(130 days)
The LoopView® is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
The endoscope is intended to provide visualization via MACROLUX™ video processor.
The endoscope is intended for use in a hospital environment. It is designed for use in adults. The ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.
The Single-Use Diaital Flexible Bronchoscope System consists of LoopView® Single Bronchoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with its accessories including power cables. The LoopView® is provided sterile (sterilized by EO) and intended to be single-use. The ViewHub® is a reusable multi-patient use device.
The built-in LED at the Distal tip of the LoopView® Single Bronchoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal; the endoscope cable connects the LoopView® to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handle connected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion; the instrument channel delivers water and other instruments. Suctioning of saliva and mucus from airway is possible through the suction system.
The ViewHub® Video Processor is a video imaging system that receives video signals from the connected endoscope, controls the light at the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.
The LoopView® Single-Use Digital Flexible Bronchoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- Camera and LED light source at the distal tip
- Sterilized by Ethylene Oxide
- For single-use
The ViewHub® Video Processor has the following physical and performance characteristics:
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Snapshot, white balance, zoom and HD video output
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supports HDMI video output formats
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Touch Panel
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Reusable
The provided text describes a 510(k) premarket notification for a medical device, the LoopView® Single-Use Digital Flexible Bronchoscope and ViewHub® Video Processor. It outlines the device's indications for use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to a predicate device.
However, the document does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, human reader improvement with AI assistance, or related ground truth establishment. The testing described focuses on the device's physical and performance characteristics, biocompatibility, sterilization, electrical safety, and software verification/validation, typical for a Bronchoscope system.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance specific to an AI/ML component.
- Sample size used for the test set and data provenance for an AI/ML study.
- Number of experts and their qualifications for establishing ground truth for an AI/ML study.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study results, effect size of human readers improving with AI vs. without AI assistance.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
- Sample size for the training set for AI/ML.
- How the ground truth for the training set was established for AI/ML.
The document discusses "software verification and validation testing" but frames it as typically done for medical device software, which ensures functionality and safety, not necessarily AI/ML performance for diagnostic or assistive tasks.
In summary, the provided text details the FDA 510(k) clearance process for a bronchoscope system and its video processor, focusing on non-clinical testing for substantial equivalence. It does not include information on acceptance criteria or a study related to an AI/ML component's performance.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.