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aScope 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.

It is designed for use in adults and intended for use in a hospital environment.

It is intended to provide visualization via Ambu Displaying Unit.

The Ambu® aScope™ 4 Broncho Sampler Set consists of:
• aScope 4 Regular/Large endoscope
• aScope BronchoSampler ™

Ambu® aScope™ 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. Both of the aScope 4 Broncho and BronchoSampler are already marketed separately.

Ambu® aScope™ 4 Broncho Sampler Set 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
• Enables aspiration and sample collection in BAL and BW procedures

The differences between the endoscope sizes are as follows:
• Distal end outer diameter
• Insertion tube outer diameter
• Working channel inner diameter
• Angulation range

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document is a 510(k) summary for the Ambu® aScope™ 4 Broncho Sampler Set, which is a medical device, but it is not an AI/ML powered device.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to a predicate device through bench testing for physical and performance characteristics, sterility, electrical safety, and electromagnetic compatibility. It explicitly states "Not applicable" for clinical performance data.

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