of submission summary. To find such information, one would need to consult the 510(k) summaries for the predicate devices (K062552 and K071250) which established the initial performance and safety characteristics.
§ 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.