(223 days)
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.
| Feature | Specification (Acceptance Criterion - implied) | Reported Device Performance and Verification Method |
|---|---|---|
| Technical Specifications (from Table 1 - implying acceptance criteria for these features) | ||
| FoV – Widefield (single capture) | 90° | Verified through bench testing using a test eye. |
| FoV - Ultra-widefield (montage) | 135° | Verified through software algorithm verification. |
| Image Resolution | 60 lp/mm at central field (0°), 40 lp/mm at 23° FOV, 25 lp/mm at 45° FOV | Data not explicitly stated, but the device "meets the requirements of ISO 10940:2009 standard," which would cover resolution. |
| Sensors | 12 megapixel monochrome | Not explicitly tested as a performance criterion, rather a design characteristic. |
| Sensor Resolution | 3000 x 3000 pixels | Not explicitly tested as a performance criterion, rather a design characteristic. |
| Focusing Range | +20 D to -24D | Data not explicitly stated, but the device "meets the requirements of ISO 10940:2009 standard," which would cover focusing range. |
| Pixel Pitch on the Fundus | 7.3 µm/pixel | Not explicitly tested as a performance criterion, rather a design characteristic. |
| General Performance/Safety (implied acceptance criteria for compliance) | ||
| Design Requirements | Satisfy established system requirements | Design verification testing demonstrated compliance. |
| Customer Acceptance | Meet requirements set by Product Requirements Specifications and user experience acceptance criteria. | Design validation testing demonstrated these were met. |
| Consensus Standards Compliance | Meet requirements for conformity to multiple industry standards. | R&D evaluation documented compliance. Includes ISO 10940:2009 for fundus cameras, ANSI AAMI 60601-1:2005/(R) 2012 and A1:2012 (Ed 3.1) for electrical safety, IEC 60601-1-2:2014 Ed 4.0 for EMC, ANSI Z80.36-2016 and ISO 15004-2:2007 for optical safety, IEC 60825-1:2007 for laser safety, ISO 15004-1:2009 for environmental conditions, NEMA PS 3.1-3.20 (2016) for DICOM. |
| Software Performance | Comply with FDA's Guidance for Industry and FDA staff, "Guidance for the Content of premarket Submissions for Software Contained in Medical Devices." | Software verification testing was conducted and documented. |
| Biocompatibility | Comply with requirements of ISO 10993-1:2009 standard for patient-contact components. | Materials for patient chin rest and forehead rest were evaluated and comply. |
| Clinical Feature Resolution | Similar amount of clinical features resolved compared to reference device. | "Study results concluded that similar amount of clinical features can be resolved on CLARUS 500 images as the images from the reference device in almost all cases." |
| FAF Imaging Performance | Performance comparable to FAF imaging mode of reference device (CIRRUS photo). | A clinical study was performed to demonstrate the performance of the FAF-B and FAF-G imaging modes as compared to the FAF imaging mode of the reference device CIRRUS photo. |
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.
§ 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.