FM-600 consists of three units, Measurement unit, Operating unit and Power supply unit. The measurement unit is contained optical system including Laser, photo receiver and CCD camera for observation. The operating unit is contained Observation monitor. Analyzer of detected photon intensity, printer for output and migratory mechanism of the units. The power supply unit is contained Power unit.

AI/ML Overview

Here's an analysis of the KOWA FM-600's acceptance criteria and study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the FM-600. Instead, it demonstrates the device's technical characteristics and performance through precision measurements (repeatability and reproducibility) and a comparison to predicate devices. The implicit acceptance is that these performance metrics are acceptable for its intended use, especially given its substantial equivalence to previously cleared devices.

I will formulate "acceptance criteria" based on the reported precision of the device and its claimed substantial equivalence.

Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Precision	Repeatability (Standard Deviation):
	- ≤ 1.5% for high flare values	1.5% at 500 mg/dL BSA (77.49 PC/ms)
	- ≤ 5% at 80 PC/ms flare	Less than 5% at 80 PC/ms
	Reproducibility (Standard Deviation):
	- ≤ 4% for high flare values	4.00 PC/ms at 1000 mg/dL BSA (144.28 PC/ms)
Functionality	Non-invasive measurement of anterior chamber protein level	KOWA FM-600 is a noninvasive flare photometry device that is able to assess anterior protein level quantitatively.
	Single-function device for flare measurement	Kowa FM-600 is a single-function device of laser flare measurement.
Safety	Compliance with optical hazard standards (ISO15004-2, IEC60825-1, IEC60601-1)	Confirmed in equivalent level of safety to the predicate devices.
Substantial Equivalence	Good correlation and low variance with predicate devices for flare value	KOWA FM-600 has good correlation and low valiance for the predicate device.

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

Sample Size: The precision study used Bovine Serum Albumin (BSA) solutions at 8 different concentrations (ranging from 0 to 2000 mg/dL). For each concentration, there were:
- 3 instruments
- 10 replicate measurements per instrument
- Total measurements = 8 concentrations * 3 instruments * 10 replicates = 240 measurements.
Data Provenance: The data is from an in-vitro study using Bovine albumin solution, not human patient data. It is from the device manufacturer, Kowa Company, Ltd., located in Japan. The study is prospective in the sense that the measurements were actively performed for the premarket notification.

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

This device measures a biophysical parameter (protein level/flare). The "ground truth" for the test set (BSA solutions) was established by the known concentrations of the prepared Bovine albumin solutions. Therefore, no human experts were used to establish ground truth for the test set in the way radiologists or pathologists would for diagnostic imaging. The accuracy of the BSA preparation would be verified by standard laboratory practices.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth was based on prepared chemical concentrations, not expert interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The study focuses on the device's technical precision and its comparison to predicate devices based on flare value measurements from BSA solutions, not on human reader performance with or without AI assistance. The KOWA FM-600 is a measurement device, not an AI diagnostic tool.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the device's performance as described (repeatability and reproducibility) represents its standalone performance. The FM-600 directly measures the flare value; human interpretation of the measurement itself is not part of its core functionality, though a clinician would interpret the result in the context of a patient's condition. The "algorithm" here is the device's internal measurement system.

7. Type of Ground Truth Used

The ground truth used for the precision study was the known, prepared concentrations of Bovine albumin solutions (BSA). This is a controlled experimental "ground truth" rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus from patient cases).

8. Sample Size for the Training Set

The document does not describe a separate "training set" in the context of machine learning. The KOWA FM-600 is a measurement device, not an AI algorithm that undergoes distinct training. Its design and calibration would be based on engineering principles and potentially internal testing data, but this is not typically referred to as a "training set" in the same way as for AI.

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

Not applicable, as there's no explicitly described "training set" for an AI algorithm. The device's fundamental measurement capabilities would be established through engineering design, calibration using known standards (like the BSA solutions), and quality control processes.

Summary

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AUG 0 7 2009 owa Kowa Company. Ltd.

ELECTRONICS & OPTICS DIVISION 4-14, NIHONBASHIHONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN TEL: +81-(0)3-5623-8063 FAX: +81-(0)3-5623-8060

510(k) Summarv

K091039

Submitter information: Applicant:

Kowa Company, Ltd. 4-14, Nihonbashi-honcho 3-Chome Chuo-ku, Tokyo, 103-8433 Japan

Contact:

Satohiko Takanashi, PE

Date summary prepared:

Aug. 4, 2009

Device identification:

Device trade name: Regulation Number: Product code: Classification name: Regulatory Class:

KOWA FM-600 21 CFR 886.1570 MYC Ophthalmoscope, Laser, Scanning Class II

Identification of predicate devices:

Kowa Company believes that this device is substantially equivalent to: Laser flare meter FM-500 manufactured by Kowa, 510(k)# K913852. Laser flare cell meter FC-1000 manufactured by Kowa, 501(k)# K880920.

Device description:

KOWA FM-600, here after refer to as FM-600, is a noninyasive flare photometry device that is able to assess anterior protein level quantitatively.

Intended use:

KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eve.

Technical characteristics:

Kowa FM-600 is a single-function device of laser flare measurement. Kowa FM-600 and the predicate devices have similar technological characteristics for flare measurement. The flare measurement volume in anterior chamber, measurement aperture and laser intensity at the patient eye are same characteristics of the predicate devices.

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The light sources of FM-600 are used a laser source for flare measurement and LED light for illumination to observe the measurement area. The laser light source wavelength is almost same to the predicate device. The light source for illumination is different type of the predicate device. To evaluate safety, tests based on optical hazard standards, ISO15004-2: 2007, IEC60825-1: 2007, and IEC60601-1: 1988 and related amendments, are performed and it is confirmed in equivalent level of safety to the predicate devices.

According to ISO5725-1 and ISO5725-2. repeatability and reproducibility are evaluated. and are obtained 1.5% for repeatability and 4% for reproducibility in standard deviation. The results are shown in Table Al.

Relation of flare value and using Bovine albumin solution, BSA, is shown in Figure A1.

Precision:

The precision is defined by standard deviation of measurement value built in calibrator of FM-600. This calibrator has a reflection ability of 80 photon counts per millisecond. The precision of FM-600 is less than 5% at 80 photon counts per millisecond.

Image /page/1/Figure/6 description: The figure is a plot of flare value in PC/ms versus BSA concentration in mg/dL. The x-axis ranges from 0 to 10000, and the y-axis ranges from 0 to 500. The plot shows a linear relationship between flare value and BSA concentration up to approximately 4000 mg/dL, with the equation y = 0.126x + 4.720 and an R-squared value of 0.993. Beyond 4000 mg/dL, the flare value plateaus around 400 PC/ms.

FIGURE A1. RELATION OF FLARE VALUE AND BSA CONCENTRATION

In figure, solid line is a linearity regression line calculated by the data up to 2000mg/dL in concentration. Briefly conversion factor is 100mg/dL equal to 13 photon count/millisecond. Error bar indicates standard deviation. The standard deviation is estimated measurements taken on the same albumin sample using different three instruments, including repeatability (in PC/ms). Measurement is performed 10 repeating at one concentration of BSA

Kowa Company, Ltd., KOWA FM-600

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BSA concentration[mg/dL]	Mean flare values[PC/ms]	Repeatability*[PC/ms]	Reproducibility**[PC/ms]
2000	248.69	4.15	11.27
1000	144.28	2.57	4.00
500	77.49	1.51	2.73
250	37.52	1.09	2.19
125	18.97	0.80	1.07
62.5	10.30	0.53	0.94
31.3	5.03	0.29	0.65
15.6	2.93	0.56	0.53
0 (HBSS)	0.96	0.33	0.32

TABLE A1. Repeatability and reproducibility (according to ISO 5725-1 and 5725-2) at eight different prepared BSA concentrations measured 30 times using three (3) instruments and ten (10) replicate measurements per instrument.

Repeatability is an estimate of the standard deviation among measurements taken on the same albumin sample using the same instruments.

** Reproducibility is an estimate of the standard deviation among measurements taken on the same albumin sample using different instruments, including repeatability.

ISO5725-1: 1994 Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions.

ISO5725-2: 1994 Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method.

Substantial equivalency of performance

Comparison with the predicate device is shown in Table A2.

To evaluate performance equivalency, performance test using Bovine albumin solution as protein model in the anterior chamber is performed. From the studies of correlation and Bland-Altman plot of the flare value, KOWA FM-600 has good correlation and low valiance for the predicate device.

It is concluded that KOWA FM-600 is substantially equivalent to the predicate devices.

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Table A2: Comparison with predicate devices
	Proposed device	Predicate devices
Proprietary name	KOWA FM-600	Laser Flare MeterFM-500	Laser Flare Cell MeterFC-1000
510(k) number	-	K91385	K880920
Indications for use or Scope	KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.	Quantitative measurement of protein concentration in the aqueous provides important information for evaluation anterior segment inflammation.	Quantitative measurement of protein concentration and cells in the aqueous provides important information for evaluation anterior segment inflammation.
Functions
Slit lamp function	No	Yes	Yes
Cell measurement	No	No	Yes
Flare measurement		Yes
Flare measurement function and principal parts
Laser source	635nm Laser diode	670nm Laser diode	0.5mW 633nm Helium Neon Laser
Laser scanning width		0.6 mm
Beam west diameter		20 μm
Laser light intensity at the subject eye		Less than 0.05mW
Photo detector		Photo multiplier tube
Measurement area		0.3 x 0.5 mm2
Measurement time	0.5 second	0.5 second	1.0 second
Illumination light source	Infrared LED	12V, 30W Halogen lamp	6V, 30W Halogen lamp
Observation method	Electrical image by CCD camera	Binocular microscope	Binocular microscope
Fixation light source		Visible LED

Kowa Company, Ltd.. KOWA FM-600

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

KOWA Company, LTD., c/o Mr. Satohiko Takanashi Chief Analyst 4-14, Nihonbashihoncho 3-chome Chuo-ku, Tokyo Japan 103-8433

AUG 0 7 2009

Re: K091039

Trade/Device Name: KOWA FM-600 Model LSS50 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: MYC Dated: July 7, 2009 Received: July 9, 2009

Dear Mr. Takanashi:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Alexander for

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

Enclosure

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510(k) Number (if know):

Ko91039

FM-600

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.

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

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

(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF MEEDED)

Concurrence of CDRH, Office of Device

(Division Sign-Off)

Division of Ophthalmie, Neurological and Ear, Nose and Throat Devices

510(k) Number K091039

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.