(274 days)
The SPECTRALIS 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 (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT BluePeak) 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 agerelated macular degeneration, macular edema, diabetic 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 and SPECTRALIS OCT include normative databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal paraments, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.
The SPECTRALIS HRA+OCT is a real-time imaging system of anterior and posterior segments 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 mount with headrest, operation panel, power supply box, operation software, and host computer. A MultiColor option is included to provide additional green reflectance imaging and a "composite color" image, which provides a different view of the features of the eye. This composite color image is not the same as fundus color photo. This submission includes Enhanced Depth Imaging (EDI) as an optional viewing mode that allows for better visualization of deep eye structures below the retina.
The provided document describes the SPECTRALIS HRA+OCT device and its updated version, focusing on software version 6.0. The acceptance criteria and the study proving the device meets them are primarily related to the precision and agreement of measurements of retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) neuroretinal rim width (BMO-MRW). The document establishes "within specified range" and "small and within expected ranges and below predefined thresholds" as acceptance criteria for precision and agreement, respectively.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative ("within the specified range," "small and within expected ranges and below predefined thresholds") rather than specific numerical thresholds presented in a table format. However, the study results, presented as coefficients of variation (CV) for precision and limits of agreement (LOA) for agreement, demonstrate that the device achieved these general criteria.
| Metric | Acceptance Criteria (General) | Reported Device Performance (CV) | Reported Device Performance (LOA) |
|---|---|---|---|
| Precision (Repeatability & Reproducibility CV) | "within the specified range for this device" | BMO-MRW: | |
| Mean CV: 1.24% - 2.92% (for RNFL thickness) | |||
| Max CV: 2.43% - 5.63% (for RNFL thickness) | N/A (LOA is for agreement, not precision) | ||
| Agreement (RNFLT 3.5mm circle vs. 12° circle scans) | "All differences…are overall small and within expected ranges and below predefined thresholds." | N/A (CV is for precision) | Normal Subjects: |
| Mean Diff [µm]: -2.6 to 9.3 | |||
| LOA (low/up) [µm]: -21.2 to 32.6 | |||
| Glaucoma Subjects: | |||
| Mean Diff [µm]: -0.2 to 10.0 | |||
| LOA (low/up) [µm]: -18.9 to 37.2 |
2. Sample Sizes Used for the Test Set and Data Provenance
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Precision Study (Test Set):
- Sample Size: 34 subjects enrolled, data from 32 subjects included in analysis (16 healthy eyes, 16 glaucomatous eyes), 16 left and 16 right eyes.
- Data Provenance: Monocentric, prospective study. The specific country is not explicitly stated but the manufacturer is Heidelberg Engineering GmbH, suggesting Germany.
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Agreement Study (Test Set):
- Sample Size: 48 subjects enrolled, data from 40 subjects included in analysis (20 healthy eyes, 20 glaucomatous eyes), 20 left and 20 right eyes.
- Data Provenance: Monocentric, prospective study. The specific country is not explicitly stated but the manufacturer is Heidelberg Engineering GmbH, suggesting Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
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Precision Study: "Three qualified individuals, each operating one of three Spectralis devices equipped with the study software, performed the study device measurements." These could be the "experts" performing the measurements that form the basis of the precision analysis. Also, "All acquired images were inspected by three experienced physicians for image quality... and layer segmentation."
- Number of Experts: 3 (for both operators and image inspection)
- Qualifications: "Qualified individuals" for device operation; "experienced physicians" for image quality inspection. Specific years of experience or specialization (e.g., radiologist) are not provided.
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Agreement Study: "All acquired images were inspected by the investigator for image quality... and layer segmentation."
- Number of Experts: 1 (the investigator).
- Qualifications: "Investigator" who inspected for image quality. Specific qualifications are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth diagnoses for the test sets in either the precision or agreement studies. The "ground truth" for these studies is the measurement values themselves and their statistical consistency, rather than a diagnostic label. For image quality and layer segmentation, images were inspected by experts, but no multi-reader adjudication process is detailed beyond inspection.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The studies focus on the precision and agreement of the device's measurements compared to a predicate device and within itself.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is an imaging system (OCT/cSLO) that performs measurements. The precision and agreement studies evaluate the measurement capabilities of the device (software version 6.0 with APS) in performing these measurements. These studies are essentially standalone evaluations of the device's measurement accuracy and consistency, as the "algorithm" here refers to the device's ability to acquire and process images to produce measurements. While operators ("qualified individuals") are involved in acquiring the images, the evaluation is of the device's output (measurements and their consistency), which is driven by its internal algorithms for processing. Therefore, the precision and agreement studies can be considered standalone performance assessments of the device's measurement functions.
7. The Type of Ground Truth Used
- Precision and Agreement Studies: The "ground truth" here is the measurement values themselves. These studies assess the device's ability to consistently reproduce measurements (precision) and agree with measurements obtained by a previous method/device (agreement). The reference ranges for "normal" are derived from large normative databases (see point 9).
8. The Sample Size for the Training Set
The document refers to "reference databases" which serve a similar purpose to a training set for normative comparisons.
- RNFL Thickness Reference Database: 330 eyes of 330 normal subjects.
- BMO-MRW Reference Database: 368 eyes of 368 normal subjects.
9. How the Ground Truth for the Training Set Was Established
The "ground truth" for the reference databases (training sets) was established by rigorously selecting "normal subjects" based on strict inclusion/exclusion criteria in prospective, multi-center, observational studies.
- Inclusion Criteria for Normal Subjects (RNFLT and BMO-MRW Databases):
- Healthy eyes without prior intraocular surgery (except cataract surgery or Lasik).
- No clinically significant vitreal, retinal, or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
- No history of glaucoma.
- Intraocular pressure ≤21 mmHg.
- Best corrected visual acuity ≥0.5.
- Refraction between +6 and -6 diopters, astigmatism ≤2 diopters.
- Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.
- Clinically normal appearance of optic disc with normal appearing neuroretinal rim with respect to color and shape.
These criteria, applied by clinical investigators, define what constitutes a "normal" ground truth for the purpose of creating the normative databases.
§ 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.