(84 days)
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series of 92 images 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 the MHRC-C1 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 to 450 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 the MHRC-C1 acquisition software. The retinal images captured by the MHRC-C1 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.
This document is a 510(k) summary for the Optina Diagnostics Mydriatic Hyperspectral Retinal Camera (MHRC-C1). It describes the device's characteristics and the performance testing conducted to support its substantial equivalence to predicate devices. However, it does not contain the level of detail typically found in a full clinical study report that would include direct acceptance criteria and detailed study results for an AI-powered device.
Based on the provided text, the MHRC-C1 is an ophthalmic camera intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions. It is not described as an AI-powered device; rather, it is a hardware device for image capture. Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance" or "standalone (i.e. algorithm only without human-in-the loop performance)", are not applicable to this specific device as presented in the summary.
The acceptance criteria and performance data described in this document relate to the camera's ability to capture images accurately and reliably, rather than the performance of an AI algorithm on those images.
Here's an analysis of the provided information relative to your request, noting where the information is not present or applicable:
Acceptance Criteria and Device Performance
Since this is a fundus camera and not an AI/algorithm-based diagnostic device, the acceptance criteria are related to the physical performance of the camera itself.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Assessed in accordance with ISO 10993-1:2018 for intact skin contact (chin and forehead). (Implies compliance was achieved, though specific results are not detailed). |
| Software Evaluation | Evaluated for use in accordance with FDA's Guidance for Industry "Off-The-Shelf Software use in Medical Devices" (September 1999) based on a "Moderate Level of Concern." (Implies compliance was achieved). |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Complies with ANSI AAMI ES60601-1:2005/(R)2012+A1:2012 for electrical safety and IEC 60601-1-2:2014 for EMC. (Implies compliance was achieved). |
| Ophthalmic Camera Consensus Standards | Complies with ISO 15004-1:2006 (general requirements for ophthalmic instruments), ISO 10940:2009 (product requirements for fundus camera), and ANSI Z80.36:2016 (optical radiation safety). Also lists IEC 60601-1-2:2014, ANSI AAMI ES60601-1::2005/(R)2012 and A1:2012. (Implies compliance was achieved). |
| Spectral Accuracy & Reliability of Images | The spectral accuracy of the illumination light and reliability of the retinal images were verified using a spectrometer and evaluated in an eye model using a reference material with tabulated spectral bands. "The testing conducted to verify the spectral accuracy and repeatability of the proposed device supports that an image with the central wavelength corresponding to a specific color would display the features expected for an image in the spectral range corresponding to the expected color, thus preventing misinterpretation of the retinal images by the eye specialist due to an error in the displayed wavelength for a given retina image." (Implies successful verification and reliability). |
Study Information
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Sample sizes used for the test set and the data provenance:
- The document describes performance testing on the device itself (e.g., electrical safety, spectral accuracy with a spectrometer and eye model) rather than a clinical study evaluating its diagnostic performance on human subjects or clinical images.
- Therefore, there is no "test set" of patient data in the sense of a clinical validation dataset for an AI algorithm. The testing involves physical measurements and eye models.
- Data provenance: Not applicable in the context of clinical image data. The testing was done on the device and its components.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a camera, not an AI diagnostic device requiring expert interpretation of a clinical test set. The ground truth for the device's technical specifications (e.g., spectral accuracy, electrical safety) would be established by engineering and metrology standards, not clinical experts for diagnostic accuracy.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the reasons stated above.
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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, an MRMC study was not done. This device is a fundus camera, primarily a hardware image acquisition device, not an AI diagnostic tool designed to assist human readers. The document does not describe any AI component or human reader study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm. It's a camera.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the device's performance relates to engineering specifications and recognized consensus standards (e.g., ISO, ANSI IEC standards for ophthalmic cameras, electrical safety, biocompatibility, and spectral accuracy measurements using laboratory equipment like spectrometers and eye models). It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.
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The sample size for the training set:
- Not applicable, as this is a hardware device, not an AI algorithm requiring a training set of data.
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How the ground truth for the training set was established:
- Not applicable for the reasons stated above.
In summary: The provided document is an FDA 510(k) summary for a Mydriatic Hyperspectral Retinal Camera, which is a hardware device for capturing images. It details the device's safety and effectiveness in performing its intended function of image acquisition by demonstrating compliance with various engineering and safety standards. It does not describe an artificial intelligence (AI) component or any clinical studies validating diagnostic performance based on image analysis (whether by AI or human readers). Therefore, many of the specific questions about AI acceptance criteria, training/test sets, expert adjudication, and MRMC studies are not addressed because they are not relevant to the type of device described.
§ 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.