(21 days)
The 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurement of posterior ocular structures including retina, retinal nerve fiber layer, macula, and optic disk. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.
The 3D OCT-2000 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. During OCT imaging, the scan beam for the 3D OCT-2000 is delivered as pulsed lighting. The PC software of the 3D OCT-2000 has same functions of the PC software of the 3D OCT-1000 and 3D OCT-10000 MARK II and also the PC software of the 3D OCT-2000 has same functions for the measurement of retinal thickness of the 3D OCT-1000 for Measurement of Retinal Thickness.
The provided text describes the Topcon 3D OCT-2000 and its substantial equivalence to previous models. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for test or training sets, ground truth establishment methods, expert involvement, or MRMC studies for this device.
The document focuses on the device's intended use, technological characteristics, and conformity to general medical device standards. The "Performance Data" section states that "Software validation testing (with PC software) and image capture testing were performed on the 3D OCT-2000. And also, the test results for the 3D OCT-2000 demonstrated sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness." However, it does not elaborate on these test results or specify any quantitative acceptance criteria.
Therefore, many of the requested details cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered based on the provided input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The document mentions conformity to several IEC and ISO standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 15004-1:2006, ISO 15004-2:2007). These standards define general safety, electromagnetic compatibility, laser safety, and fundamental requirements for ophthalmic instruments. While successfully meeting these standards implies acceptance, the document does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity for disease detection) with corresponding acceptance thresholds.
- Reported Device Performance: The document only generally states, "The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device." It also mentions "sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness," but no numerical data is provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document does not detail any studies involving expert ground truth establishment for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. 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
- Not specified. This device (3D OCT-2000) is a diagnostic imaging device, not explicitly an AI-assisted diagnostic tool as described in the context of MRMC for AI improvement. The document presents it as substantially equivalent to prior predicate devices based on technological characteristics and intended use, not necessarily improved human reader performance with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is an imaging system. Its 'performance' would be related to image quality, measurement accuracy, and safety, not an algorithm's standalone diagnostic performance in the AI sense. The document states "software validation testing" was done, but gives no specifics on algorithm-only performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified.
8. The sample size for the training set
- Not applicable/Not specified. The document describes a "substantially equivalent" declaration, not a de novo clearance for a machine learning algorithm that typically requires a distinct training set.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
Summary of available information:
| Category | Information from Document |
|---|---|
| Acceptance Criteria | Not explicitly stated as specific performance metrics. Implicitly, conformity to general medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 15004-1:2006, ISO 15004-2:2007) and "sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness" were the basis for acceptance. |
| Reported Device Performance | "The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device." "demonstrated sufficient equivalence with measuring the retinal thickness from the 3D OCT-1000 for Measurement of Retinal Thickness." No specific quantitative performance values are provided. |
| Sample Size (Test Set) | Not specified. |
| Data Provenance (Test Set) | Not specified. |
| Number of Experts (Ground Truth) | Not specified. |
| Qualifications of Experts | Not specified. |
| Adjudication Method | Not specified. |
| MRMC Comparative Effectiveness Study | Not performed/Not applicable in the context of typical AI-driven improvement studies. The device is an imaging instrument, declared substantially equivalent to previous models based on its core imaging capabilities. |
| Standalone Performance Study (Algorithm) | Not explicitly detailed or applicable in the sense of AI algorithm performance. "Software validation testing" and "image capture testing" were performed. |
| Type of Ground Truth Used | Not specified for any performance evaluation in terms of disease detection. For retinal thickness measurement equivalence, the ground truth would presumably be the measurements from the predicate device (3D OCT-1000 for Measurement of Retinal Thickness). |
| Sample Size (Training Set) | Not applicable for a traditional medical device substantial equivalence submission where an AI algorithm's training set is not the primary focus. |
| Ground Truth for Training Set | Not applicable. |
§ 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.