The Ophthalmoscope F-10 is categorized as a Class 1 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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving device performance in the way typically required for AI/ML-driven medical devices. This document is a 510(k) summary for an Ophthalmoscope, which is a hardware device for capturing images, not an algorithm for image analysis or diagnosis.

Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, etc.) are not applicable to this type of device and submission.

However, I can extract the information that is present:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional specifications met	"Nidek Company Ltd. has verified and validated that the Ophthalmoscope F-10 meets its functional specifications"
Performance requirements met	"Nidek Company Ltd. has verified and validated that the Ophthalmoscope F-10 meets its ... performance requirements"
Compliance with applicable U.S. and international standards	"complies with applicable U.S. and international standards (IFC 60601-1, 60601-1-1, 60601-1-2, 60825-1 and ISO 15004-2:2007) for products of its kind. This device complies with 21 CFR Parts 1010 and 1040, with the exception of those allowable performance deviations noted in FDA's Laser Notice 50."
Substantial equivalence to predicate devices regarding safety and effectiveness and intended use	"The Ophthalmoscope F-10 is substantially equivalent to the predicate devices... It is similar in characteristics, materials, features, has similar technological features, intended use and indications for use as the predicates, and do not raise any new questions of safety and effectiveness." (K971671: Heidelberg Retina Angiograph FA/ICGA (HRA/C) and K871268: Rodenstock Scanning Laser Ophthalmoscope)
No new potential safety risks	"Nidek Company Ltd., is of the opinion that the Ophthalmoscope F-10 docs not introduce any new potential safety risks"
Effective and performs as well as other devices on the market	"is as effective, and performs as well as devices currently on the market"

Study Details (Based on the Provided Text)

Sample size used for the test set and the data provenance: Not applicable. This device is a hardware ophthalmoscope, not an algorithm analyzing a dataset. The "performance" assessment focuses on engineering and safety standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI models is not relevant here.
Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI/ML device providing assistance to readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a hardware device like an ophthalmoscope, "ground truth" would relate to its physical specifications and imaging capabilities (e.g., resolution, light output, image clarity). The document states it meets "functional specifications" and "performance requirements" but does not detail how these were measured or against what absolute "ground truth" they were compared other than compliance with engineering standards.
The sample size for the training set: Not applicable. This device does not use a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K072259

MAY - 6 2008

Pre-Market Notification 510(k) Summary

1. Sponsor Information:

Company Name & Address: NIDEK Company, Ltd. 34-14 Maehama, Hiroishicho Gamagori, Aichi, 443-0038 Japan Contact Person: Yoneji Mizuno Contact Title: Manager Regulatory Affairs Contact Phone Number: +81-533-67-8901 Contact Fax Number: +81-533-67-6610

Date of Summary:

May 5, 2008

2. Device Name and Classification:

Common and Usual Name:	Ophthalmoscope
Proprietary Name:	Ophthalmoscope F-10
Classification Name:	Ophthalmoscope, AC-Powered (21 CFR § 886.1570)
Product Code:	MYC
Class:	II
Performance Standards:	No applicable performance standards have been issued under section 514 or under section 513(b) of the Food, Drug and Cosmetic Act.

Performance Standards issued for Light Emitting Products: 21CFR Part 1040, Section 1040.10 and 1040.11 (Laser Products).

3. Predicate Device(s):

K971671:	Heidelberg Engineering
	Heidelberg Retina Angiograph FA/ICGA (HRA/C)
K871268:	G. Rodenstock Instrumente, GMBH
	Rodenstock Scanning Laser

Ophthalmoscope F-10 510(k) Summary

NIDEK COMPANY, LTD.

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4. Description of Device:

న్. Indications for Use:

The Ophthalmoscope F-10 is intended for use in capturing images of the fundus which can be used for diagnosis of fundus diseases.

6. Comparison with Predicate Device(s):

The Ophthalmoscope F-10 is substantially equivalent to the predicate devices identified and other commercially available SLO products. It is similar in characteristics, materials, features, has similar technological features, intended use and indications for use as the predicates, and do not raise any new questions of safety and effectiveness.

7. Non-Clinical Performance Summary:

Nidek Company Ltd. has verified and validated that the Ophthalmoscope F-10 meets its functional specifications, performance requirements and complies with applicable U.S. and international standards (IFC 60601-1, 60601-1-1, 60601-1-2, 60825-1 and ISO 15004-2:2007) for products of its kind. This device complies with 21 CFR Parts 1010 and 1040, with the exception of those allowable performance deviations noted in FDA's Laser Notice 50.

8. Conclusions:

In summary, Nidek Company Ltd., is of the opinion that the Ophthalmoscope F-10 docs not introduce any new potential safety risks, is as effective, and performs as well as devices currently on the market, and concludes that the Ophthalmoscope F-10 is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three curved lines that resemble a human figure or a symbol representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 6 2008

NIDEK Co., Ltd. c/o Mr. Paul Sumner Vice President of Regulatory, Clinical & & Quality Systems Arkin Consulting Group, LLC 1733 Canton Lane Marietta, GA 30062

Re: K072259

Trade/Device Name: Ophthalmoscope F-10 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: April 16, 2008 Received: April 18, 2008

Dear Mr. Sumner:

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,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 (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.

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Page 2- Mr. Paul Sumner

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M. B. Egelston, m.d.

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 Statement

510(k) Number (if known):

K072254

Device Name:

OPHTHALMOSCOPE F-10

Indications For Use:

The Ophthalmoscope F-10 is intended for use in capturing images of the fundus, which can be used for the diagnosis of fundus diseases.

Prescription Use XX (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Derick

Page 1 of 1

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

510(k) Number K072259

NIDEK COMPANY, LTD.

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.