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The iVue with Normative Database is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.

The iVue 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 retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The i Vue 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.

iVue with Normative Database (NDB) is a modification of its predicate device iVue (K091404) through the inclusion of the database collected with the iVue. The intent of use, system performance, majority of sub-assemblies, and key components of the iVue with NDB are all the same as iVue and RTVue with NDB.

iVue with NDB, based on the same Optical Coherence Tomography (OCT) technology that is used in the predicate device iVue (K091404) and RTVue with NDB (K101505), is a noninvasive diagnostic device for viewing the ocular tissue structure with micrometer range resolution. Both iVue and RTVue with NDB are designed and manufactured by Optovue, Inc.

The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K091404). The current submission is for a software modification through the addition of a normative database feature, similar to the NDB feature on the cleared predicate device RTV ue with NDB (K101505). With the addition of the normative database (NDB), the iVue can compare the measured data from the Retina Map scan, the Nerve Fiber scan, and the iWellness scan, to the normative database. The iVue/RTVue with Normative Database provide a comparison of the scanned measurements to a database of known normal subjects to provide a reference of where the patient's measurement stands in relation to the normative distribution. The iVue with normative database provides analysis information to be used as a clinical reference to aid in the diagnosis and management of ocular health and diseases. There is no hardware change from the 510(k) cleared iVue System (K091404). Additional scan patterns and acquisition of 3-D disc scan as ONH scan reference, optic disc analysis, and modification of the blood vessel extraction for the retina map scan are other software changes implemented in the current submission. These software changes are similar to features in the predicate RTVue device (K101505) and do not impact the safety and effectiveness of the system.

The device scans a patient's eye and uses a low coherence interferometer to measure the reflectivity of the retinal and corneal tissue. The cross sectional B-scan of the retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The patient will rest their head on the forehead and chin rest while the operator uses a joystick to align the device to the patient's eve. The computer has a graphic user interface for acquiring and analyzing the image.

iVue with NDB has similar scan patterns and analysis functions as the predicate device RTVue with NDB.

Here's a breakdown of the acceptance criteria and study information for the Optovue iVue NDB, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the repeatability and reproducibility of the iVue with NDB. While explicit "acceptance criteria" for performance are not directly stated in the traditional sense (e.g., a specific target for reproducibility SD), the study's goal is to show that the iVue's performance is "reasonably similar" and "substantially equivalent" to the predicate RTVue with NDB. The reported performance is captured in tables of repeatability and reproducibility, as well as comparison against the predicate device.

Implicit Acceptance Criteria (Performance should be "reasonably similar" and "substantially equivalent" to predicate):

2. Sample size used for the test set and the data provenance:

• Repeatability and Reproducibility Study:

  • Test Set Sample Size: 14 normal subjects, 13 patients with glaucoma, 13 patients with retina disease. Only one eye per subject was included.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study design indicates it was a "repeatability and reproducibility study... conducted with IRB approval," suggesting a prospective clinical study environment.

• Comparison to Predicate Device Study:

  • Test Set Sample Size:
    • GCC comparison: 21 subjects (normal group), 24 subjects (glaucoma group).
    • ONH (Disc Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • ONH (RNFL Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • Retina Map comparison: 21 subjects (normal group), 19 subjects (retina group).
    • iWellness (GCC Parameters) comparison: 21 subjects (normal group), 23 subjects (glaucoma group).
    • iWellness (Retina Parameters) comparison: 21 subjects (normal group), 16 subjects (retina group).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The comparison study implicitly uses data collected with the iVue and the predicate RTVue from the same or similar populations to assess equivalence.

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

• The document describes studies for repeatability and reproducibility of measurements and comparison against a predicate device. These types of studies typically do not involve experts establishing "ground truth" for diagnosis in the test set. Instead, the "ground truth" for these studies is the actual measurement obtained by the device (or predicate device) itself.
• The subjects are categorized as "normal," "glaucoma," or "retina disease," implying that these diagnoses were established clinically, presumably by ophthalmologists, but the document does not specify the number or qualifications of these diagnostic experts.

4. Adjudication method for the test set:

• No explicit adjudication method is mentioned for the test set in the context of establishing a diagnostic ground truth. The studies focus on device measurement precision and equivalence.

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 MRMC comparative effectiveness study was done, as this submission is for an Optical Coherence Tomography (OCT) system that provides quantitative measurements and a normative database comparison, not an AI-assisted diagnostic tool that human readers would interpret. The device itself performs the measurements and comparisons.

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

• Yes, the performance presented is standalone in the sense that the device's measurement repeatability, reproducibility, and comparison to a known database are evaluated directly. The iVue with NDB is an imaging device that provides quantitative data and a normative comparison; its output (color-coded percentile categories) is directly generated by the algorithm based on the acquired OCT images. Human operators acquire the images, but the measurement and comparison algorithms function independently.

7. The type of ground truth used:

• For Repeatability and Reproducibility studies: The "ground truth" is the device's own measurement. The studies assess how consistently the device produces these measurements under repeated conditions.
• For Comparison to Predicate Device studies: The "ground truth" for comparison is the measurement obtained by the predicate device (RTVue with NDB). The iVue with NDB's measurements are compared to the predicate's measurements to establish substantial equivalence.
• The normative database used by the device serves as a reference "ground truth" for defining "normal," "borderline," or "outside normal" ranges for patient measurements. The database was populated using data from "known normal subjects."

8. The sample size for the training set:

• The document states that the iVue normative database was established using a "nearly identical methodology as that of the predicate RTVue with NDB." It also mentions "the total number of normal subjects is also similar in the two normative databases."
• For the RTVue with NDB (predicate), which the iVue NDB is compared to, the previous 510(k) (K101505) would contain the detailed training set information. This document does not explicitly state the training set size for the iVue NDB itself, other than implying it's similar to the RTVue NDB. A previous submission for RTVue NDB (K101505) described collecting data from 300 normal subjects (as mentioned in other similar submissions).

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

• The "ground truth" for the normative database (which can be considered the training set for the "normal" ranges) was established by collecting data from "known normal subjects."
• Specific details mentioned:
  • "The iVue normative database collection was based on a similar study design, study protocol, and data collection method as those of predicate RTVue NDB data collection."
  • "The inclusion and exclusion criteria are identical in the two protocols."
  • Image quality review criteria were similar.
  • The database contains a "mixture of ethnicities, and have similar age, gender, and refractive error range coverage."
  • Regression models were employed to estimate normative limits, taking into account covariates such as age, signal strength, and optic disc size.
  • The comparison is displayed in color-coded percentile categories ('within normal', 'borderline', or 'outside normal') based on cut-off levels of 5% and 1%, which would have been derived from the statistical analysis of this normative database.

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