(258 days)
The fiber slit illuminator is indicated for use as an alternative illumination system to the surgical microscope in ophthalmic microsurgery for procedures on the anterior and posterior segments of the eye. The fiber slit illuminator is not equipped with a light source, but uses the light transferred from the microscope by a light guide.
The VISULUX is intended to be used together with a microscope to perform ophthalmic observations. The device is primarily used by surgical ophthalmologists. As the device has no own light source the microscope must provide an additional separate light source or at least a separate S-light guide to be connected to the VISULUX. The light is brought by a light guide in the device and is channeled through an optical system to leave the device as a bright, sharp slit. The operator can adjust the beam with a slideable aperture to have different widths.
The provided document is a 510(k) summary for the VISULUX device, a fiber slit illuminator. It indicates that the device's substantial equivalence was demonstrated through non-clinical data, specifically compliance with various safety and performance standards. No clinical studies, animal studies, or software verification/validation were conducted. Therefore, the information requested regarding acceptance criteria, study design for proving performance, and details about human-in-the-loop performance or ground truth for AI models is not applicable or available in this document.
However, based on the provided text, I can extract the following information about the tests performed and their general compliance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ISO 14971:2007 | Compliance with risk management processes |
| ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Compliance with basic safety and essential performance |
| IEC 60601-1-2:2007 | Compliance with electromagnetic compatibility (EMC) |
| ISO 10939:2007 | Compliance for ophthalmic instruments and slit-lamp microscopes (with applicable light sources: LED, Halogen, Xenon) |
| ISO 15004-2:2007 | Compliance with light hazard protection requirements |
| IEC 62366-1:2015 | Compliance with human factors engineering processes (usability engineering) |
2. Sample size used for the test set and the data provenance: Not applicable. The document describes compliance with standards through non-clinical testing, not a study involving a test set of data or human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set was mentioned.
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: No, an MRMC comparative effectiveness study was not done. The device (VISULUX) is a physical fiber slit illuminator, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Compliance was demonstrated through engineering and safety standard testing, not through comparison to a clinical ground truth.
8. The sample size for the training set: Not applicable. This is a physical device, and no training set for an algorithm was mentioned.
9. How the ground truth for the training set was established: Not applicable.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.