(86 days)
This device is indicated for use as a wide field ophthalmoscope for diagnosing and monitoring diseases or disorders that manifest themselves in the posterior pole of the eye.
The Optos' Panoramic200 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 a color 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 digitized and used to build up an electronic picture either in a personal computer and displayed either on a cathode ray tube or an liquid crystal display.
This 510(k) summary for the Optos Panoramic200 Ophthalmoscope does not provide a study to prove the device meets acceptance criteria.
Instead, it argues for substantial equivalence to predicate devices (Odyssey S2LO and Rodenstock SLOs) based on similar intended use, indications, and principles of operation. The document focuses on regulatory compliance and comparison to existing, legally marketed devices rather than presenting a performance study with specific acceptance criteria and results.
Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in this document.
Here's an overview of what can be extracted based on the provided text:
Acceptance Criteria and Device Performance (Not Applicable - No Performance Study Provided)
Since no performance study is detailed, there are no explicit acceptance criteria or reported device performance metrics in the context of a clinical or technical performance study. The document focuses on compliance with general safety and electrical standards.
Study Details (Not Applicable - No Performance Study Provided)
- Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 applicable. The device is an imaging tool, not one with AI assistance for interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information that is available from the document:
- Intended Use: To examine the retina of the eye for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye.
- Predicate Devices: Odyssey Optical Systems' S2LO (K981640), Rodenstock Scanning Laser Ophthalmoscope (K882517), and Rodenstock Scanning Laser Ophthalmoscope (K871268).
- Technological Characteristics: Scanning Laser Ophthalmoscope (SLO) method, using a laser light source scanned across the retina to generate a color image. Returned light is detected, digitized, and displayed electronically.
- Differences from Predicates (and why they don't raise new safety/effectiveness questions):
- Lack of an infrared laser.
- Different size and shape of the deflection system.
- Different display format.
- Wider imaging angle.
- Higher resolution.
- Use of an eyepiece.
- The document asserts these differences "do not raise any new questions of safety or effectiveness."
- Compliance Standards: The device is a Class I laser device and complies with 21 C.F.R., Parts 1010 and 1040. It also complies with various international and national electrical and safety standards (BS EN 60601 series, BS EN 60825-1, UL2601, CAN/CSA-C22.2 No.601.1-M90, AS 3200.1:1990/NZ 6150:1990, JIST 1001/1002:1992).
Conclusion: The submission for the Optos Panoramic200 relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a novel performance study to meet specific acceptance criteria for a new clinical claim.
§ 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.