The KOWA DR-1a is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

Device Description

The KOWA DR-1a is ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by a physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. This instrument is intended to observe and record a video of the interference image with illuminating white light on the tear film layer. Users can replay the recorded image on the instrument's monitor to observe the condition of the tear film layer. In addition, using the image currently being replayed, users can measure the duration time by specifying 2 different point of time. This instrument has a function that allows users to output a video or a still image clipped from the video to an external personal computer.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text, categorized by your requests.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It is not a detailed clinical study report designed to prove clinical accuracy or effectiveness of an AI algorithm in the specific ways you requested (e.g., MRMC study, standalone performance, expert consensus as ground truth for AI model). The KOWA DR-1a is an ophthalmic camera, and the performance data presented primarily focuses on its physical and optical characteristics compared to the predicate, and safety/electrical/biocompatibility testing. There is no mention of an AI component in this device or its performance evaluation. Therefore, many of your questions related to AI performance, such as sensitivity, specificity, MRMC studies, or training/test set ground truth for AI, cannot be answered from this document.

Acceptance Criteria and Device Performance (Based on Device Characteristics and Comparative Testing, Not AI Performance)

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for an ophthalmic camera and not an AI algorithm, the "acceptance criteria" are generally that the new device is as safe and effective as the predicate, with no new safety or effectiveness concerns. The performance data presented focuses on physical and optical characteristics.

Acceptance Criteria (Implied / Comparator)	Reported Device Performance (KOWA DR-1α)
Illumination Area (Similar to Predicate)	Wide type: Diameter: 8.0 mm, Height: 7.2 mm Narrow type: Width: 3.4 mm, Height: 2.5 mm (Test results indicated similar Illumination area to LipiView)
Image Resolution (At least comparable to Predicate)	Narrow type: 45.3 line pairs / mm Wide type: 18.0 line pairs / mm (Test results indicated higher Image resolution than LipiView)
Interference Image (Similar to Predicate)	(Test results indicated similar Interference image to LipiView)
Repeatability of Hue Values (Within Acceptance Range)	Hue values obtained did not exceed the acceptance range (tested with three units and three examiners, 5 repetitions each).
Optical Radiation Safety (Compliance with ANSI Z80.36-2016)	Classified in Group 1 of continuous wave instrument; complies with ANSI Z80.36-2016.
EMC and Electrical Safety (Compliance with IEC 60601-1-2.2007 and IEC 60601-1:2012)	Confirmed in accordance with specified IEC standards.
Biocompatibility (Compliance with ISO 10993-1:2009 and FDA guidance, no adverse reactions)	Cytotoxicity, Sensitization, and Irritation tests conducted for forehead and chin rests according to ISO 10993-1:2009.
Software Validation (Compliance with FDA guidance)	Software validated according to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

2. Sample size used for the test set and the data provenance

Sample Size for Comparative Testing: Not explicitly stated with patient numbers. The performance comparison refers to "Test was performed to evaluate performance of the KOWA DR-1a compared to the LipiView regarding Illumination area, Image resolution and Interference image." It doesn't specify if this involved human subjects or just device measurements.
Sample Size for Repeatability: "The repeatability was investigated by comparing the hue values measured with three units of DR-1α and by three examiners. Each measurement was repeated 5 times." This refers to device measurements, not a patient test set.
Data Provenance: The document is a 510(k) submission from Kowa Company, Ltd. in Japan. The testing described would typically be conducted by the manufacturer in a controlled environment. The document does not specify country of origin for any "test set" and given it's a device performance study for substantial equivalence, it's unlikely to involve large-scale retrospective or prospective patient data in the way an AI algorithm study would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is an ophthalmic camera. The performance tests described relate to its physical and optical characteristics (e.g., image resolution, illumination, repeatability of hue values) and safety. There is no mention of "ground truth" in the context of clinical interpretation by experts because the device itself does not provide a diagnosis or interpretation that would require clinical ground truth for validation in this submission.
For the repeatability test, "three examiners" were used. Their qualifications are not specified, but they would likely be trained operators or engineers.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images and their consensus or a tie-breaker establishes a "ground truth" for disease presence/absence or findings.
Not applicable for the device performance tests described in this 510(k) summary, as it does not involve clinical interpretation or a "test set" requiring adjudication of clinical findings.

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

An MRMC study is designed to evaluate the impact of a new technology (like AI) on physician performance.
No MRMC study was performed or needed for this 510(k) submission, as the KOWA DR-1a is an ophthalmic camera and the document does not indicate it incorporates an AI component influencing clinical decision-making or diagnosis. The focus is on the device's ability to capture images.

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

This question pertains to the performance of an AI algorithm independent of human interaction (e.g., its sensitivity, specificity, AUC for a diagnostic task).
Not applicable. The KOWA DR-1a is an ophthalmic camera. The document does not describe any standalone AI algorithm for interpretation or diagnosis.

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

As explained above, the "ground truth" concept (e.g., for disease diagnosis) is not relevant to the performance tests reported here.
The reported performance tests rely on technical measurements and compliance with established standards:
- Illumination area and image resolution are measured specifications.
- Repeatability is assessed against an "acceptance range" for hue values (an objective measurement).
- Safety checks (optical radiation, EMC, electrical, biocompatibility) are assessed against specific industry and regulatory standards.

8. The sample size for the training set

This question applies to AI/machine learning models.
Not applicable. This document is for the clearance of an ophthalmic camera and does not describe the development or validation of an AI algorithm, thus there is no "training set."

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

This question applies to AI/machine learning models.
Not applicable. As there's no mention of an AI model or training set, this information is not provided.

Summary

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June 4, 2019

Kowa Company, Ltd. Nariaki Morita Manager of Development Management Dept. 3-1 Chofugaoka 3-Chome Chofu City Tokyo, 182-0021 JAPAN

Re: K190573

Trade/Device Name: KOWA DR-1α Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: December 14, 2018 Received: March 6, 2019

Dear Nariaki Morita:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bradley S. Cunningham -S

for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190573

Device Name

KOWA DR-1a

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

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Kowa) Kowa Company. Ltd.

Chofu Factory

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510k Summary

A. Owner/Company name, address

Kowa Company, Ltd.

3-1, Chofugaoka 3-Chome Chofu Tokyo, JAPAN 182-0021

Phone: +81-42-440-7612 +81-42-440-7618 Fax:

B. Contact

Nariaki Morita Kowa Company, Ltd. Medical Device Division 3-1, Chofugaoka 3-Chome Chofu Tokyo, JAPAN 182-0021 Phone: +81-42-440-7627 Fax: +81-42-440-7618 Email: n-morita@kowa.co.jp

C. Date prepared

December 14, 2018

D. Name of device

Trade Name:	KOWA DR-1α
Regulation Number:	21 CFR 886.1120
Regulation Name:	Ophthalmic Camera
Regulatory Class:	II
Product Code:	HKI

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E. Predicate and Reference Devices

Predicate Device
510(k) number:	K091935
Trade name:	LipiView Ocular Surface Interferometer
Regulation Number:	21 CFR 886.1120
Regulation Name:	Ophthalmic Camera
Regulatory Class:	II
Product Code:	HKI, HJO

The predicate device is hereinafter called "the LipiView" in this submission.

Reference Device

The forehead rest of the proposed device is identical to the forehead rest of the reference device. Both proposed and reference devices are the ophthalmic cameras and a patient contacts the forehead rest for a very short time. In addition, both forehead rests are disinfected with rubbing alcohol.

510(k) number:	K112330
Trade name:	KOWA VX-20
Regulation Number:	21 CFR 886.1120
Regulation Name:	Ophthalmic Camera
Regulatory Class:	II
Product Code:	HKI

F. Description of the device

This instrument is intended to observe and record a video of the interference image with illuminating white light on the tear film layer. Users can replay the recorded image on the instrument's monitor to observe the condition of the tear film layer

In addition, using the image currently being replayed, users can measure the duration time by specifying 2 different point of time. This instrument has a function that allows users to output a video or a still image clipped from the video to an external personal computer.

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G. Indications for Use Statement

H. Discussion of substantial equivalence

Comparative Information

Both the KOWA DR-1a and the predicate device are an ocular surface interferometer. The indications for use statement of the KOWA DR-1a is virtually the same as for the LipiView. The differences of the indications for use statement are minor and do not alter the intended use.

Fundamental technology as ocular surface interferometer is similar between the two devices as shown below:

Technological Principle of the LipiView

The LipiView operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The patient's eye is positioned in front of an illumination source directed toward the tear film on the corneal surface. Light from the illumination source passes through the outer lipid layer of the tear film and is secularly reflected into a camera. The light reflecting through back the lens in the camera forms an interference pattern, called an "interferogram". The computer system captures a video image file that is recorded over time since the interference pattern changes as the lipid layer of the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display and in a printed report.

Technological Principle of the KOWA DR-1α

The KOWA DR-1a is intended to observe and record a video of the interference image with illuminating white light on the tear film layer. Users can replay the recorded image on the instrument's monitor to observe the condition of the tear film layer.

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The surface layer of the tear film layer is called the tear film lipid layer. It is a thin layer of approximately 100nm thick. When white light is irradiated on the tear film surface, several interference patterns appear by difference in two specular reflection light paths obtained between the surface and the back of the lipid layer. For the reflection light at the tear film layer, the KOWA DR-1a uses two polarizer (parallel), only the reflected image of the illumination light is captured by the camera, and the external light is not taken into the camera. As a result, background image such as iris and sclera does not appear and the interference image of the tear film layer can be efficiently observed.

The similarities between KOWA DR-1α and LipiView are:

. Intended use
Capability to record interference image ●
Camera resolution ●
Illumination source .
Illumination area ●
Interference image ●
Power supply ●

The differences between KOWA DR-1α and LipiView are:

Image resolution ●
Dimension .
Weight ●
Power consumption ●

The differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The performance data to prove the safety and performance of KOWA DR-1a are provided in section of Performance data of this summary below.

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Following table shows comparison between the proposed and predicate devices.

	Proposed device	Predicate device
Device name	KOWA DR-1a	LipiView Ocular SurfaceInterferometer
510(k) number	K190573	K091935
Indications foruse statement	The KOWA DR-1a is an ocular surfaceinterferometer, which is an ophthalmicimaging device that is intended for useby physician in adult patients to observeand record a video image of specular(interferometric) observations of the tearfilm, which can be visually monitoredand photographically documented.	The LipiView Ocular SurfaceInterferometer is an ophthalmic imagingdevice that is intended for use by aphysician in adult patients to capture,archive, manipulate and store digitalimages of specular (interferometric)observations of the tear film, which canbe visually monitored andphotographically documented.
Performance Specifications
Illumination area	Wide type (low magnification)Diameter: 8.0 mmHeight: 7.2 mmNarrow type (high magnification)Width: 3.4 mmHeight: 2.5 mm	Width: 9.5 mmHeight: 4.6 mm
Image resolution	45.3 line pairs / mm (Narrow)18.0 line pairs / mm (Wide)	14.3 line pairs / mm
Other Specifications/Characteristics
Cameraresolution	640 x 480 pixels	Same
Illuminationsource	White LED	Same
Dimension	290(W) x 365(D) x 455(H) mm	430(W) x 720(D) x 430(H) mm
Weight	14 kg	24.95 kg
Power supply	AC100-240V,50/60Hz	Same
Power	70VA	80VA
consumption

Table 1. Comparison Table

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I. Performance data

Dimension, weight and power consumption of the KOWA DR-1a are less compared to the LipiView. Such differences do not result in lower performance as shown in the comparison table. The comparison of quality of images obtained from the proposed and predicate devices was conducted because of the differences of Illumination area and Image resolution.

Performance Comparison with the Predicate Device

Test was performed to evaluate performance of the KOWA DR-1a compared to the LipiView regarding Illumination area, Image resolution and Interference image.

Test results indicated that the KOWA DR-1a has similar Illumination area and Interference image to the LipiView and higher Image resolution than the LipiView.

The following performance tests were conducted in support of the substantial equivalence determination.

Testing for Repeatability

The repeatability was investigated by comparing the hue values measured with three units of DR-1α and by three examiners. Each measurement was repeated 5 times. The hue values obtained did not exceed the acceptance range.

Optical Radiation Safety

KOWA performed estimation of the light hazard and evaluation as to whether the KOWA DR-1a satisfied the requirements of ANSI Z80.36-2016. As a result, the KOWA DR-1a is classified in Group 1 of the continuous wave instrument. Therefore, the KOWA DR-1a complies with ANSI Z80.36-2016.

EMC and Electrical Safety

EMC and Electric safety were confirmed in accordance with IEC 60601-1-2.2007 and IEC 60601-1:2012, respectively.

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Biocompatibility

The forehead rest and the chin rest of the proposed device contact intact patient skin for a very short time. The biocompatibility evaluation for those parts were conducted in accordance with ISO 10993-1:2009 and referencing FDA guidance entitled "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The following tests were conducted to evaluate biocompatibility of the proposed device:

Cytotoxicity ●
Sensitization ●
Irritation ●

Software validation

The software of the proposed device has been validated according to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Conclusion J.

Based on the information described above, KOWA DR-1a is substantially equivalent to the predicate device in technical characteristics, operating principles and performance characteristics for the intended uses in the stated medical specialties. There are no new safety and effectiveness issues being raised.

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.