FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.

Device Description

Lightsource or illuminator I-100

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Lightsource Model or Illuminator I-100". It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

None of the requested details regarding acceptance criteria, device performance, study designs (sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information are present in the provided text.

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K Number

K980166

Device Name

LIGHTSOURCE OR ILLUMINATOR

Manufacturer

CUDA PRODUCTS CO.

Date Cleared

1998-04-01

(75 days)

Product Code

HET,FCR,FCW,FFS,HBI

Regulation Number

884.1720

Type

Traditional

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource actaches to fiberoptic cable which is then attached to an instrument or headlight.

Device Description

Lightsource or Illuminator M2-250TR or 1-250

AI/ML Overview

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "I-250 and M2-250TR Lightsources." This document indicates that the device has been cleared for marketing based on its substantial equivalence to previously marketed devices. However, this clearance letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval, not a scientific study report.