(328 days)
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]: The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
· the retina, retinal nerve fiber layer, optic disc, and
· the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)
and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.
Scanning Laser Ophthalmoscope Mirante [SLO Model]: The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments. It is intended to work with compatible NIDEK ophthalmic devices.
The Nidek Mirante is an Optical Coherence Tomography (OCT) system intended for use as a non-invasive imaging device for viewing and measuring ocular tissue structures with micrometer range resolution. The Nidek Mirante is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The Nidek Mirante uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds. The Mirante utilizes Fourier spectroscopic imaging a Michelson interferometer. The interfering light of the reference light and the reflected light from the test eye obtained by the Michelson interferometer are spectrally divided by a diffraction grating and the signal is acquired by a line scan camera. The signal is inverse Fourier transformed to obtain the reflection intensity distribution in the depth direction of the patient's eve. The galvano mirror scans the imaging light in the XY direction to obtain a tomographic image. The Mirante includes scanning laser ophthalmoscope (SLO) functions as well as the OCT functions. The SLO component uses a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected by the hole mirror and the signal is obtained by the detector. A resonant mirror and a galvanometer mirror placed in the imaging optical path scan the imaging light in the XY direction to obtain a flat surface image. The device includes Image Filing Software NAVIS-EX which is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.
The provided documentation describes the acceptance criteria and the study results for the Nidek Mirante Scanning Laser Ophthalmoscope and the Image Filing Software NAVIS-EX.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to previously cleared predicate devices through agreement and precision analyses, and superior or equivalent image quality. The performance is reported in terms of comparisons against these predicate devices.
Nidek Mirante (OCT Component) vs. Optovue Avanti (Predicate)
| Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Nidek Mirante) |
|---|---|---|
| Agreement Analysis (Mean Difference) | Demonstrate agreement with predicate device deemed clinically acceptable. | [ILM-RPE/BM] Thickness: Higher than Avanti (10-20 µm thicker). All parameters and populations met agreement performance goals. |
| Disc Map RNFL Thickness: Higher than Avanti (around 10 µm thicker), with the exception of TSNIT Temporal. All parameters and populations met agreement performance goals. | ||
| Disc Map Optic Disc: Lower Horizontal C/D Ratio and Vertical C/D Ratio, higher Disc Area and Cup Area (All Subjects). Similar differences for Normal, lower values for Glaucoma. All parameters and populations met agreement performance goals. | ||
| Cornea Radial CCT: Higher than Avanti (around 15 µm thicker). Agreement performance goals met for All Subjects, but not met for Normal and Corneal Disease populations. | ||
| Precision Analysis (Repeatability) | Demonstrate acceptable variation (coefficient of variation, %CV) for measurements. | [ILM-RPE/BM] Thickness: Met precision goals for all parameters and groups. |
| Disc Map RNFL Thickness: Met most precision goals for Normal population; most met for Glaucoma except for one TSNIT Nasal and one TSNIT Temporal parameter (slightly missed). | ||
| Disc Map Optic Disc: Met most precision goals for Normal and Glaucoma populations, except for Cup Area in both populations (slightly missed). | ||
| Cornea Radial CCT: Met precision goals for all parameters and populations. | ||
| Image Quality (ACA) | Clinically useful and overall quality comparable to predicate. | Not statistically significant difference in clinical utility and overall quality compared to Avanti. |
Nidek Mirante (SLO Component) vs. OPTOS P200DTx (Predicate)
| Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Nidek Mirante) |
|---|---|---|
| Image Quality (Color Fundus) | Clinically useful and overall quality comparable to predicate. | Provided better clinical utility and overall quality compared to P200DTx (p |
§ 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.