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aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.

The Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Broncho System is a combination of an endoscope, Ambu® a5cope™ 5 Broncho, and a compatible displaying unit, Ambu® aView™ 2 Advance.

Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size configurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size, the endoscopes share a similar design. The inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a working channel system within the endoscope for use with endotherapy instillation of fluids. An introducer (luer lock adaptor), which is supplied together with the endoscopes, can be attached to the working channel port during of blood, saliva, and mucus from airway is possible through the suction system. Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor.

The Ambu® aView™ 2 Advance, also referred to as a displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8" LCD screen. The device is powered through a Lithium-ion (Li-ion) battery or a separate power adapter.

Ambu® aView™ 2 Advance displaying unit has the following physical and performance characteristics:

• · Displays the image from the Ambu® aScope™ 5 Broncho endoscope on the screen.
• · Can record snapshots or video of image from Ambu® aScope™ 5 Broncho endoscope.
• · Can connect to an external monitor.
• · Reusable device.

No information regarding acceptance criteria or a study proving the device meets the acceptance criteria is provided in the document. The document is a 510(k) clearance letter from the FDA for a bronchoscope system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical performance testing.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information. The document merely confirms that the "Ambu® aScope™ 5 Broncho System performed as expected and met the test specifications set." but does not elaborate on these specifications or the studies performed.

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Ambu® aScope™ 5 Broncho Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.

Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.

Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.

The Ambu® aScope™ 5 Broncho Sampler Set consists of:

• Ambu® aScope™ 5 Broncho endoscope .
• Two Sample Containers (Ambu® aScope BronchoSampler™ 60 SC)
• Suction Connection Tube (SCT)
• Bronchoscope Attachment Part (BAP)
• 2 Luer lock adapters (Introducers) .

Ambu® aScope™ 5 Broncho is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree (K230428).

The Ambu® aScope BronchoSampler™ 60 SC is a 510(k)-exempt device, also sold alone under the trade name Ambu® aScope BronchoSampler™ SC.

The combination of the Ambu® aScope BronchoSampler™ 60 SC, the Bronchoscope Attachment Part (BAP) and Suction Connection Tube (SCT) is collectively referred to as the BronchoSampler 60.

BronchoSampler 60 is a sterile, single-use medical component designed as an accessory to aScope™ 5 Broncho single-use endoscopes. It is used for fluid sampling in bronchoscopic procedures such as 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.

The Ambu® aScope BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure.

The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® aScope BronchoSampler™ 60 SC, where the aspirated sample is stored.

The Suction Connection Tube (SCT) facilitates connection to suction tubing.

The Ambu® aScope BronchoSampler™ 60 SC plus an additional Sample Container, BAP, SCT and two introducers will be packaged and sterilized together with Ambu® aScope™ 5 Broncho endoscope to form a self-contained set, the Ambu® aScope™ 5 Broncho Sampler Set.

Ambu® aScope™ 5 Broncho Sampler Set has the following physical and performance characteristics:

• Maneuverable Ambu® aScope™ 5 Broncho endoscope tip controlled by the user
• Flexible Ambu® aScope™ 5 Broncho endoscope insertion cord
• Camera and LED light source at the distal tip of the Ambu® aScope™ 5 Broncho endoscope
• Sterilized by Ethylene Oxide
• For single use
• Enables aspiration and sample collection in BAL and BW procedures

The provided document is a 510(k) summary for the Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance benchmarks. Therefore, many of the requested categories are "Not Applicable" or information is unavailable from this document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format requested for a software device or diagnostic tool. Instead, it lists types of bench testing performed to verify design input requirements related to safety and functionality due to the addition of sampling functionality.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document only mentions "bench testing" without detailing the number of units or tests conducted for each category.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, likely at the manufacturer's facility (Ambu A/S, Denmark) or a contracted lab. The data is prospective in the sense that the tests were designed and executed to verify the new product's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a medical instrument (bronchoscope and sampling set), not an AI/diagnostic software. Ground truth in this context would refer to objective physical and chemical measurements or engineering standards, not expert medical consensus on images or data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not relevant for bench testing of a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a physical medical device, not an AI software intended to assist human readers in interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm. The device, as a physical product, operates as described (e.g., provides visualization, allows instrument passing, enables aspiration), and its performance is verified through physical and functional testing.

7. The Type of Ground Truth Used

The ground truth used for bench testing typically involves:

• Engineering specifications and design input requirements.
• Industry standards (e.g., ISO for biological evaluation, sterilization).
• Physical measurements (e.g., suction pressure, flow rates, dimensions).
• Functional checks (e.g., maneuverability, connectivity).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for a physical medical device.

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aScope™ 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope™ 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Broncho System is a combination of a displaying unit, the Ambu® aBox™ 2, and a compatible endoscope, Ambu® aScope™ 5 Broncho.

Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size confiqurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size, the endoscopes share a similar design. The insertion portion is inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a working channel system within the endoscope for use with endotherapy instruments or instillation of fluids. An introducer (luer lock adaptor), which is supplied together with the endoscopes, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from airway is possible through the suction system.

Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor.

The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

The Ambu® aBox™ 2 has the following physical and performance characteristics:

• Displays the image from Ambu® aScope™ 5 Broncho endoscope . on the screen
• . Can record snapshots or video of image from Ambu® aScope™ 5 Broncho endoscope
• Can connect to an external monitor .
• . Is a reusable device

Here's an analysis of the provided text regarding acceptance criteria and study details for the Ambu® aScope™ 5 Broncho System.

Much of the information requested, particularly regarding specific numerical acceptance criteria and the detailed outcomes of human-in-the-loop studies (MRMC), is not explicitly present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence through design and performance testing against recognized standards and a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and overall conclusions but does not provide a table with specific numerical acceptance criteria alongside reported numerical performance for each. Instead, it generally states that the device "performed as expected and met the test specifications set."

Note: For the optical performance marked with an asterisk, the document states these were compared to a reference device (Ambu® aScope™ 4 Broncho) to demonstrate substantial equivalence, rather than directly stating a specific numerical acceptance criterion was met against a pre-defined threshold.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for the various performance and verification tests. It lists the types of tests performed (e.g., optical performance tests, mechanical tests) but not the number of units or data points included in each test.

The provenance of the data is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device and the types of tests listed (bench testing, sterilization validation, biocompatibility), these are typically prospective laboratory and bench studies conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The listed tests are primarily objective engineering and performance evaluations. There is no mention of expert human assessment or ground truth establishment in the context of diagnostic performance or clinical interpretation, as this device primarily provides visualization.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The listed tests are primarily objective performance evaluations (e.g., measuring dimensions, suction flow, optical parameters) and do not involve human adjudication for establishing ground truth from subjective observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned in the document. The device (Ambu® aScope™ 5 Broncho System) is an endoscope and display unit for visualization and therapeutic interventions. Its primary function is to provide images for a clinician to interpret and act upon. The document focuses on the device's technical performance and safety, not on human interpretive performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study is not mentioned or applicable. This device is an imaging tool used by a human operator; it does not contain AI algorithms that would operate standalone for diagnostic purposes.

7. The Type of Ground Truth Used

For the various performance tests (e.g., dimensions, optical parameters, suction, electrical safety), the ground truth is established by objective measurements against engineering specifications and international standards (ISO, IEC). These are not clinical "ground truths" in the sense of pathology or outcomes but rather engineering and performance "ground truths" defined by validated measurement methods.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As explained, this device does not contain AI/ML components that would require a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided, as there is no mention of a training set for an AI/ML algorithm.

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