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The RTVue with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as an aid in the diagnosis and management of retinal disease. The RTVue with Normative Database is also a quantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue is a computer controlled ophthalmic imaging and measurement system that employs optical coherence tomography to image and measure the posterior segment of the eye. The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K062552). Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disk structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL. GCC. the outer retinal thickness and total retinal thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE. The current submission is for a software modification to add a normative database. With the additional normative database (NDB), the RTVue can compare the measured data from the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to the normative database. The RTVue with Normative Database provides a statistical reference of the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to a database of known normal subjects. The RTVue with Normative Database will provide the analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular diseases.

1. Acceptance Criteria and Reported Device Performance:

The document describes a precision study to evaluate the RTVue with Normative Database. The acceptance criteria are implicitly demonstrated by presenting the repeatability and reproducibility standard deviations for various measurements. The "Performance Data" section outlines these results.
The acceptance criteria are not explicitly stated, however based on the precision study results for repeatability and reproducibility, the device performance is within acceptable limits for a medical device.

Table of Performance Results

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: A total of 36 subjects were used in the precision study. This included 4 normal subjects, 4 retina patients, and 4 glaucoma patients for each of the 3 RTVue devices used (12 subjects per device).
• Data Provenance: The data was collected at two clinical sites. The document implies a prospective nature as subjects were "enrolled in the study," and "data was carefully reviewed for completeness and quality." The country of origin is not explicitly stated but can be inferred as the United States given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: The ground truth for subject classification (normal, glaucoma, retina pathology) was established by the "Principal Investigator (PI) at each clinical site." The exact number of PIs is not specified but there were two clinical sites.
• Qualifications of Experts: The PIs diagnosed glaucoma and various retina pathologies. Their specific qualifications (e.g., "Radiologist with 10 years of experience") are not detailed beyond being a "Principal Investigator" responsible for diagnosis.

4. Adjudication Method:

The document mentions that all data was "carefully reviewed for completeness and quality in two levels," including a review of the CRF by the PI against inclusion/exclusion criteria, and a review of individual scans for image quality. There is no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) for establishing the diagnostic ground truth for patient classification. The PI at each site made the diagnosis.

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

No MRMC comparative effectiveness study is described. The study focuses on the precision (repeatability and reproducibility) of the RTVue device itself, not on the improvement of human readers with AI assistance. The additional normative database (NDB) functions as a reference tool for comparison rather than a direct AI-assisted diagnostic aid for human readers in the context of this study.

6. Standalone Performance:

Yes, a standalone performance study was done. The precision study evaluates the RTVue device (algorithm only, in the sense of its measurement capabilities and normative database comparison) without human interpretation as the primary outcome. The results presented are the repeatability and reproducibility of the device's measurements.

7. Type of Ground Truth Used:

The ground truth used for classifying subjects into normal, glaucoma, or retina pathology groups was expert consensus (diagnosis by the Principal Investigator).

8. Sample Size for Training Set:

The "Normative Databases" section states that normative data was collected from 480 individuals (over 640 eyes) for the database. This acts as the "training set" for the normative database comparison feature of the device.

9. How Ground Truth for Training Set was Established:

The ground truth for the normative database was established by enrolling "known healthy eyes" from these 480 individuals. This implies that subjects were deemed healthy based on a medical evaluation, likely conducted by qualified medical professionals at the 11 clinical sites following an IRB approved protocol. The criteria for "healthy eyes" would have been part of this protocol, but are not explicitly detailed in the document.

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