(86 days)
The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and threedimensional imaging and measurement of anterior ocular structures, including retina, retinal netve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of a known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.
The Avanti with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.
The Avanti is a computer-controlled ophthalmic imaging system that acquires cross-sectional tomograms of the anterior and posterior ocular structures (including cornea, anterior chamber angle, retina, ganglion cell complex, retinal nerve fiber layer, and optic disc). It employs noninvasive, non-contact, low-coherence interferometry to obtain these high-resolution reflectance images and, by rapidly repeating the cross-sectional image at same location, to produce high resolution motion-contrast images of the retina microvasculature. Using this non-invasive optical technique, the Avanti produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-invasive angiographic imaging of the retinal microvasculature based on OCT angiography (OCTA). Qualitative analyses are provided for the cornea and layers of the cornea, the retina and layers of the retina, the optic disc and the nerve fiber layer, and the retinal microvasculature.
The provided text describes acceptance criteria and study details for the Optovue Avanti device. Here's a structured summary based on your request:
Acceptance Criteria and Device Performance
The document does not explicitly present a discrete "table of acceptance criteria and reported device performance" as typically found in clinical trial reports with pass/fail metrics against a predefined threshold. Instead, it details various performance metrics (repeatability, reproducibility, agreement) in descriptive tables (Tables 6-16 for AngioRetina scans, Tables 12-13 for AngioDisc scans, Tables 27-31 for Corneal Epithelial Thickness R&R, and Tables 39-43 for Corneal Epithelial Thickness Agreement with Manual measurements) that implicitly demonstrate the device's performance is acceptable for its intended use, especially when compared to predicate devices or manual methods.
The overall conclusion states: "The results from the software, non-clinical and clinical performance testing demonstrate that the Avanti device with software modification is as safe and effective as its predicate devices." This implies that the performance demonstrated in the various tables met the internal acceptance criteria for substantial equivalence.
As a representative example, here's how some of the reported performance metrics could be conceptualized in a table:
| Metric Category | Parameter Example (from given tables) | Reported Performance (Mean or LOA) | Implicit Acceptance Criteria (Inferred from context of Substantial Equivalence and ranges presented) |
|---|---|---|---|
| Non-clinical Performance (Accuracy) | Superficial Vessel Density (%) | Average Difference: 2.3% | Differences between software-reported and expected "vascular" density values must be small. |
| Deep Vessel Density (%) | Average Difference: 0.0% | ||
| Clinical Performance (R&R - Normal) | 3-mm AngioRetina Scan: Superficial WI | Reproducibility CV: 4.8% | Reproducibility CV should be low, indicating consistent measurements. |
| 4.5-mm HD AngioDisc: RNFL Thickness PP | Reproducibility CV: 1.5% | ||
| Clinical Performance (Agreement) | FAZ Area (OCTA vs. FA) | Mean Difference: 0.070 mm² | Differences between device and reference standard should be clinically acceptable. |
| FAZ Perimeter (OCTA vs. FA) | Mean Difference: 0.205 mm | ||
| ET Epithelium C_2 (Software vs. Manual) | Mean Difference: -0.4 | Differences between device and manual measurements should be clinically acceptable. |
Detailed Study Information:
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A table of acceptance criteria and the reported device performance:
As noted above, explicit pass/fail acceptance criteria are not presented in a direct table. The document demonstrates performance across various metrics and clinical populations. The overall "acceptance" is implied by the FDA's clearance of the device based on the provided data and the statement of substantial equivalence to predicate devices. The tables throughout the document (e.g., Tables 6-16, 27-31, 39-43) present the reported device performance. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Clinical Performance Testing (Section 1 - AngioVue R&R):
- Sample Size: 67 participants (15 Normal, 16 Glaucoma, 36 Retinal conditions).
- Provenance: Prospective, observational study conducted at a single clinical U.S. site.
- FAZ Parameter Validation (Section 2 - non-vascular FAZ Parameters):
- Sample Size: 30 eyes of 26 subjects.
- Provenance: Case series from 3 clinical sites (country not specified, but likely U.S. given the FDA submission). Data origin (retrospective/prospective) is not explicitly stated, but the "case series" implies existing data.
- FAZ Parameters Agreement between 3-mm AngioRetina and 6-mm HD AngioRetina Scans (Section 3):
- Sample Size: 62 subjects/eyes (from the R&R study data set, after exclusions).
- Provenance: Derived from the prospective R&R study data.
- Retinal Thickness, RNFL Thickness, and Disc Measurements Agreement Evaluation (Section 4):
- Sample Size: 67 subjects for Full and Inner Retina thickness; 31 subjects for RNFL thickness and optic disc measurement.
- Provenance: Subset of the prospective R&R study data.
- Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping with SD-OCT (Section 5):
- Sample Size: 60 participants (12 Normal, 12 Contact Lens, 11 Dry Eye, 12 Post-LRS, 13 Keratoconus).
- Provenance: Prospective, observational study conducted at a single clinical U.S. site.
- Evaluation of the Agreement of the Corneal Epithelial Thickness Mapping with SD-OCT (Section 6):
- Sample Size: 85 subjects (17 Normal, 15 Contact Lens, 18 Dry Eye, 19 Post-LRS, 16 Keratoconus).
- Provenance: Prospective, observational study conducted at three study sites (country not specified, but likely U.S.).
- Clinical Performance Testing (Section 1 - AngioVue R&R):
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- FAZ Parameter Validation (Section 2): "Three readers experienced in FA image grading performed FAZ measurements." Specific qualifications (e.g., years of experience, board certification) are not provided.
- Corneal Epithelial Thickness Agreement (Section 6): "Manual measurements performed by three qualified graders." Specific qualifications are not provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- FAZ Parameter Validation (Section 2): Graders were "masked to each other's results through the entire grading process". No explicit mention of an adjudication process (e.g., tie-breaking by a senior reader) if reader consensus was needed. It seems individual reader measurements were compared against the device.
- Corneal Epithelial Thickness Agreement (Section 6): Similar to FAZ, graders were masked. No explicit mention of an adjudication process.
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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 MRMC comparative effectiveness study involving human readers with/without AI assistance is described in this document. The studies primarily focus on the device's technical performance (repeatability, reproducibility, and agreement with human or phantom measurements) rather than its impact on human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done for the Non-clinical Performance Testing (phantoms) to validate the accuracy of the software's vessel density measurements (Section 7, page 7-8). The tables (e.g., for 3-mm AngioRetina Scan) present the difference between software-reported values and "expected 'vascular' density values computed directly from the model." This represents an algorithm-only performance assessment against a known ground truth.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Non-clinical Performance Testing (Phantoms): "Known ground truth" from 3D phantom models with predefined vessel densities.
- Clinical Performance Testing (R&R of AngioVue, Retinal/RNFL/Disc Measurements): Implicitly, the Avanti software's measurements were compared against its own repeated measurements (for R&R) and against the predicate device's measurements (for agreement), establishing consistency and comparability rather than an external "ground truth" like pathology.
- FAZ Parameter Validation: Manually graded FAZ measurements from fluorescein angiography images by "three readers experienced in FA image grading." This is a form of expert consensus/manual measurement ground truth.
- Corneal Epithelial Thickness Mapping Agreement: Manual measurements performed by "three qualified graders" using a caliper tool on a previously cleared device. This is a form of expert consensus/manual measurement ground truth.
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The sample size for the training set:
- The document does not specify the sample size of any training set used for the device's algorithms. This information is typically proprietary to the manufacturer and not included in 510(k) summaries unless directly relevant to a specific re-training or modification evaluation.
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How the ground truth for the training set was established:
- Since the training set size is not provided, the method for establishing its ground truth is also not detailed in this document.
§ 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.