(89 days)
The TRC-NW300 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 the use of a mydriatic.
The Topcon TRC-NW300 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-NW300 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-NW300 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 commercially available memory card inserted in the memory card slot of the TRC-NW300, to a commercially available image filing system, or on a commercially available storage device (such as a flash memory, a hard disk or a card reader/writer) connected to the TRC-NW300. A photographed image may also be printed on a commercially available digital printer connected to the TRC-NW300.
The provided 510(k) summary for the Topcon TRC-NW300 Non-Mydriatic Retinal Camera primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself.
Therefore, many of the requested details, particularly regarding specific numerical performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for a diagnostic effectiveness study, are not explicitly present in the provided document. The document mainly highlights compliance with safety and electrical standards and modifications from previous models.
However, based on the information provided, here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, image quality scores) and corresponding reported device performance metrics in the way a diagnostic study would.
Instead, the performance data section states:
- "The TRC-NW300 has been tested and found in compliance with the following recognized consensus standards: IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2."
- "Additionally, design verification tests were performed as a result of the risk analysis assessment. These test results demonstrated that the TRC-NW300 met predetermined acceptance criteria."
The "acceptance criteria" here refer to meeting the requirements of these standards and the predetermined criteria of internal design verification tests, which are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The document does not describe a clinical performance study with a test set of images or patients for diagnostic accuracy. The "test results" refer to engineering design verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided. There is no mention of a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable/Not provided. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a retinal camera, not an AI diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
Not applicable/Not provided. The device is a retinal camera for image capture, not an AI algorithm for standalone diagnosis. The "performance data" refers to the camera's technical performance and safety compliance.
7. Type of Ground Truth Used
Not applicable/Not provided in the context of a diagnostic performance study. The ground truth for the device's functional integrity was established through compliance with recognized safety and performance standards (e.g., electrical safety, light hazard protection) and internal design verification against "predetermined acceptance criteria."
8. Sample Size for the Training Set
Not applicable/Not provided. The device is a camera, and there is no mention of a training set as would be used for a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or rather, the evidence provided to demonstrate that the TRC-NW300 meets its acceptance criteria, is based on:
- Compliance with Recognized Consensus Standards: The device was tested and found compliant with:
- IEC 60601-1: General Requirements for Safety of Medical Electrical Equipment.
- IEC 60601-1-2: Electromagnetic Compatibility.
- ISO 15004-1: General requirements applicable to all ophthalmic instruments.
- ISO 15004-2: Light hazard protection for ophthalmic instruments.
- Design Verification Tests: These tests were performed as a result of a risk analysis assessment. The document states that "These test results demonstrated that the TRC-NW300 met predetermined acceptance criteria." These are internal engineering and functional tests to ensure the device performs as designed and safely, especially considering the modifications from its predicate.
- Substantial Equivalence Argument: The core of the 510(k) submission is to argue that the TRC-NW300 is substantially equivalent to its predicate devices (TRC-NW200 and TRC-NW8F). This argument is based on the device having the "same intended use and similar indications, principles of operation, and technological characteristics." The modifications (e.g., higher megapixel camera, smaller pupil photography, auto-focus, automatic flash, USB memory card capability) were evaluated, and Topcon determined "they do not affect the safety or effectiveness of the device." Many of the new features were already cleared in the TRC-NW8F.
In essence, the "acceptance criteria" here are primarily functional, safety, and performance standards as an ophthalmologic imaging device, and the "proof" is through conformity to these standards and a comparison to previously cleared, substantially equivalent devices. The document does not describe a clinical study focused on diagnostic accuracy or reader performance.
§ 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.