Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. Optomed Smartscope M5 with optics module ES2 is intended to capture images and video of the surface of the human eye and surrounding areas.

Device Description

Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. The device set for retinal imaging consists of: Camera handset M5, Attachable ophthalmic lens EY4, Eye cup for EY4, Cradle for charging and image transfer, Slit Lamp Adapter. Optomed Smartscope M5 with optics module ES2 is intended to capture images and the surface of the human eye and surrounding areas. The device set for anterior ophthalmic imaging consists of: Camera handset M5, Attachable anterior ophthalmic lens ES2, Cradle for charging and image transfer. EY4 has an LED light source with visible white and infrared light. Also red light target LED's are used to eye position fixation during imaging. ES2 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Optomed Smartscope M5:

Acceptance Criteria and Device Performance Study

The provided document (K132186) describes the Optomed Smartscope M5 digital camera with EY4 and ES2 optics modules and its substantial equivalence to a predicate device, the Optomed Smartscope M5 with EY3 and ES1 optics modules. The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to the predicate device, particularly regarding safety and effectiveness, which were assessed through comparison of technical information and bench testing.

No specific quantitative clinical performance metrics (e.g., sensitivity, specificity for a diagnostic task) are presented in this 510(k) summary with explicit acceptance criteria and corresponding reported device performance values. Instead, the focus is on technical specifications, safety standards, and modifications that improve image quality or user experience while maintaining or exceeding the predicate's performance.

The "study" that proves the device meets the acceptance criteria is a bench test and comparison study against a predicate device, rather than a clinical trial with human participants assessing diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are implied by the technical specifications and safety standards followed, and the "reported device performance" is essentially the device meeting or improving upon these.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Optical radiation safety according to ISO 15004-2	Classified as Class 2 instrument per ISO 15004-2:2007 (meets standard)
Safety: Classified as "Exempt Group" LED product per EN 62471:2008	"Exempt Group" LED product per EN 62471:2008 (meets standard)
Safety: Classified as Class 1 LED per IEC 60825-1:2001	Class 1 LED per IEC 60825-1:2001 (meets standard)
Technical Equivalence (EY4 vs. EY3): Resolution	Improved to meet ISO10940 (Fundus camera standard)
Technical Equivalence (EY4 vs. EY3): Target LEDs	New target LEDs for eye position fixation
Technical Equivalence (ES2 vs. ES1): Illumination concept	Improved illumination concept and diffuser structure
Technical Equivalence (ES2 vs. ES1): Image Quality	New diffuser structure to improve image quality
Technical Equivalence (ES2 vs. ES1): Contrast	Separate baffle to enhance image contrast
Technical Equivalence (ES2 vs. ES1): Integration Times	Allows shorter camera integration times to reduce motion blur
Indications for Use: Capture digital images/video of fundus	Intended to capture digital images and video of the fundus
Indications for Use: Capture images/video of surface/surrounding areas	Intended to capture images and video of the surface and surrounding areas
Dioptre compensation (patient)	at least -20 D to +20 D (matches predicate)
Picture angle	40 degrees (similar to predicate's "Over 40 degrees")
Storage media	Flash memory card (matches predicate)
Image data format	JPEG, MPEG-1, MPEG-4 (matches predicate)

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

Sample Size: Not applicable in the context of clinical images or patient data. The "test set" consists of the physical devices themselves undergoing bench testing.
Data Provenance: The study is based on technical specifications, comparisons with a predicate device, and measurements from laboratory bench tests. All testing appears to have been conducted by Optomed Oy in Finland.

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

Number of Experts: Not explicitly stated. The document mentions that the devices were "evaluated by Optomed development team and practicing physicians throughout the product development." No specific number or qualifications (e.g., years of experience, specialization) of these physicians are provided for establishing a "ground truth" for a test set in a diagnostic sense. Their role seems to be more in providing feedback during development rather than ground truth labeling for a specific dataset.
Qualifications of Experts: The document generically refers to "practicing physicians."

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no mention of a formal adjudication process (e.g., 2+1, 3+1) for discrepant interpretations, as this was not a clinical effectiveness study involving human interpretation of images. The evaluation primarily involved technical measurements and comparisons.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technical comparisons and bench testing.
Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study or AI assistance is mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This device is a digital camera, an image acquisition device, not an image analysis algorithm or AI system. Therefore, assessing "standalone performance" of an algorithm is not relevant to this submission.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is based on:
- Technical Specifications and Standards: Compliance with international standards such as ISO 15004-2, EN 62471, IEC 60825-1, and ISO 10940 for resolution.
- Bench Test Measurements: Maximum photometric luminance, ultraviolet, infrared, visible light, and near IR radiation levels.
- Direct Comparison: Side-by-side comparison of device features and performance to a legally marketed predicate device.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a medical device for image acquisition, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable. Since there is no AI/ML algorithm, there is no training set or associated ground truth.

Summary

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13.12.2013 1/3

DEC 18 2013

K132186

510(k) Su nmary

Date:	December 13, 2013
510(k) owner's name:	Optomed Oy
Address:	Hallituskatu 13-17 D, 90100 Oulu, Finland
Contact person:	Jyri Leskelä, Quality Manager
Company phone:	+358 20 741 3380
Fax number:	+358 42 588 1187
Device name:	Trade name: Optomed Smartscope M5 digital camera withOptomed Smartscope EY4 optics module and OptomedSmartscope ES2 optics moduleCommon/usual name: Ophthalmic cameraClassification name: camera, ophthalmic; ac-powered (21 CFR886.1120, Product code: HKI)
Predicate device:	Optomed Smartscope M5 with optics modules EY3 with ES1(510(k) number: K110986, Product code: HKI)
Indications for Use:	Optomed Smartscope M5 digital camera with EY4 optics module isintended to capture digital images and video of the fundus of thehuman eye. Optomed Smartscope M5 with optics module ES2 isintended to capture images and video of the surface of the humaneye and surrounding areas.
Point of comparison	Optomed Smartscope M5 with EY4 and ES2	Optomed Smartscope M5 with EY3 and ES1
Indications for use	Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye. Optomed Smartscope M5 with optics module ES2 is intended to capture images and video of the surface of the human eye and surrounding areas.	Optomed Smartscope M5 camera with optics modules EY3 and ES1 is digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area.
Usage	Prescription use	Prescription use
Use condition	Intended to use without mydriatic but can be used also with mydriatic	Intended to use without mydriatic but can be used also with mydriatic
Observation light source	Visible and infrared LED. EY4 LEDs:White: OSRAM Oslon LUW-H9GPNIR: OSRAM Oslon SFH-4715Target LEDs: OSRAM LR QH9FES2 LEDs: White : Osram Advanced Power Topled LW G6SP-EAFA-JKQL-1Blue : Osram Advanced Power Topled LB G6SP-V2BB-35-1	Visible and infrared LED. EY3 LEDs:White: LWW5SM-KY-QK.NIR: SFH4232 (bin DA)ES1 LEDS:: White : Osram Advanced Power Topled LW G6SP-EAFA-JKQL-Blue : Osram Advanced Power Topled LB G6SP-V2BB-35-1
Observation and display system	2.4" active matrix color TFT LCD	2.4" active matrix color TFT LCD
Photographing light source	Visible and infrared LED	Visible and infrared LED
Camera specification	Color CMOS camera maximum resolution 5Mp. ES2 uses maximum resolution. EY4 uses 1,77 Mp.	Color CMOS camera maximum resolution 5Mp. ES1 uses maximum resolution. EY3 uses 2,76 Mp.
Dioptre compensation (patient)	at least -20 D to +20 D	at least -20 D to +20 D
Picture angle	40 degrees	Over 40 degrees
Storage media	Flash memory card	Flash memory card
Image data format	JPEG, MPEG-1, MPEG-4	JPEG, MPEG-1, MPEG-4
Weight	Camera: 400g, EY4: 300g, ES2: 92g	Camera: 400g, EY3: 180g, ES1: 80g
Power consumption	Re-chargeable Ni-MH Battery 4.8V;Charging unit 44 VA	Re-chargeable Ni-MH Battery 4.8V;Charging unit 44 VA
Output terminals and	USB (1.1) terminal (B-connector)	USB (1.1) terminal (B-connector)

Device description, Intended use & Effectiveness:

Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye.

The device set for retinal imaging consists of:

Camera handset M5 .
Attachable ophthalmic lens EY4 ●
Eye cup for EY4 .
Cradle for charging and image transfer
Slit Lamp Adapter

Optomed Smartscope M5 with optics module ES2 is intended to capture images and the surface of the human eye and surrounding areas.

. :

i l

The device set for anterior ophthalmic imaging consists of

Camera handset M5
Attachable anterior ophthalmic lens ES2
- Cradle for charging and image transfer

Optomed O

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EY4 has an LED light source with visible white and infrared light. Also red light target LED's are used to eye position fixation during imaging. ES2 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery. Table 1 below includes a summary of the technical information used in the substantial equivalence comparison.

Optomed Oy,
Hallituskatu 1 90100 Oulu Finland 14

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Exposure parameters	"Exempt Group" (no risk) LED productaccording to EN 62471:2008Group 2 instrument according to ISO15004-2:2007	Class 1 LED according to IEC 60825-1:2001Group 1 instrument according to ISO15004-2:2007
Standards	IEC 60601-1:2005 (3rd edition)IEC 60601-1-2:2007 (3rd edition)EN 62471:2008ISO 15004-2:2007	IEC 60601-1:1988+A1+A2IEC 60601-1-2:2001+A1 IEC 60601-1-4:2000EN (IEC) 60825-1:2001+A1:2002+A2:2001ISO 15004-2:2007

Technical Information was gathered by side-by-side comparison and labeling of the devices. Optomed Smartscope M5 with optics modules EY4 and ES2 and its predicate was also evaluated by Optomed development team and practicing physicians throughout the product development.

Following laboratory bench tests demonstrate Optical radiation safety of the Optomed Smartscope M5 with EY4 and ES2:

1. Optical radiation hazards as defined by standard ISO 15004-2, Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection, First edition 2007-02-15.
1. Maximum photometric luminance
the optical radiation hazards as defined by ISO 15004 for: 3. (i) ultraviolet and infrared radiation, and (ii) visible light and near IR radiation (blue-light weighted radiance and aphakic weighted radiance).

Optomed Smartscope M5 with optics modules EY4 and ES2 is classified as Class 2 instrument according to the international standard ISO 15004-2:2007.

Optomed Smartscope EY3 eye optics is a predecessor of EY4 eye optics The modifications in M5 camera with EY4 optics compared to M5 camera with EY3 optics are:

Resolution is improved to meet the requirements of ISO10940 (Fundus camera standard) .
- Target LED's for eye position fixation during imaging
  - 9 pcs of LEDs at different viewing angles o
  - o Allows stabilizing the eye of the patient for a specific direction.

Optomed Smartscope ES1 eye optics is a predecessor of ES2 eye optics. The modifications in M5 camera with ES2 optics compared to M5 camera with ES1 optics are:

Illumination concept is improved
Finland
New diffuser structure to improve image quality o
Separate baffle is included in the illumination path to block excess reflections of o stray light from the sides of the module

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to enhance image contrast : O
to allow shorter camera integration times to reduce n - O

Based on the comparison and supportive information, the subject device is subs equivalent to the predicate device.

Od.Oy
katu 13-17,D
Oulu
www.optomed.com

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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized symbol with three abstract human figures connected in a circular shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is printed in a simple, sans-serif font to the right of the symbol.

Food and Drug Administration 10903 New Hampshire Avenu Document Control Center - WO66 Silver Spring, MD 20993-0002

December 18, 2013

Optomed Oy % Mr. Jyri Leskelä Quality Manager Hallituskatu 13-17 FI 90100, Oulu Finland

Re: K132186

Trade/Device Name: Optomed Smartscope M5 digital camera with Optomed Smartscope EY4 optics module and Optomed Smartscope ES2 optics module Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: November 4, 2013 Received: November 6, 2013

Dear Mr. Leskelä:

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.

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

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Page 2 - Mr. Jyri Leskelä

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Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-204] or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Kesia Y.Alexander -S

for Malvina B. Eydelman, M.D.

Director

Division of Ophthalmic, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K132186

Device Name: Optomed Smartscope M5 digital camera, Optomed Smartscope EY4 optics module, Optomed Smartscope ES2 optics module

Indications for Use:

Optomed Smartscope M5 digital camera with EY4 optics module is intended to capture digital images and video of the fundus of the human eye.

Optomed Smartscope M5 with optics module ES2 is intended to capture images and video of the surface of the human eye and surrounding areas.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew Yang -S
2013.12.15
21:44:49 -05'00'

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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.