(120 days)
The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.
The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.
The CLARUS 700 is an active, software controlled, high resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Auto-fluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Fluorescein Angiography, Stereo External eye and Fluorescein Angiography- Indocyanine green angiography (FA-ICGA). All true color images can be separated into red, green and blue channel images to help enhance visual contrast of details in certain layers of the retina.
The CLARUS 700 angiography imaging aids in the visualization of the vascular structures of the retina and the choroid. With a single capture, CLARUS 700 produces a 90º high definition widefield image. Widefield images are automatically merged to achieve a 135º ultra-widefield of view. The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection. The ultra-widefield montage on CLARUS 700 is no longer dependent just on the patient accurately fixating their gaze on the internal fixation. With the ONH detection, the software will find the optic nerve and determine based on the image(s) captured where the patient was gazing at the point of capture. The CLARUS 700 device allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow in-depth analysis of eye health. CLARUS 700 is designed to optimize each patient's experience by providing a simple head and chin rest that allows the patient to maintain a stable, neutral position while the operator brings the optics to the patient, facilitating a more comfortable imaging experience. The ability to swivel the device between the right and left eye helps technicians capture an image without realigning the patient. Live IR Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures.
The CLARUS 700 device's principle of operation is Slit Scanning Ophthalmic Camera also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a line of illumination passes through the slit and scans across the retina. A 2D monochromatic camera captures the returned light to image the retina. A single sweep of the illumination is used to illuminate the retina for image capture. Repeated sweeps of near infrared light are used for a live retina view for alignment. Red, green and blue LEDs sequentially illuminate to generate true color images. Blue and green LED illumination enables Fundus Autofluorescence (FAF) imaging. Fluorescein Angiography images are captured with green LED illumination at a wavelength that stimulates fluorescence of the injected sodium fluorescein dye. The principle of operation of CLARUS 700 has not changed since the previous clearance, K191194.
The CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.
The device hardware is based on the predicate CLARUS 700 (K191194) hardware. The new ICGA imaging mode on the device required the following hardware changes as stated in the summary above:
- Lightbox for Infrared (IR) Laser
- Modified Slit filter – FA/ICG Slit Excitation Filter – new coating, no change to FA
- Modified Turret Filter 1- FA/ICG Dual Band barrier filter – new coating, no change to FA.
- Added Turret Filter 2 – Added second filter. Same coating as Turret Filter 1 to eliminate cornea reflex band in ICG images with a different shape.
- Added Large Alignment Tool (LAT)
- Added ICG Power Meter Tool
The CLARUS software provides the user the capability to align, capture, review and annotate images. The software has two installation configurations: Software installed on the Instrument (Acquisition & Review) as well as Software installed on a separate 'Review Station' (Laptop or Computer) (only Review).
The DEVICE software version 1.2 is based on the predicate CLARUS 700 software version 1.0 (K191194).
Added capability for DEVICE software version 1.2 include:
- Simultaneous capture of Fluorescein Angiography (FA) + Indocyanine Green Angiography (ICGA)
- Angiography Movie: Capture of multiple pictures in sequence, after a single press of a button. Available for FA, ICGA and Simultaneous FA+ICGA.
- Early Treatment Diabetic Retinopathy Study (ETDRS) – Manual placement of ETDRS grids (7 field ETDRS and Macula ETDRS) over the pictures:
- The ETDRS 7-fields grid in CLARUS is a display of the standard 7-fields in Color Fundus Photography used to determine an ETDRS (Early Treatment Diabetic Retinopathy Study) level for patients with Diabetic Retinopathy. These 7-fields in and around the macular region are displayed in one single widefield image according to definitions followed by the gold-standard 7-field images using narrow-field fundus cameras.
- The Macular ETDRS grids display assists in the identification of an ETDRS level in nine subfields centered around the fovea.
- ICGA Boost Mode: user-selectable option for ICGA capture that increase used light to obtain better picture at later phase.
- 8 up view: addition of the possibility to view eight pictures side by side (currently it is only possible to see 1, 2, 4, 16)
The CLARUS 700 device meets the requirements of ISO 10940:2009 standard. The device technical specifications are identical to the predicate device.
The provided text is a 510(k) clearance letter and summary for the CLARUS 700 ophthalmic camera, particularly focusing on the new v1.2 software update. While it discusses the device's intended use, technical characteristics, and various tests performed, it does not contain detailed acceptance criteria or the specific results of a comprehensive clinical study in the format of "acceptance criteria vs. reported device performance."
The document mentions "clinical testing aimed at demonstrating the ability of the new model of CLARUS 700 to image a variety of retinal and choroidal conditions using simultaneous FA and simultaneous ICGA and standalone ICGA." It states that "Our analysis of the grading of angiography images showed that the quality of the images captured by the CLARUS 700 simultaneous FA, simultaneous ICGA, and standalone ICGA were clinically acceptable by three independent graders." However, this is a qualitative statement rather than quantitative acceptance criteria with specific performance metrics.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text. I can, however, extract related information from the "Clinical Data" section:
Acceptance Criteria and Study Details (Based on provided text)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Quantitative/Specific) | Reported Device Performance (Quantitative/Specific) |
|---|---|
| Not explicitly defined in the provided document. | Not explicitly defined in the provided document beyond a qualitative statement. |
| Example of typical criteria (not from text): Minimum percentage of images graded as "clinically acceptable" | Reported: "Our analysis of the grading of angiography images showed that the quality of the images captured by the CLARUS 700 simultaneous FA, simultaneous ICGA, and standalone ICGA were clinically acceptable by three independent graders." |
Explanation: The document states that the "quality of the images... were clinically acceptable by three independent graders." This implies an implicit acceptance criterion that images must be "clinically acceptable." However, no quantitative threshold (e.g., "90% of images must be clinically acceptable") is provided, nor are specific quantitative performance metrics (e.g., actual percentage of acceptable images).
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only states "ZEISS conducted clinical testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Three independent graders.
- Qualifications of Experts: Not specified (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified beyond "three independent graders." It does not mention if consensus, majority rule (e.g., 2+1), or another method was used for discordant readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the Effect Size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not described. The study focused on the image quality produced by the device as assessed by human graders, not on the improvement of human readers' performance with AI assistance.
- Effect Size: Not applicable, as no MRMC study comparing human readers with/without AI assistance was conducted or reported. The device's deep learning algorithm for ONH detection is noted, but its specific impact on reader performance or an MRMC study related to it is not detailed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not explicitly detailed or quantified. The document notes that "The CLARUS 700 makes use of a deep learning algorithm for Optic Nerve Head (ONH) detection." However, no standalone performance metrics (e.g., specificity, sensitivity, accuracy) for this algorithm are provided in the clinical data summary.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Expert grading/consensus from "three independent graders" on "clinical acceptability" of angiography images. It is not stated if this was against a pathology or outcomes data gold standard.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not specified in the provided text. The document refers to a "deep learning algorithm for Optic Nerve Head (ONH) detection." While this implies a training set was used, its size is not disclosed.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not specified.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.