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The Ambu® aScope™ 2 is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non- difficult and difficult intubating procedures or for visualization of the airway during Percutaneous Tracheostomy (PT) procedures. The Ambu® aScope™ 2 achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu® aScope™ 2 is in the human anatomy. The flexible tip of the Ambu® aScope™ 2 allows the user to guide the ETT in the desired direction. The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.

Ambu aScope System consist of Ambu aScope 2 and Ambu aScope Monitor. Ambu aScope 2 is for viewing anatomical structures in the upper airways, and as an aid in placement of an endotracheal tube (ETT), an ETT size 6 or larger can be used. A camera at the distal tip of the aScope provides the user with an indication of the placement of the aScope. The manoeuvrable tip allows the user to guide the ETT in the desired direction. Ambu aScope is for single patient use and it is sterile. The Ambu aScope 2 must be connected to Ambu aScope Monitor. The monitor displays the image and it is reusable. Ambu aScope 2 has the following physical and performance characteristics: - Manoeuvrable tip controlled by the clinician - Flexible insertion cord - Camera and LED light source at the distal tip - Topical Anaesthetics can be administered to the patient via a channel, with standard Luer connector - Oxygen flow can be applied via a channel using a flow connector attached to the Luer connector - Sterile by Ethylene Oxide sterilisation - For Single Patient Use Ambu aScope Monitor has the following physical and performance characteristics: - Displays the image from Ambu aScope 2 on the screen. - Can be fixed to e.g. an IV pole. - By connecting a Video Out Cable to the Ambu aScope Monitor the image can be displayed and/or recorded on an external monitor and/or video recorder. - Reusable device.

Here's a breakdown of the acceptance criteria and study information for the Ambu® aScope™ 2 and Ambu® aScope™ Monitor, based on the provided text:

Acceptance Criteria and Reported Device Performance

• EN 60068-2-27 (Shock: 500 repetitive shocks, 400 m/s^2)
• EN 60068-2-64 (Vibration: 1.6 grms, 10-150Hz, 30 min/axis)
• EN 60068-2-31 (Rough handling: 12 falls from 1.2m height) | All products and packaging passed the tests. |
  | Device performance maintained after (without packaging):
• EN 60608-2-6 (Vibration: 5Hz, 1grms, 1 hour)
• EN 60068-2-31 (Free fall: Ambu aScope 2: 2 falls per relevant orientation from 1.2m to concrete; Ambu aScope Monitor: 2 falls per relevant orientation from 0.2m to concrete) | All products and packaging passed the tests. |
  | Biocompatibility (ISO 10993-1): | |
  | Cytotoxicity (ISO 10993-5) | All tests were passed. |
  | Sensitization (ISO 10993-10) | All tests were passed. |
  | Intracutaneous reactivity test (ISO 10993-10) | All tests were passed. |
  | General Requirements: | |
  | Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation (AAMI TIR12 and AAMI TIR30) | All tests were passed. |
  | Electro Magnetic Compatibility (IEC 60601-1-2) | All tests were passed. |
  | Electrical Safety (IEC 60601-1 and IEC 60601-2-18) | All tests were passed. |

Study Details

1. Sample size used for the test set and the data provenance:

   • Ambu aScope 2 (Single-Use): Not explicitly stated how many individual devices were tested for "manoeuvrability," "endurance," "Luer channel," "temperature," and "shelf life." The shelf life testing was done on "finished, sterilized, shipped and aged products," implying a specific batch or set of products.
   • Ambu aScope Monitor (Reusable): For imaging performance, 32 scopes were evaluated. For cleaning endurance and battery capacity, the reports state tests demonstrated the monitor "can withstand" or has "at least 70% battery capacity after 150 times reprocessing/charging," implying the test was conducted on at least one monitor undergoing 150 cycles.
   • Environmental Tests: For transportation, the tests were conducted with dedicated packaging. For bounce and free fall, tests were conducted without packaging. The specific number of devices tested for these environmental assessments is not explicitly stated beyond "All products and packaging passed the tests."
   • Biocompatibility & General Requirements: Standardized tests (e.g., ISO, AAMI, IEC) are mentioned, which would involve a defined number of samples per test, but the exact number isn't quantified in this summary.
   • Data Provenance: The studies were conducted by Ambu A/S, indicating internal testing. The country of origin for the data (Denmark) is implied by the submitter's address. All studies appear to be prospective bench testing or product performance evaluations, not involving patient data or human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This submission describes bench testing and performance evaluations against engineering specifications and international standards, not clinical studies requiring expert ground truth for interpretation of medical images or outcomes. Therefore, no information on experts establishing ground truth for a test set is provided as it's not applicable to this type of submission.

3. Adjudication method for the test set:

   • Not applicable, as this is a bench testing and performance evaluation summary, not a clinical study involving human interpretation or adjudication of medical findings.

4. 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 MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or reported in this 510(k) summary. The device is a physical endoscope and monitor system, not an AI-powered diagnostic tool. The focus is on demonstrating the safety, functionality, and performance of the hardware.

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

   • No standalone algorithm performance study was conducted. This device is a manual endoscope system and does not involve an AI algorithm.

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

   • For the performance tests, the "ground truth" was the pre-defined engineering specifications and internationally recognized consensus standards (e.g., specific angles for tip manoeuvrability, volume expelled from a channel, temperature limits, seal strength, battery capacity, compliance with ISO, AAMI, IEC standards).

7. The sample size for the training set:

   • Not applicable. This is a medical device hardware submission, not a machine learning or AI algorithm submission that would require a 'training set.'

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI algorithm. The performance criteria were established through engineering design, risk analysis, and adherence to relevant industry standards for medical devices.

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