(145 days)
Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu® displaying unit, and to allow passing 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 HD System is a combination of the displaying unit, Ambu aBox 2, and a compatible Ambu endoscope, the Ambu aScope 5 Broncho HD 5.0/2.2 or the Ambu aScope 5 Broncho HD 5.6/2.8.
The Ambu aScope 5 Broncho HD endoscopes are single-use endoscopes designed to be used with Ambu displaying units, endotherapy instruments and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The insertion portion is inserted into the patient airway through the mouth, nose, or a tracheostomy. It is lubricated with a water-soluble medical grade lubricant to ensure the lowest possible friction when inserted into the patient. There is a working channel system within the endoscope for use with endotherapy instruments. An introducer (luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from the airway is possible through the suction system.
Ambu aScope 5 Bronco HD features an integrated camera module, with built-in dual LED illumination. The image module provides a cropped 800x800 Pixels signal from the 1280x800 (1 megapixel) 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.
Ambu® aBox 2 displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen. Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope. Can connect to an external monitor. Reusable device.
This document describes a 510(k) premarket notification for the Ambu aScope 5 Broncho HD system. The acceptance criteria and the study proving the device meets these criteria are primarily based on bench testing and adherence to international standards for endoscopes, rather than a clinical study evaluating AI performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance requirements evaluated in accordance with the ISO 8600 series: | All tests passed. |
| - ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements | Met standard requirements. |
| - ISO 8600-3:2019 Optics and optical instruments - Medical endoscopes and certain accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics | Met standard for field of view and direction of view. |
| - ISO 8600-4:2014 Endoscopes - Medical endoscopes and endotherapy devices - Determination of maximum width of insertion portion | Met standard for insertion portion width. |
| - ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics | Met standard for optical resolution. |
| - ISO 8600-6:2020 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary | Met standard for vocabulary. |
| Performance test reports to document the following properties: | All tests passed. |
| - Field of view | Met specifications. |
| - Direction of view | Met specifications. |
| - Depth of Field | Met specifications. |
| - Insertion cord dimensions | Met specifications. |
| - Suction performance | Met specifications. |
| - Bending performance | Met specifications. |
| - Duration of use | Met specifications. |
| Performance test reports to document shelf life. Tests were performed on finished, sterilized, and aged products: | All tests passed. |
| - Performance tests | Met specifications after aging. |
| - Sterile packaging integrity | Maintained integrity after aging. |
| Biocompatibility according to ISO 10993-1 including cytotoxicity, irritation, sensitization, and systemic toxicity: | All tests passed. |
| - Cytotoxicity (ISO 10993-5) | Met standard. |
| - Irritation (ISO 10993-23) | Met standard. |
| - Sensitization (ISO 10993-10) | Met standard. |
| - Systemic toxicity test (ISO 10993-11) | Met standard. |
| Test reports that verify the Electromagnetic Compatibility and Electrical Safety: | All tests passed. |
| - Electromagnetic Compatibility in compliance with IEC 60601-1-2 | Met standard. |
| - Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18 | Met standard. |
| Overall conclusion: The Ambu® aScope™ 5 Broncho HD system performed as expected and met the test specifications set. | The device system met all test specifications and performed as expected. |
2. Sample size used for the test set and the data provenance
The document describes bench testing and adherence to international standards for device performance, biocompatibility, electromagnetic compatibility, and electrical safety. It does not refer to a "test set" in the context of a clinical study with patient data (e.g., images). Therefore:
- Sample size for the test set: Not applicable in the context of clinical data. The "samples" would be the devices and materials tested according to the listed standards. The exact number of devices or material samples used for each bench test is not specified.
- Data provenance: Not applicable in the context of clinical data. The data is generated from laboratory bench tests and material analyses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the provided document focuses on bench testing and engineering performance evaluations, not diagnostic accuracy studies involving expert interpretation of medical images or data. Ground truth for these types of tests is generally based on objective measurements by calibrated instruments and adherence to established engineering standards.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. The testing described here involves objective pass/fail criteria based on physical and electrical properties, and compliance with standards.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance was not done or reported in this submission summary. The device described (a bronchoscope and display unit) is a visualization and instrument delivery system, not an AI-powered diagnostic tool. The submission focuses on the safety and effectiveness of the hardware itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a medical device hardware system, not an AI algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on objective measurements against established engineering and safety standards (e.g., ISO 8600 series, IEC 60601 series, ISO 10993 series parameters for field of view, suction performance, electrical safety, biocompatibility limits, etc.). It is not derived from expert consensus, pathology, or outcomes data in the traditional sense of clinical diagnostic ground truth.
8. The sample size for the training set
Not applicable. This submission is for a medical device (bronchoscope system), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI algorithm, so there is no training set or associated ground truth establishment process in this context.
§ 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.