(234 days)
The SLIT LAMP is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.
The slit lamp is an instrument consisting of a high-intensity light source that can be focus to shine a thin sheet of light into the eye. The binocular slit-lamp examination provides a stereoscopic magnified view of the eye structure in detail, enabling diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye. The device consists of a base plate, chin rest, fixation light, illumination light, slit project, focusing ring and other accessories that in aid of examination. The patients can rest their chin and forehead on a support to keep the head steady.
It is powered by the specified adapter (model: MDS-060BAS12A) which is certificated by ANSI/AAMI ES 60601-1 and considered as part of this equipment. Appliance coupled with US Plug.
The provided document is a 510(k) summary for a medical device called "SLIT LAMP, Model: YF-100." This document outlines the device's technical specifications, intended use, and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.
However, the document describes a traditional medical device (a physical slit lamp biomicroscope), not an AI/ML-driven device. As such, it does not contain information about acceptance criteria or a study proving an AI device meets those criteria. The testing performed is related to electrical safety, EMC compliance, environmental tolerance, and photo-biological safety of the hardware, not the performance of an algorithm or AI model in diagnostic tasks.
Therefore, I cannot extract the specific information requested regarding AI/ML device acceptance criteria and study data because the provided text does not describe such a device or study.
To address your request, if this were an AI/ML device, the sections would typically describe:
- A table of acceptance criteria and the reported device performance: This would involve metrics like sensitivity, specificity, accuracy, AUROC, positive/negative predictive values, or agreement rates for a diagnostic task. The document would list the target values for these metrics and the actual achieved values from the study.
- Sample size used for the test set and the data provenance: Details on the number of cases (e.g., images, scans, patient records) in the test set, and whether the data was collected retrospectively or prospectively, and its geographic origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For AI in medical imaging, this would involve radiologists, ophthalmologists, pathologists, etc., with specified experience levels (e.g., board-certified, years of experience).
- Adjudication method for the test set: How disagreements among experts were resolved to establish the final ground truth (e.g., majority vote, senior expert arbitration, additional expert review).
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: An MRMC study assesses the performance of human readers with and without AI assistance to quantify the improvement. The effect size (e.g., increase in sensitivity, decrease in false positives) would be reported.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Performance metrics of the AI algorithm operating independently, without human interaction.
- The type of ground truth used: Whether it was expert consensus, pathology confirmation, clinical outcomes data, or a combination.
- The sample size for the training set: The number of cases used to train the AI model.
- How the ground truth for the training set was established: The process for labeling or annotating the training data to provide the AI with correct answers to learn from.
Given the content of the provided document, I must state that it does not contain the information necessary to fulfill your request for an AI/ML device.
§ 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.