(179 days)
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in-vivo imaging, axial crosssectional, and three-dimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database, the iVue is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
The iVue is used to capture, store, display and print spectral domain-optical coherence tomography (SD-OCT) images of the posterior and anterior structure of the eye. The device software includes a Normative Database (NDB), consisting of OCT data from a range of known normal subjects that can be used to compare a new patient's measurements in relation to the normal distribution.
iVue is a computer-controlled ophthalmic imaging system using either a laptop computer or "All-in-One" computer. For laptop systems there are two control box options of 120 or 230 volts. The control box interfaces between the motorized table column and the medical-grade power supply for the computer.
iVue System Key Functional Components:
- Scanner Head
- Computer
- Control Box
- Joystick and Chinrest Assembly
- Footswitch (optional)
- Motorized Table (optional)
- Cornea Adapter Module
The provided document is a 510(k) Premarket Notification for the Optovue iVue device, seeking clearance for a software modification that allows automated segmentation and measurement of corneal epithelial and stromal layer thickness. The document describes two clinical studies conducted to support the substantial equivalence claim.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format with pass/fail thresholds. Instead, it presents the results of repeatability, reproducibility, and agreement studies, and then concludes whether these results demonstrate "good repeatability and reproducibility" and "good agreement."
Based on the summaries provided, the implicit acceptance criteria seem to be related to achieving clinically acceptable levels of repeatability, reproducibility, and agreement with manual measurements for corneal pachymetry, epithelial thickness, and stromal thickness, across various patient groups.
Table of Implicit Acceptance Criteria and Reported Device Performance:
| Metric | Acceptance Criteria (Implicit, based on conclusion) | Reported Device Performance (Summary) |
|---|---|---|
| Repeatability (SD) | Demonstrated "good repeatability" | Pachymetry: |
- Normal Group: 1.7 to 7.6 µm (across zones)
- Corneal Patients (pooled): 3.3 to 8.6 µm
- Subgroups (Contact Lens, Dry Eye, Post-LRS, KCN): Ranged from 1.5 to 13.4 µm (max in Dry Eye S_5_6_Pachy).
Epithelial Thickness: - Normal Group: 0.8 to 1.4 µm
- Corneal Patients (pooled): 1.2 to 1.9 µm
- Subgroups: Ranged from 0.6 to 2.9 µm (max in Dry Eye I_5_6_Epi and IT_5_6_Epi, and Post-LRS C2 Epi)
Stromal Thickness: - Normal Group: 1.6 to 7.6 µm
- Corneal Patients (pooled): 2.8 to 8.8 µm
- Subgroups: Ranged from 1.4 to 13.4 µm (max in Dry Eye S_5_6_Stroma) |
| Reproducibility (SD) | Demonstrated "good reproducibility" | Pachymetry: - Normal Group: 2.2 to 7.7 µm
- Corneal Patients (pooled): 3.6 to 8.8 µm
- Subgroups: Ranged from 1.8 to 13.7 µm (max in Dry Eye S_5_6_Pachy).
Epithelial Thickness: - Normal Group: 0.9 to 1.5 µm
- Corneal Patients (pooled): 1.2 to 1.9 µm
- Subgroups: Ranged from 0.7 to 2.9 µm (max in Dry Eye I_5_6_Epi and IT_5_6_Epi, and Post-LRS C2 Epi)
Stromal Thickness: - Normal Group: 2.0 to 7.6 µm
- Corneal Patients (pooled): 3.1 to 9.0 µm
- Subgroups: Ranged from 1.8 to 13.7 µm (max in Dry Eye S_5_6_Stroma).
The report notes: "Repeatability standard deviation was similar to the Reproducibility standard deviation for all study parameters and therefore is not detailed separately in the summary tables below." The tables for each parameter show Reproducibility SD values. |
| Agreement (Mean of Differences) | Demonstrated "good agreement" | Mean of differences between software output and manual measurements for all zonal parameters: - Corneal Epithelial Mapping:
§ 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.