(157 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
- · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
- fundus imaqinq
- · fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
- autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
- · performing 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
The device is indicated for viewing geographic atrophy.
The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
• a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)
The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laser- scanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.
A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the crosssectional images.
The following modifications have been applied to the device subject of this 510(k):
- . Addition of scan acquisitions for the SPECTRALIS OCT Angiography Module (OCTA) at 125 kH
- Addition of a General-Purpose Graphics Processing Unit (GPGPU)
Here's a breakdown of the acceptance criteria and study details based on the provided FDA 510(k) summary:
Device: SPECTRALIS HRA+OCT and variants
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense for a pass/fail. Instead, it demonstrates similarity and non-inferiority to a predicate device. The performance metrics reported serve as evidence that the new modifications do not negatively impact the device's functionality compared to the predicate.
| Acceptance Criterion (Implicitly Demonstrated) | Reported Device Performance (Investigational SPECTRALIS with 125 kHz scan types) |
|---|---|
| Image Quality: Overall image quality sufficient to assess clinically relevant content. | 96.2% of HR10 @ 125 kHz images graded better than Poor on consensus. |
| 98.7% of HS20 @ 125 kHz images graded better than Poor on consensus. | |
| 98.7% of Scout @ 125 kHz images graded better than Poor on consensus. | |
| Visualization of Key Anatomical Vascular Structures: Ability to visualize key anatomic structures. | ≥ 92.3% of assessments on HR10 @ 125 kHz. |
| ≥ 93.6% on HS20 @ 125 kHz. | |
| ≥ 96.2% on Scout @ 125 kHz. | |
| Agreement in Identification of Vascular Abnormalities (Microaneurysms (MA), Retinal Ischemia (RI), Retinal Neovascularization (RNV), Choroidal Neovascularization (CNV)) between investigational and predicate scan types. | Agreement rate, PPA, and NPA ≥ 88.7% for all pre-specified vascular abnormalities (except RI, which was 86.5% in Pathology population). |
| Agreement in Identification of Primary Vascular Abnormality of Interest (PVAOI) between investigational and predicate scan types. | Agreement rate, PPA, and NPA ≥ 85.7% for 10x10 HR scan types. |
| Agreement rate, PPA, and NPA ≥ 92.3% for 20x20 HS scan types. |
Overall Conclusion from Study: The investigational SPECTRALIS OCTA images provide similar visibility as compared to the predicate (85 kHz) and the ability to identify each pre-specified vascular abnormality is similar between the predicate and investigational scan types.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Effectiveness Analysis Population): 79 subjects. However, the exact count for direct comparison between the predicate and investigational device varied depending on the scan type.
- Data Provenance:
- Country of Origin: United States
- Retrospective or Prospective: Prospective
- Study Design: Observational Case Study (S-2020-5)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three independent reviewers.
- Qualifications of Experts: The document states they were "from a reading center" but does not specify their individual qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document explicitly states that the analyses were based on "the grading results from the effectiveness analysis population," and imagery was "graded better than Poor on consensus." This implies a consensus-based adjudication method for image quality and visualization of structures, and agreement analysis for vascular abnormalities. It does not specify a 2+1 or 3+1 rule, but highlights the "consensus" aspect.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a typical MRMC comparative effectiveness study, designed to measure how much human readers improve with AI vs. without AI assistance, was not conducted. This study's primary goal was to demonstrate that modifications to an existing device (adding new scan acquisitions, increasing scan speed, and GPU processing) did not negatively impact its performance compared to its predicate. It assesses the similarity of the device's output (images) between the investigational and predicate versions.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Since the device in question is an imaging device (OCT) that captures and processes images for clinical evaluation by a human, and the study involves human graders assessing image quality and identifying pathologies, a "standalone algorithm-only" performance evaluation (without human-in-the-loop) in terms of clinical interpretation was not the primary focus or design of this particular study. The assessment revolves around the quality of the device's output for human interpretation.
7. Type of Ground Truth Used
The ground truth was established by expert consensus from the three independent reviewers from a reading center, who graded the OCTA scans on image quality, visibility of key anatomical vascular structures, and identification of pathologies.
8. Sample Size for the Training Set
The document does not provide information about a training set. This study is a clinical performance evaluation of an updated imaging device, not typically a machine learning model that requires a discrete training set for its core function. The modifications involve hardware (scan speed, GPU) and an investigational scan type, and the performance assessment is against a predicate device.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of device modification study, this information is not applicable.
§ 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.