The EAS-1000 "Anterior Eye-Segment Analysis System" is intended to take photographs of the eye and surrounding area, for non-invasive illumination, magnification, observation, analysis and photography of the anterior segments of the eye, which include the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate and analyze conditions of lens (opaque crystalline lens), lens position (pre and post Intraocular Lens Transplant), anterior or posterior cortical opacity, cataracts (nuclear, subcapsular and or cortical) using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.

Device Description

This DEVICE is a non-invasive, table mounted, AC powered diagnostic sytem intended to take photographs of the eye and surrounding area. The system contains a illumination device, viewing optics, a computer (CPU), image capturing devices, and is based on the Scheimpflug Principle for Slit Image photography. The system uses a Xenon flash lamp for Flash Photography, and an Infrared LED for Retro-Illumination.

AI/ML Overview

The provided 510(k) summary for the Nidek EAS-1000 Anterior Eye-Segment Analysis System does not include acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as pre-existing, legally marketed devices, rather than proving performance against quantified metrics.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The 510(k) submission does not define specific performance acceptance criteria for the EAS-1000. It focuses on comparing the new device's features and intended use to those of predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: Not applicable, as no dedicated test set or clinical study with a specified sample size is described for the EAS-1000's performance validation against specific criteria.
Data provenance: Not applicable. The submission refers to "Published Journal Articles" to support claims for use, accuracy, safety, and effectiveness, but it doesn't describe a specific study conducted for this device with a given test set and provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since no specific test set or ground truth establishment process is described for the EAS-1000's performance validation, information about experts and their qualifications is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described as there is no specific test set and ground truth process provided for the EAS-1000.

5. 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 comparative effectiveness study was not done. The device is a diagnostic imaging system, not an AI-assisted diagnostic tool, and the submission does not mention any AI components or human-in-the-loop performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The EAS-1000 is a hardware device for taking photographs; it does not explicitly describe an algorithm operating in standalone mode that would require such testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The submission refers to "Published Journal Articles," implying that the claims are supported by existing scientific literature and general clinical understanding of similar devices, rather than a specific ground truth set up for this device.

8. The sample size for the training set

Not applicable. This device is a camera system, not an algorithm that requires a training set in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. As described above, there is no mention of a training set for this device.

Summary of Device Acceptance:

Instead of demonstrating a device meeting specific acceptance criteria through a dedicated study, the Nidek EAS-1000 gained acceptance (510(k) clearance) by demonstrating substantial equivalence to predicate devices already on the market.

The key arguments for substantial equivalence were:

General Intended Uses: All three devices (EAS-1000, Nidek 3-DXF Stereo Fundus Camera, KOWA SC-1200 Slit Lamp) share the general intended use "to take photographs of the eye and surrounding area."
Operating Principles: They utilize similar operating principles, including optical systems, illumination sources for observation and photography, and photographic mediums.
Device Features: They share common device features such as a head stabilizing device, external fixation target, joystick/control mechanism, and exposure control.
Illumination and Safety: All use illumination sources and flash output sources, and photo toxicity is not an issue for these devices. They are considered non-invasive and "Non Significant Risk" devices.
Safety and Effectiveness: The manufacturer states the EAS-1000 is non-invasive, does not pose new risks, meets electrical safety requirements, and is proven effective through "internal company and independent international clinical studies" (though no specifics of these studies are provided in the summary).

The FDA concurred with the claim of substantial equivalence, allowing the device to be marketed.

Summary

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K991284

510(k) SUMMARY [As required by 21 CFR 807.93]

GENERAL INFORMATION I

Applicant's Name & Address: Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474 Mr. Jerry Tsutsumi Contact: Regulatory/Quality Manager Date Summary Prepared: 12 April 1999

DEVICE NAME II

Trade or Proprietary Name: Model Number: Common/Classification Name: Class: Classification Panel: Product Code: Regulation Number:

Anterior Eye-Segment Analysis System EAS-1000 Ophthalmic Camera Class II 86 MXK 886.1850

III PREDICATE DEVICES

The Nidek EAS-1000 Anterior Eye-Segment Analysis System is claimed to be substantially equivalent to the following currently Marketed Devices:

Nidek, 3-DXF Stereo Fundus Camera K973533 received 11/4/ 97 .
KOWA Optimed Inc., SC-1200 Slit Lamp -- K955442 received 1/3/96 .

IV PRODUCT DESCRIPTION

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	EW DEVICE.	PREDICATE DEVICE	PREDICATION WORLDE
	Nidek Inc.	Nidek Inc.	Kowa Optimed
	EAS-1000	3DXF Stereo Fundus Camera	KOWA SC-1200
	Single Aperature	Stereo Aperature	Single or Stereo
			Aperature
	5.5" Black & White CRT	Eyepiece, Stereo Viewing	Eyepiece, Stereo/Mono
		Optics	Viewing Optics
	Infrared LED for Retro-	Halogen Lamp	Halogen Lamp
	Illumination 800 nm	50W	30W
	Xenon Lamp	Xenon Lamp	Xenon Lamp
	200Wsec	200Wsec	300W
	4 Step - Selectable	5 Step – Manual	5 Step - Manual
	(50, 100, 150, 200 WS)	(25, 50, 100, 200, 400 WS)	(25, 50, 100, 200, 300 WS)
	CCD Camera	35 mm Film Plane	35 mm Film Plane
		or Polaroid Media	or Polaroid Media
	Data digital and can be	Image is a film hard copy	Image is a film hard copy
	displayed on a CPU	only	only
	640 x 400 pixels	N/A	N/A

GAMAN	8 mm X 6.6 mm	20 mm X 16 mm (stereo)	24 mm X 17 mm (stereo)
			24 mm X 24 mm (mono)
			24 mm X 36 mm (right)
otograph	Offers Photographic angles	Offers a swing angle of 15°	Offers a Slit Projection
	from 0 to 180°	right or left	angle of 90° from vertical
	0.5 X	2.6X	0.7, 1.1, 1.7, 2.8, 4.3X
			Stereo
	2 ~ 14 mm, adjustable	N/A	0 ~ 11 mm, adjustable
	150 V A	600 VA	1300 VA

	100 Vac	AC 100, 120, 220, 240V	AC 100, 117 , 220, 240V
	50/60 Hz	50/60 Hz	50/60 Hz
	25 Kg	30 kg	N/A

INDICATIONS FOR USE V

Intended Use: The EAS-1000 is intended to take photographs of the eye and surrounding area, which includes the cornea, aqueous, lens, vitreous and retina of the eye. To evaluate:

corneal shape,
and analyze conditions of lens (opaque crystalline lens), ●
the state of lens (pre and post Intraocular Lens Transplant), .
and analyze anterior chamber angles, .
and analyze anterior or posterior cortical opacity, .
the degree and location of cataracts (nuclear, subcapsular and or cortical) . using cross slit imaging or retro-illumination, or both with densitometry and biometry analyses where applicable.

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VI CLINICAL PERFORMANCE DATA

Published Journal Articles were supplied to support the claims for use, accuracy, safety and effectiveness of the EAS-1000 for the prescribed intended uses defined in this submission.

VII NON-CLINICAL PERFORMANCE DATA

None provided at this time.

VIII RATIONAL FOR SUBSTANTIAL EQUIVALENCE

The GENERAL INTENDED USES of all three of these devices is "to take photographs of the eye and surrounding area".

Our claim of Substantial Equivalence, and is also based on the following;

The devices compared, utilize the same or similar OPERATING PRINCIPLES, in . that they all contain an optical system, a source of illumination for observation, a source of illumination for photography, and photographic mediums.
All three devices utilize the same DEVICE FEATURES, a Head Stabilizing device, . an External Fixation Target, a Joy Stick or Control Mechanism, and a Exposure Control.
All three devices utilize a ILLUMINATION SOURCE, and a FLASH OUTPUT ● SOURCE, and safety concerns regarding "Photo Toxicity" is not an issue with these devices.
All three devices are considered "Non Invasive" devices as defined in 21 CFR . §812.3(k) and are considered NOT to be a "Significant Risk Device" as defined in 21 CFR §812.3(m).

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IX SAFETY AND EFFECTIVENESS

The EAS-1000 is a non-invasive diagnostic system and only contacts the patient on his/her chin and forehead, and DOES NOT present or pose any new or additional significant effects or risks on the safety, performance, use or effectiveness for its prescribed intended uses. Light safety concerns or "Photo Toxicity" is not an issue with this device as light output is of an eyesafe intensity and wavelength. Electrical Safety requirements for medical device are met. The device is proven effective for its intended uses through internal company and independent international clinical studies. The information provided in this submission reasonably assures this product to be Safe and Effective for it intended uses.

CONCLUSION ×

We believe that the data submitted in this document, demonstrates that the EAS-1000 is substantially equivalent with respect to the indications for use, operating principles, and the device features to other legally market predicate devices. The safety and effectiveness of this product can be reasonably assured, as the EAS-1000 DOES NOT pose any new or additional significant effects on the safety, performance, use or effectiveness of this device for its prescribed intended uses. We believe that this device clearly meets the requirement for substantial equivalence according to the 510(k) guidelines. Therefore, justifying 510(k) PreMarket Notification Clearance for commercial sale and distribution of this product within the United States.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -6 1999

Mr. Jerry Tsutsumi Regulatory/Quality Manager Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474

Re: K991284 Trade Name: Anterior Eye-Segment Analysis System Regulatory Class: II Product Code: 86 MXK Dated: July 13, 1999 Received: July 14, 1999

Dear Mr. Tsutsumi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Jerry Tsutsumi

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Concurrence of CDRH ODE Form

510(k) Number (if known): K991284

Device Name: Nidek Inc. EAS-1000 Anterior Eye Segment Analysis System

INDICATIONS FOR USE:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Everett Beam
(Division Sign-Off)

Prescription Use
(Per 21 CFR 801.109)
OR

Over the Counter Use

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.