(105 days)
The TRC-NW400 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, without use of a mydriatic.
The Topcon TRC-NW400 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-NW400 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-NW400 houses a color LCD monitor used for observation and display of a photographed image and a digital photography unit used for recording images. A photographed image may be recorded on a personal computer (hereinafter referred to as a PC), or on a commercially available storage device (such as a flash memory, a hard disk or a card reader/writer) connected to the TRC-NW400. A photographed image may also be printed on a commercially available digital printer connected to the TRC-NW400 or PC.
Patient information may be input on the control panel of the main unit or by using a commercially available data input device (for example: a bar code reader or a magnetic card reader) or PC.
The provided text describes a 510(k) premarket notification for the Topcon TRC-NW400 Non-Mydriatic Retinal Camera. This document is focused on demonstrating substantial equivalence to a predicate device, the TRC-NW300, rather than providing detailed acceptance criteria and a comprehensive study report for standalone device performance.
Therefore, much of the requested information regarding specific acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods is not explicitly detailed in this 510(k) summary. The document focuses on regulatory compliance and a comparative analysis.
Here's an attempt to extract and infer information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory standards and comparative study) | Reported Device Performance (TRC-NW400) |
|---|---|
| Compliance with IEC60601-1:2005 (Basic Safety & Essential Performance) | Compliant |
| Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility) | Compliant |
| Compliance with ISO 15004-1:2006 (General requirements for ophthalmic instruments) | Compliant |
| Compliance with ISO 15004-2:2007 (Light hazard protection) | Compliant |
| Compliance with ISO 10940:2009 (Fundus cameras) | Compliant |
| Image quality (sharpness, focus, resolution power) for model eye images | Equivalent to predicate device (TRC-NW300) |
| Image quality for clinical images | Equivalent to or better than predicate device (TRC-NW300) |
| Color imaging quality | Equivalent to predicate device (TRC-NW300) |
| Intended Use | Same as predicate device |
| Technological Characteristics | Similar to predicate device, minor differences do not raise new safety/effectiveness questions |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated. The document mentions "an analysis was performed of images captured with the TRC-NW400 and the predicate device which were formally evaluated" and "the grading of clinical images from the TRC-NW400." This implies a test set of images, but the number is not provided.
- Data provenance: Not explicitly stated. It refers to "model eye images" and "clinical images," but the country of origin or whether the study was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. It only states that images were "formally evaluated" and "graded."
4. Adjudication method for the test set
- This information is not provided in the document.
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
- No, an MRMC comparative effectiveness study involving human readers and AI assistance is not mentioned. The study described compares the TRC-NW400's image quality to that of a predicate device (TRC-NW300). The device itself (TRC-NW400) is a retinal camera, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the context of this device. The TRC-NW400 is a retinal camera that captures images for an eye care professional to interpret; it is not an algorithm that performs standalone diagnoses. The "performance data" presented relates to the technical image capture capabilities of the camera.
7. The type of ground truth used
- For "model eye images," the ground truth implicitly would be the known ideal conditions and characteristics of the model eye.
- For "clinical images," the "grading" suggests that expert assessment was used to determine image quality, though the specific 'ground truth' criteria (e.g., presence/absence of disease, image clarity ratings) and how it was established are not detailed.
8. The sample size for the training set
- This information is not provided. The document describes a comparison study, not the development of an algorithm that would typically require a training set.
9. How the ground truth for the training set was established
- This information is not applicable as no training set for an algorithm is mentioned.
§ 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.