The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.

Device Description

The Annidis RHA2020U multi-spectral digital ophthalmoscope which presents eye care practitioners (optometrists and ophthalmologists) with a series of retinal spectral images from each eye of a patient. The images each have a spatial resolution of over four million pixels spread over a visual range of greater than 40 degrees. The instrument also captures an image of the iris and pupil.

The device is arranged in four major hardware subcomponents and one remote software component used for clinical visualization and tracking purposes. The four hardware components are listed below:

The Optical Head Unit (OHU) contains the camera and the illuminating LEDs and is aligned to the eye of the sitting patient whose head is stabilized using a chin-rest and forehead brace. The OHU contains the optical and electrical systems required to capture images of the eye and the means to align the patient with the device.
The Host Computer (HC), a Linux-based host computer that serves as the operator interface.
The Universal Power Supply (UPS), a custom designed power supply receives A power from the AC mains and supplies power using low voltage DC to the host computer, the display, and the optical head unit (OHU).
The Touch Screen Display, that displays information from the host computer, configures the optical head unit for patient comfort, visualizes the patient data and triggers image capture.

AI/ML Overview

Below is an analysis of the provided text regarding the Annidis RHA2020-U multi-spectral digital ophthalmoscope, focusing on acceptance criteria and the study proving adherence to them.

Acceptance Criteria and Device Performance Study for the Annidis RHA2020-U Multi-spectral Digital Ophthalmoscope

The information provided describes the non-clinical performance summary for the Annidis RHA2020-U. The acceptance criteria are broadly defined as meeting functional specifications and performance requirements, with a direct comparison to predicate devices, focusing on image output comparability.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Functional Specifications & Performance Requirements	The device (RHA2020-U) met its functional specifications and performance requirements, as detailed in the Product Requirements Specifications and confirmed by Performance Testing Reports and Performance Traceability Matrices.
Image Output Comparability to Predicate Devices	The digital images captured by the RHA2020-U were found to be "comparable" to the image output of two selected predicate devices. This conclusion was drawn by the Performance Test Investigator.
Compliance with Electrical Standards	The RHA Multi-Spectral Ophthalmoscope complies with IEC 60601-1, IEC 60601-1-1, UL 60601-1, CAN/CSA C22.2 No. 601.1-M90, and IEC 60950-1, indicating conformity with general safety for medical electrical equipment and information technology equipment.
Compliance with EMC Standards	The RHA Multi-Spectral Ophthalmoscope complies with IEC 60601-1-2, ensuring electromagnetic compatibility.
Compliance with Light Safety Standards	The RHA Multi-Spectral Ophthalmoscope complies with ISO 15004-2, addressing light hazard protection for ophthalmic instruments.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "digital images evaluated from digital scan output taken of non-mydriatic eyes of human subjects" and "digital images evaluated from digital scan output taken of mydriatic eyes of human subjects." However, the specific number of human subjects or images in the test set is not provided.
Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given Annidis Health Systems Corp. is based in Ottawa, Ontario, Canada, it is likely the data was sourced from Canada, but this isn't confirmed. The clinical data appears to be prospective, as it involves capturing new images from human subjects specifically for this testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document states that the "Performance Test Investigator" reviewed the direct comparison of images.
The number of experts is not specified, and it appears to be a single "Investigator" who made the assessment.
The qualifications of this "Performance Test Investigator" are not provided. The text does not mention if they are radiologists, ophthalmologists, or other specialists, nor does it indicate their years of experience.

4. Adjudication Method for the Test Set

The document states that the "Performance Test Investigator" made the determination regarding image comparability.
No formal adjudication method (e.g., 2+1, 3+1) is described. The assessment seems to rely on a single reviewer's judgment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The comparison was between the device's image output and that of predicate devices, assessed by a single investigator, not a study evaluating human reader performance with and without AI assistance.
Therefore, no effect size for human readers improving with AI vs. without AI assistance is reported as this type of study was not conducted or reported. The RHA is an imaging device, not an AI-powered diagnostic aid that improves human interpretation directly.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance assessment focused on the device's ability to capture images comparable to predicate devices. It's a fundamental imaging device, not an AI algorithm performing diagnostic tasks in isolation.
The comparison was a direct assessment of image output and functional performance. There was no standalone algorithm-only performance study in the context of diagnostic accuracy/performance. The "performance testing was conducted" on the software and firmware. This is likely an internal verification that the software performs its intended functions correctly, not an independent clinical standalone performance evaluation for diagnostic output.

7. Type of Ground Truth Used

The "ground truth" for the test set was broadly defined as the comparability of digital images captured by the RHA2020-U to those captured by predicate devices. This comparability was evaluated by a "Performance Test Investigator."
It is not pathology, outcomes data, or an expert consensus in the traditional sense of validating diagnostic accuracy against a definitive diagnosis. Instead, it is an assessment of technical image quality and equivalence to established devices.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The RHA2020-U is described as an ophthalmoscope that captures images, with its software providing "clinical visualization and tracking purposes." There is no indication of an AI model within the device that requires a training set for learning a diagnostic task. The "software and firmware" were subject to performance testing, which refers to verifying functional correctness rather than training a machine learning model.

9. How Ground Truth for the Training Set was Established

As no training set is mentioned or implied for an AI model, this information is not applicable and not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Annidis Health Systems. The logo features a stylized eye symbol to the left of the text "ANNIDIS". Below "ANNIDIS" is the text "HEALTH SYSTEMS" and "Promoting early detection and care" in a smaller font. The logo is black and white.

RHA SUMMARY

Annidis Health Systems Corp., 2650 Queensview Drive, Suite 245, Ottawa, Ontario, K2B 8H6 Tel: 613.596.1800 Fax: 613.596.9453

510(k) Number K//153/

1. Sponsor Information

Applicant Name:	Annidis Health Systems Corp.2650 Queensview Drive, Suite 245,Ottawa, Ontario, K2B 8H6, CanadaTel: 613.596.1800; Fax: 613.596.9453Email: mmcdonnell@annidis.com
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Contact Person:	Michael R McDonnell
	Annidis Health Systems Corp.
	2650 Queensview Drive, Suite 245, Ottawa, Ontario,
	K2B 8H6, Canada
	Tel: 613.596.1800 Ext 2019; Fax: 613.596.9453
	Email: mmcdonnell@annidis.com

Date of Summary: Mar 31st, 2011

2. Device Name and Classification

Common Name:	RHA Multi-spectral Digital Ophthalmoscope
Trade Name:	RHA
Model:	RHA2020-U
Classification Name (Primary):Classification Name (Secondary):	CFR Classification section 886.1570 (HLI)CFR Classification section 886.1120 (HKI)
Classification:	Class II medical device

3. Predicate Devices:

The RHA multi-spectral digital ophthalmoscope is substantially equivalent to a combination of the following predicate devices:

510(k) No.	Trade Name	Product Code(s)
K983999	Panoramic 200 Ophthalmoscope	HLI
K072259	Ophthalmoscope F-10	MYC
K092056	Smartscope M3-1 EY1	HKI

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Image /page/1/Picture/0 description: The image shows the logo for Annidis Health Systems. The logo features a stylized eye inside of a triangle on the left. To the right of the eye is the text "ANNIDIS" in large, bold letters, with the words "HEALTH SYSTEMS" in smaller letters below. Below that is the text "Promoting early direction and care".

Innidis Health Systems Corp. 2650 Queensview Drive, Suite 245, Ottawa, Ontario, K2B 8H6 Tel: 613.596.1800 Fax: 613.596.9453

4. Device Description:

The device is arranged in four major hardware subcomponents and one remote software component used for clinical visualization and tracking purposes. The four hardware components are listed below:

ア The Optical Head Unit (OHU) contains the camera and the illuminating LEDs and is aligned to the eye of the sitting patient whose head is stabilized using a chin-rest and forehead brace. The OHU contains the optical and electrical systems required to capture images of the eye and the means to align the patient with the device.
A The Host Computer (HC), a Linux-based host computer that serves as the operator interface.
The Universal Power Supply (UPS), a custom designed power supply receives A power from the AC mains and supplies power using low voltage DC to the host computer, the display, and the optical head unit (OHU).

The Touch Screen Display, that displays information from the host computer, configures the optical head unit for patient comfort, visualizes the patient data and triggers image capture.

5. Intended Use:

The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases

6. Predicate Devices:

The Annidis retinal health assessment device is substantially equivalent to a combination of the following predicate devices:

. The Optos Panoramic 200 (K983999) is a scanning laser ophthalmoscope (SLO). It uses a laser as a light source that is scanned by a deflection system in two axes across the retina of the eye to generate a colour image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal. The electrical signal is digitized and used to build up an

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Image /page/2/Picture/0 description: The image shows the logo for ANNIDIS Health Systems. The logo features a stylized letter "A" with an eye inside of it. To the right of the "A" is the text "ANNIDIS" in bold, followed by "HEALTH SYSTEMS" and "Promoting early detection and care" in smaller fonts.

Annidis Health Systems Corp., 2650 Queensview Drive, Suite 245, Ottawa, Ontario, K2B 8H6 Tel: 613.596.1800 Fax: 613.596.9453

electronic picture in a personal computer and displayed either on a cathode ray tube or on a liquid crystal display.

. The Nidek Ophthalmoscope F-10 (K072259) is categorized as a Class I confocal laser scanning ophthalmoscope. The F-10 captures and records confocal images of the fundus by laser scanning using a selection of laser colors: IR (infrared). blue, green, and red and affords Indocyanine green (ICG) and fluorescein (FAG) angiography.
. The Optomed Smartscope M3-1 EY1 (K092056) is a hand-held digital ophthalmoscope used to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye. M3-1 EY 1 has a LED light source. Image data is stored on the Flash memory card using 6.6 megapixel CMOS sensor and transferred to the PC by using USB connection. The device has rechargeable batteries.

	AnnidisRHA	NidekF-10	OptosP200	OptomedSmartscope3M-1 EY1
field of view (degrees)	42	40	>90	30
physical configuration	tabletop withheadrest	tabletop withheadrest	stand alone andpatientmanipulation	handheld
spectral rangecovered	green-nearinfrared	blue-nearinfrared	green & red	visible
number of spectralbands	6	4	2	~3
type of source	LED	laser	laser	LED
image constructionprocess	imaging	scan	scan	imaging
indicated for retinalimaging	yes	yes	yes	yes
viewing software	software accessory	medical device(NAVIS)	software accessory	softwareaccessory
product classification	CFR 886.1570	CFR 886.1570	CFR 886.1570	CFR 886.1120
product code	HLI (primary)HKI(Secondary)	MYC (couldalso be HLI)	HLI	HKI

Table 5-1: Table of similarities between the RHA and the predicate devices

7. Comparison with Predicate Devices

Substantial equivalence of the Annidis RHA Multi-Spectral Ophthalmoscope is addressed relative to three legally marketed predicate devices. The Nidek F-10 and the Optos P-200 are scanning laser ophthalmoscopes, and the Optomed Smartscope is a

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Image /page/3/Picture/0 description: The image shows the logo for Annidis Health Systems. The logo features a stylized triangle shape on the left, with a design resembling an eye within it. To the right of the triangle is the text "ANNIDIS" in bold, uppercase letters, with the words "HEALTH SYSTEMS" below it in a smaller font. Below that is the text "Promoting early direction and care".

Annidis Health Systems Corp., 2650 Queensview Drive, Suite 245, Ottawa, Ontario, K2B 8H6 Tel: 613.596.1800 Fax: 613.596.9453

handheld digital ophthalmoscope, The data set available for the predicate device parameters has been compared to the similar data for the RHA to provide evidence for the substantial equivalence of the RHA to the legally marketed devices. Based on the data and comparisons presented in this section, the RHA is substantially equivalent to the legally marketed predicate devices. It is similar in characteristics, materials, has similar technological features, intended use and indications for use as the predicates, and does not raise any new questions of safety and effectiveness.

8. Performance Standards:

No applicable performance standards have been issued under the Food, Drug and Cosmetic Act.

The RHA retinal health assessment device has been tested by an accredited third party test laboratory and conforms to the following voluntary standards:

A IEC 60601-1:1988 Medical Electrical Equipment; Part 1: General Requirements for Safety + A1:1991 and A2:1995, including Appendix - National Deviations -Test Results according to ONLINE CB BULLETIN as of June 2009.
A IEC60601-1-1:2000 Medical Electrical Equipment - Part 1: General Requirements For Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems, 2nd Edition.
A IEC 60601-1-2:2001 Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests + A1:2004
A ISO 15004-2:2007 Ophthalmic Instruments - Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection.
A UL 60601-1 (first Edition, 2003): Medical Electrical Requirements Part 1: General requirements for Safety.
IEC60950-1 (First Edition 2001) A11:2004: Information Technology Equipment - Safety- Part 1: General Requirements.
人 CAN / CSA C22.2 No. 601.1-M90 Medical Electrical Equipment - Part 1: General Requirements for Safety (Adopted IEC 601-1, Amendment 1:1991)

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Image /page/4/Picture/0 description: The image shows the logo for Annidis Health Systems. The logo features a stylized eye symbol to the left of the word "ANNIDIS" in large, bold letters. Below the name, the words "HEALTH SYSTEMS" are printed in a smaller font, followed by the tagline "Promoting early detection and care".

alth Systems Corp. 2650 Queensview Drive, Suite 245, Ottawa, Ontario, K2B 8H6 Tel: 613.596.1800 Fax: 613.596.9453

9. Non-Clinical Performance Summary:

Annidis Health Systems Corp. has verified and validated that the RHA Multi-Spectral Digital Ophthalmoscope meets its functional specifications and performance requirements.

The requirements for the RHA are set out in the Product Requirements Specifications, and addressed by Performance Testing Reports and are illustrated through the use of Performance Traceability Matricies. The RHA is controlled mostly by software and firmware to which performance testing was conducted. The test management process used was an industry off-the-shelf validated management tool.

The RHA2020-U Multi-Spectral Digital Ophthalmoscope was subjected to Performance Testing and the image output of the RHA2020-U device was compared with two predicate devices. The results of Performance Testing demonstrates substantial equivalence between the image output (i.e.. subject digital images captured) of the two selected predicate devices and those of the digital images captured using the RHA2020-U device when reviewed by the Performance Test Investigator. Submitted data included:

. Digital images evaluated from digital scan output taken of non-mydriatic eyes of human subjects.
. Digital images evaluated from digital scan output taken of mydriatic eyes of human subjects.

It is concluded that in a direct comparison of images between subject and predicate devices, that the images are comparable and meet performance requirements for acceptance and the intended use.

The RHA Multi-Spectral Ophthalmoscope complies with applicable U.S. and international electrical, electromagnetic compatibility and light safety standards (as outlined above) for products of its kind.

10. Conclusions

Based on the information contained in this submission, similarity to the predicate devices (the Optos Panoramic 200, the Nidek Ophthalmoscope F-10, and the Optomed Smartscope M3-1 EY1), and the results of our design control activities and non-clinical performance testing, has been established.

In summary, Annidis Health Systems Corp. believes that the RHA Multi-Spectral Ophthalmoscope is as effective, and performs as well as devices currently on the market, and concludes that the RHA Multi-Spectral Ophthalmoscope is substantially equivalent to the predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Annidis Health Systems Corp. c/o William Sammons Third Party Reviewer Intertek Testing Services NA, Inc. 2307 E. Aurora Rd. Unit B7 Twinsburg, OH 44087

JUL - 8 2011

Re: K11531

Trade/Device Name: RHA Multi-spectral Digital Ophthalmoscope Model RHA2020-U Regulation Number: 21 CFR 886.1570 Regulation Name: Opthalmoscope Regulatory Class: Class II Product Code: HLI and HKI Dated: June 1, 2011 Received: June 2, 2011

Dear Mr. Sammons:

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. 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.

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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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kenia Alexander

Image /page/6/Picture/8 description: The image shows a handwritten cursive "for" on the left side of the image. To the right of the cursive text are three lines of text that are cut off. The text is in a serif font and is black.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Annidis 510(k)

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

RHA2020-U multi-spectral digital ophthalmoscope

Indications for Use:

The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thoms Axhm

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K///53/

Page 1 of 1

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.