(156 days)
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.
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.
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.
§ 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.