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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 laserscanning 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 cross-sectional images.

Because of discontinuation of device components, the following changes have been applied to the device:

• . Replacement of the OCT line camera in the spectrometer with an equivalent camera from the same manufacturer, and comparable specifications;
• . Update of the digital device interface from Thunderbolt to Thunderbolt 2;
• With the update of the TDI, the device complies with electromagnetic compatibility standard IEC 60601-1-2 Edition 4.0.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical performance testing (bench testing), not human subject testing. Therefore, there is no information about a "test set" in terms of patient data or its provenance. The testing was conducted on the modified device itself.

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)

Not applicable. As described above, no human subject testing with expert-established ground truth was performed for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human subject testing was performed.

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

Not applicable. This 510(k) submission is for a device modification (hardware updates to an existing SPECTRALIS HRA+OCT) and does not involve AI or human-in-the-loop performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an imaging system (hardware and software) and not an AI algorithm intended for standalone performance evaluation in the context of an "algorithm only" study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the non-clinical performance testing, the "ground truth" was the predefined technical specifications and standards (e.g., AAMI / ANSI ES60601-1:2005 Edition 3.1 for electrical safety, IEC 60825-1:2007 for laser safety, and specific quantitative metrics for OCT sensitivity and signal rolloff).

8. The sample size for the training set

Not applicable. This submission is for a hardware modification, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set was used.

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