(174 days)
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."
| Acceptance Criteria (General Description) | Reported Device Performance (General Description) |
|---|---|
| Adherence to ISO 8600-1 (General requirements) | Performed in accordance with ISO 8600-1 |
| Adherence to ISO 8600-3 (Field/Direction of View) | Performed in accordance with ISO 8600-3 |
| Adherence to ISO 8600-4 (Insertion Portion Width) | Performed in accordance with ISO 8600-4 |
| Insertion portion dimensions | Met test specifications |
| Bending performance | Met test specifications |
| Suction performance | Met test specifications |
| Duration of use | Met test specifications |
| Optical performance (Field of view, Direction of view) | Met test specifications |
| Optical performance (Depth of field*, Resolution*, Color performance*, Image intensity uniformity*, Geometric distortion*) | Results compared to reference device (Ambu® aScope™ 4 Broncho) demonstrating substantial equivalence. |
| Photobiological safety (IEC 62471) | Met test specifications |
| Transportation study | Met test specifications |
| Sterilization validation (ISO 11135) | Met test specifications |
| Stability study (shelf life, packaging integrity) | Met test specifications |
| Biocompatibility (ISO 10993-1, -5, -10, -23) | Met test specifications |
| Electrical Safety and performance (IEC 60601-1, -2-18) | Met test specifications |
| Electromagnetic Compatibility (IEC 60601-1-2) | Met test specifications |
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.
§ 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.