(123 days)
The Topcon 3D OCT-1000 MARK II 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 retina, 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 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 3D OCT-1000 Mark II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are the identical for the two devices, with the exception that during OCT imaging, the scan pattern for the 3D OCT-1000 is delivered as continuous wave (CW) light source; whereas, it is delivered as pulsed lighting in the 3D OCT-1000 Mark II.
The provided 510(k) summary for the Topcon 3D OCT-1000 MARK II indicates that its acceptance criteria and the study proving it meets these criteria are based on demonstrating substantial equivalence to a legally marketed predicate device, the 3D OCT-1000. This is not a study proving clinical diagnostic performance against specific acceptance criteria for a new clinical claim, but rather a technical comparison.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (3D OCT-1000) for: |
- Intended Use
- Indications for Use
- Technological Characteristics
- Engineering Design and Specifications
- Software Design and Specifications
- Laser Classification | The 3D OCT-1000 MARK II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are identical, with the exception of the scan pattern light source (continuous wave for predicate, pulsed lighting for 3D OCT-1000 MARK II).
Software validation testing and image capture testing were performed on the 3D OCT-1000 MARK II.
Test results demonstrated sufficient agreement with captured images from the 3D OCT-1000.
The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device. |
Study Details
The "study" in this context is a comparison to a predicate device, not a typical clinical trial assessing diagnostic accuracy against an established ground truth.
-
Sample Size used for the test set and the data provenance:
- No specific sample size for a "test set" (in the sense of patient data for diagnostic accuracy) is mentioned.
- The document implies a technical comparison and validation of the device's imaging capabilities against the predicate. Data provenance is not specified other than it being from performance and software validation testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as a traditional "test set" with expert-established ground truth for diagnostic accuracy was not performed in this 510(k) submission. The "ground truth" for the device's performance was its agreement with the predicate device's output.
-
Adjudication method for the test set:
- Not applicable for the reasons stated above.
-
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 MRMC study was conducted or reported. This device is an imaging system, not an AI-powered diagnostic tool requiring human reader assistance assessment.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No "standalone" algorithm performance study (in the context of automated diagnosis) was performed. The device itself is an imaging system, and its performance was assessed in terms of its ability to acquire images and its agreement with the predicate device's image acquisition.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission was the performance and output of the legally marketed predicate device, the Topcon 3D OCT-1000. The new device's images and performance were compared for "sufficient agreement" with the predicate.
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set of data.
-
How the ground truth for the training set was established:
- Not applicable as there was no training set.
§ 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.