(80 days)
The STRATUSOCT™ is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures, It is used for in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk. 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, central serous retinopathy, and glaucoma. The STRATUSOCT™ with Retinal Nerve Fiber Layer ("RNFL") Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. The RNFL Normative Database is intended for use as a diagnostic aid in the detection and management of ocular diseases, especially glaucoma.
The STRATUSOCT™ with RNFL Normative Database is a microprocessor-based low-coherence digital intrument employing low coherence interferometry to generate images of internal ocular tissue microstructures. The device measures optical reflections or backscatter from tissue using optical beam. Results obtained for Retinal Nerve Fiber Layer can be compared to a database of known normal human subjects.
{
"acceptance_criteria_study": {
"acceptance_criteria_and_performance_table": {
"headers": ["Acceptance Criteria", "Reported Device Performance"],
"rows": [
["Device is safe and effective for its intended use", "All testing deemed necessary was conducted to ensure the device is safe and effective."],
["Substantially equivalent to predicate device", "Substantially equivalent with regard to intended use, operating principle, function, and materials."],
["Supports expanded indications for use", "Clinical evaluation performed supports expanded indications for use statement."],
["Does not raise new questions regarding safety and effectiveness", "Demonstrates the device does not raise new questions regarding safety and effectiveness."]
]
},
"sample_size_test_set_data_provenance": "Clinical data was collected on a statistically significant number of normal human subjects. The provenance (country of origin, retrospective/prospective) is not specified.",
"number_of_experts_ground_truth_test_set": "Not specified in the provided text.",
"qualifications_of_experts_ground_truth_test_set": "Not specified in the provided text.",
"adjudication_method_test_set": "Not specified in the provided text.",
"mrmc_comparative_effectiveness_study": {
"performed": false,
"effect_size_human_readers_with_ai_vs_without_ai": "Not applicable, as no MRMC study with AI assistance is mentioned. The device itself is a diagnostic tool, not an AI assisting human readers in a comparative task."
},
"standalone_algorithm_performance": true,
"type_of_ground_truth_used": "Comparison to a database of known normal human subjects (implicitly, normal anatomical parameters for RNFL).",
"sample_size_training_set": "Not explicitly stated as 'training set' but the clinical evaluation involved a 'statistically significant number of normal human subjects' for the RNFL Normative Database. The exact number is not provided.",
"how_ground_truth_for_training_set_established": "The RNFL Normative Database was established by collecting and analyzing clinical data from a statistically significant number of human subjects identified as 'normal'."
}
}
§ 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.