(449 days)
The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber laver and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy. The device is indicated for assessing the area, location, and measurement of retinal thickness, including in patients with retinal pathologies. In addition, the device is indicated to detect separation between identified retinal layers and surfaces, i.e., retinal tissue layers.
The Topcon 3D OCT-1000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurements of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.
The Topcon 3D OCT-1000 for Measurement of Retinal Thickness uses optical coherence tomography, which relies upon interferometry of superluminescent diode light reflected from the fundus of the eye to obtain cross-sectional images of the retina. The Topcon 3D OCT-1000 for Measurement of Retinal Thickness is identical to the FDA-cleared Topcon 3D OCT-1000 (K063388), with the exception of the addition of a new software module allowing for the measurement of retinal thickness.
{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": "The device provides accurate measurements that correlate with manually identified retinal boundaries in both healthy and diseased retinas.",
"Reported Device Performance": "Topcon conducted performance testing demonstrating that from an analytical perspective, the device provides accurate measurements. Additional performance testing demonstrated that the accuracy of the measurements reported from the device correlate with measurements calculated using manually identified retinal boundaries in a population with healthy retinas and a population with diseased retinas."
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The sample size for the test set is not specified. The study included 'a population with healthy retinas and a population with diseased retinas'. Data provenance (country of origin, retrospective/prospective) is not specified.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "The document states that measurements were correlated with 'manually identified retinal boundaries'. The number and qualifications of experts involved in this manual identification are not specified.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Adjudication method is not specified.",
"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": "A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the correlation between device measurements and manually identified boundaries, not on human reader performance with or without AI assistance.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, a standalone performance study was conducted. The document states, 'Topcon conducted performance testing demonstrating that from an analytical perspective, the device provides accurate measurements.' and 'the accuracy of the measurements reported from the device correlate with measurements calculated using manually identified retinal boundaries'. This indicates an evaluation of the algorithm's direct measurement capabilities.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth used was based on 'manually identified retinal boundaries'. This implicitly suggests expert human assessment as the basis for comparison.",
"8. The sample size for the training set": "The sample size for the training set is not specified.",
"9. How the ground truth for the training set was established": "How the ground truth for the training set was established is not specified in the provided document."
}
§ 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.