(345 days)
The iVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases.
iVue is a modification of its predicate device RTVue (K062552). The intent of use, system performance, majority sub-assemblies, and key components of the iVue are all the same as RTVue. The intention of this redesign is to make the size of the iVue more compact and more affordable.
iVue also has a cornea lens adapter, like the predicate device CA (K071250), which can be attached to the front of the instrument to enable the iVue to image the cornea and anterior chamber of the eye.
i Vue, based on the same Optical Coherence Tomography (OCT) technology that is using in the predicate device RTVue (K062552) and CA (K071250), is a non-invasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue are designed and manufactured by Optovue Inc. A brochure of the RTVue and CA system is in appendices [1].
Like RTVue, iVue is a computer controlled ophthalmic imaging system. RTVue uses a desktop computer while i Vue uses a laptop computer. The device scans a patient's eye and uses 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 patient will rest their head on the forehead and chin rest while the operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquiring and analyzing the image.
i Vue also has similar scan patterns and analysis functions as used in RTVue.
The provided text describes a 510(k) summary for the Optovue iVue, an Optical Coherence Tomography (OCT) system. The document focuses on demonstrating substantial equivalence to predicate devices (RTVue and CA) rather than establishing new performance criteria for a novel device. Therefore, instead of "acceptance criteria," the document presents "precision results" and "agreement results" to show that the iVue performs comparably to its predicates.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds against which the iVue was measured. Instead, it presents precision results (repeatability and reproducibility standard deviations) and agreement results (mean differences and standard deviations of differences compared to the predicate RTVue). The implicit acceptance criteria are that these precision and agreement metrics demonstrate substantial equivalence to the predicate device.
Since there are no explicit acceptance values, I will present the reported device performance for several key measurements from the Glaucoma, Retina, and Cornea scans. Each section below represents a comparison between the iVue and the predicate RTVue.
Glaucoma Scan Performance (Avg RNFL thickness, Normal Patients)
| Metric | iVue Reported Performance (Mean Differences, Min-Max, SD) |
|---|---|
| Mean Difference (iVue vs RTVue) | -0.55 (-0.61, -0.49) |
| Estimated STDEV (iVue vs RTVue) | 2.25 (2.12, 2.38) |
Retina Scan Performance (Full Retina Fovea thickness, Normal Patients)
| Metric | iVue Reported Performance (Mean Differences, Min-Max, SD) |
|---|---|
| Mean Difference (iVue vs RTVue) | 2.64 (1.91, 3.37) |
| Estimated STDEV (iVue vs RTVue) | 3.79 (3.39, 4.20) |
Cornea Scan Performance (Central Cornea 0-2mm thickness, Normal Patients)
| Metric | iVue Reported Performance (Mean Differences, Min-Max, SD) |
|---|---|
| Mean Difference (iVue vs RTVue) | -0.44 (-0.64, -0.23) |
| Estimated STDEV (iVue vs RTVue) | 5.25 (4.86, 5.63) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: A total of 48 subjects were included in the study. This comprised:
- 4 normal subjects for each of the 3 pairs of iVue/RTVue devices (12 total normal subjects across all pairs and operators).
- 4 cornea patients for each of the 3 pairs.
- 4 retina patients for each of the 3 pairs.
- 4 glaucoma patients for each of the 3 pairs.
- The document also states varying "number of scans" for different measurements after quality review: e.g., 72 scans for normal patients in Glaucoma scans, 70 for normal patients in Cornea scans. This indicates that while 48 subjects were enrolled, the actual number of analyzed scans varied due to quality control.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was conducted at two clinical sites. No specific country is mentioned.
- Retrospective or Prospective: The study was prospective. Subjects were enrolled and scanned for the purpose of this comparison study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: The ground truth for subject classification (normal, glaucoma, retina, cornea patients) was established by the Principal Investigator (PI) at each clinical site. The number of PIs is not explicitly stated, but since there were two clinical sites, there would be at least two PIs involved.
- Qualifications of Experts: The PIs diagnosed the patients' conditions (e.g., "glaucoma patients were diagnosed as having glaucoma by the PI at each site"). The specific qualifications (e.g., years of experience, subspecialty) of these PIs are not provided.
4. Adjudication method for the test set
- Adjudication Method: The document does not describe an explicit adjudication method for the test set in terms of multiple expert reviews and reconciliation. Subject inclusion criteria were reviewed by comparing the study protocol with the Case Report Forms (CRF) at the subject level. At the individual scan level, data was reviewed for quality (overall signal strength, localized weak signals, eye blink, data out of boundary, data off-center) and scans with poor image quality were excluded. This is more of a quality control process for the images than an adjudication of diagnostic outcomes.
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 MRMC study as described: This document describes a comparison between two medical devices (iVue and RTVue, both OCT systems) for their measurement precision and agreement. It is not an AI diagnostic device or a study evaluating human readers with or without AI assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focused on human reader improvement with AI assistance was not performed, and no effect size for such a scenario is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not an AI algorithm. The "device" (iVue) itself is an Optical Coherence Tomography system, which is an imaging device that produces measurements. The study evaluates the precision and agreement of these measurements between the new device (iVue) and a predicate device (RTVue). Therefore, the concept of "standalone performance" of an algorithm without human-in-the-loop is not applicable in this context. The reported performance is the standalone performance of the device's measurement capabilities.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for classifying subjects into different patient groups (normal, glaucoma, retina, cornea) was based on clinical diagnosis by a Principal Investigator (PI) at each clinical site. The measurements generated by the OCT devices (RNFL thickness, retinal thickness, cornea thickness) were compared against each other, with the predicate device (RTVue) essentially serving as the reference for agreement. It's a comparison for substantial equivalence, not against a gold standard like pathology in all cases.
8. The sample size for the training set
- Not Applicable: This study is on a medical imaging device (OCT scanner), not an AI algorithm that requires a training set. The iVue is a modification of an existing device (RTVue), and the study aim is to demonstrate its measurement precision and agreement with the predicate. Therefore, there is no training set in the context of an AI/machine learning model.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set for an AI algorithm, this question is not relevant to the described study.
§ 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.