(77 days)
The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree.
The aScope 3 system is for use in a hospital environment.
The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes:
| Minimum ETT inner diameter | Minimum DLT size | |
|---|---|---|
| aScope 3 Slim 3.8/1.2 | 5.0 mm | 37 Fr |
| aScope 3 Regular 5.0/2.2 | 6.0 mm | 41 Fr |
| aScope 3 Large 5.8/2.8 | 7.0 mm | - |
Endoscopic accessories designed for a minimum working channel width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.
Endoscopic accessories designed for a minimum working channel width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.
Endoscopic accessories designed for a minimum working channel width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.
The Ambu® aScope™ 3 System consists of:
Ambu® aScope™ 3 Regular 5.0/2.2
Ambu® aScope™ 3 Slim 3.8/1.2
Ambu® aScope™ 3 Large 5.8/2.8
Ambu® aView™ Monitor
Ambu® aScope™ 3 is a sterile single use flexible bronchoscope and Ambu® aView™ is a reusable monitor.
Ambu® aScope™ 3 endoscopes 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
Working channel
Sterilized by Ethylene Oxide
For single use
The differences between the Ambu® aScope™ 3 endoscope sizes are as follows:
Distal end outer diameter
Insertion tube outer diameter
Working channel inner diameter
Angulation range
Ambu® aView™ Monitor has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 3 endoscope on the screen.
Can record snapshots or video of image from Ambu® aScope™ 3 endoscope.
Can connect to an external monitor.
Reusable device
The provided document is a 510(k) summary for the Ambu® aScope™ 3 System, which includes flexible bronchoscopes and an associated monitor. It describes the device, its intended use, and a comparison to predicate devices, along with performance data.
However, the document states "Performance Data - Clinical: Not applicable." and focuses primarily on bench testing for the product line extension (Ambu® aScope™ 3 Large). This means that a clinical study to prove device performance in the context of patient outcomes or diagnostic accuracy in a clinical setting, or involving human readers and AI assistance, was not required or provided for this particular submission.
Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as they relate to clinical performance and AI algorithm evaluation, which are not detailed here.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document primarily details bench testing for the "Ambu® aScope™ 3 Large" product line extension. Acceptance criteria are implied by the successful completion of these tests.
| Acceptance Criteria (Implied by passed tests) | Reported Device Performance (Ambu® aScope™ 3 Large) |
|---|---|
| Compliance with ISO 8600-1, -3, -4, and ISO 594-1 | Declaration of Conformity maintained |
| Acceptable Bending Angle Performance | Tests passed |
| Acceptable Bending Section Endurance | Tests passed |
| Acceptable Aging Performance | Tests passed |
| Acceptable Sterile Packaging Integrity | Tests passed |
| Electrical Compatibility with IEC 60601-1-2 | Tests passed |
| Electrical Safety with IEC 60601-1 and IEC 60601-2-18 | Tests passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for each bench test. It mentions "Performance tests to document the properties" and "Aging Performance Test", but not the number of units tested. This data is from bench testing, not human or clinical data. The submitter is Ambu A/S, based in Denmark.
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)
Not applicable. The ground truth for bench tests would be defined by engineering specifications and objective measurements, not expert human assessment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used for clinical data interpretation or image annotation, not for bench testing of device specifications.
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. The document explicitly states "Performance Data - Clinical: Not applicable," and this submission does not involve clinical performance evaluation or AI capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a medical instrument (bronchoscope and monitor), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the ground truth would be established by engineering standards, material specifications, and objective measurement tools. For example, a bending angle would be measured against a defined specification, not an expert's opinion.
8. The sample size for the training set
Not applicable. This document describes a medical device (endoscope and monitor), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI algorithm discussed in this document.
§ 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.