The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.

Device Description

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.

AI/ML Overview

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

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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the reasons stated above.
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.
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.
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.
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.
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.

Summary

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April 27, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Optina Diagnostics % Elisa Harvey Principal Consultant CardioMed Device Consultants LLC 1783 Forest Drive, #254 Annapolis, Maryland 21401

Re: K200254

Trade/Device Name: Mydriatic Hyperspectral Retinal Camera (MHRC-C1) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI, NFJ Dated: January 30, 2020 Received: February 3, 2020

Dear Elisa Harvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Ng Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200254

Device Name

Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

Indications for Use (Describe)

The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Optina Diagnostics. The logo consists of a blue circular graphic on the left and the company name "Optina" in gray, with "DIAGNOSTICS" in blue underneath. To the right of the logo is the company's address: 7405 ROUTE TRANSCANADIENNE, #330, ST-LAURENT, QUÉBEC, H4T 1Z2, CANADA.

510(k) Summary

APPLICANT:	Optina Diagnostics, Inc7405 Route Transcanadienne, Suite #330Montréal, Québec, Canada, H4T 1Z2Phone : 514-394-0797
DATEPREPARED:	April 24, 2020
CONTACTPERSON:	Jean-Philippe Sylvestre
TRADE NAME:	Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
COMMON NAME:	Fundus camera
REGULATION	Regulation Number: 21 CFR 886.1120Regulation Name: Ophthalmic CameraProduct Code: HKI, NFJ
DEVICECLASSIFICATION:	Class 2
PREDICATEDEVICE(PRIMARY)	KOWA VX-20 (K112330)
REFERENCEDEVICE	Topcon TRC-50DX (K123101)

Device Description 1.

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diopters. The images are displayed on a monitor and can be saved on the computer for future consultation.

2. Indications for Use

The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.

Technological Characteristics: 3.

The MHRC-C1 is similar in form and function to the predicate mydriatic fundus cameras (see Table 1 below). Indeed, the device is intended to obtain images of the retina with the use of a mydriatic. The contact areas of the patients are the same as for the predicate devices. The operator interface to perform retinal imaging is also similar to the predicate devices. Although there are differences in the technology to provide illumination of the retina. equivalent information may be inferred by scrolling through the monochromatic images obtained with the MHRC-C1 compared to what may be obtained in the color and red free monochrome imaging modes of the predicate devices. Performance testing was performed to verify that this technological difference raised no new concerns regarding the safety and efficacy of the device.

4. Performance Testing

The following performance data were conducted to support the substantial equivalence determination.

Biocompatibility

The intact skin from the chin and forehead of the patient is intended to contact the MHRC-C1 for a short period of time. The biocompatibility of the MHRC-C1 was assessed in accordance with ISO 10993-1:2018.

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Image /page/5/Picture/1 description: The image shows the logo for Optina Diagnostics. The logo consists of a blue circular design on the left, followed by the word "Optina" in gray and "DIAGNOSTICS" in blue below it. On the right side, the text "OPTINA DIAGNOSTICS" is printed above the address "7405 ROUTE TRANSCANADIENN ST-LAURENT, QUÉBEC, H4T 1Z2 CANADA".

Software evaluation

The MHRC-C1 uses embedded Off-The-Shelf software. This software was evaluated for use in accordance with the FDA's Guidance for Industry "Off-The-Shelf Software use in Medical Devices" (September 1999) based on a "Moderate Level of Concern".

Electrical safety and electromagnetic compatibility

It was verified that the MHRC-C1 complies with the standard ANSI AAMI ES60601-1:2005/(R)2012+A1:2012 for electrical safety and with the standard IEC 60601-1-2:2014 for electromagnetic compatibility.

Evaluation of recognized consensus standards for ophthalmic cameras

The MHRC-C1 was found to comply with the recognized consensus standard ISO 15004-1:2006 specifying general requirements for ophthalmic instruments.

The MHRC-C1 was found to comply with the recognized consensus standard ISO 10940:2009 specifying product requirements for fundus camera.

The MHRC-C1 was found to comply with the recognized consensus standard ANSI Z80.36:2016 specifying fundamental requirements for optical radiation safety for ophthalmic instruments.

Spectral accuracy and reliability of the retinal images

The spectral accuracy of the illumination light of the MHRC-C1 was verified using a spectrometer.

The spectral accuracy and reliability of the retinal images were evaluated in an eye model using a reference material with tabulated spectral bands.

5. Substantial Equivalence

The MHRC-C1 is similar in form and function to the predicate and reference mydriatic fundus camera (see Table 1 below) and product testing was performed to demonstrate that the proposed device meets the recognized consensus standards related to a fundus camera. However, the MHRC-C1 uses "multiple wavelength (colors) imaging" which represents a hyperspectral feature that is a different technology in comparison to the proposed predicate device and reference device. Indeed, the technology to provide illumination of the retina in the proposed device consists in a tunable light source that sequentially present the retina with monochromatic light in the spectral range 905 nm to 450 nm in steps of 5 nm, while the predicate device and reference device use a xenon flash lamp with a broad white illumination spectrum. Despite this difference in technology, equivalent information may be inferred by scrolling through the monochromatic images obtained with the MHRC-C1 than what may be obtained in the color and red free monochrome imaging modes of the predicate and reference devices. Indeed, the images obtained with the MHRC-C1 cover the full visible spectral range that is covered in a color

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Image /page/6/Picture/1 description: The image contains the logo for Optina Diagnostics. The logo features a blue circular design on the left, with the word "Optina" in gray and "DIAGNOSTICS" in a smaller blue font underneath. To the right of the logo, there is contact information including the company name, address (7405 ROUTE TRANSCANADIEN, ST-LAURENT, QUÉBEC, H4T 1Z), and country (CANADA).

fundus image, typically composed of 3 broad spectral bands (red, green and blue) covering the spectral range 450 nm to 750 nm. Similarly, scrolling the images obtained with the MHRC-C1 in the spectral range corresponding to the green color (500-565 nm) covers the typical spectral range used to obtain retinal images in the red free mode. Moreover, 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. It follows that the new feature of the proposed device, therefore, did not raise new concern regarding its safety and efficacy.

In conclusion, the performance testing supports that the MHRC-C1 meets the recognized consensus standards for a fundus camera and that retinal imaging at multiple wavelengths (colors) may be accurately and reliably achieved. The proposed device did not raise new concerns regarding its safety and efficacy for its intended use and was therefore deemed substantially equivalent to the predicate devices.

Device Name	MHRC-C1	Kowa VX-20	TRC-50DX
510(k) number	K200254	K112330	K123101
Regulation number	21 CFR 886.1120	21 CFR 886.1120	21 CFR 886.1120
Product code	HKI, NFJ	HKI, NFJ	HKI
Intended use	The MHRC-C1 is intendedto capture images of theretina at multiplewavelengths (colors) undermydriatic conditions.	The device is intended fortaking pictures of fundusimages with mydriatic orwithout mydriatic	The TRC-50DX RetinalCamera is intended for usein capturing images of theretina and the anteriorsegment of the eye andpresenting the data to theeye care professional, withthe use of a mydriatic
Camera function	Mydriatic	Mydriatic or non-mydriatic	Mydriatic
Photography type	Monochrome (92 colorbands, 905 nm to 450 nmin steps of 5 nm)	ColorMonochrome (Red free)FluorescenceAutofluorescence	ColorMonochrome (Red free)FluorescenceAutofluorescence
Observation media	Video feed on LCD monitor	Video feed on LCD monitoror Optical viewfinder	Optical viewfinder
Record media	Digital	Digital	Digital or 35 mm film
Contact areas with thepatients	Chin and forehead	Chin and forehead	Chin and forehead
Mean for alignment	Positioning base withjoystick	Positioning base withjoystick	Positioning base withjoystick
Field of View	31.5 degrees	50 / 30 degrees	50 / 35 / 20 degrees
Working Distance	46.7 mm	39.0 mm	39.0 mm
Minimum pupil diameter	6 mm	5.5 mm (4.0 mm in non-mydriatic mode)	5.5 mm (4.5 mm in smallpupil mode)

Table 1. Similarities and differences between the proposed device and the predicate device and reference device.

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OPTINA DIAGNOSTICS
7405 ROUTE TRANSCANADIENNE, #330
ST-LAURENT, QUÉBEC, H4T 1Z2
CANADA

Eye Fixation Navigation	External fixation target	External or internal fixationtarget	External or internal fixationtarget
Focusing	Focus wheel	Focus knob	Focus knob
Diopter compensationrange of patient's eye	-15D to + 15D	-32D to + 35D	-23D to + 41D
Alignment/visualizationlight source	Monochromatic light (700nm)	Halogen lamp	Halogen lamp
Photographing lightsource	Monochromatic light(sequential from 905 nm to450 nm in steps of 5 nm)	Xenon lamp (flash)	Xenon lamp (flash)
Conformed performancestandards	ISO 10940:2009ISO 15004-1:2006ISO15004-2:2007ANSI Z80.36IEC 60601-1-2:2014ANSI AAMI ES60601-1::2005/(R)2012 andA1:2012	IEC 60601-1:1988+A1:1991+A2:1995IEC 60601-1-1:2007	IEC 60601-1-1:2001ISO 15004-1:2006ISO15004-2:2007

Regulation Number and Section

§ 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.