(73 days)
This device is indicated for use as a wide field and retinal fluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest themselves in the retina.
The Optos Panoramic 200A and the predicate devices are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. They use a laser or lasers as a light source that is scanned by a deflection system in two axes across the retina of the eye to generate an image. The returned light then travels back along the same path to a light detector that converts the light to an electrical signal. This electrical signal is digitised and used to build up an electronic picture in a personal computer and displayed either on a cathode ray tube or a liquid crystal display.
The provided text describes the marketing authorization for the Optos Panoramic 200A Angiograph Ophthalmoscope based on its substantial equivalence to predicate devices, rather than a study demonstrating its performance against specific acceptance criteria.
The submission focuses on the lack of new questions of safety or effectiveness due to minor technological differences compared to predicate devices, and adherence to relevant safety and electrical standards. It does not present a performance study with defined acceptance criteria for the device's diagnostic capabilities.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not provided in the given document, as it's a 510(k) summary for substantial equivalence.
Here's an attempt to fill in the table and address the questions based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (from K042001 summary) |
|---|---|
| Intended Use Equivalence: The device should have the same intended use and indications as the predicate devices. | The Panoramic 200A Ophthalmoscope has the same intended use and same indications as the predicate devices (Panoramic 200, Heidelberg Retina Angiography 2, and Rodenstock SLOs) for examining the retina, diagnosing and monitoring retinal diseases/disorders, and imaging fluoresced ocular vasculature. (Explicitly stated in "Intended Uses" section) |
| Similar Principle of Operation: The device should work by the same method as predicate devices. | The Optos Panoramic 200A and the predicate devices are Scanning Laser Ophthalmoscopes (SLO) that work by the same method: using a laser to scan across the retina, and a detector to convert returned light to an electrical signal for image display. (Explicitly stated in the first paragraph of the "Technological Characteristics" section) |
| No New Safety/Effectiveness Questions: Any technological differences should not raise new questions of safety or effectiveness. | The technological differences (lack of infrared laser, different display format, wider imaging angle, and associated resolution) between the Panoramic 200A and its predicate devices in angiographic mode "do not raise any new questions of safety or effectiveness." (Explicitly stated in the second paragraph of the "Technological Characteristics" section) |
| Compliance with Performance Standards: Adherence to relevant safety and electrical standards. | The device complies with 21 C.F.R., Parts 1010 and 1040, and the following standards: IEC 60601-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, UL60601-1, and CAN/CSA-C22.2 No.601.1-M90. (Explicitly stated in the "Performance Standards" section) |
| Substantial Equivalence Conclusion: The device should be deemed substantially equivalent to legally marketed predicate devices. | The FDA reviewed the premarket notification and "determined the device is substantially equivalent...to legally marketed predicate devices." (Stated in the FDA's letter, K042001) |
2. Sample size used for the test set and the data provenance:
- Not provided. The 510(k) summary for the Panoramic 200A does not describe a clinical performance study with a specific test set. The submission is based on engineering similarity and compliance with safety standards rather than a clinical performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. As no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- No. An MRMC study was not described. The device is an imaging tool, and the submission focuses on its equivalence to existing imaging tools, not on its role in aiding human readers or AI integration.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is an imaging device, not an AI algorithm. Its performance is inherent in its ability to acquire images, which is assessed for technical specifications and safety rather than standalone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No clinical performance study requiring ground truth is described. The "ground truth" for this 510(k) revolved around ensuring the technical specifications and safety profile were equivalent to predicate devices and met relevant standards.
8. The sample size for the training set:
- Not applicable/Not provided. This device is hardware and software for image acquisition, not an AI model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 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.