(36 days)
The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.
The Annidis RHA2020U multi-spectral digital ophthalmoscope which presents eye care practitioners (optometrists and ophthalmologists) with a series of retinal spectral images from each eye of a patient. The images each have a spatial resolution of over four million pixels spread over a visual range of greater than 40 degrees. The instrument also captures an image of the iris and pupil.
The device is arranged in four major hardware subcomponents and one remote software component used for clinical visualization and tracking purposes. The four hardware components are listed below:
- The Optical Head Unit (OHU) contains the camera and the illuminating LEDs and is aligned to the eye of the sitting patient whose head is stabilized using a chin-rest and forehead brace. The OHU contains the optical and electrical systems required to capture images of the eye and the means to align the patient with the device.
- The Host Computer (HC), a Linux-based host computer that serves as the operator interface.
- The Universal Power Supply (UPS), a custom designed power supply receives A power from the AC mains and supplies power using low voltage DC to the host computer, the display, and the optical head unit (OHU).
- The Touch Screen Display, that displays information from the host computer, configures the optical head unit for patient comfort, visualizes the patient data and triggers image capture.
Below is an analysis of the provided text regarding the Annidis RHA2020-U multi-spectral digital ophthalmoscope, focusing on acceptance criteria and the study proving adherence to them.
Acceptance Criteria and Device Performance Study for the Annidis RHA2020-U Multi-spectral Digital Ophthalmoscope
The information provided describes the non-clinical performance summary for the Annidis RHA2020-U. The acceptance criteria are broadly defined as meeting functional specifications and performance requirements, with a direct comparison to predicate devices, focusing on image output comparability.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Specifications & Performance Requirements | The device (RHA2020-U) met its functional specifications and performance requirements, as detailed in the Product Requirements Specifications and confirmed by Performance Testing Reports and Performance Traceability Matrices. |
| Image Output Comparability to Predicate Devices | The digital images captured by the RHA2020-U were found to be "comparable" to the image output of two selected predicate devices. This conclusion was drawn by the Performance Test Investigator. |
| Compliance with Electrical Standards | The RHA Multi-Spectral Ophthalmoscope complies with IEC 60601-1, IEC 60601-1-1, UL 60601-1, CAN/CSA C22.2 No. 601.1-M90, and IEC 60950-1, indicating conformity with general safety for medical electrical equipment and information technology equipment. |
| Compliance with EMC Standards | The RHA Multi-Spectral Ophthalmoscope complies with IEC 60601-1-2, ensuring electromagnetic compatibility. |
| Compliance with Light Safety Standards | The RHA Multi-Spectral Ophthalmoscope complies with ISO 15004-2, addressing light hazard protection for ophthalmic instruments. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "digital images evaluated from digital scan output taken of non-mydriatic eyes of human subjects" and "digital images evaluated from digital scan output taken of mydriatic eyes of human subjects." However, the specific number of human subjects or images in the test set is not provided.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given Annidis Health Systems Corp. is based in Ottawa, Ontario, Canada, it is likely the data was sourced from Canada, but this isn't confirmed. The clinical data appears to be prospective, as it involves capturing new images from human subjects specifically for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document states that the "Performance Test Investigator" reviewed the direct comparison of images.
- The number of experts is not specified, and it appears to be a single "Investigator" who made the assessment.
- The qualifications of this "Performance Test Investigator" are not provided. The text does not mention if they are radiologists, ophthalmologists, or other specialists, nor does it indicate their years of experience.
4. Adjudication Method for the Test Set
- The document states that the "Performance Test Investigator" made the determination regarding image comparability.
- No formal adjudication method (e.g., 2+1, 3+1) is described. The assessment seems to rely on a single reviewer's judgment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned. The comparison was between the device's image output and that of predicate devices, assessed by a single investigator, not a study evaluating human reader performance with and without AI assistance.
- Therefore, no effect size for human readers improving with AI vs. without AI assistance is reported as this type of study was not conducted or reported. The RHA is an imaging device, not an AI-powered diagnostic aid that improves human interpretation directly.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The performance assessment focused on the device's ability to capture images comparable to predicate devices. It's a fundamental imaging device, not an AI algorithm performing diagnostic tasks in isolation.
- The comparison was a direct assessment of image output and functional performance. There was no standalone algorithm-only performance study in the context of diagnostic accuracy/performance. The "performance testing was conducted" on the software and firmware. This is likely an internal verification that the software performs its intended functions correctly, not an independent clinical standalone performance evaluation for diagnostic output.
7. Type of Ground Truth Used
- The "ground truth" for the test set was broadly defined as the comparability of digital images captured by the RHA2020-U to those captured by predicate devices. This comparability was evaluated by a "Performance Test Investigator."
- It is not pathology, outcomes data, or an expert consensus in the traditional sense of validating diagnostic accuracy against a definitive diagnosis. Instead, it is an assessment of technical image quality and equivalence to established devices.
8. Sample Size for the Training Set
- The document does not mention a training set or its sample size. The RHA2020-U is described as an ophthalmoscope that captures images, with its software providing "clinical visualization and tracking purposes." There is no indication of an AI model within the device that requires a training set for learning a diagnostic task. The "software and firmware" were subject to performance testing, which refers to verifying functional correctness rather than training a machine learning model.
9. How Ground Truth for the Training Set was Established
- As no training set is mentioned or implied for an AI model, this information is not applicable and not provided.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.