(151 days)
The Spectralis HRA+OCT is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging, cross-sectional imaging, fundus photography, and fluorescence imaging (fluorescein, indocyanine green and autofluorescence), and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases including: age-related macular degeneration, macular edema, diabetic retinopathy, retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The Spectralis HRA+OCT includes a retinal nerve fiber layer thickness normative database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to a database of Caucasian normal subjects; the classification result is valid only for Caucasian subjects.
The Spectralis HRA+OCT is a real-time imaging system of the posterior segment of the human eye and for aiding in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma. The device is a combination of optical coherence tomography (OCT) with confocal scanning laser ophthalmoscopy (cSLO). OCT imaging includes high-resolution cross-sectional imaging of ocular structures (e.g., retina, macula, optic nerve head); cSLO imaging includes high-resolution and dynamic infrared reflectance, blue reflectance, fluorescein angiography, indocyanine green angiography, and autofluorescence imaging. OCT images and cSLO images are acquired simultaneously and are viewed side-by-side on the computer screen. Images are acquired and stored using Spectralis operation software, which runs on a standard personal computer. Spectralis components include a laser scanning camera, camera mount with headrest, operation panel, power supply box, operation software, and host computer.
I am sorry, but the provided text primarily describes the device, its intended use, and a review of the substantial equivalence for its 510(k) submission. It also details the creation and characteristics of a normative database for Retinal Nerve Fiber Layer (RNFL) thickness used by the device.
However, the document does not contain the following information that you requested:
- A table of acceptance criteria and the reported device performance: While it mentions accuracy testing was performed and confirmed accuracy, a specific table of criteria and corresponding performance metrics is not provided.
- Sample sizes used for the test set and the data provenance for performance evaluation. The "Normative Database" section uses 201 subjects but this is for establishing a normative range, not a test set for a classification algorithm.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
- If a standalone (algorithm only) performance study was done. The device's primary function described is imaging and measurement, with the normative database providing a comparison, not a standalone classification algorithm in the modern AI sense.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an algorithm's performance evaluation. The ground truth for the normative database subjects was established by two ophthalmologists deeming eyes "normal" based on examination and history.
- The sample size for the training set. (The normative database of 201 subjects serves as reference data, not a training set for an AI algorithm in the typical sense).
- How the ground truth for the training set was established.
The document discusses:
- Reproducibility and Repeatability study: conducted on human volunteers, with coefficients of variation within specified range. Exact sample size for this is not given beyond "human volunteers."
- Normative Database: 201 Caucasian subjects for RNFL thickness. Ground truth for "normal" was established by two ophthalmologists through patient history and physical examination.
- Agreement Study with Predicate: Compared RNFL classification results between Spectralis HRA+OCT and Stratus devices. Included 101 healthy subjects and 183 glaucoma patients. The study focused on correlation of measurements, not on demonstrating the Spectralis device's classification accuracy against a clinical ground truth set.
- Studies in Eyes with Disease: Case Reports and Case Series of patients with various pathologies were examined. No artifacts were found, and RNFL thickness was predictably decreased in glaucoma subjects. This is descriptive, not a quantitative performance study with specific metrics and acceptance criteria.
The information provided primarily focuses on the device's technical specifications, safety, and the establishment of a normative database for comparison, rather than an AI/ML algorithm's performance evaluation using acceptance criteria as is typical in more recent submissions involving machine learning.
§ 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.