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The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in-vivo imaging, axial crosssectional, and three-dimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database, the iVue 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 iVue is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

The iVue is used to capture, store, display and print spectral domain-optical coherence tomography (SD-OCT) images of the posterior and anterior structure of the eye. The device software includes a Normative Database (NDB), consisting of OCT data from a range of known normal subjects that can be used to compare a new patient's measurements in relation to the normal distribution.

iVue is a computer-controlled ophthalmic imaging system using either a laptop computer or "All-in-One" computer. For laptop systems there are two control box options of 120 or 230 volts. The control box interfaces between the motorized table column and the medical-grade power supply for the computer.

iVue System Key Functional Components:

• Scanner Head
• Computer
• Control Box
• Joystick and Chinrest Assembly
• Footswitch (optional)
• Motorized Table (optional)
• Cornea Adapter Module

The provided document is a 510(k) Premarket Notification for the Optovue iVue device, seeking clearance for a software modification that allows automated segmentation and measurement of corneal epithelial and stromal layer thickness. The document describes two clinical studies conducted to support the substantial equivalence claim.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format with pass/fail thresholds. Instead, it presents the results of repeatability, reproducibility, and agreement studies, and then concludes whether these results demonstrate "good repeatability and reproducibility" and "good agreement."

Based on the summaries provided, the implicit acceptance criteria seem to be related to achieving clinically acceptable levels of repeatability, reproducibility, and agreement with manual measurements for corneal pachymetry, epithelial thickness, and stromal thickness, across various patient groups.

Table of Implicit Acceptance Criteria and Reported Device Performance:

• Normal Group: 1.7 to 7.6 µm (across zones)
• Corneal Patients (pooled): 3.3 to 8.6 µm
• Subgroups (Contact Lens, Dry Eye, Post-LRS, KCN): Ranged from 1.5 to 13.4 µm (max in Dry Eye S_5_6_Pachy).
  Epithelial Thickness:
• Normal Group: 0.8 to 1.4 µm
• Corneal Patients (pooled): 1.2 to 1.9 µm
• Subgroups: Ranged from 0.6 to 2.9 µm (max in Dry Eye I_5_6_Epi and IT_5_6_Epi, and Post-LRS C2 Epi)
  Stromal Thickness:
• Normal Group: 1.6 to 7.6 µm
• Corneal Patients (pooled): 2.8 to 8.8 µm
• Subgroups: Ranged from 1.4 to 13.4 µm (max in Dry Eye S_5_6_Stroma) |
  | Reproducibility (SD) | Demonstrated "good reproducibility" | Pachymetry:
• Normal Group: 2.2 to 7.7 µm
• Corneal Patients (pooled): 3.6 to 8.8 µm
• Subgroups: Ranged from 1.8 to 13.7 µm (max in Dry Eye S_5_6_Pachy).
  Epithelial Thickness:
• Normal Group: 0.9 to 1.5 µm
• Corneal Patients (pooled): 1.2 to 1.9 µm
• Subgroups: Ranged from 0.7 to 2.9 µm (max in Dry Eye I_5_6_Epi and IT_5_6_Epi, and Post-LRS C2 Epi)
  Stromal Thickness:
• Normal Group: 2.0 to 7.6 µm
• Corneal Patients (pooled): 3.1 to 9.0 µm
• Subgroups: Ranged from 1.8 to 13.7 µm (max in Dry Eye S_5_6_Stroma).
  The report notes: "Repeatability standard deviation was similar to the Reproducibility standard deviation for all study parameters and therefore is not detailed separately in the summary tables below." The tables for each parameter show Reproducibility SD values. |
  | Agreement (Mean of Differences) | Demonstrated "good agreement" | Mean of differences between software output and manual measurements for all zonal parameters:
• Corneal Epithelial Mapping:

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The iFusion connects the iCam (K122572) and iVue (K121739) devices via a sliding bracket mechanism (iShuttle), to facilitate switching between the two devices. The iShuttle provides position adjustment ability of the iCam or iVue device during use.

The iFusion interfaces with the iCam and iVue devices to enable the operation of the iCam and iVue devices from one computer unit.

iFusion is a combination of the cleared iVue with NDB (K121739)("iVue") and the cleared iCam Fundus Camera (K122572)("iCam") on a shuttle platform, called the iShuttle. The iShuttle mounts to a joystick assembly using a central nut and bolt and four adjustable set screws. The iShuttle consists of a sliding metal plate supporting the iVue and the iCam. The iShuttle travels on tracks fitted to the X-Y-Z joystick assembly which helps position the iVue and the iCam devices. A release button is located at the front of the iShuttle to lock the iShuttle in position for the iVue and the iCam device. The iCam can be switched in position by pressing on the release button to unlock the iShuttle platform, then the iVue or the iCam can be pushed to slide to an opposite end until it is locked into position. In addition, the software of the iFusion system is created to allow the user to switch between the iVue and the iCam programs with the same computer. The iVue and the iCam programs use the same data communication and programming storage with a single shared database.

The provided document is a 510(k) summary for the Optovue iFusion device. This submission is for a combination device that integrates two previously cleared predicate devices (iVue and iCam) onto a new sliding bracket (iShuttle) and includes minor software changes. The primary goal of this type of submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than to prove clinical effectiveness and safety through de novo clinical studies with specific acceptance criteria related to disease diagnosis or treatment.

Therefore, the information typically found in acceptance criteria tables and detailed study reports for showing diagnostic/predictive performance (like sensitivity, specificity, AUC) or comparative effectiveness (like MRMC studies) is not present in this document. This submission focuses on demonstrating that the changes (the iShuttle and minor software updates) do not negatively impact the safety and effectiveness of the already cleared component devices.

Here's an breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance in the typical sense for diagnostic or prognostic claims (e.g., sensitivity, specificity, accuracy for a particular disease). Instead, the "acceptance criteria" for this 510(k) were focused on demonstrating that the new iFusion system, with its integrated iShuttle and minor software changes, maintained the safety and effectiveness of the predicate devices.

The "performance data" section states:

"Verifications and validations were performed for mechanical and functional testing according to IEC 60601-1 and 60601-1-2 for the new iShuttle bracket and the software changes."
"The results demonstrated that the changes in iFusion did not affect the intended use or alter the fundamental technological characteristics of the predicate devices and that the iFusion is substantially equivalent to its predicate devices."

This implies that the acceptance criteria for these tests would have been along the lines of "meet IEC 60601-1 and 60601-1-2 standards" and "no degradation in function or safety of iVue and iCam components." However, the specific quantitative results or acceptance thresholds for these engineering tests are not provided in this summary.

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

Not applicable in the context of this 510(k) submission. This is not a study assessing diagnostic performance on a patient dataset. The "test set" would have been the iFusion device itself subjected to mechanical and software integrity tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There's no clinical ground truth established for this submission as it's not a study on diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable for this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not described or performed for this 510(k) submission. The iFusion device is essentially a physical integration and software interface for two existing devices, not a new diagnostic algorithm requiring human-in-the-loop performance measurement.

6. If a Standalone Study Was Done

Not applicable in the sense of an algorithm-only diagnostic performance study. The "standalone" testing here refers to the verification and validation of the iShuttle's mechanical and functional aspects, and the software changes, to ensure they didn't compromise the existing functionalities of the iVue and iCam.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical ground truth. The "ground truth" for this engineering/integration submission would be adherence to safety standards (IEC 60601-1, 60601-1-2) and confirmation that the iVue and iCam components function as intended when integrated into iFusion.

8. The Sample Size for the Training Set

Not applicable. There is no mention of an algorithm being "trained" in this submission. The software changes are "minor" and related to user interface and data communication/storage, not a new AI/ML algorithm.

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

Not applicable, as there was no training set for an AI/ML algorithm.

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