Search Results

The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT BluePeak) and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including agerelated macular degeneration, macular edema, diabetic retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include normative databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal paraments, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.

The SPECTRALIS HRA+OCT is a real-time imaging system of anterior and posterior segments of the human eye and for aiding in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma.

The device is a combination of optical coherence tomography (OCT) with confocal scanning laser ophthalmoscopy (cSLO). OCT imaging includes high-resolution cross-sectional imaging of ocular structures (e.g., retina, macula, optic nerve head); cSLO imaging includes high-resolution and dynamic infrared reflectance, blue reflectance, fluorescein angiography, indocyanine green angiography, and autofluorescence imaging. OCT images and cSLO images are acquired simultaneously and are viewed side-by-side on the computer screen. Images are acquired and stored using SPECTRALIS operation software, which runs on a standard personal computer. SPECTRALIS components include a laser scanning camera mount with headrest, operation panel, power supply box, operation software, and host computer. A MultiColor option is included to provide additional green reflectance imaging and a "composite color" image, which provides a different view of the features of the eye. This composite color image is not the same as fundus color photo. This submission includes Enhanced Depth Imaging (EDI) as an optional viewing mode that allows for better visualization of deep eye structures below the retina.

The provided document describes the SPECTRALIS HRA+OCT device and its updated version, focusing on software version 6.0. The acceptance criteria and the study proving the device meets them are primarily related to the precision and agreement of measurements of retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) neuroretinal rim width (BMO-MRW). The document establishes "within specified range" and "small and within expected ranges and below predefined thresholds" as acceptance criteria for precision and agreement, respectively.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative ("within the specified range," "small and within expected ranges and below predefined thresholds") rather than specific numerical thresholds presented in a table format. However, the study results, presented as coefficients of variation (CV) for precision and limits of agreement (LOA) for agreement, demonstrate that the device achieved these general criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision Study (Test Set):

  • Sample Size: 34 subjects enrolled, data from 32 subjects included in analysis (16 healthy eyes, 16 glaucomatous eyes), 16 left and 16 right eyes.
  • Data Provenance: Monocentric, prospective study. The specific country is not explicitly stated but the manufacturer is Heidelberg Engineering GmbH, suggesting Germany.

• Agreement Study (Test Set):

  • Sample Size: 48 subjects enrolled, data from 40 subjects included in analysis (20 healthy eyes, 20 glaucomatous eyes), 20 left and 20 right eyes.
  • Data Provenance: Monocentric, prospective study. The specific country is not explicitly stated but the manufacturer is Heidelberg Engineering GmbH, suggesting Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Precision Study: "Three qualified individuals, each operating one of three Spectralis devices equipped with the study software, performed the study device measurements." These could be the "experts" performing the measurements that form the basis of the precision analysis. Also, "All acquired images were inspected by three experienced physicians for image quality... and layer segmentation."

  • Number of Experts: 3 (for both operators and image inspection)
  • Qualifications: "Qualified individuals" for device operation; "experienced physicians" for image quality inspection. Specific years of experience or specialization (e.g., radiologist) are not provided.

• Agreement Study: "All acquired images were inspected by the investigator for image quality... and layer segmentation."

  • Number of Experts: 1 (the investigator).
  • Qualifications: "Investigator" who inspected for image quality. Specific qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth diagnoses for the test sets in either the precision or agreement studies. The "ground truth" for these studies is the measurement values themselves and their statistical consistency, rather than a diagnostic label. For image quality and layer segmentation, images were inspected by experts, but no multi-reader adjudication process is detailed beyond inspection.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The studies focus on the precision and agreement of the device's measurements compared to a predicate device and within itself.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an imaging system (OCT/cSLO) that performs measurements. The precision and agreement studies evaluate the measurement capabilities of the device (software version 6.0 with APS) in performing these measurements. These studies are essentially standalone evaluations of the device's measurement accuracy and consistency, as the "algorithm" here refers to the device's ability to acquire and process images to produce measurements. While operators ("qualified individuals") are involved in acquiring the images, the evaluation is of the device's output (measurements and their consistency), which is driven by its internal algorithms for processing. Therefore, the precision and agreement studies can be considered standalone performance assessments of the device's measurement functions.

7. The Type of Ground Truth Used

• Precision and Agreement Studies: The "ground truth" here is the measurement values themselves. These studies assess the device's ability to consistently reproduce measurements (precision) and agree with measurements obtained by a previous method/device (agreement). The reference ranges for "normal" are derived from large normative databases (see point 9).

8. The Sample Size for the Training Set

The document refers to "reference databases" which serve a similar purpose to a training set for normative comparisons.

• RNFL Thickness Reference Database: 330 eyes of 330 normal subjects.
• BMO-MRW Reference Database: 368 eyes of 368 normal subjects.

9. How the Ground Truth for the Training Set Was Established

The "ground truth" for the reference databases (training sets) was established by rigorously selecting "normal subjects" based on strict inclusion/exclusion criteria in prospective, multi-center, observational studies.

• Inclusion Criteria for Normal Subjects (RNFLT and BMO-MRW Databases):
  • Healthy eyes without prior intraocular surgery (except cataract surgery or Lasik).
  • No clinically significant vitreal, retinal, or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
  • No history of glaucoma.
  • Intraocular pressure ≤21 mmHg.
  • Best corrected visual acuity ≥0.5.
  • Refraction between +6 and -6 diopters, astigmatism ≤2 diopters.
  • Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.
  • Clinically normal appearance of optic disc with normal appearing neuroretinal rim with respect to color and shape.

These criteria, applied by clinical investigators, define what constitutes a "normal" ground truth for the purpose of creating the normative databases.

Ask a specific question about this device

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

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.

Ask a specific question about this device