The TRC-50DX Retinal Camera 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.

Device Description

The Topcon TRC-50DX Retinal Camera is designed to observe, photograph and record the fundus oculi of a patient without coming into contact with the patient's eye and provide an electronic image of the fundus oculi information for subsequent diagnosis. The TRC-50DX is provided in several configurations based on the photography needs of the user.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Topcon TRC-50DX Retinal Camera, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "device must achieve a score of X or higher"). Instead, it describes a comparative study where the TRC-50DX's image quality was evaluated against predicate devices. The acceptance criterion is implicitly that the TRC-50DX's image quality is "similar to or better than" the predicate devices.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Image Quality	Image scores based on evaluation of: - Focus- Illumination- Field Definition- Artifact- Small Pupil Artifact- Media Opacity	"The study found the scores from the TRC-50DX images were similar to or better than the scores of the images from the predicate devices." (Predicate devices: Topcon TRC-NW7SF Mark II Retinal Camera and Canon CX-1)
Safety	Compliance with relevant safety standards (e.g., optical radiation, electrical safety)	"Software verification and validation, system performance testing, optical radiation safety hazard analysis (ISO 15004-1 and ISO 15004-2) and electrical safety and EMC testing (IEC 60601-1 and IEC 60601-1-2) have been performed to support the substantial equivalence of the TRC-50DX."
Substantial Equivalence	Same intended use, similar indications for use, technological characteristics, and principles of operation as predicate devices.	"The Topcon TRC-50DX Retinal Camera has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates. The Topcon TRC-50DX Retinal Camera is as safe and effective as its predicate devices, and thus, substantially equivalent."

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not specified. The document does not mention the country of origin or if the data was retrospective or prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not explicitly stated. The document mentions "a masked examiner."
- Qualifications of Experts: Not explicitly stated beyond "a masked examiner."
Adjudication Method:
- Not specified. The document only mentions that images were "evaluated and graded by a masked examiner." This implies a single grader, not an adjudication process involving multiple experts for discrepant cases.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No, an MRMC comparative effectiveness study, in the sense of comparing human readers' performance with and without AI assistance, was not performed. The study involved a human examiner grading images from different cameras, not evaluating the impact of an AI algorithm on human reading.
- Effect Size: Not applicable, as no such study was conducted.
Standalone Performance (Algorithm Only):
- Was it done? No. The TRC-50DX is a retinal camera (hardware device) for capturing images, not an AI algorithm for interpreting them. The performance testing focused on the image quality of the camera itself, as evaluated by a human.
Type of Ground Truth Used:
- Expert Consensus/Grading: The "ground truth" for image quality in this context was established through subjective grading by "a masked examiner" based on specific image quality factors (focus, illumination, field definition, artifact, small pupil artifact, and media opacity).
Sample Size for the Training Set:
- Not applicable. This device is a retinal camera (hardware), not an AI algorithm that requires a training set. The performance testing assessed the camera's ability to produce images, not the performance of a learned model.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as no AI model training was involved.

Summary

{0}------------------------------------------------

K123101

510(k) SUMMARY Topcon Medical Systems, Inc. TRC-50DX Retinal Camera

JUN 5 2013

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Topcon Medical Systems, Inc. 111 Bauer Drive Oakland, NJ 07436 Phone: (201) 599-5553 Facsimile: (201) 599-5240 Contact Person: Michael Gusel

Additional Correspondent:

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: May 29, 2013

Name of Device and Name/Address of Sponsor

Topcon TRC-50DX Retinal Camera Topcon Medical Systems, Inc. 111 Bauer Drive Oakland, NJ 07436

Common or Usual Name

Retinal Camera

Classification Name

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

{1}------------------------------------------------

Predicate Devices

Topcon TRC-NW7SF Mark II Retinal Camera (K090115) Canon CX1 (K092565)

Intended Use / Indications for Use

Technological Characteristics

Configuration	Digital Cameraattachment		Digital Camera Body			ImagingMode
			Nikon D90	PikeF-1100C	StingrayF-145B
1	Main Body	Lowermount		√		Color, RedFree, FA
2	Relay LensTL-211	Port1	√			Color, RedFree, FA
3	Main Body	Lowermount		√		Color
	Relay LensTL-209	Port1			√	Red Free,FA, AF
4	Relay LensTL-238D	Port1Port2	√		√	ColorRed Free,FA, AF

TRC-50DX

TRC-50DX Type IA

Configuration	Digital Cameraattachment		Digital Camera Body			ImagingMode
			Nikon D90	PikeF-1100C	StingrayF-145B
3 Type IA	Main Body	Lowermount		√		Color
3 Type IA	Relay LensTL-209	Port1			√	Red Free,FA, ICG,AF
4 Type IA	Relay LensTL-238D	Port1Port2	√			Color
4 Type IA					√	Red Free,FA, ICG,AF

The fundamental technical specifications of the Relay Lenses and Digital Cameras are shown in below.

{2}------------------------------------------------

Model	Type	Port and Mount		Size
TL-209	1 Port	Port 1	C Mount	85×140×236
TL-211	1 Port	Port 1	F Mount	85×140×236
TL-238D	2 Port	Port 1	F Mount	85×189×236
		Port 2	C Mount

Digital CameraBody	Specification
Nikon D90	APS-C size CMOS single-lens reflex digital camera (Color) 12.3M pixels
Allied	35mm CCD and single-plate digital camera (Color) 11M pixels
Pike F-100C
Allied	2/3 inch CCD single-plate digital camera (B/W) 1.4M pixels
Stingray F-145B

Performance Testing

Software verification and validation, system performance testing, optical radiation safety hazard analysis (ISO 15004-1 and ISO 15004-2) and electrical safety and EMC testing (IEC 60601-1 and IEC 60601-1-2) have been performed to support the substantial equivalence of the TRC-50DX. Additionally performance testing which compares image quality with the TRC-50DX to the Topcon TRC-NWSF MARK II and Canon CX-1 was performed. Images were evaluated and graded by a masked examiner based on the following image quality factors: focus, illumination, field definition, artifact, small pupil artifact and media opacity. The study found the scores from the TRC-50DX images were similar to or better than the scores of the images from the predicate devices.

Substantial Equivalence

The Topcon TRC-50DX Retinal Camera is as safe and effective as the identified predicate devices including the Topcon TRC-NW7SF Mark II Retinal Camera (K090115) and the Canon CX-1 (K092565). The Topcon TRC-50DX Retinal Camera has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates. The Topcon TRC-50DX Retinal Camera is as safe and effective as its predicate devices, and thus, substantially equivalent.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three overlapping human figures, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.

June 5, 2013

Public Health Service

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

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

Re: K123101

Trade/Device Name: TRC-50DX Retinal Camera Regulation Number: 21 CFR 886.1120 Regulation Name: AC-Powered Ophthalmic Camera · Regulatory Class: Class II Product Code: HKI Dated: May 29, 2013 Received: May 30, 2013

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.

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

{4}------------------------------------------------

Page 2 -- Ms. Maureen O'Connell

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K123101

Device Name: Topcon TRC-50DX Retinal Camera

Indications For Use:

The TRC-50DX Retinal Camera is intended for use in capturing images of the retina and anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic.

Prescription Use X (part 21 CFR 801 Subpart D)

AND/OR

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

... __________________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office_of_Device_Evaluation(ODE) ______________________________________________________________________________________________________________________

Image /page/5/Picture/10 description: The image shows the text "Ka N. To" on the top line. The second line of text reads "2013.06.05 10:33:06 -04'00'". There is a graphic in the middle of the two lines of text.

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:_ K123101

Page 1 of _ 1

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.