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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:

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.

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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:

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.

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The CLARUS 500 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™ 500 is an active, software controlled, high-resolution ophthalmic imaging device for In-vivo imaging of the human eye. Imaging modes include True color, Fundus Autofluorescence with green excitation, Fundus Auto-fluorescence with blue excitation, Stereo and External eye. 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. With a single capture, CLARUS 500 produces a 90° high definition widefield image. Widefield images are automatically merged to achieve a 135° ultra-widefield view. The technology allows clinicians to easily review and compare high-quality images captured during a single exam while providing annotation and caliper measurement tools that allow analysis of eye health. CLARUS 500 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 Infrared Preview allows the technician to confirm image quality and screen for lid and lash obstructions, prior to imaging, ensuring fewer image recaptures.

The CLARUS 500 device's principle of operation is based on Slit Scanning Ophthalmoscope also referred to as Broad Line Fundus Imaging (BLFI). During image capture, a broad line of illumination is scanned across the retina. A 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.

The CLARUS 500 system is mainly comprised of an acquisition device, all-in-one PC, keyboard, mouse, instrument lift table and external power supply.

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 500 technical features relevant to the user are: Field of View (FoV), Image Resolution, Pixel Pitch and Focusing Range. The device meets the requirements of ISO 10940:2009 standard. The performance specifications are summarized in the Table 1 below.

The provided document describes the Carl Zeiss Meditec CLARUS 500 ophthalmic camera. However, it does not explicitly state acceptance criteria or a detailed study proving the device meets specific performance criteria in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices for FDA clearance.

Despite this, I can extract information related to performance and testing:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a formal "acceptance criteria" table like one might find in a clinical trial protocol for an AI device. Instead, it lists technical specifications and states that the device meets an ISO standard and passed various verification and validation tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document mentions "A clinical study was conducted" for both general imaging modes and FAF imaging modes.

• Sample Size: Not specified.
• Data Provenance: Not specified (country/region, retrospective/prospective). It simply states "A clinical study was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not specified. The document only mentions that the study "concluded that similar amount of clinical features can be resolved." There is no detail on how this "ground truth" or comparison was established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

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, this is not an AI device, and therefore no MRMC comparative effectiveness study involving AI assistance for human readers was done or described. The clinical study mentioned compares the device's imaging modes to a reference device. The focus is on the performance of the imaging capture, not an AI interpretation aid.

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

The CLARUS 500 is an imaging device, not an AI algorithm for interpretation. Its performance is inherent in the quality of the image capture. The "standalone" performance would be the image quality itself, which is verified through technical specifications and ISO compliance. The clinical study compares the "performance of the CLARUS 500 imaging modes" (standalone imaging output) to a reference device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the clinical study on imaging modes, the "ground truth" seems to be the ability to resolve "clinical features" when compared to images from a reference device. This implies a qualitative assessment, likely by clinicians, but the specific method or standard for "ground truth" (e.g., expert consensus on feature visibility, comparison to an actual disease state) is not detailed.

8. The sample size for the training set:

Not applicable, as this is an imaging device, not a machine learning algorithm that requires a training set in the typical sense. The software verification would involve testing against requirements, not "training data."

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

Not applicable, as it's not a machine learning algorithm with a training set.

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