(53 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™ model 700 is a new addition to the CLARUS product family consisting of existing model 500 (K181444). The CLARUS 700 is an active, software controlled, highresolution 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 and External eve. 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 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° 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), same as the predicate CLARUS 500 (K181444). 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 CLARUS 700 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.
The CLARUS 700 hardware is based off the predicate CLARUS 500 (K181444) hardware. New FA imaging mode on the CLARUS 700 require the below hardware changes:
- Added filters to support FA imaging mode .
- Updated slim turret and motor with new positions for reliability, angiography filters and ● FPGA code
- Updated calibration tool for new turret positions and differentiation
- Change to lightbox board for reliability and support higher duty cycle in support of FA imaging
- Updated Onyx All-in-one Computer for 32GB RAM and 2TB HDD storage space
- Updated belt driven slit for reliability and to support FA imaging mode ●
- . Updated camera to support FA imaging mode
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 CLARUS software version 1.1 is based off the predicate CLARUS software version 1.0 (K181444). Added image capture modality includes Fluorescein Angiography. Other changes implemented in the software version 1.1 include:
- Automated Optic Nerve Head (ONH) detection for montaging ●
- Smart (Region of Interest) Focus ●
- Auto brightness for FA image series
- Calibration software update for DEVICE hardware changes ●
- . FORUM/ Other EMR connectivity updates for new FA imaging mode
The CLARUS 700 device meets the requirements of ISO 10940:2009 standard. The device technical specifications are identical to the predicate device. The performance specifications relevant to the user are summarized in the Table 1 below.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the CLARUS 700:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria # | Criteria Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | Area and lesion of interest is visible on the angiogram | N/A (implied high visibility) | 17/20 (85%) |
| 2 | Clinically useful image. Image appearance is consistent with the disease and transit phase of dye | N/A (implied high clinical utility) | 19/20 (95%) |
| 3 | Artifacts, if any, do not interfere with ability to interpret image | N/A (implied minimal interference) | 19/20 (95%) |
Note: The document only provides the reported device performance as "passing rates" for the Fluorescein Angiography (FA) imaging mode, without explicitly stating numerical acceptance criteria for each point. The acceptance criteria are implied to be high percentages, demonstrating good clinical utility and image interpretability.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 20 eyes from 13 subjects (11 male, 2 female)
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, based on the nature of a "clinical study to support indications for use," it is highly probable that it was a prospective study designed for regulatory submission. The location of the manufacturer (Dublin, California, USA) suggests the study might have been conducted in the US, but this is not explicitly stated for the clinical data itself.
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 or their specific qualifications for establishing the ground truth of the test set images. It mentions "clinically useful image" and "ability to interpret image," implying expert evaluation, but the specifics are not provided in this summary.
4. Adjudication Method for the Test Set:
The document does not mention any specific adjudication method (e.g., 2+1, 3+1). Expert consensus or independent review by a single expert is implied by the evaluation of "clinical utility" and "interpretability," but the process is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No, a traditional MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly conducted or reported for the performance of AI on human readers.
- Effect Size: Therefore, no effect size for human reader improvement with AI assistance is reported.
Note on AI: The device does make use of a deep learning algorithm for Optic Nerve Head (ONH) detection to improve montage creation, but the clinical study described focuses on the overall performance of the Fluorescein Angiography imaging mode, not specifically on the impact of ONH detection AI on reader performance.
6. Standalone (Algorithm Only) Performance:
The document does not present separate standalone (algorithm-only) performance metrics for the deep learning algorithm (ONH detection). The clinical study evaluates the device's ability to capture useful images, which would indirectly incorporate the functionality of the device's software, but it's not a standalone performance evaluation of the AI component in isolation.
7. Type of Ground Truth Used:
The ground truth used for evaluating the clinical utility of the Fluorescein Angiography images appears to be expert clinical judgment/interpretation of the images. The criteria like "Area and lesion of interest is visible on the angiogram" and "Clinically useful image" strongly suggest evaluation by a medical professional or panel thereof. The study's objective was to demonstrate the device's ability to capture images useful for "diagnosis and monitoring of diseases and disorders," further supporting expert clinical judgment as the ground truth.
8. Sample Size for the Training Set:
The sample size for the training set of the deep learning algorithm (ONH detection) is not specified in the provided document.
9. How the Ground Truth for the Training Set Was Established:
The document briefly mentions "deep learning algorithm for Optic Nerve Head (ONH) detection" but does not detail how the ground truth for training this algorithm was established. It can be inferred that it would involve expertly annotated images for ONH location, but the specifics are not provided.
§ 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.