(226 days)
The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.
The components of the Topcon 3D OCT-1000 include a Main Unit, which houses three optical systems for observing and photographing the retina, a Power Supply Unit, a chin rest, a Spectroscope, and the ability to connect a personal computer for image viewing and analysis.
Here's a breakdown of the acceptance criteria and study details for the Topcon 3D OCT-1000 Optical Coherence Tomography System, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance of the Topcon 3D OCT-1000 in providing diagnostic images compared to a predicate device (Carl Zeiss, Inc. Humphrey OCT Scanner or Carl Zeiss Ophthalmic Systems, Inc.'s, Humphrey OCT 3). The Topcon image should meet as many or more image criteria to support diagnostic use than the predicate device image. | In all 55 pairs of images, the graders (with consensus score) demonstrated that the Topcon image met as many or more image criteria to support a diagnostic use of the image than the predicate device image. |
| Specifically, the Topcon image was scored as meeting the same number of image quality criteria in 81 of 110 scorings, and as meeting more of the predefined criteria in 29 of 110 scorings. | |
| This resulted in an overall agreement of 100% (110 of 110 images) where the Topcon image met the same or more criteria than the predicate device image. | |
| Maximum exposure levels | The maximum exposure has been demonstrated to be well below the accepted threshold limits set out in IEC 60825-1:2001. |
| Functionality | In all instances, the Topcon 3D OCT-1000 functioned as intended. |
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size: 55 images from 31 eyes. This included at least seven pairs each from subjects with normal eyes, macular holes, cystoid macular edema (CME), epiretinal membrane (ERM), and both dry and wet form age-related macular degeneration.
- Data Provenance: Not explicitly stated in terms of country of origin. The study appears to be a prospective collection of images specifically for this comparison, as it states "Topcon collected 55 images from 31 eyes... obtained using both the 3D OCT-1000 device and a predicate device." This suggests a controlled collection rather than a retrospective analysis of existing data.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Two graders.
- Qualifications: "Predefined diagnostic image criteria" were used, implying the graders were qualified to interpret these images against those criteria, but their specific qualifications (e.g., ophthalmologists, optometrists, years of experience) are not explicitly stated.
4. Adjudication Method for the Test Set
- The text states: "Paired images were independently graded by two graders using predefined diagnostic image criteria. In all of the 55 pairs of images, the graders (with the consensus score) demonstrated..." This indicates an agreement/consensus method, likely a 2-reader consensus where their independent gradings were reconciled to arrive at a "consensus score." The exact method of achieving consensus (e.g., discussion, third reader) is not detailed beyond "consensus score."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not explicitly conducted in the typical sense of measuring human reader improvement with and without AI assistance. This study was a direct comparison of image quality between two devices (the new device and a predicate) as graded by human readers, not an assessment of AI's augmentative effect on human performance.
- Effect Size of Human Readers with vs. Without AI: Not applicable, as this was not the design of the study.
6. Standalone Performance (Algorithm Only)
- Yes, a standalone performance study was implicitly done for the device itself. The study's primary goal was to demonstrate that the device (Topcon 3D OCT-1000), in isolation, produced images of comparable or superior diagnostic quality to the predicate device. The grading by human experts was used to evaluate the device's output, not the performance of an AI algorithm within the device. The device's performance was assessed based on the quality of the images it generated.
7. Type of Ground Truth Used
- Expert Consensus / Predefined Diagnostic Image Criteria: The ground truth for evaluating image quality was established by "predefined diagnostic image criteria" applied by two independent graders, whose scores were then subject to a "consensus score." This is a form of expert consensus based on established criteria.
8. Sample Size for the Training Set
- Not applicable/Not provided. The provided text describes a device comparison study for regulatory submission, not the development or validation of an AI algorithm. Therefore, there is no mention of a training set for an AI model.
9. How Ground Truth for the Training Set Was Established
- Not applicable/Not provided (see point 8).
§ 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.