(28 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 200MA and the predicate device are Scanning Laser Ophthalmoscopes (SLO) that work by the same method. Both devices use a laser or lasers as a light source that is scanned by a deflection system in two axes across the retina 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 computer and displayed either on a cathode ray tube or a liquid crystal display.
The provided text describes a 510(k) submission for the Optos Panoramic 200MA Ophthalmoscope, asserting its substantial equivalence to a predicate device (Optos Panoramic 200A). This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those for novel devices or AI-powered diagnostics.
Therefore, the information required to populate the table and answer the subsequent questions regarding acceptance criteria, study design, and ground truth establishment, as typically understood in the context of an AI/ML device, is not present in the provided document.
Here's why and what can be inferred:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The submission focuses on compliance with standards (IEC, EN, UL, CAN/CSA) and the device's functional equivalence to the predicate.
- Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device against specific clinical criteria. The performance is implicitly deemed acceptable because it is "substantially equivalent" to the predicate device.
2. Sample size used for the test set and the data provenance:
- Not Applicable: There is no mention of a "test set" in the context of evaluating diagnostic performance from data. The submission is about the physical device and its operational characteristics being similar to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: No ground truth establishment for a test set is discussed.
4. Adjudication method for the test set:
- Not Applicable: No test set or corresponding adjudication is mentioned.
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: This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No: This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable: There is no ground truth used in the context of evaluating a diagnostic algorithm's performance against clinical findings. The "ground truth" for this 510(k) submission is that the device's physical and operational characteristics comply with regulations and are equivalent to the predicate, and that the predicate itself is legally marketed and generally accepted as safe and effective for its intended use.
8. The sample size for the training set:
- Not Applicable: This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable: This is not an AI/ML device.
Summary based on the provided document:
The submission for the Optos Panoramic 200MA Ophthalmoscope relies on demonstrating substantial equivalence to a previously cleared predicate device (Optos Panoramic 200A). The "acceptance criteria" are primarily related to:
- Identical Intended Use and Indications: Both devices are "intended to examine the retina and are indicated to aid in the diagnosing and monitoring disease and disorders that manifest in the retina" and "for imaging the fluoresced ocular vasculature."
- Similar Principles of Operation and Technological Characteristics: Both are Scanning Laser Ophthalmoscopes (SLO) using lasers, a defiance system, and light detectors to generate digital images. The document states, "The detailed technological differences do not raise any new questions of safety or effectiveness."
- Compliance with Recognized Standards: The device complies with various international and national safety and electrical standards (e.g., 21 C.F.R., Parts 1010 and 1040, EN 60825:2001, IEC 60601-1, UL60601-1, CAN/CSA-C22.2 No.601.1-M90).
The "study that proves the device meets the acceptance criteria" is the 510(k) submission itself, which presents arguments and evidence for substantial equivalence, focusing on the lack of new safety or effectiveness concerns due to minor technological differences from the predicate. No independent diagnostic accuracy study comparing the device's clinical performance against a gold standard or human readers is detailed, as it's not typically required for this type of submission.
§ 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.