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MiiS Horus Bronchoscope:

The MilS Horus Bronchoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiS Horus Endoscope Display System -Video Box (EVS 700). The device provides endoscopic visualization of airways and tracheobronchial tree, in conjunction with displaying system to perform various endoscopic procedures.

The MilS Horus Bronchoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.

MiiS Horus Endoscope Display System -Tablet:

The MiS Horus Endoscope Display System -Tablet (EDS 500) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.

MiiS Horus Endoscope Display System -Video Box:

The MilS Horus Endoscope Display System -Video Box (EVS 700) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.

MiiS Horus Bronchoscope (ECB 100 S/R/L) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree.

MiiS Horus Bronchoscope (ECB 100 S/R/L) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System - Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.

MiiS Horus Endoscope Display System -Tablet (EDS 500) is a tablet which showing live image or snapshot from ECB 100.

MiiS Horus Endoscope Display System -Video Box (EVS 700) is a standalone imaging transfer system; it can be connected to computer to project live imaging. If needed, the pictures or videos can be storage to Tablet (EDS 500 Tablet) or computer.

There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The working channel provide access for accessories to conduct surgical procedures.

MiiS Horus Bronchoscope has been designed to be compatible with the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA).

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) premarket notification summary for the MiiS Horus Bronchoscope and its compatible display systems, aiming to demonstrate substantial equivalence to a predicate device.

The document states that no clinical studies were performed (page 9, "Clinical Tests"). Therefore, there is no information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence through nonclinical tests and comparison of technological characteristics with the predicate device.

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