Search Results

Optina-4C™ is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying, storing, and transferring images of the retina. The Optina-4C is indicated for the viewing of the posterior segment of the eye at multiple wavelengths (colors) under mydriatic conditions.

Images are intended to aid clinicians in the detection, diagnosis, and management of ocular health and disease.

The Optina-4C™ (MHRC-C1N) is a non-contact mydriatic retinal camera (also called a fundus camera) designed to provide eye care professionals with a series of images of the retina obtained at specific wavelengths (colors). The Optina-4C processes images using algorithms that take advantage of the spectral information to produce 2D en face images of the retina as an aid to clinicians in the diagnosis of age-related macular degeneration (AMD), retinal pigment epithelium (RPE) disruptions and lesions, retinopathies, and other retinal diseases.

Utilizing Hyperspectral Imaging (HSI) technology, the Optina-4C captures a series of 92 high-resolution images at precise 5 nm wavelength increments across the visible and near-infrared (NIR) spectrum on a ~31° field-of-view. Image acquisition takes under two seconds, with only 0.92 seconds of light exposure time. During this time, the camera scans through all wavelengths from 905 to 450 nm, spending 10 milliseconds per 5 nm step.

The Optina-4C processes the images to provide spectrally calibrated, normalized, and registered images in a structured Hyperspectral Cube format for scroll-through viewing. The spectral resolution supports visualization and differentiation of drusenoid deposit types, as well as high contrast viewing of the retinal chromophores hemoglobin, melanin, and carotenoids (combination of lutein and zeaxanthin). Images can be viewed, stored or transferred in their native .h5 format, or as DICOM or PNG formats. Optina-4C images offer sharp, vivid, high-contrast coronal views of the posterior segment of the eye for clinical assessment and evaluation by eye care professionals.

The HSI NormReg Cube is a processed data set of 91 hyperspectral images that have undergone intensity normalization and spatial registration. Normalization corrects for the non-uniform illumination profile of the imaging system and the spectral sensitivity of the camera, while registration compensates for intra-scan eye movement to ensure consistent alignment across frames. The result is a hyperspectral image cube with enhanced spatial and spectral fidelity, referred to as the HIS-NormReg Cube.

N/A

Ask a specific question about this device

Optina-4C™ is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.

Optina-4C™ (model: MHRC-C1N) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series of the retina obtained sequentially at specific wavelengths (colors) in the spectral range 905 nm to 450 nm in steps of 5 nm.

Pictures of the retina are obtained on a field-of-view of 31.5° without contact with the eye. The patient is positioned in front of the device with the chin on the chinrest and forehead on the forehead rest and a positioning system is used to align the camera relative to the patient's eye. An external fixation target is available to guide the patient's eye. A focus wheel allows for the accommodation for eye refractive error in the range of -15 to +15 diopters. The images are displayed on a monitor and can be saved on the computer for future consultation.

The illumination light of Optina-4C™ is provided by a Tunable Laser Source (TLS). The TLS selects a narrow band of light from a broadband white illumination source. Only a single monochromatic band can output the TLS at a time. The alignment of the retinal camera relative to the patient's eye phase is performed with the illumination light set at a wavelength of 700 nm. The image acquisition phase consists of the sequential acquisition of a series of 92 monochromatic images at wavelengths from 905 nm in steps of 5 nm. Each frame is captured with an exposure time of 10 ms, resulting in a total acquisition time of 920 ms.

The 92 images can be visualized one by one in Optina-4C™ acquisition software. The retinal images captured by Optina-4C™ are monochromatic images having a spectral bandwidth of "10 nm centered on the wavelength indicated in the upper left corner of the visualization pane, with a spectral accuracy of 7.5 nm.

The provided text is a 510(k) summary for the Optina-4C (MHRC-C1N) device, which is a mydriatic fundus camera. The document primarily focuses on demonstrating substantial equivalence to a predicate device (MHRC-C1) and outlines various performance tests conducted to support this claim.

However, the document does not contain specific acceptance criteria for the device's performance regarding its intended use of capturing retinal images, nor does it present a detailed study that proves the device meets such criteria in terms of clinical accuracy or utility.

Instead, the document focuses on:

• Technological equivalence: Stating that the main elements of the hardware, illumination, and monochromatic images are the same as the predicate.
• Verification of safety and regulatory compliance: Covering software evaluation, electrical safety, electromagnetic compatibility, biocompatibility, and compliance with recognized consensus standards for ophthalmic cameras (ISO 15004-1:2020, ISO 10940:2009, ANSI Z80.36:2021).
• Spectral accuracy and reliability of retinal images: This was evaluated in an "eye model using a reference material with tabulated spectral bands," but no specific acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy for a particular clinical task) are provided from this evaluation.

Therefore, I cannot populate the requested table and information as the necessary details regarding acceptance criteria, reported device performance related to a specific clinical task, test set characteristics, expert involvement, adjudication, or a multi-reader multi-case study are not present in the provided text. The document describes tests to ensure the device functions safely and in a manner similar to its predicate, but not how well it performs a particular diagnostic task against established clinical benchmarks or ground truth.

Missing Information:

• No specific acceptance criteria for diagnostic performance (e.g., image quality metrics, sensitivity/specificity for detecting a condition).
• No reported clinical performance metrics directly related to the device's ability to 'capture images' that translates to a clinical outcome.
• No details on a clinical study where the device's images were evaluated for a specific purpose against a ground truth.

The document seems to describe the device as an image capture device, and the "performance testing" focuses on its technical specifications and safety rather than its diagnostic accuracy for a particular condition.

Ask a specific question about this device