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

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

The Ambu® aScope™ 5 Broncho HD Sampler Set consists of:
Ambu® aScope™ 5 Broncho HD
Two Sample Containers (aScope BronchoSampler™ 60 SC)
Suction Connection Tube (SCT)
Bronchoscope Attachment Part (BAP)
2 Luer lock adapters (introducers)

Ambu® aScope™ 5 Broncho HD 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.

The Ambu® BronchoSampler™ 60 SC is a sterile, single-use medical device designed as an accessory to aScope 5 Broncho HD single- use endoscopes. It enables aspiration and collection of fluid samples.

The Ambu® BronchoSampler™ 60 SC will be sold alone as an add-on to aScope 5 Broncho HD and as a part in the Ambu® aScope™ 5 Broncho HD Sampler Set.

The Ambu® BronchoSampler™ 60 SC achieves its function by being inserted into the suction pathway between the endoscope and the vacuum source.

The Sample Container Ambu® 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 HD endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® BronchoSampler™ 60 SC, where the aspirated sample is stored.

The Suction Connection Tube (SCT) facilitates connection to suction tubing having end connectors of the male type, instead of the more typical female type.

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

There will be two sets, corresponding to the two sizes of aScope 5 Broncho HD:
a. Ambu® aScope 5 Broncho HD 5.6/2.8 Sampler Set
b. Ambu® aScope 5 Broncho HD 5.0/2.2 Sampler Set

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

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

The following characteristic of the endoscope varies between sizes:

• Distal end outer diameter
• Insertion tube outer diameter
• Working channel inner diameter ●
• . Angulation range

This document describes the Ambu® aScope™ 5 Broncho HD Sampler Set, a new device that builds upon the previously cleared Ambu® aScope™ 5 Broncho HD endoscope by adding components for aspiration and collection of fluid samples. The clearance is based on proving substantial equivalence to the predicate device, Ambu® aScope™ 5 Broncho HD (K220606).

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, as this is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device for an accessory, not a diagnostic AI device requiring such metrics.

Instead, the performance data provided focuses on verifying the safety and functionality of the added components and their integration with the existing endoscope. The acceptance is based on successful verification of design input requirements related to safety and functionality.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not involve clinical data or patient samples in the traditional sense for evaluating diagnostic performance. The "test set" refers to the specific physical devices and components undergoing bench testing. The sample sizes for these bench tests are not explicitly quantified in the provided text (e.g., "Performance tests related to the modifications was performed"). The provenance information (country of origin, retrospective/prospective) is not applicable or provided given the nature of the bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this submission. The "ground truth" for these engineering and safety tests is established by documented design specifications and engineering standards, not by expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the focus here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (endoscope with sampling accessory), not an AI-powered diagnostic tool. The document explicitly states "Performance Data - Clinical: Not applicable."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical endoscope and sampling system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the bench testing is defined by the device's design input requirements, engineering specifications, and applicable medical device standards (e.g., ISO 14971 for risk management). Successful verification against these established requirements constitutes the "ground truth" for demonstrating the safety and performance of the device's modifications.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. There is no training set for this type of medical device submission.

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