(274 days)
The Canon OCT-A1 is an optical coherence tomography system indicated for the in-vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as a tool and an aid in the diagnosis and management of retinal diseases by a clinician.
The Canon OCT-A1 *- 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 OCT-A1 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.
Here's a summary of the acceptance criteria and study details for the Canon OCT-A1, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with specific numerical targets in the context of device performance. Instead, it demonstrates substantial equivalence to a predicate device (Optovue RTVue XR OCT Avanti) by showing agreement and precision in measurements. The performance is reported in terms of mean differences and 95% Limits of Agreement (LOA) for agreement, and repeatability/reproducibility standard deviations (SD) and limits, along with Coefficient of Variation (CV%), for precision.
The key finding for agreement is that mean differences were small, often less than 10% of the thickness, with some wide LOAs particularly in diseased eyes. For precision, the Canon OCT-A1 showed comparable or better precision than the predicate device for many parameters, especially in normal and retinal disease groups, while occasionally showing more variability in glaucoma for some FRT and ONH parameters. The differences in FRT measurements (around 25 µm) were attributed to different segmentation methodologies (inclusion/exclusion of RPE).
Below is a summary table based on the provided data, reflecting the reported performance relative to the predicate rather than predefined absolute acceptance criteria.
Measurement Parameter | Subject Population | Canon OCT-A1 Mean (SD) / Repeatability Limit (CV%) | Predicate Device Mean (SD) / Repeatability Limit (CV%) | Mean Difference (SD) / LOA (for Agreement) | Interpretive Summary of Performance against Predicate (for Precision where available) |
---|---|---|---|---|---|
Full Retinal Thickness (FRT) | |||||
Central (µm) | Normal | 267.20 (19.396) / 17.37 (2.34%) | 248.89 (18.222) / 5.28 (0.76%) | 18.32 (5.056) / (8.20, 28.43) | Canon OCT-A1 had higher mean FRT (due to RPE inclusion) and generally wider LOA. For central FRT, predicate showed less variability (Repeatability Limit Ratio: 3.2893 in favor of Optovue). |
Central (µm) | Glaucoma | 281.48 (35.758) / 18.17 (2.29%) | 261.59 (34.850) / 10.29 (1.41%) | 19.90 (24.654) / (-29.41, 69.21) | Similar trend as normal group for FRT. Predicate showed less variability (Repeatability Limit Ratio: 1.7658 in favor of Optovue). |
Central (µm) | Retinal Disease | 301.31 (76.663) / 27.65 (3.30%) | 283.08 (87.687) / 32.29 (4.15%) | 18.23 (26.086) / (-33.94, 70.40) | Canon OCT-A1 showed slightly better repeatability (Repeatability Limit Ratio: 0.8565 in favor of Canon). |
Other FRT parameters | All groups | (See Tables 1 & 5 for full details) | (See Tables 1 & 5 for full details) | Mean differences 10-30 µm, wide LOAs in some cases. | Mixed precision results, some parameters comparable, others one device better. |
Retinal Nerve Fiber Layer (RNFL) Thickness | |||||
TSNIT Average (µm) | Normal | 103.673 (9.5828) / 3.638 (1.247%) | 100.302 (7.9933) / 5.631 (2.001%) | 3.371 (4.9991) / (-6.628, 13.369) | Mean differences generally |
§ 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.