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The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid.

The PLEX™ Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The PLEX™ Elite 9000 SS-OCT is a computerized instrument that acquires cross-sectional tomograms of the posterior ocular structures (including cornea, retinal nerve fiber layer, macula, and optic disc). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, the PLEX Elite SS-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-contrast angiographic imaging of the retinal microvasculature.

The PLEX Elite 9000 SS-OCT is offered in one model, the Elite 9000 in a new compact desktop system. The PLEX Elite SS-OCT contains a swept source, Class 1 Laser system operating at 1060 nm and includes a new system computer and archive with up to 24 TB storage capacity. The PLEX Elite also contains an iris viewer, fixation system and the fundus camera is a similar line-scanning ophthalmoscope (LSO) as used on the CIRRUS HD-OCT system, model 4000.

The provided text describes the Carl Zeiss Meditec, Inc. K161194 submission for the PLEX Elite 9000 SS-OCT device. However, it does not explicitly detail a standalone study with acceptance criteria and reported device performance in the format requested. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technological comparisons, bench testing, non-clinical tests, and a clinical case series.

Here's an attempt to extract and synthesize the information based on the provided document, acknowledging the limitations regarding the specific details of a formal "acceptance criteria and study" as might be found in a performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding reported performance for a standalone clinical study. Instead, it describes general claims of improved performance compared to the predicate device.

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

The document mentions a "case series study" as part of the clinical report. However, it does not specify the exact sample size of patients or images used for this case series. It only states that the study included "subjects with varying retinal pathologies."

The data provenance is implicit: the clinical imaging was "performed on human eyes," indicating prospective data collection for the purpose of this submission, likely from clinical sites where the device was being evaluated. The document does not specify the country of origin of the data.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions that a "clinical report is provided that includes clinical images" and compares PLEX Elite 9000 OCT angiography to "FA, ICGA, CIRRUS HD-OCT angiography, and color fundus photography." This implies that existing clinical imaging modalities and potentially expert interpretations of these modalities were used as a reference, but the process for establishing ground truth for the test set images is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for images or findings within the clinical report/case series. The comparison is made against other imaging modalities like FA and ICGA, suggesting these served as reference standards, but a formal adjudication process for a "test set" in the context of an algorithm's performance is not described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, where human readers analyze images with and without AI assistance to quantify the effect size of AI improvement, is not described in this document. The clinical evaluation focuses on demonstrating the device's ability to produce high-quality images and visualize structures similarly to or better than the predicate, mostly through direct comparison of image characteristics and content.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

While the device itself is a standalone imaging system (producing images without human real-time intervention for image generation), the submission does not describe a standalone algorithm performance study. The context is that of an imaging device. The document does refer to "En Face Algorithm," "Angiography OMAG Complex and a structure cube Algorithm," and algorithms for retinal tracking, but there are no standalone performance metrics specifically for these algorithms presented in this summary beyond their contribution to image quality.

7. The Type of Ground Truth Used

The ground truth implicitly used for the clinical report/case series appears to be a combination of established clinical imaging modalities (Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), CIRRUS HD-OCT angiography, and color fundus photography) for validating the visualization capabilities of the new SS-OCT angiography. For the general imaging capabilities (posterior ocular structures), the ground truth is the ability to visualize these structures as demonstrated by the images themselves and comparison to the predicate. No specific "expert consensus," "pathology," or "outcomes data" are explicitly stated as ground truth for the clinical evaluation of the device in this summary, although ICGA and FA are considered gold standards for certain vascular pathologies.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This submission is for an imaging device, not explicitly for an AI/CADe/CADx algorithm that requires a distinct training set in the way a deep learning model would. While the device utilizes "proprietary algorithms" for features like FastTrac™ 2.0 Retinal Tracking Technology and OCT angiography processing, the document does not elaborate on their development or training methodology.

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

Since a training set and its sample size are not mentioned, the method for establishing its ground truth is also not provided in this document.

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