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SOLIX™ is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the threedimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database. SOLIX™ is also a quantitative tool for the comparison of the retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The SOLIX™ with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

The non-mydriatic color fundus camera of SOLIX™ is an integrated non-contact. high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The SOLIX™ fundus camera component is indicated for in-vivo viewing of the posterior and external area of the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

SOLIX is a computer-controlled, ophthalmic imaging system with combined spectral-domain optical coherence tomography (SD-OCT) and non-mydriatic, digital fundus camera. The SD-OCT employs non-invasive, non-contact, low coherence interferometry to acquire crosssectional tomograms of the anterior and posterior segment of the eye and motion-contrast images of the retinal microvasculature (i.e., OCT "angiography" [OCTA]). The fundus camera produces color internal and external ocular images.

The provided text details the 510(k) premarket notification for the Optovue SOLIX device, stating its substantial equivalence to predicate devices Avanti and iCam. It includes information on performance testing, but the document does not explicitly state defined acceptance criteria for many of the quantitative measurements (e.g., repeatability limits for OCT and OCTA parameters, quality metrics for fundus photography). Instead, it presents the results of these tests.

Therefore, the table below will present the reported device performance, and where an indirect acceptance can be inferred (e.g., for comparative image quality), that will be noted.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document primarily presents performance results without explicitly listing acceptance criteria with numerical targets for many parameters. Where an inference of acceptance can be made (e.g., general clinical utility, improvements over predicate), it is noted.

2. Sample Size Used for the Test Set and Data Provenance

• Anterior Segment OCT Performance Study:
  • Sample Size: 61 eligible participants (30 "Normal," 31 "Cornea" subgroup).
  • Data Provenance: Prospective, observational study conducted at a single clinical U.S. site.
• Posterior Segment OCT and OCTA Performance Study:
  • Sample Size: 83 participants completed the study (30 "normal," 25 "Glaucoma," 28 "Retina" subgroup).
  • Data Provenance: Prospective, observational study conducted at a single clinical U.S. site.
• Fundus Photography Study:
  • Sample Size: Data from 112 participants included (31 "normal," 26 glaucoma, 55 retinal disease). 126 were enrolled, 121 met enrollment criteria.
  • Data Provenance: Prospective, observational study conducted at two clinical sites (country not explicitly specified but implies U.S. given other contexts).
• Reference Database (RDB) Generation Study:
  • Sample Size: 427 eligible participants (out of 482 enrolled). The number included for each scan pattern ranged from 416 to 426.
  • Data Provenance: Prospective, observational study conducted at five U.S. clinical sites.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Anterior Segment OCT & Posterior Segment OCT/OCTA Studies:
  • No external "experts" were formally used to establish ground truth in the sense of adjudication for these quantitative repeatability and reproducibility studies. The metrics (e.g., thickness, density) are generated by the device's algorithms based on the acquired OCT/OCTA data. The study design focused on evaluating the device's consistency and agreement with the predicate. Manual editing of segmentation boundaries and foveal center detection was performed by study personnel, implying expertise in OCT interpretation and anatomy, but specific qualifications are not detailed.
• Fundus Photography Study:
  • Number of Experts: Three independent graders.
  • Qualifications: "at a third-party reading center." Specific qualifications (e.g., ophthalmologist, Ophthalmic Photographer, years of experience) are not explicitly stated in the provided text.
• Reference Database (RDB) Generation Study:
  • Ground truth for inclusion criteria was based on clinical examination, fundus photography, and visual field testing, reviewed by clinicians at 5 U.S. clinical sites. Segmentation boundaries and disc margins required manual correction in some cases (e.g., 8% for BMO), implying expert review but specific "number of experts" or their "qualifications" for this aspect are not specified beyond being "study personnel" or "clinicians." The ground truth for the RDB itself is derived from a cohort of normal subjects without significant ocular pathology.

4. Adjudication Method for the Test Set

• Anterior Segment OCT & Posterior Segment OCT/OCTA Studies:
  • No formal adjudication method (like 2+1 or 3+1) is described for these quantitative R&R studies. The primary analysis was statistical (ANOVA, Bland-Altman, Deming regression) comparing successive measurements from the device itself and against the predicate. Manual edits for segmentation errors were performed, but the process of who made these edits or if there was a consensus method is not detailed.
• Fundus Photography Study:
  • Adjudication Method: Images were graded by "three independent graders." It is not explicitly stated whether a consensus method (e.g., 2-out-of-3 majority) was used for conflicting grades, or if individual grader results were reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done? Yes, for the fundus photography component. The study compared image quality and clinical utility of SOLIX images vs. iCam images, with three independent graders.
• Effect size of human readers improvement with AI vs. without AI assistance? This study was not designed as an AI-assistance study (human-in-the-loop improving their performance with AI). It was a standalone comparison of the image quality of two devices (SOLIX vs. predicate iCam), where human readers were evaluating the device outputs. Thus, no effect size related to "human readers improving with AI vs. without AI assistance" is provided or applicable here. The study concluded that SOLIX image quality was similar or better, and clinical utility was equivalent to iCam (97.3%).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done? Yes, several aspects of the device's performance were evaluated in a standalone manner:
  • OCT and OCTA Performance Studies (Anterior and Posterior Segments): These evaluated the device's quantitative measurements (repeatability, reproducibility, and agreement with predicate) entirely based on algorithmic outputs. While some manual editing of segmentations was noted, the core performance metrics derived were from the algorithm.
  • OCT Angiography (Vessel Density): A dedicated bench test using 3D digital phantoms was performed to determine the accuracy of SOLIX device software for vessel density measurement. This is a clear standalone performance evaluation.

7. Type of Ground Truth Used

• Anterior Segment OCT & Posterior Segment OCT/OCTA Studies (R&R/Agreement):
  • The "ground truth" here is the consistency of the device's own measurements. For agreement, the predicate device (Avanti) served as a comparative reference. The accuracy of measurements like epithelial thickness, corneal pachymetry, GCC thickness, retina thickness, vessel density, RNFL thickness, and ONH parameters are directly calculated by the device's algorithms. Manual corrections of segmentation errors or foveal center detection by presumably expert human reviewers could be considered a form of "expert consensus" for refining the algorithmic output for analysis.
• Fundus Photography Study (Image Quality/Utility):
  • Expert Consensus: Three independent graders evaluated image quality and clinical utility based on pre-specified grading criteria.
• Reference Database (RDB) Generation Study:
  • Clinical Diagnosis/Expert Opinion: The ground truth for this set was based on a cohort of "normal subjects without significant ocular pathology" confirmed by clinical examination, fundus photography, and visual field testing, effectively an expert-determined healthy cohort.

8. Sample Size for the Training Set

The document does not explicitly provide information about the sample size used for the training set of the algorithms within SOLIX. The studies described are primarily for clinical performance validation and RDB generation, not for training data specifics.

9. How the Ground Truth for the Training Set Was Established

As the training set size is not provided, the method for establishing its ground truth is also not detailed in this document. Information regarding the development and training of the algorithms (including how features like PAR, vessel extraction, or segmentation were trained and validated) is typically part of a separate technical documentation.

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