(323 days)
The Optos spectral OCT/SLO with Microperimetry is indicated for use for in vivo viewing, axial cross section, and three dimensional imaging and measurement of posterior ocular structures including retina, macula, retinal nerve fiber layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior of the eye. In addition, cornea sclera and conjunctiva can be imaged with the system by changing the focal position.
The additional microperimetry functionality is indicated for use as a fixation examiner locating the patient's fixation site and by using the patient's subjective answer to light stimuli, generating a sensitivity map of the inspected retinal region.
The Optos OCT/SLO Microperimeter is a non-contact, non-invasive, high-resolution device that is an add-on module to the FDA-cleared Optos Optical Coherence Tomography/Scanning Laser Ophthalmoscope (OCT/SLO). The OCT/SLO is a computerized instrument that employs non-invasive, low-coherence interferometry to acquire simultaneous high-resolution cross-sectional OCT and confocal images of ocular structure, including retinal nerve fiber layer, macula and optic disc of the eye. The light source used for this is a super luminescent diode (SLD).
The microperimetry test runs simultaneously with the confocal ophthalmoscope (SLO) and provides real-time tracking of retinal motion and patient fixation during the exam. Additionally, the patient's subjective response by depressing a button to light stimuli generates a sensitivity map for the inspected retinal region. The variable light stimuli are generated by an organic light emitting diode (OLED).
The provided document describes two clinical evaluations for the Optos Spectral OCT/SLO Microperimeter device: a Precision Study and an Agreement Study.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the provided "Repeatability SD Limit*" which is derived from ISO 5725-1 and ISO 5725-6. The "Agreement study" also describes an acceptable range of agreement with the predicate device.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Precision Study) | Reported Device Performance (Agreement Study) |
|---|---|---|---|
| Repeatability SD (Normal) | Repeatability SD ≤ 1.49 dB (Upper 95% limit for difference between repeated results, based on 2.8 * Repeatability SD) | 0.531 dB | Not applicable |
| Repeatability SD (Pathology) | Repeatability SD ≤ 1.91 dB (Upper 95% limit for difference between repeated results, based on 2.8 * Repeatability SD) | 0.682 dB | Not applicable |
| Agreement (Attenuation) | Within ± 1 attenuation step, or ± 2 steps at attenuation scale extremes, when compared to the predicate device (Nidek MP-1). | Not applicable | Approximates to ± 1 attenuation step (excluding extremes), ± 2 steps at extremes. Note: Systematic difference of 1 ½ steps (3dB's) for normal eyes and ¼ step (0.5dB's) for diseased eyes. Agreement not consistent across all values, with ranges provided in the description. Measurements are not interchangeable. |
2. Sample Sizes and Data Provenance:
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Precision Study:
- Sample Size (Test Set): 12 subjects total (4 normal, 4 with early/intermediate AMD, Geographic Atrophy, Diabetic Retinopathy, Macular Edema, Retinal Vein Occlusion, Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane, or Macular Hole - total 8 diseased subjects, likely 1 eye per subject), with 3 replicates each.
- Data Provenance: Not explicitly stated, but given the "in-house" nature of the agreement study and the UK submitter, it's likely originating from the UK or a similar region. It appears to be a prospective study based on the "replicates with repositioning at the start of each test" methodology.
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Agreement Study:
- Sample Size (Test Set): 40 eyes (20 normal, 20 diseased).
- Data Provenance: "An in-house study was conducted," implying a prospective study conducted by the manufacturer. Country of origin not explicitly stated, but likely the UK given the submitter.
3. Number and Qualifications of Experts for Ground Truth:
- The document does not specify the number of experts or their qualifications for establishing ground truth in either study. Instead, the studies focus on quantitative measurements and their consistency/agreement, rather than a subjective assessment of clinical findings by experts. The "diseased" and "normal" classifications infer a pre-existing diagnosis, but the process of confirming these diagnoses for the study subjects is not detailed.
4. Adjudication Method:
- The document does not mention any adjudication method for establishing ground truth in either study. The precision study focuses on repeatability of measurements, and the agreement study compares device measurements to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is reported in the provided text. The studies focus on device performance (precision, agreement) and not on human reader improvement with or without AI assistance.
6. Standalone Performance (Algorithm Only):
- Yes, the studies describe standalone performance. Both the Precision Study and the Agreement Study evaluate the device's ability to produce consistent and comparable measurements without explicit human interpretation being part of the primary outcome assessment. The "patient's subjective answer to light stimuli" is input for the microperimetry functionality, but the reported performance metrics are related to the device's measurement and tracking capabilities.
7. Type of Ground Truth Used:
- The ground truth for the Precision Study is implicitly defined by the physical state of the eye (normal vs. specific pathologies). The study measures the device's consistency in reporting attenuation values for these known states.
- The ground truth for the Agreement Study is the measurement obtained from the predicate device (Nidek MP-1 Microperimeter). The study assesses how closely the Optos device's measurements align with those of an already marketed device.
8. Sample Size for the Training Set:
- The document does not mention a training set or its sample size. The studies described are clinical evaluations for a 510(k) submission, typically focused on verification and validation of the finished device and its algorithms, rather than the development and training of new machine learning models.
9. How the Ground Truth for the Training Set was Established:
- As no training set is mentioned, this information is 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.