The Non-Mydriatic Retinal Camera TRC-NW8F plus is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without the use of a mydriatic.

Device Description

The Topcon TRC-NW8F plus is a fundus camera designed to observe, photograph and record the fundus oculi of a patient's eye with or without the use of a mydriatic. The TRC-NW8F plus does not come into contact with the patient's eye and provides the fundus oculi image information as an electronic image for later analysis. The TRC-NW8F plus performs color photography, fluorescein fundus angiography and Autofluorescence (FAF) photography. This product is equipped with an observation monitor used for observation purposes and display of a photographed images. The TRC-NW8F plus uses an attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A built in digital camera is used for taking autofluorescence images. The TRC-NW8F plus is only to be used with the Nikon D7000 digital camera.

A photographed image may be recorded on a commercial memory card built into a commercial digital single-lens reflex camera, a personal computer or commercial memory device (flash memories, hard disc, etc.). A commercial digital printer is connected and can print the observed images and the photographed images of the fundus.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the Topcon Non-Mydriatic Retinal Camera TRC-NW8F plus. The clearance is based on demonstrating substantial equivalence to predicate devices (TRC-NW8F and TRC-50DX). The performance data primarily focuses on image quality comparison rather than clinical diagnostic accuracy against a disease state.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative, pass/fail manner for clinical performance in this document. Instead, the study's acceptance is based on demonstrating that image quality from the TRC-NW8F plus is "either equivalent or similar" to its predicate devices.

Acceptance Criteria Category	Specific Criteria (Implicitly Derived)	Reported Device Performance
Image Quality (Model Eye)	Sharpness, image focus, and chart readings comparable to predicate devices.	"model eye images from the TRC-NW8F plus and from the predicate device were either equivalent or similar in terms of sharpness, image focus and chart readings."
Image Quality (Clinical)	Clinical image quality comparable to predicate devices.	"The results from the grading of clinical images from the TRC-NW8F plus were either equivalent or were similar for the predicate devices."
Autofluorescence Imaging	Image grading results for autofluorescence images comparable to TRC-50DX.	"The image grading results of autofluorescence images show that the TRC-NW8F plus is equivalent to the TRC-50DX for autofluorescence imaging."
Safety and Effectiveness	New device is as safe and effective as predicate devices.	"Performance data demonstrates that the TRC-NW8F plus is as safe and effective as the TRC-NW8F."

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

Test Set Sample Size: Not explicitly stated. The document refers to "an analysis... of images captured" and "grading of clinical images," but does not provide specific numbers of images or patients.
Data Provenance: Not explicitly stated. There is no mention of the country of origin or whether the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated. The document refers to an "analysis" and "grading," implying human review, but does not quantify the number of experts.
Qualifications of Experts: Not explicitly stated. There is no mention of the background or experience of the individuals who performed the image evaluation/grading.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The document simply states "formally evaluated" and "grading," without detailing if consensus, majority vote, or other adjudication methods were used.

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

Was an MRMC study done? No. This type of study would compare human reader performance with and without the AI device's assistance in diagnosing conditions. This submission focuses on the camera's image quality compared to predicate devices, not on diagnostic aid.
Effect size of improvement: N/A, as an MRMC study was not performed.

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

Was a standalone study done? No. The device itself is an ophthalmic camera. The "performance data" discussed relates to the quality of the images it captures, not an automated diagnostic algorithm. There is no mention of an AI algorithm within this device in the context of standalone diagnostic performance.

7. Type of Ground Truth Used

"Ground Truth" for Image Quality: The "ground truth" in this context is implicitly the comparator predicate devices' image quality. The study aimed to show the new device's images were "equivalent or similar" to images from established predicate devices in terms of sharpness, focus, and clinical grading. For "model eye images," the ground truth would be the known properties of the model eye and the expected output for a well-functioning camera. For "clinical images," the "ground truth" for the grading is based on expert visual assessment and comparison to predicate device images. This is not a clinical diagnostic ground truth (e.g., pathology confirmed disease, long-term outcomes), but rather an image quality assessment ground truth.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a retinal camera, not an AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) system that would typically have a "training set" for an algorithm. The "TRC-NW8F plus" is a hardware device for capturing images.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no mention of a training set for an AI algorithm.

Summary

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

October 23, 2014

Topcon Corp. % Ms. Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864

Re: K141325

Trade/Device Name: Trc-nw8f Plus Non-mydriatic Retinal Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: September 11, 2014 Received: September 12, 2014

Dear Ms. O'Connell,

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.

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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 devicerelated 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 yours.

Kesia Y. Alexander -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) K141325

Device Name NON-MYDRIATIC RETINAL CAMERA TRC-NW8F plus

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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510(k) SUMMARY

Non-Mydriatic Retinal Camera TRC-NW8F plus

510(k) Owner

Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174-8580 Phone: (201) 599-5553 Facsimile: (201) 599-5240 Contact Person: Michael Gusel

510(k) Submitter:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541

Date Prepared: September 11, 2014

Name of Device

Non-Mydriatic Retinal Camera TRC-NW8F plus

Common or Usual Name Retinal Camera

Classification Name

Camera, Ophthalmic, AC-Powered 21 C.F.R. 886.1120 Product Code: HKI

Predicate Devices

Non-Mydriatic Retinal Camera TRC-NW8F (K100207) Retinal Camera TRC-50DX (K123101)

Indcations for Use

The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F plus is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without use of a mydriatic.

Technological Characteristics

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image information as an electronic image for later analysis. The TRC-NW8F plus performs color photography, fluorescein fundus angiography and Autofluorescence (FAF) photography. This product is equipped with an observation monitor used for observation purposes and display of a photographed images. The TRC-NW8F plus uses an attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A built in digital camera is used for taking autofluorescence images. The TRC-NW8F plus is only to be used with the Nikon D7000 digital camera.

Performance Data

The TRC-NW8F plus has been tested and found in compliance with the following recognized consensus standards:

AAMI ANSI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance;

IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance: Collateral Standard: Electromagnetic Capability - Requirements and Tests:

ISO 15004-1:2006 Ophthalmic instruments – Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments;

ISO 15004-2:2007 Ophthalmic Instruments – Fundamental requirements and test methods - Part 2: Light hazard protection;

ISO 10940: 2009 Ophthalmic instruments - Fundus cameras

An analysis was performed of images captured with the TRC-NW8F plus and the predicate device which were formally evaluated and it was found that model eye images from the TRC-NW8F plus and from the predicate device were either equivalent or similar in terms of sharpness, image focus and chart readings. The results from the grading of clinical images from the TRC-NW8F plus were either equivalent or were similar for the predicate devices. This study demonstrated that the TRC-NW8F plus with a digital cameras and imaging mode is substantially equivalent to the predicate devices.

Substantial Equivalence

The TRC-NW8F plus has the same intended use and indications for use, and similar technological characteristics and principles of operation as the TRC-NW8F and the TRC-50DX. Although there are minor differences between the TRC-NW8F plus and the predicate devices, those differences do not raise new questions of safety or efficacy. Thus,

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the TRC-NW8F plus is substantially equivalent. Performance data demonstrates that the TRC-NW8F plus is as safe and effective as the TRC-NW8F. The image grading results of autofluorescence images show that the TRC-NW8F plus is equivalent to the TRC-50DX for autofluorescence imaging. Thus, the TRC-NW8F plus is substantially equivalent to its predicate devices.

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.