(202 days)
- General ophthalmic imaging including retinal, corneal, and external imaging. .
- Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). ♥
- Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or Zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.
The RetCam 3 Ophthalmic Imaging System utilizes a digital camera in a handpiece with multiple field of view lenses to capture color ophthalmic digital images including retinal, corneal, and external images. An on board computer is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used to provide illumination to the eye through the handpiece. An optional Xenon light source is also available with the RetCam 3 to facilitate imaging with fluorescein angiography. Light intensity, camera focus, and image capture are controlled by the use of a RetCam 3 footswitch and can also be controlled by a keyboard on the RetCam 3 consoles. A console monitor is provided with the RetCam 3 for viewing images. Proprietary software is installed in the computer to capture, store, view, retrieve, and export ophthalmic images.
A device modification to the RetCam 3 is being made to replace the Xenon light source module with an LED light source module. Third party testing has been performed and formal certification has been obtained verifying compliance with the applicable IEC 60601 electrical safety and electromagnetic compatibility standards. Bench testing has verified comparable safe maximum light irradiance output of the Xenon and LED light source modules. Bench testing has verified comparable fluoresce dye responses to the Xenon and LED light sources.
This document describes the RetCam 3 Ophthalmic Imaging System, and a modification to replace its Xenon light source with an LED light source. The provided text primarily focuses on clinical performance data for screening Retinopathy of Prematurity (ROP) using the RetCam system, which supports the overall indication for use.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of numerical sensitivity and specificity targets. Instead, it presents the results of a clinical study and concludes that these results support the device's indications for use. For the purpose of this response, we'll infer the reported performance as the de-facto "met" criteria. The study aimed to measure the accuracy, reliability, and image quality of RetCam wide-field digital images to screen for ROP.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Grader A) | Reported Device Performance (Grader B) | Reported Device Performance (Grader C) |
|---|---|---|---|---|
| Sensitivity (for Type 2 Pre-threshold ROP or worse) | High sensitivity (to avoid missing cases) | 1.0 (26/26) (95% CI: 0.868, 1.0) | 1.0 (26/26) (95% CI: 0.868, 1.0) | 1.0 (26/26) (95% CI: 0.868, 1.0) |
| Specificity (for Type 2 Pre-threshold ROP or worse) | Reasonable specificity (to limit false positives) | 0.883 (83/94) (95% CI: 0.802, 0.933) | 0.851 (80/94) (95% CI: 0.765, 0.909) | 0.851 (80/94) (95% CI: 0.765, 0.909) |
| Image Quality (adequate or possibly adequate) | High percentage of adequate images | 93.3% to 100% | 93.3% to 100% | 93.3% to 100% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Eyes from 67 consecutive infants. The total number of eyes is not explicitly stated but implies 134 eyes if both eyes were imaged and analyzed per infant. However, the sensitivity and specificity values are based on 26 positive cases for ROP and 94 negative cases, suggesting a total of 120 cases (eyes or infants) for the ROP diagnosis evaluation. The document states "31 to 33 weeks and/or 35 to 37 weeks postmenstrual age (PMA)".
- Data Provenance: The study was a prospective trial. The geographical origin of the data is not explicitly stated, but the study was conducted by "Chiang, et. al." and published in "Archives of Ophthalmology," which suggests it's likely from a US-based medical institution, common for such publications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts for Device Interpretation: Three (3) expert retinal specialist graders interpreted the images. Their specific qualifications (e.g., years of experience) are not detailed beyond "expert retinal specialist graders."
- Number of Experts for Ground Truth: The reference standard (ground truth) was established by experienced pediatric ophthalmologists using binocular indirect ophthalmoscopy (BIO). The exact number of these ophthalmologists is not specified.
4. Adjudication Method for the Test Set
The document states, "Images were interpreted by three expert retinal specialist graders who provided a diagnosis and evaluation of image quality. Findings were compared with a reference standard of binocular indirect ophthalmoscopy (BIO) by experienced pediatric ophthalmologists."
This implies that each of the three graders interpreted the images independently. There is no mention of a consensus or adjudication process among the image graders for their reported performance. Their individual performances are presented. The "ground truth" was established separately by BIO.
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 Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study with AI: The study described is not an MRMC study comparing human readers with and without AI assistance. It focuses on the diagnostic accuracy of human readers interpreting images acquired by the RetCam system compared to a clinical gold standard (BIO). The device is an imaging system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No Standalone Algorithm Performance: The device being evaluated is an imaging system, not an AI algorithm. The performance reported is that of human experts interpreting images generated by the device. Therefore, no standalone algorithm performance was conducted.
7. The Type of Ground Truth Used
- The ground truth used was expert clinical diagnosis by experienced pediatric ophthalmologists using binocular indirect ophthalmoscopy (BIO). This is a recognized gold standard for ROP diagnosis.
8. The Sample Size for the Training Set
- The document does not describe a training set for an AI algorithm. The study is a prospective trial evaluating the diagnostic performance of human interpreters using the RetCam imaging system.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of an AI algorithm or a training set, the establishment of ground truth for a training set is not applicable to this document.
§ 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.