(237 days)
An optical coherence tomography system indicated for the in vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases.
The SOCT Copernicus is an AC-powered device containing illumination and viewing optics intended to examine the retina of the eye. The SOCT Copernicus consists of a main unit, which houses the optical system used for imaging the retina, the light source, and a power supply. In addition, both systems utilize a chin rest/forehead rest assembly for patient interface and a computer with software for data analysis / image processing.
Here's an analysis of the SOCT Copernicus device based on the provided 510(k) summary, detailing its acceptance criteria and the supporting studies:
Acceptance Criteria and Device Performance for SOCT Copernicus
The SOCT Copernicus is an Optical Coherence Tomography (OCT) system intended for in-vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases. The device's acceptance criteria are implicitly derived from its comparison to a legally marketed predicate device (Carl Zeiss STRATUS OCT) and its demonstrated precision.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Repeatability & Reproducibility) | Good agreement across operators and devices. | Statistical analysis of the study data showed "good agreement" across devices and operators for measurements from normal and pathological eyes (diabetic macular edema, wet AMD, dry AMD, cystoid macular edema, vitreous hemorrhage, epiretinal membrane and/or vitromacular traction, and macular holes). |
| Clinical Equivalence to Predicate Device | No medically significant difference in measurements compared to the predicate device (STRATUS OCT). | A prospective case series comparing measurements from the SOCT Copernicus and the STRATUS OCT in 27 eyes (21 patients) with various vitreo-retinal disorders (including 5 normal eyes) found "no medically significant difference" based on statistical analysis of nine retinal fields (central subfield, temporal inner retina, superior inner retina, nasal inner retina, inferior inner retina, temporal outer retina, superior outer retina, nasal outer retina, and inferior outer retina). |
| Technological Characteristics | Similar fundamental technology and intended use, with potential improvements. | Uses Optical Coherence Tomography (OCT). Shares similar hardware components (main unit, optical system, light source, power supply, chin rest/forehead rest, computer with software). Differences: SOCT Copernicus uses Spectral/Fourier Domain OCT (faster, higher resolution) vs. STRATUS OCT's Time Domain OCT. SOCT Copernicus has higher A-scan rate (25,000/sec vs. 400/sec) and better depth resolution (6µm vs. 10µm). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Test:
- Sample Size: 10 normal eyes and 10 pathological eyes.
- Data Provenance: Not explicitly stated, but likely from a single study center given the description "structured study". It is prospective as operators were "unaware of patient pathology", suggesting a controlled, forward-looking data collection.
- Clinical Comparison:
- Sample Size: 27 eyes from 21 patients.
- Data Provenance: Prospective case series conducted at the Cleveland Clinic Cole Eye Institute (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Precision Test: The ground truth for this test was the measurements taken by the device itself under different operating conditions. There's no mention of external human experts establishing a separate "ground truth" for these measurements. The "3 operators" involved were observing and potentially performing the scans, but their role was in data collection for precision, not adjudication of pathology.
- Clinical Comparison: The "ground truth" (or reference for comparison) in this study was the measurements obtained from the predicate device (Carl Zeiss Meditec Stratus™ Time Domain OCT). The study focused on comparing the measurements between the two devices, not on validating the absolute accuracy against a gold standard established by a panel of experts. The physicians performing the scans would implicitly be qualified, but their role in establishing a separate "ground truth" is not described as involving a consensus process.
4. Adjudication Method for the Test Set
- Precision Test: No explicit adjudication method is described. The "good agreement" was determined through statistical analysis of measurements, not by expert consensus on image interpretation.
- Clinical Comparison: No explicit adjudication method is described. The comparison was statistical, between measurements obtained from the two devices themselves.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an imaging device (an OCT scanner), not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here. The studies focused on the device's technical precision and its equivalence to a predicate device in terms of measurement output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the studies describe a standalone performance evaluation of the device. The "SOCT Copernicus Precision Test" evaluated the device's inherent repeatability and reproducibility. The "SOCT Copernicus Clinical Comparison" evaluated its measurement capabilities in direct comparison to another device, without human interpretation of the images themselves being the primary endpoint, but rather the measurements derived from the images. While humans operate the device, the performance being assessed is the device's ability to produce consistent and comparable measurements.
7. The Type of Ground Truth Used
- Precision Test: The ground truth was the measurements taken by the device itself, with the goal of showing consistency between repeated measurements and different operators.
- Clinical Comparison: The ground truth for comparison was the measurements obtained from the predicate device (Carl Zeiss Meditec Stratus™ Time Domain OCT).
8. The Sample Size for the Training Set
No information about a "training set" is provided. This device is an imaging instrument (hardware and embedded software), not a machine learning or AI algorithm that typically requires a separate training set. The descriptions relate to validation/testing of the device's performance, not the training of a predictive model.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable in the context of this device's validation, there is no information on how its ground truth would have been established.
§ 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.