An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capsule.

It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.

Device Description

An AC-powered slit lamp 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.

The slit lamp illumination is composed of the light source, the slit, collimation and imaging optics, and infrared and ultra violet filters and a dielectric mirror. The slit lamp have the option to combine a background illumination together with the slit illumination.

The patient sits in front of the slit lamp with his chin rest and his forehead against the forehead band. The chin rest is adjusted in height until the eyes of the patient are level with the black mark of the headrest column. The light is switched on and the brightness is controlled with a knob on the power supply. With the joystick control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. Various magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally and the angle between the illumination unit and the microscope can also be varied horizontally.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Marco Ultra M3 and Marco Ultra M4 slit lamp biomicroscopes. This notification focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance or diagnostic accuracy enhancements. Therefore, the document does not contain details about acceptance criteria, a study proving device performance in terms of diagnostic accuracy, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/diagnostic performance.

Instead, the "acceptance criteria" for this type of submission are primarily related to safety, electrical compatibility, and optical performance in comparison to predicate devices, and the "study" is a series of tests to confirm compliance with recognized standards.

Here's an analysis of the provided information, focusing on what is present:

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

The document doesn't provide a table of acceptance criteria in the context of diagnostic performance or AI accuracy. Instead, it demonstrates compliance with recognized safety and performance standards. The "performance" reported are the characteristics of the device itself and its adherence to these standards.

Acceptance Criteria (Compliance with Standards)	Reported Device Performance (Compliance)
Adherence to ISO 15004-2:2007 (Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection)	In compliance with ISO 15004-2:2007 for radiation hazards.
Adherence to ISO 10939:2007 (Ophthalmic instruments — Slit-lamp microscopes)	In compliance with ISO 10939:2007 for radiation hazards.
Adherence to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)	In compliance with IEC 60601-1 for electrical safety.
Adherence to IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests)	In compliance with IEC 60601-1-2 for electromagnetic compatibility.

The document also provides a comparison of technological characteristics between the proposed devices (MARCO ULTRA M3, MARCO ULTRA M4) and their predicate devices (Slit Lamp BM900, Z2 Slit lamp microscope). These comparisons are used to argue for substantial equivalence, implying that the new devices perform safely and effectively within the established range for such devices. Examples of characteristics compared include:

Brightness Controls: Variable control vs. Light intensity control knob, Maximum brightness (e.g., 240,000 Lux for M3 vs. 450,000 Lux for BM900; 150,000 Lux for M4 vs. 150,000 Lux for Z2).
Slit image width: 0-14mm continuous for all proposed models vs. 0-8mm for BM900 and 0-14mm for Z2.
Slit image length: 1-14mm continuous for all proposed models vs. 1-8mm for BM900 and 1-14mm for Z2.
Illumination field Diameter: Specific discrete values compared (e.g., φ10,φ5, φ3, φ2, φ1, φ0.2 mm for M3 vs. φ8,φ5,φ3,φ2,φ1,φ0.2 mm for BM900).
Radial movement of the slit light illumination: Horizontal ±90° for all, Vertical 0°,5°,10°,15°,20° for M3 vs. 0-20° for BM900, and Vertical "don't apply" for M4 vs. Z2.
Light source: LED for all.
Background illumination: None for M3 vs. Option for BM900; Mounted in Slit lamp unit for M4 vs. None for Z2.

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

This information is not provided in the document. The tests performed are compliance tests against established engineering and safety standards, not clinical trials with patient data.

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)

This information is not provided in the document. As stated above, the "tests" are technical compliance tests, not clinical evaluations requiring expert consensus for ground truth.

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

This information is not provided. The document details technical compliance testing, which does not involve adjudication of expert interpretations.

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

This information is not provided. The device in question is an AC-Powered Slit-lamp Biomicroscope, which is a foundational diagnostic instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this submission.

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

This information is not provided. The device is an optical instrument for direct human examination, not a standalone algorithm.

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

This information is not applicable as the document describes technical compliance testing for an optical instrument, not a diagnostic device relying on ground truth for performance evaluation in a clinical sense. The "ground truth" here would be the specifications and requirements defined by the referenced international standards.

8. The sample size for the training set

This information is not applicable as the device is an optical instrument and does not involve machine learning or AI that would require a "training set."

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

This information is not applicable for the same reasons as #8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 14, 2017

Takagi Seiko Co., Ltd. Hagiwara Toru Official Correspondent 330-2 Iwafune, Nakano-Shi, Nagano-Ken Nakano, 383-8585 JP

Re: K162636

Trade/Device Name: Marco Ultra M3, Marco Ultra M4 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: March 2, 2017 Received: March 7, 2017

Dear Hagiwara Toru:

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. 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.

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

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(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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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for 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

510(k) Number (if known) K162636

Device Name Marco Ultra M3, Marco Ultra M4

Indications for Use (Describe)

An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capsule.

It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.

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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B-TQMS4101Letterhead Rev. 1

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330-2 IWAFUNE, NAKANO-SHI, NAGANO-KEN, +81-269-22-4512 FAX +81-269-2 http://www.takagi-i.com E-mail: in

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Submitter of this pre-market notification:

TAKAGI SEIKO CO., LTD. 330-2 Iwafune, Nakano-shi, Nagano-ken, Japan 383-8585

Contact Person: Toru Hagiwara Phone: +80-269-22-4511 Fax : +81-269-26-6321 Email: hagiwara.Toru@takagi-j.com

Date prepared: This summary was prepared on April 10, 2017

2.Trade names of the devices: MARCO ULTRA M3 MARCO ULTRA M4

3.Common / Usual name: AC-Powered Slit-lamp Biomicroscope

4.Classification Information:

Classification name: CFR title: Product code: Device Class: Classification Panel:
Biomicroscope, Slit-Lamp, AC-Powered 21 CFR 886.1850 HJO Class II Ophthalmic Panel

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Predicate Devices:

We claim substantial equivalence to the following devices Manufacture: Haag-Streit AG Device name: Slit Lamp BM900 510(k) Premarket Notification No: K100202 Classification name: Biomicroscope, Slit-Lamp, AC-Powered CFR title: 21 CFR 886.1850 Product code: HJO Device Class: Class II Classification Panel: Ophthalmic Panel Manufacture: TAKAGI SEIKO CO., LTD Device name: Z2 Slit lamp microscope 510(k) Premarket Notification No: K152535 Biomicroscope, Slit-Lamp, AC-Powered Classification name: CFR title:

Product code: Device Class: Classification Panel: 21 CFR 886.1850 HJO Class II Ophthalmic Panel

6. General Device Description:

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

An AC-Powered slit lamp 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.

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7. Indication for use:

An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posteriorcapsule. It is used to aid in the diagnosis of diseases or traumas which affect the structural properties of the anterior eye segment.

8. Comparison with predicate devices:

The MARCO ULTRA M3 is substantially equivalent to the predicate device Slit Lamp BM900 because they use similar technology and perform similar functions to provide the physician with the necessary information to aid in diagnosis.

The MARCO ULTRA M4 is substantially equivalent to the predicate device Z2 Slit lamp microscope because they use similar technology and perform similar functions to provide the physician with the necessary information to aid in diagnosis.

	Predicate Device Slit lamps	TAKAGI Slit lamps
	Slit Lamp BM900((K100202)	MARCO ULTRA M3(K162636)
	Z2 Slit lamp microscope(K152535)	MARCO ULTRA M4(K162636)
BrightnessControls	For BM900 (K100202)	For ULTRA M3(K162636)
	Variable control by potentiometer	Control by Light intensity control knob
	Maximum brightness	Maximum brightness
	approx. 450'000 Lux	approx. 240'000 Lux
	For Z2(K152535)	For ULTRA M4(K162636)
	Control by Light intensity control knob	Control by Light intensity control knob
	Maximum brightnessapprox. 150'000 Lux	Maximum brightnessapprox. 150'000 Lux
Slit imagewidth	For BM 900(K100202)0-8mm continuous	For all Slit lamps(K162636)0-14mm continuous
	For Z2(K152535)
	0-14mm
Slit imagelength	For BM 900 (K100202)1-8mm continuous	For all Slit lamps(K162636)1-14mm continuous
	For Z2(K152535)
	1-14mm continuous

Major different technological characteristics are as follows:

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	Predicate Device Slit lamps	TAKAGI Slit lamp
	Slit Lamp BM900 (K100202)	MARCO ULTRA M3(K162636)
	Z2 Slit lamp microscope(K152535)	MARCO ULTRA M4(K162636)
IlluminationfieldDiameter	For BM900(K100202)	For M3(K162636)
	φ8,φ5,φ3,φ2,φ1,φ0.2 mm	φ10,φ5, φ3, φ2, φ1, φ0.2 mm
	For Z2(K152535)	For M4(K162636)
	φ14,φ8,φ5, φ3,φ0.3 mm	φ14,φ8,φ5, φ3,φ0.3 mm
Radialmovement ofthe slit lightilluminationrelative to themicroscopeaxis	For BM900(K100202)	For M3(K162636)
	Horizontal ±90°	Horizontal±90°
	Vertical 0 - 20°	Vertical 0°,5°,10°,15°,20°
	For Z2(K152535)	For M4(K162636)
	Horizontal±90°Vertical don't apply	Horizontal±90°Vertical don't apply
Light source	For BM900(K100202) and Z2(K152535)	For all Slit lamps(K162636)
	LED	LED
Backgroundillumination	For BM900(K100202)	For M3(K162636)
	Option	None
	For Z2(K152535)	For M4(K162636)
	None	Mounted in Slit lamp unit

9. Performance, safety and EMC Data:

The slit lamps M3 and M4 were tested according to ISO 15004-2:2007 and ISO10939:2007 for radiation hazards, to IEC60601-1 for electrical safety and IEC-60601-1-2 for electromagnetic compatibility. In all tests, the slit lamps were in compliance with these FDA recognized standards.

10.Conclusions:

In accordance to 21 CFR 807.92(d) and based on the technical characteristics and the results of the performance tests we conclude that the slit lamps M3 and M4 are safe and effective compared to the predicate device slit lamps BM 900 and Z2.

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.