TRC-50DX RETINAL CAMERA

• K Number: K123101
• Device Name: TRC-50DX RETINAL CAMERA
• Manufacturer: TOPCON MEDICAL SYSTEMS, INC.
• Date Cleared: 2013-06-05 ( 244 days)
• Product Code: HKI
• Regulation Number: 886.1120
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: K090115 , K092565

Intended Use

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

1. 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.

2. 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."

3. 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.

4. 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.

5. 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.

6. 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).

7. 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.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as no AI model training was involved.

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.