The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for a medical device efficacy study (e.g., sensitivity, specificity, accuracy targets).

Instead, the document is a 510(k) premarket notification summary for the Nidek Microperimeter MP-3, asserting substantial equivalence to a predicate device (MP-1 MICROPERIMETER). The "testing" referred to is primarily bench testing to demonstrate that the modified device (MP-3) meets its functional specifications, performance requirements, and complies with applicable international standards for safety and electrical compatibility, and that its performance is "as well as" the predicate device.

Here's an attempt to answer your questions based on the provided text, highlighting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It focuses on the device's functional integrity and compliance with safety standards, and equivalence in performance to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Specifications	Meets functional specifications for Color retinography, Fixation examiner, Fundus-related microperimetry.
Performance Requirements	Meets performance requirements.
Safety Standards Compliance	Complies with IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2, ISO 12866, ISO 10940. Specifically, light hazard compliance with ISO 15004-1 and ISO 15004-2, and voluntary ISO 12866.
Equivalence to Predicate	Performs "as well as" the predicate device (MP-1 MICROPERIMETER). Minor differences (automatic alignment/focusing, broader background/stimulus luminance ranges) do not raise new safety or efficacy issues.
Intended Use/Indications	Does not affect the intended use or indications for use (Color retinography, Fixation examiner, Fundus-related microperimetry).
Fundamental Scientific Technology	Does not alter the fundamental scientific technology.

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

The document refers to "bench testing" and "all necessary safety tests" and "all the necessary performance tests." It does not specify a sample size, test set, or data provenance (e.g., country of origin, retrospective/prospective clinical data). This suggests that the testing was likely internal engineering and quality assurance testing rather than a clinical study with human subjects.

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

This information is not provided. Given that the testing mentioned is primarily "bench testing" and "functional specifications," it's unlikely that external experts were involved in establishing "ground truth" in a clinical sense.

4. Adjudication method for the test set

This information is not provided.

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

There is no indication of an MRMC comparative effectiveness study, AI assistance, or human reader improvement in the provided text. The device described does not appear to be an AI-driven diagnostic aid that would typically involve such a study design. It's a diagnostic instrument for acquiring images and microperimetry data.

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

This concept is not applicable to the device described. The Microperimeter MP-3 is an instrument operated directly by a human. The "automatic alignment and focusing" mentioned are features of the device's operation, not a standalone AI algorithm generating interpretations.

7. The type of ground truth used

The concept of "ground truth" in a clinical diagnostic sense (e.g., pathology, outcomes data) is not explicitly addressed. The testing focused on verifying the device's functional integrity, compliance with technical standards, and performance against its own specifications and the predicate device's established performance. For example, light hazard compliance would be against ISO standards, and image acquisition would be verified against internal specifications for image quality.

8. The sample size for the training set

This information is not applicable as the device is not described as having an AI component 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 reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

June 6. 2016

Nidek Co., Ltd. % Enrico Bisson Regulatory Affairs Manager Nidek Technologies Srl Via Dell' Artigianato, 6/a Albignasego (Padova), 35020 IT

Re: K152729

Trade/Device Name: Microperimeter MP-3 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI, HPT Dated: April 19, 2016 Received: May 3, 2016

Dear Mr. Bisson:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 yours,

Denise L. Hampton -S

for Malvina 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name MP-3 MICROPERIMETER

Indications for Use (Describe) MP-3 MICROPERIMETER is indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect. of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of a sourser any information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

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14:33:30

Page 1 of 1

PSC Publishing Services (301) 443-6740 E

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Image /page/3/Picture/0 description: The image shows the logo for NIDEK, a company that specializes in eye care products. The logo features a stylized eye in a blue box, with the word "NIDEK" printed in bold, sans-serif font below the eye. The eye is white with a blue outline, and the pupil is represented by a white circle. The overall design is simple and modern, conveying a sense of trust and expertise in the field of ophthalmology.

Image /page/3/Picture/1 description: The image shows the text "NIDEK CO., LTD." in bold, followed by the address "34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan" in a smaller font size. The text appears to be a company name and address. The text is left-aligned and the background is a light color.

TEL +81-533-67-6611
FAX +81-533-67-6610
URL http://www.nidek.co.jp

This summary of the 510(k) premarket notification for the Microperimeter MP-3is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

510(k) Notification

GENERAL INFORMATION

Applicant:

NIDEK CO., LTD. 34-14 Maehama, Hiroishi Gamagori, Aichi, 443-0038 Japan

Contact Person:	Yoneji Mizuno
Contact Title:	Corporate Officer and Senior Manager, Regulatory
	Affairs Department
Contact Phone Number:	+81-533-67-8901
Contact Fax Number:	+81-533-67-6628
E-mail:	yoneji_mizuno@nidek.co.jp.

Official Correspondent:	Enrico Bisson
Contact Title:	Manager, Regulatory Affairs Department
	Nidek Technologies Srl
	Via dell'Artigianato, 6/A,
	35020 Albignasego (Padova) , Italy
Contact Phone Number:	+39-049 8629200
Contact Fax Number:	+39-049 8626824
E-mail:	enricobisson@nidektechnologies.it

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Image /page/4/Picture/0 description: The image shows the logo for NIDEK. The logo consists of a blue eye symbol above the word "NIDEK" in blue, block letters. To the right of the logo are the words "34-14, Mae" and "Manufacturer" in a smaller, sans-serif font.

TEL	+81-533-67-6611
-----	-----------------

FAX +81-533-67-6610

http://www.nidek.co.jp
http://www.nidek.com

Date Prepared: September 4, 2015

Classification: 21 CFR§ 886.1120, Class II - 21 CFR§ 886.1605 , Class I

Classification name:

Camera, Ophthalmic, AC-Powered Perimeter, Automatic, AC-Powered

Product Code: HKI. HPT

Trade Name: Microperimeter MP-3

Generic/Common Name: MICROPERIMETER

Predicate Device MP-1 MICROPERIMETER (K023719) Nidek Technologies Srl

Indications for use

The Microperimeter MP-3is indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry

Product Description

The Microperimeter MP-3performs the following basic functions:

Color retinography Fixation examiner Fundus-related microperimetry

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Image /page/5/Picture/0 description: The image shows the logo for NIDEK, a company that specializes in eye care products. The logo features a stylized eye in a blue square. The word "NIDEK" is printed in bold, sans-serif font below the eye. The logo is simple and modern, and the blue color is associated with trust and reliability.

34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
Manufacturers, Exporters & Importers of Ophthalmic Instruments, and Opto-Electronics Instrumen

TEL +81-533-67-6611
FAX +81-533-67-6610
URL http://www.nidek.co.jp
http://www.nidek.com

Color retinography

This function allows a 45° image of the efthe eye fundus to be acquired without the need for a mydriatic agent. Auto alignment is performed while observing on the LCD, the front of the patient's eve illuminated by the eve front illumination LED (infrared light). After the alignment is roughly complete, the mode automatically changes to the fundus observation mode. The fundus of the patient's eye is illuminated by the fundus illumination LED (infrared light). After alignment and focusing are automatically performed on the fundus, white light from the xenon flash lamp is emitted on the fundus. The light reflected from the fundus is captured by the built-in color CCD camera for fundus image capture.

Fixation examiner

This function allows recording of the patient's fixation position changes in time and plotting of them onto a stable retinal image, acquired at the beginning of the exam. It is therefore an accurate survey of the stability of fixation itself.

Fundus-related microperimetry

This function allows a visual sensitivity mapping that can be displayed using static perimetry principle. Stimuli and a fixation target are displayed by the built-in LCD projector. While focusing on the fixation target, the patient presses the response button to indicate that they saw a stimulus projected at the location and light intensity specified by the internal measurement program or the operator. The patient's response signals are computed by the device and measurement results are displayed on the LCD.

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Image /page/6/Picture/0 description: The image contains the logo for NIDEK. The logo consists of a blue square with a stylized eye inside, and the word "NIDEK" printed below the eye. To the right of the logo is the word "NIDEK" in large, bold letters. Below the word "NIDEK" is the address "34-14, Maehama" and the text "Manufacturers, Exporters".

Gamagori, Aichi 443-0038, Japan
ers of Ophthalmic Instruments, and Opto-Electronics Instruments

Substantial Equivalence

The Microperimeter MP-3is substantially equivalent to the predicate device with regard to design, function, technological characteristics, intended use and performance characteristics.

The differences between the proposed and predicate device and justifications as to why these differences do not raise safety or efficacy concerns are as follows.

Differences in Color retinography

The subject device may perform alignment and focusing automatically, while the predicate device performs the same operation only manually.

Differences in Fixation examiner

The subject device may perform alignment and focusing automatically, while the predicate device performs the same operation only manually. The exam is performed in the same way, but the subject device has improved the result display.

Differences in Fundus-related microperimetry

The subject device may perform alignment and focusing automatically, while the predicate device performs the same operation only manually.

The background luminance can be set at 31.4 asb or 4 asb, while the predicate device allowed only 4 asb. The maximum stimulus luminance is 10,031.4asb, while the predicate device allows only 404asb. These larger ranges don't raise any safety issue.Compliances with both the light hazard recognized standards ISO 15004-1 and ISO 15004-2, and voluntary ISO 12866 standards are documented in Appendix 2.8 and 2.9.

The design modifications outlined in this Special 510(k) premarket notification do not (1) affect the intended use or the indication for use or (2) alter the fundamental scientific technology of the device. The proposed Microperimeter MP-3shares the equivalent indications for use, the same technological characteristics and the same principle of operation as the predicate devices. Therefore, based on the similarities between the devices, the

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Image /page/7/Picture/0 description: The image shows the logo for NIDEK. The logo features a stylized eye graphic in blue, with the word "NIDEK" printed below it in a sans-serif font. To the right of the logo are the numbers "34-14" and the word "Manufacturing".

i-cho, Gamagori, Aichi 443-0038, Japan
Importers of Ophthalmic Instruments, and Opto-Electronics Instruments

proposedMicroperimeter MP-3 is substantially equivalent to MP-1MICRO PERIMETER (K 023719).

Testing in Support of Substantial Equivalence Determination

We have verified and validated that the Microperimeter MP-3meets its functional specifications and performance requirements, and complies with applicable international standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2,ISO 12866, ISO 10940).

As mentioned, all necessary bench testing was conducted on the modifications, the addition of the proposed Microperimeter MP-3, to support a determination of substantial equivalence to the predicate device.

Summary of Safety and Effectiveness

All the necessary safety tests were performed and documented. The results demonstrate that the subject device complies with applicable international standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2,ISO 12866, ISO 10940) and it is safe as the predicate device. All the necessary performance tests in support of substantial equivalence determination were conducted. The tests demonstrate that the subject device is effective and performs as well as the predicate device. The minor differences between the devices do not raise any new issues of safety or efficacy.

Thus the proposed Microperimeter MP-3 is substantially equivalent to the predicate device.

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.