(184 days)
OptoMedical Technologies OCT-Camera ID 21101A3 is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera ID 21101A3 is indicated for the use as an aid in the diagnosis of physiologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on all patient populations except premature and is suitable for patients ambulatory or confined. The system is indicated for use in supine imaging, mounted to the surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.
The OCT-Camera ID 21101A3 can connected via the camera port of surgical microscopes. The OCT-Camera ID 21101A3 is completely integrated into the surgical procedure by enabling the OCT imaging before, during, and after microsurgery without disrupting the microscopic view. Individual steps of surgical procedures can be visualized in real time. The OCT-Camera ID 21101A3 by OptoMedical Technologies GmbH facilitates the intraoperative use of OCT (iOCT). It is called OCT-Camera ID 21101A3, because it can be attached to the camera port of an operating microscope like any common camera that are used for the purpose of providing live view images of the surgical field.
The provided text describes a 510(k) submission for the OCT-Camera ID 21101A3, which is an ophthalmoscope using Spectral Domain Optical Coherence Tomography (SD-OCT). The submission aims to demonstrate substantial equivalence to a predicate device, the OCT-Camera (ID 21101A1).
The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study. The "acceptance criteria" presented are in the context of meeting internal and external regulatory standards, and the "study" referred to is a series of non-clinical performance and safety tests.
Therefore, many of the requested categories for a clinical study proving device performance are not applicable or cannot be extracted from this document, as it is a 510(k) summary for regulatory clearance based on substantial equivalence.
Here's the information that can be extracted and a breakdown of why some fields are not available:
1. A table of acceptance criteria and the reported device performance
The document details various non-clinical performance and safety tests that were passed, rather than clinical performance metrics. The acceptance criteria are "PASSED required testing" for each standard.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility evaluation per ISO 10993-1 | Demonstrated no direct patient-contacting materials (PASSED) |
| Electrical safety testing per ANSI/AAMI ES 60601-1 | PASSED required testing |
| Electromagnetic Compatibility per IEC 60601-1-2 | PASSED required testing |
| Laser Safety testing per IEC 60825-1 | PASSED required testing |
| Light Hazard Protection per ANSI Z80.36-2016 | PASSED required testing |
| Software V&V per IEC 62304/FDA Guidance, Moderate Concern | PASSED required testing (functional, system compatibility, risk analysis) |
| Usability engineering testing per IEC 62366-1 | PASSED required testing |
| Risk Management per EN ISO 14971 | All requirements met, risks reduced as far as possible |
The document also provides technological specifications as part of the comparison to the predicate, which can be seen as performance characteristics:
| Performance Characteristic | Subject Device (OCT-Camera ID 21101A3) | Predicate Device (OCT-Camera ID 21101A1) |
|---|---|---|
| Laser | 830 nm | 840 nm |
| Optical Power (OCT Light) | ≤1500 μW at cornea during OCT scan | ≤2350 μW at cornea during OCT scan |
| Resolution, Axial | ≤ 7.5 μm in tissue | ≤ 10 μm in tissue |
| Depth Range (in tissue) | 2.8 mm | 3.1 mm |
| Scan Rate | 35000 A-Scans/s | 15000 A-Scans/s |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document describes non-clinical engineering and safety tests, not a clinical study on a test set of patient data.
3. 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)
This information is not available. The document focuses on technical and safety compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. No clinical test set or adjudication process is described.
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 available. The device described is an imaging camera (OCT-Camera), not an AI-powered diagnostic algorithm designed to assist human readers, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-th e-loop performance) was done
This information is not available. The device is an imaging hardware system, not a standalone algorithm. Its function is to acquire, process, display, and save images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available. As there is no clinical performance study on a test set mentioned, there is no discussion of ground truth for such a study. The "ground truth" in the context of this document is adherence to various engineering, safety, and regulatory standards.
8. The sample size for the training set
This information is not available. The device is a hardware imaging system, and while it includes software (iOCT-Control3), the document does not suggest the software involves machine learning or requires a "training set" in the AI sense. Software validation is mentioned on a functional level.
9. How the ground truth for the training set was established
This information is not available. As no training set for an AI algorithm is indicated, no ground truth for it would be established based on 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.