(84 days)
The Documenting Laser Slit Lamp is a diagnostic instrument using an AC-powered slit lamp biomicroscope designed to examine the eye through a control diaphragm a thin, intense beam of light.
The Documenting Laser Slit Lamp is a non-invasive, hand held diagnostic instrument designed to take photographs of the anterior eye segment using an AC- powered slit lamp biomicroscope. The system contains an illumination device, image-capturing device used for slit image photography. The image is captured on the computer, viewed as still photographs or in a series of images in a video format. The patient data and images are displayed, stored and retrievable.
The provided text describes a 510(k) premarket notification for a medical device called the "Documenting Laser Slit Lamp." This document focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory purposes.
None of the requested information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or training/ground truth for the AI aspects of the device is present in the provided text.
The document primarily focuses on:
- Device Identification: Name, submitter, and contact information.
- Predicate Devices: Comparison to existing legally marketed devices (Talia Laser Slit Lamp K930518 and Nidek Anterior Eye-Segment Analysis System K991284).
- Device Description: Non-invasive, handheld diagnostic instrument to take photographs of the anterior eye segment using an AC-powered slit lamp biomicroscope, capturing images on a computer.
- Intended Use: Diagnostic instrument to examine the eye through a control diaphragm with a thin, intense beam of light.
- Technological Characteristics Comparison: States that the device uses similar operating principles (optical system, illumination, photographic mediums) to predicate devices.
- Nonclinical Tests: Mentions meeting EN/IEC 601 safety and electromagnetic compatibility standards.
- FDA Correspondence: FDA's letter of substantial equivalence.
Therefore, I cannot provide the requested information. The document does not contain details about:
- Acceptance criteria or device performance table: Not present.
- Sample size for test set or data provenance: Not present.
- Number of experts and qualifications for ground truth: Not present.
- Adjudication method: Not present.
- MRMC comparative effectiveness study: Not present.
- Standalone performance study: Not present.
- Type of ground truth used: Not present.
- Sample size for training set: Not present.
- How ground truth for training set was established: Not present.
§ 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.