(79 days)
The Cirrus™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial cross-sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. 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 holes, cystoid macular edema, diabetic retinopathy, age- related macular degeneration and glaucoma.
The Cirrus™ HD-OCT is a computerized instrument that acquires and analyzes crosssectional tomograms of posterior ocular structures (including retina, retinal nerve fiber layer, macula, and optic disc.). It employs non-invasive, non-contact, low-coherence interferometry to obtain these high-resolution images. Using this non-invasive optical technique, Cirrus HD-OCT produces high-resolution cross-sectional tomograms of the eye without contacting the eye.
The document provided is a 510(k) Summary for the Carl Zeiss Meditec Inc. Cirrus™ HD-OCT device, submitted to the FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results for device performance.
Therefore, the requested information elements related to specific acceptance criteria, detailed device performance metrics, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, and comparative effectiveness studies cannot be fully extracted from the provided text.
Here's a breakdown of what can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The 510(k) summary asserts that "all testing deemed necessary was conducted" and that the device "demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes." However, no specific performance metrics or acceptance criteria (e.g., accuracy, sensitivity, specificity, measurement tolerances) are detailed.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical data was collected and evaluated."
- Data Provenance (e.g., country of origin, retrospective/prospective): Not explicitly stated. It only mentions "Clinical data was collected."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
This information is not provided in the document.
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:
This information is not provided and is unlikely to be relevant. The Cirrus™ HD-OCT is described as an imaging device for "in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures." It's a diagnostic device to aid in detection and management of diseases. The description does not suggest an AI-driven interpretation or assistive role for human readers in the way an MRMC study typically assesses. The primary goal of the 510(k) is to demonstrate substantial equivalence of the device itself as an ophthalmoscope, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. As noted above, the device's function is imaging and measurement, not solely algorithmic diagnosis.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. The document only states "Clinical data was collected and evaluated."
8. The Sample Size for the Training Set:
This information is not provided. The Cirrus™ HD-OCT is an imaging device, and the summary focuses on its hardware and measurement capabilities rather than an AI model that would require a distinct training set. If there are normative databases, their sample sizes are not mentioned.
9. How the Ground Truth for the Training Set was Established:
This information is not provided.
Summary of available information regarding the clinical evaluation (as described in the 510(k) summary):
The document states:
- Study Purpose: "Clinical data was collected and evaluated to support the indications for use statement for the Cirrus™ HD-OCT and to demonstrate substantial equivalence to the Stratus OCT."
- Conclusion: "As described in this 510(k) Summary, all testing deemed necessary was conducted on the Cirrus™ HD-OCT to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use."
Crucially, this 510(k) summary is for an ophthalmoscope, an imaging device. The focus is on its ability to produce images and measurements comparable to existing predicate devices, rather than a novel AI diagnostic algorithm with specific performance criteria against a detailed ground truth. The document does not provide the kind of detailed clinical study results (e.g., sensitivity, specificity, AUC, reader performance) that would typically be found for an AI-powered diagnostic aid. The substantial equivalence argument often relies on demonstrating that the new device operates similarly and yields comparable output to predicate devices, without needing to re-prove the clinical utility of the imaging modality itself.
§ 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.