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The iVue 500 with normative database is an optical coherence tomography system intended for in vivo imaging, axial crosssectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

The iVue 500 with normative database is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population. (identical to predicate device)

The iVue 500 is a modification of its predicate device iVue with Normative Database (NDB) (K121739). The intended use, system performance, sub-assemblies, and key components of the iVue with NDB are all the same as the iVue with NDB. The intent of this redesign was to make the iVue a more compact desktop device, so it is more convenient to use and set-up in a typical office. Additionally operation via touchscreen or mouse driven technology, makes it simpler for a technician to use.

The iVue 500 is a non-invasive device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution.

Here's a breakdown of the acceptance criteria and the study details for the Optovue iVue 500 (K133892) based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: The document mentions using "2 model eyes" for the bench testing. This is a very limited sample size, suggesting the testing was highly controlled and focused on mechanical and alignment capabilities rather than diverse clinical data.
   • Data Provenance: Not explicitly stated, but given the use of "model eyes" and the nature of the bench test, it is not clinical data from human subjects. It represents a controlled laboratory environment. Retrospective or prospective study types are not applicable here as it's not a clinical study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. Given that the testing involved "model eyes" and focused on alignment within mechanical tolerances, it's unlikely that clinical experts were involved in establishing "ground truth" in the typical sense (e.g., diagnosing disease). The "ground truth" for this test was the predefined mechanical tolerances.

3. Adjudication method for the test set:

   • This information is not provided and is not applicable given the nature of the bench test with model eyes. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a clinical ground truth.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a modified version of an existing OCT device, focusing on mechanical and alignment performance rather than clinical diagnostic efficacy with human readers or AI assistance. The document does not describe any AI component or human reader performance evaluation.

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

   • Yes, in a sense, a "standalone" test of the device's alignment capabilities was performed. The "software assisted motorized iVue 500" was tested to ensure it could align to the appropriate working distance and pupil centering with model eyes. This is an evaluation of the device's automated functions without human diagnostic interpretation in the loop. However, it's not a standalone diagnostic algorithm performance test as might be seen for an AI-powered diagnostic tool. The device itself is the "algorithm only" in this context of automated alignment.

6. The type of ground truth used:

   • The ground truth used was predefined mechanical tolerances (e.g., "±1mm tolerance") for working distance, centering, and pupil distance. This relates to the physical positioning and alignment capabilities of the device in a controlled setting, not clinical diagnosis.

7. The sample size for the training set:

   • This information is not applicable/not provided. The iVue 500 is a modification of an existing OCT system (K121739), not an AI algorithm that typically requires a separate training set. The existing normative database mentioned in the indications for use would have been developed previously, but details on its training set size are not part of this 510(k) submission. The current submission focuses on verifying the mechanical integrity and performance of the modified hardware.

8. How the ground truth for the training set was established:

   • This information is not applicable/not provided for this 510(k) submission. As mentioned above, this submission is for hardware modification. The existing "normative database" (which might be considered a form of a "training set" for comparison) would have had its ground truth established based on measurements from "known normal subjects," but the details of that establishment are not within the scope of this submission.

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