The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.

Device Description

The Optyse™ is a compact battery-powered handheld direct ophthalmoscope for use by trained personnel for viewing the fundus or the inside of the back of the eye of a patient.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Reported Device Performance
Clarity of View Equivalent performance
Ability to Visualize Abnormalities Equivalent performance
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated, but described as "user studies comparing the effectiveness of the Optyse™ with legally marketed ophthalmoscopes."
- Data Provenance: Not explicitly stated, but the studies were conducted by "practising optometrists," suggesting they involved real-world clinical use. It is prospective as it describes clinical performance which would be observed during testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The ground truth was established by "practising optometrists." The specific number or their experience level (e.g., years of experience) is not provided.
Adjudication Method for the Test Set:
- Not explicitly stated. The document mentions "user studies comparing the effectiveness," which might imply a qualitative assessment rather than a formal adjudication method.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable/Not performed. The submission describes "user studies" that assessed "equivalent performance" by optometrists using the device in comparison to other ophthalmoscopes. This is not presented as an MRMC study designed to quantify human reader improvement with or without AI assistance.
Standalone Performance:
- Yes, a standalone performance was done for the device itself.
  - Non-clinical tests: The Optyse™ device underwent compliance testing to two engineering standards: ISO 10942:1998 (Ophthalmic Instruments – Direct Ophthalmoscopes) and IEC 60601-1:1988 (Medical Electrical Equipment - Part 1 Requirements for Safety (General)). Declarations of conformity were provided for both.
  - Clinical performance: User studies were conducted to compare the device's effectiveness.
Type of Ground Truth Used:
- Expert consensus/clinical assessment by "practising optometrists" regarding "clarity of view and ability to visualise abnormalities."
Sample Size for the Training Set:
- Not applicable/Not stated. The Optyse™ is a hardware medical device (an ophthalmoscope), not an AI/algorithm. Thus, it does not have a "training set" in the context of machine learning.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as it's a hardware device and not an AI/algorithm that requires a training set.

Acceptance Criteria	Reported Device Performance
Clarity of View	Equivalent performance
Ability to Visualize Abnormalities	Equivalent performance

Summary

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Ophthalmos Ltd. Optyse™ USA 510(k) Submission

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SECTION 6: 510(K) SUMMARY

510(k) Summary of Safety and Effectiveness as required per 21 CFR 807.92. April 15, 2006

(1) Submitter Details:
Ophthalmos Ltd Abbey Barns Duxford Road Ickleton Cambridge CB10 1SX United Kingdom

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Contact: Laura Garcia Position: Chief Executive Officer Phone: +44 1799 532777 Fax: +44 1799 532701

Date of submission: April 15, 2006

(2) Device Name and Classification

Device name: Optyse™ Device Common Name: Ophthalmoscope

Classification, product code (3)

Class:	II
Product Code:	HLJ
CFR: 886.1570	Ophthalmoscope, battery-powered

(4) Predicate Device Information

The device has been compared to the following cleared device:

Company	Device	510(k)
Rudolf Riester GMBH	Uni II	K925756

(5) Device Description

The Optyse™ is a compact battery-powered handheld direct ophthalmoscope for use by trained personnel for viewing the fundus or the inside of the back of the eye of a patient.

(6) Intended Use

The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.

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(7) Technological Characteristics

The Optyse™ is very similar in design to commercially available hand-held ophthalmoscopes including the named predicate device, the Reister Uni II ophthalmoscope (510 (k) # K925756). The Optyse™ and the Uni II are both considered to be pocket sized, simple direct ophthalmoscopes having the same intended use. The viewing systems use similar sources of illumination, are powered by alkaline batteries and provide a reversed image of the patient's retina to the trained personnel. Both kits are provided with simple carrying cases for storage when the ophthalmoscope is not in use.

(8) Performance Data

a. Non-clinical tests

The Optyse™ has been compared with legally marketed devices and has been tested according to the standards listed below.

ISO 10942

Compliance testing of the Optyse™ device to ISO 10942:1998 Ophthalmic Instruments – Direct Ophthalmoscopes has been conducted and a declaration of conformity provided.

IEC 60601-1

Compliance testing of the Optyse™ device to IEC 60601-1:1988 Medical Electrical Equipment - Part 1 Requirements for Safety (General) has been conducted and a declaration of conformity provided.

b. Clinical performance data for equivalence

Clinical trials were not required, however, user studies comparing the effectiveness of the Optyse™ with legally marketed ophthalmoscopes by practising optometrists demonstrated equivalent performance in clarity of view and ability to visualise abnormalities that may be indicative of medical conditions.

Summary

The comparison of intended use and technological features of the Optyse™ device with the cleared device taken together with the safety and effectiveness tests and other information in this submission indicate the device is substantially equivalent in safety, effectiveness and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ophthalmos Ltd c/o Mr. Neil E. Devine Intertek Testing Services 2307 East Aurora Rd. Twinsburg, OH 44087

Re: K061278

MAY 16 2006

. Trade/Device Name: Optyse™ Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: HLJ Dated: May 4, 2006 Received: May 8, 2006

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, as excerdance with the provisions of the Federal Food, Drug, de necs that have been recised in at require approval of a premarket approval application (PMA). and Costinetter (110.) that to novice, subject to the general controls provisions of the Act. The I ou may, dicrorore, mains of the Act include requirements for annual registration, listing of general voltaren profissioning practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de ree to such 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 801); 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.

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Page 2 – Mr. Neil E. Devine

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

MB Eychhus - MD

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

Enclosure

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INDICATIONS FOR USE

Indications for Use

510(k) Number (if known):

K061278 (k)

Device Name:

Optyse TM Ophthalmoscope

Indications For Use:

The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used to examine the fundus or the inside of the back of the eye

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510(k) Number

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.