(11 days)
The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.
The HRA 2 / OCT is an add-on to the Heidelberg Retina Angiograph (HRA 2). It is intended for the imaging of the retina and retinal structures. With the additional HRA 2 / OCT it is possible to perform axial cross sectional images of the retina or 3-dimensional volume scans of the retina. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used. The intensity of the back-reflected light is measured and displayed as gray-values on a computer monitor. The light sent to the probe interferes with the light that is back-reflected from the probe. The optical interference of both light beams is detected and the spectrum of the light is analyzed in an optical spectrometer. This technology is called spectral-domain optical coherence tomography (SD-OCT) or Fourier-domain OCT (FD-OCT). The images acquired by the device can be displayed, edited and stored using the Heidelberg Eye Explorer Software.
The provided text is a 510(k) Summary for the Heidelberg Retina Angiograph 2 / Optical Coherence Tomograph (HRA 2 / OCT). This document focuses on demonstrating substantial equivalence to a predicate device (Carl Zeiss Ophtalmic Systems Inc. Humphrey Octical Coherence Tomographer 3, K012727), rather than presenting a performance study with specific acceptance criteria as you might find for a novel device or a clinical trial.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, and MRMC studies is not explicitly available within this 510(k) summary.
However, I can extract the information available and highlight what is missing based on your request.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not define specific numerical acceptance criteria for a performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device (Humphrey OCT3, K012727) based on technological characteristics, intended use, safety, and effectiveness.
The "reported device performance" is essentially that the HRA 2 / OCT was found to meet all requirements of safety standards and its images were comparable to the predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (HRA 2 / OCT) |
|---|---|
| Safety: Compliance with relevant electrical safety and laser safety standards. | Passed IEC 60601-1 and IEC 60601-1-2. Classified as Class 1 laser product (21 CFR Part 1040 Section 1040.10 and IEC 60825-1:1993+A2:2001). |
| Technological Characteristics: Similarities in imaging principle, resolution, scanning capabilities, etc., compared to predicate. | Utilizes Spectral-Domain OCT (FD-OCT), offering high lateral (14 μm) and depth (6.9 μm) optical resolution. Acquires 2D and 3D scans. Comparisons to predicate device (OCT3) highlighted differences (e.g., FD-OCT vs Time Domain OCT) but overall equivalence for intended use. |
| Intended Use: Device performs its stated function for imaging and aiding in assessment of ocular diseases. | Intended for imaging of retina and retinal structures, aiding in assessment and management of AMD, diabetic retinopathy, and glaucoma. |
| Image Quality / Effectiveness: Images acquired are comparable to those from the predicate device and support the intended use. | "The evaluation of the device and comparison of acquired images resulted in substantial equivalence to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "evaluation of the device and comparison of acquired images" but provides no details on the number of images or patients used for this comparison.
- Data Provenance: Not specified. It does not mention the country of origin of any data, nor whether it was retrospective or prospective. Given the context of a 510(k) for a medical imaging device, any "comparison of acquired images" implicitly refers to clinical or phantom data, but no specifics are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No. This 510(k) is for an imaging device (OCT) and does not involve AI or human-in-the-loop performance evaluation in the context of comparative effectiveness. It's a submission for the hardware and basic image acquisition software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This 510(k) is for the HRA 2 / OCT imaging device itself, not for an algorithm providing automated analysis or diagnosis.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. The summary mentions "comparison of acquired images." For an imaging device, the "ground truth" for image quality typically relies on expert assessment of image clarity, resolution, and ability to visualize relevant anatomical structures and pathologies, often compared against a known, established predicate device or other gold standard imaging. However, specific methods are not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes an imaging device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a machine learning algorithm described.
§ 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.