(108 days)
KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea 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 eye segment.
The KOWA SL-19 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye.
Illumination light that emitted from a white light source is applied to the eyeball, Refractive media, Eye Anatomy, Ocular Adnexa, Iris, etc. are magnified and observed with a binocular microscope. Fluorescence of the cornea, conjunctiva, etc. can be observed by irradiating background illumination light and irradiating blue illumination light with a built-in light source.
The background White LED function is added to the KOWA SL-19.
The blue filter with white LED for the predicated device is removed, and this function is replaced by blue LED for the KOWA SL-19.
Duration of illumination is lengthened from 140 min to 360 min from predicate device to the KOWA SL-19 due to replace the battery type from AAA battery to AA battery.
The provided text describes a 510(k) premarket notification for the Kowa SL-19, a handheld slit-lamp biomicroscope. This document asserts substantial equivalence to a predicate device (Kowa SL-17) rather than providing a detailed study of an AI/ML-driven device's performance against specific acceptance criteria.
Therefore, the information required to answer your questions regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, and MRMC studies for an AI/ML device is not present in the provided text. The document focuses on the safety and efficacy of a traditional medical device through comparison with a predicate device and adherence to established standards for electrical safety, biocompatibility, software validation, and optical radiation safety.
The acceptance criteria mentioned are related to compliance with recognized standards for safety and performance of a slit lamp, not a new AI-driven diagnostic or assistive technology.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- No AI/ML Device: The Kowa SL-19 is a hardware device (a slit lamp), not an AI/ML algorithm. Its "software" refers to internal operational software, not an AI model that processes images for diagnosis or assistance.
- No "Acceptance Criteria" for AI Performance: The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI model, nor does it present data demonstrating such performance.
- No "Study Proving Device Meets Acceptance Criteria" for AI: The "Performance Testing" section refers to compliance with safety and performance standards (e.g., IEC, ANSI, ISO), not a clinical study evaluating an AI's diagnostic performance.
- No Discussion of Test Sets, Training Sets, Ground Truth, or Experts for AI: These concepts are relevant to the development and validation of AI/ML models, which are not described here.
In summary, the provided document is a regulatory submission for a conventional medical device and does not contain the information necessary to describe an acceptance criteria and study for an AI/ML-driven 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.