The MICROPERIMETER MP-3 and MICROPERIMETER MP-3 Type S are indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry Visual rehabilitation

Device Description

The modified NIDEK Microperimeter MP-3 type S measure the visual sensitivity of a specified area on the fundus and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundusimage-correlated evaluation. With reference to the Microperimeter MP-3, cleared with K152729, a rehabilitation function and the capability to performs exams in scotopic environments (only MP-3 type S) have been added.

Visual sensitivity mapping function
Visual sensitivity mapping 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 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.

Fixation function
The MicroperimeterMP-3 can measure fixation and determine the preferred retinal locus, simply by having the patient fixate on a target. Any change in fixation can be compared pre- and post-treatment because the patiently tracked during microperimetry.

Fundus photography function
Auto alignment is performed while observing on the LCD, the front of the patient's eye 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 illumination LED (infrared light). After alignment and focusing are automatically performed on the fight 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.

Visual rehabilitation
Visual rehabilitation is a collective name of Fundus-related microperimetry, Feedback exam, They are used to support the fixation training for patient.
Feedback exam: similar function with the Fixation exam. The same as those in Fixation exam, Feedback exam, and Fixation exam, and differ only in the following characteristics: in the Feedback exam, a sound is heard and the appearance of the fixation target changes when the patient's vision inside the circle specified by the operator (TRL Trained[tarqet] Retinal Locus, which the patient cannot see).

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria for performance, nor does it describe a study that explicitly proves the device meets such criteria with quantitative results.

Instead, the document primarily focuses on regulatory approval (510(k) summary) and establishes substantial equivalence to a predicate device. It states that the device has undergone non-clinical testing to verify its functions and performance requirements and compliance with applicable international standards. However, it does not provide the specific performance metrics (e.g., sensitivity, specificity, accuracy) that would constitute "acceptance criteria" in the context of diagnostic device validation.

Here's a breakdown of what is and isn't present, addressing your numbered points:

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

Not provided. The document states that "performance tests... demonstrate that the subject device is effective and performs as well as the predicate device" but does not define specific acceptance criteria (e.g., minimum accuracy percentages, sensitivity/specificity thresholds) or report quantitative performance metrics for the device or its predicate.

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

Not provided. The document mentions "non-clinical testing" but does not describe a clinical test set, its sample size, or data 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/Not provided. Since no clinical test set or diagnostic efficacy study is detailed, there's no mention of experts establishing ground truth for such a test.

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

Not applicable/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

Not applicable/Not provided. This document does not describe AI assistance or MRMC studies. The device itself is a Microperimeter and Ophthalmic Camera, not an AI-driven diagnostic system in the sense of assisting human readers.

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

Not applicable/Not provided in the context of diagnostic performance. The device is a diagnostic tool, and its "standalone" performance would likely refer to its ability to measure visual sensitivity and capture images, which are assessed through engineering and design validation, not typically through standalone diagnostic accuracy studies described in this type of summary.

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

Not provided/Not explicitly applicable. For a device acting as a measurement tool (microperimeter) and an imaging device (ophthalmic camera), ground truth during its development and validation would primarily relate to the accuracy of its measurements against known standards or the fidelity of its image capture. The document states "We have verified and validated that the Microperimeter MP-3 meets its functions and performance requirements," implying internal validation against engineering specifications and applicable standards, but not a "ground truth" derived from clinical diagnostic outcomes.

8. The sample size for the training set

Not applicable/Not provided. The device is not described as an AI/machine learning system that requires a "training set."

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

Not applicable/Not provided.

Summary of what is present regarding "acceptance criteria" and "study":

The core of the documentation provided is a 510(k) Summary for a medical device (Microperimeter MP-3, Microperimeter MP-3 Type S). A 510(k) submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific clinical acceptance criteria in the same way a PMA (Premarket Approval) would require.

Acceptance Criteria (Implied): The implied acceptance criteria are that the device performs "as well as the predicate device" and complies with relevant international standards.
- "Effective and performs as well as the predicate device." (from section "Non-Clinical and/or Clinical Tests Summary & Conclusions").
- Compliance with international standards: IEC 60601-1-2, ISO 15004-1, ANSI Z80.36, ISO 12866, ISO 10940, IEC 62366-1, and IEC 62304 (for software). These standards address safety, performance, and usability aspects. The document states, "The results demonstrate that the subject device complies with applicable international standards... and it is safe as the predicate device."
Study Proving Acceptance Criteria: The "study" mentioned is non-clinical testing (bench testing, software verification and validation).
- Type of Study: Non-clinical testing, including bench testing and software verification and validation.
- Purpose: To "verify and validate that the Microperimeter MP-3 meets its functions and performance requirements, and complies with applicable international standards."
- Clinical Data: The document explicitly states "Clinical Summary: Not Applicable," indicating no new clinical studies were conducted for this 510(k) submission to demonstrate performance in a patient population. Substantial equivalence relies on the known performance and safety profile of the predicate device and the demonstration that the new device's differences do not raise new questions of safety or efficacy.

Summary

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April 1, 2019

Nidek Co., Ltd % Enrico Bisson Manager, Regualatory Affairs Department Nidek Technologies Srl Via dell'Artigianato, 6/A Albignasego, 35020 It

Re: K190198

Trade/Device Name: Microperimeter MP-3, Microperimeter MP-3 Type S Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI, HPT Dated: January 29, 2019 Received: February 4, 2019

Dear Enrico 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. 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/cfdocs/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours, Alexander 2019.04.01 12:21:16 -04'00' Bevlin -S 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) K190198

Device Name

Microperimeter MP-3, Microperimeter MP-3 Type S

Indications for Use (Describe) The MICROPERIMETER MP-3 and MICROPERIMETER MP-3 Type S are indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry Visual rehabilitation

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Preparation Date: 3/20/2019

Contact Details			21 CFR 807.92(a)(1)
Applicant Name	NIDEK CO., LTD.
Applicant Address	34-14 Maehama, Hiroishi-cho Gamagori, AICHI, 443-0038, JA
Applicant Telephone Number	011-815-33678901
Applicant Contact	Mr. Mizuno Yoneji
Applicant Contact Email	Yoneji_Mizuno@nidek.co.jp
Correspondent Name	Nidek Technologies srl
Correspondent Address	Via dell'Artigianato, 6/A, Albignasego, Padova, 35020, IT
Correspondent Telephone Number	003-932-86439091
Correspondent Contact	Mr. Enrico Bisson
Correspondent Contact Email	enricobisson@nidektechnologies.it
Device Name			21 CFR 807.92(a)(2)
Device Trade Name	Microperimeter MP-3
Common Name	OPTHALMIC CAMERA.
Classification Name	CAMERA, OPHTHALMIC, AC-POWERED; PERIMETER, AUTOMATIC, AC-POWERED
Regulation Number	886.1120
Product Code	HKI; HPT
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate (510(k)) #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K061768	MP-1 MICRO PERIMETER	HKI
K152729	Microperimeter MP-3	HKI
Device Description Summary			21 CFR 807.92(a)(4)

Visual sensitivity mapping function

Visual sensitivity mapping 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 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.

Fixation function

The MicroperimeterMP-3 can measure fixation and determine the preferred retinal locus, simply by having the patient fixate on a target. Any change in fixation can be compared pre- and post-treatment because the patiently tracked during microperimetry.

Fundus photography function

Auto alignment is performed while observing on the LCD, the front of the patient's eye 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 illumination LED (infrared light). After alignment and focusing are automatically performed on the fight 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.

Visual rehabilitation

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Preparation Date: 3/20/2019

510(k) Summary

Visual rehabilitation is a collective name of Fundus-related microperimetry, Feedback exam, They are used to support the fixation training for patient.

Feedback exam: similar function with the Fixation exam. The same as those in Fixation exam, Feedback exam, and Fixation exam, and differ only in the following characteristics: in the Feedback exam, a sound is heard and the appearance of the fixation target changes when the patient's vision inside the circle specified by the operator (TRL Trained[tarqet] Retinal Locus, which the patient cannot see).

Intended Use/Indications for Use

The MICROPERIMETER MP-3 and MICROPERIMETER MP-3 Type S are indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry

Visual rehabilitation

Indications for Use Comparison

The indications for use are identical.

Technological Comparison

The Microperimeter MP-3 and MP-3 Type S are 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 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 0.003 asb (Type S), while the predicate device allowed only 4 asb. The minimum stimulus luminance is 4.4 asb (4 asb - white - 34 dB mode) and 35.4 asb (31.4 asb white on white 34 dB mode) and for Type S 0.0042 asb (0.003 asb - white on white - 24 dB mode), while the predicate device allows only 8 asb. The maximum stimulus luminance is 10,031.4 asb, while the predicate device allows only 404 asb.

These larger ranges don't raise any safety issue. Compliances with both the light hazard recognized standards ISO 15004-1 and ANSI Z80.36, and voluntary ISO 12866 standards are documented.

Differences in Visual Rehabilitation

In the predicate device the bio-feedback audible signal consists of an internitting sound, with frequency increasing the doser the new PRL is to (center of) the central target until a continuous sound is heard. The subject device allows both continuous sound and music when the exam is successfully completed.

The subject device allows user to change the position of the Stimulation Pattern, while the predicate doesn't allow. The design modifications outlined in this Traditional 510(k) premarket notification do not (1) affect the intendication for use or (2) alter the fundamental scientific technology of the device. The proposed Microperimeter MP-3 and MP-3 Type S share 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 proposed Microperimeter MP-3 is substantially equivalent to MP-1MICRO PERIMETER (K061768) .

Testing in Support of Substantial Equivalence Determination

We have verified and validated that the Micropermeter MP-3 and MP-3 Type S meet its functions and performance requirements, and complies with applicable international standards (IEC 60601-1-2, ISO 15004-1, ANSI Z80.36, ISO 12866, ISO 10940).

As mentioned, all necessary bench testing was conducted on the addition of the proposed Microperimeter MP-3 and MP-3 Type S, 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 60601-1-2, ISO 15004-1, ANSI Z80.36, ISO 12866, ISO 10940) and it is safe as the predicate device.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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510(k) Summary

Preparation Date: 3/20/2019

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 and MP-3 Type S are substantially equivalent to the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Non-Clinical Summary:

We have verified and validated that the Microperimeter MP-3 meets its functions and performance requirements, and complies with applicable international standards ISO 15004-1, ANSI Z80.36, ISO 10940, ISO 12866, IEC 62366-1. Software verification and validation were performed according to the internal Software Design and Development Procedure in compliance with IEC 62304. The software of this device was considered as a "Moderate" level of concern based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued on: May 11, 2005.

Clinical Summary: Not Applicable

Conclusions:

All the necessary safety tests were performed and documented. The results device complies with applicable international standards ISO 15004-1, ANSI Z80.36, ISO 10940, ISO 12866, IEC 62366-1 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.

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.