(121 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 imaging
- · 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 super-luminescent diode and a spectral interferometer are used to create the cross-sectional images.
The provided text is a 510(k) summary for the Heidelberg Engineering SPECTRALIS HRA+OCT and variants, a non-contact ophthalmic diagnostic imaging device. The submission outlines modifications to an existing cleared device (K192391).
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or reported device performance in a dedicated table format. Instead, it uses a "TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART" to compare the modified device against its predicate (K192391). The "Discussion" column in this chart implicitly indicates whether performance is considered equivalent ("Same") or if differences are minor and do not impact safety/effectiveness.
The implied acceptance criterion for most characteristics is "Same as predicate device" or that any differences do not introduce new safety or effectiveness concerns.
| Feature | Predicate Device (K192391 SPECTRALIS HRA+OCT) | Subject Device | Discussion / Implied Performance |
|---|---|---|---|
| Device classification name | Optical Coherence Tomographer (OCT) | Optical Coherence Tomographer (OCT) | Same |
| Technology and optical setup | Confocal Scanning Laser Ophthalmoscope (SLO) and Spectral-Domain Optical Coherence Tomograph (OCT) | Confocal Scanning Laser Ophthalmoscope (SLO) and Spectral-Domain Optical Coherence Tomograph (OCT) | Same |
| Light sources and wavelength | Near infrared, blue, green diode lasers; superluminescence diode for OCT | Near infrared, blue, green diode lasers; superluminescence diode for OCT | Same |
| Amount of light irradiated | Low amount, does not exceed Class I laser accessible emission limits | Low amount, does not exceed Class I laser accessible emission limits | Same |
| Accessory objective lenses | ASM, WFO, UWF, HMM | ASM, WFO, UWF, HMM | Same |
| Lateral field of view (SLO) | $15°x15°$ to $30°x30°$ (SO), $8°$ (HMM), $25°x25°$ to $55°$ (WFO/WFO2), $51°x51°$ to $102°$ (UWF) | Same range as predicate | Same |
| Lateral digital resolution (SLO) | high speed mode: 3µm (HMM), 11 µm (SO) to 40 µm (UWF); high resolution mode: 1.5µm (HMM), 6 µm (SO) to 20 µm (UWF) | Same resolution as predicate | Same |
| Lateral optical resolution (OCT) | 14 µm (standard objective), 24 µm (WFO/WFO2) | Same resolution as predicate | Same |
| Optical depth resolution (OCT) | 7 µm | 7 µm | Same |
| Digital image size (SLO) | High Speed mode: 384x384 to 768x768 pixels; High Resolution mode: 768x768 to 1536x1536 pixels | Same size ranges as predicate | Same |
| OCT acquisition speed | 40 kHz (Firewire), 85 kHz (Thunderbolt) | 40 kHz (Firewire), 85 kHz (Thunderbolt) | Same |
| OCT Scanner Controller | Standard controller | Updated controller | Different; reduces scanner non-linearity, repositioning error, settle times (Improvement) |
| OCT Beam Splitter | Standard coating | Modified coating | Different; modified to allow more light to the reference arm (Improvement) |
| OCT imaging modes | Standard, Enhanced Depth Imaging (EDI) | Standard, Enhanced Depth Imaging (EDI), Enhanced Vitreous Imaging (EVI) | Different; Addition of EVI mode (New Feature) |
| OCTA scan types | Volume | Volume, OCTA Scout, OCTA DART Volume, OCTA DART Line | Different; Additional predefined OCTA scan patterns (New Feature) |
Study Proving Acceptance Criteria:
The study proving the device meets acceptance criteria is described as non-clinical performance testing, including bench testing of OCT imaging properties, validation and verification activities, and ongoing quality control. These tests confirmed that the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The study described is entirely non-clinical bench testing, not a human reader study or clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study was non-clinical bench testing. There were no human experts establishing ground truth for a test set in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
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
No. The document explicitly states: "The changes applied to the SPECTRALIS since the clearance in K192391 do not change the intended patient populations, the type of acquired images, or that the SPECTRALIS may be used as an aid to clinical evaluation." This implies that the device is an imaging tool, not one that directly interacts with human readers for diagnostic interpretation (i.e., no AI assistance component or comparative effectiveness with human readers is mentioned).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The device is an imaging hardware system, not an algorithm, and the modifications are to hardware and software features that enhance image acquisition and scanning patterns, not an AI or standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" would be established by objective physical measurements, engineering specifications, and validated measurement standards to assess optical properties, scanner linearity, light exposure, and image quality parameters. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of an algorithm or AI model.
9. How the ground truth for the training set was established
Not applicable. The document does not describe the development or training of an algorithm or AI model.
§ 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.