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Ambu® aScope™ Colon:
The aScope™ Colon is a sterile, single-use, flexible colonoscope intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy.
The aScope™ Colon is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
Ambu® aBox™ 2:
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Colon Endoscopy System is a system used for endoscopic procedures in the gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Colon, and a displaying unit, the Ambu® aBox™ 2.
The Ambu® aScope™ Colon is a sterile, single-use flexible colonoscope for accessing and examining the lower gastrointestinal anatomy. The endoscope provides a working channel for use of endotherapy accessories, as well as insufflation suction, rinsing and a water jet function. Visualization is realised via an integrated camera module with bulit-in LEDs for illumination.
The Ambu® aBox™ 2 displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ Colon endoscope on the screen Can record snapshots or video of image from Ambu® aScope™ Colon endoscope Can connect to an external monitor Is a reusable device

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

The provided FDA 510(k) Summary for the Ambu® aScope™ Colon and Ambu® aBox™ 2 is for a medical device, not a software AI algorithm. Therefore, the device performance is evaluated based on bench testing of physical and functional characteristics, rather than AI performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML-based medical devices.

Consequently, many of the requested categories (e.g., effect size of human readers with AI, standalone performance, training set details, expert qualifications for ground truth, adjudication methods) are not applicable to this type of device submission. The safety and effectiveness are established through engineering and biological testing, demonstrating that the device performs as intended and is safe for its stated indications.

Acceptance Criteria and Study Details for Ambu® aScope™ Colon Endoscopy System

Due to the nature of this submission being for a physical medical device (an endoscope and its display unit) rather than an AI/ML algorithm, the concept of "acceptance criteria" and "study" differs significantly. The acceptance criteria here refer to the successful completion of various engineering, performance, safety, and biocompatibility tests. The "study" is a compilation of these various tests and validations confirming the device's adherence to established standards and specifications.

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

Overall Conclusion: "In all instances, the Ambu® aScope™ Colon Endoscopy System performed as expected and met the set test specifications."

2. Sample size used for the test set and the data provenance
This information is not provided in the summary. For a physical device, the "test set" would refer to the number of devices or components subjected to each specific test. The provenance would refer to the manufacturing site and conditions, not typically specified in such detail in a 510(k) summary. Given this is a sterile, single-use device, extensive bench testing would typically be performed on a statistically relevant sample size from manufacturing lots, although the exact numbers are not detailed here.

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 device is not an AI/ML algorithm requiring expert ground truth for classification. Ground truth for a physical device is established by engineering specifications, validated test methods, and compliance with recognized standards.

4. Adjudication method for the test set
This is not applicable as the device is not an AI/ML algorithm requiring expert consensus for annotation or diagnosis. Performance is based on objective measurements against predefined 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
This is not applicable. The device is a direct visualization tool without AI assistance. Its effectiveness is based on its ability to provide clear visualization and facilitate endoscopic procedures, not on enhancing human interpretation through AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical endoscope and a display unit, not an algorithm. Its performance is inherently tied to human operation and observation.

7. The type of ground truth used
For physical device testing, the "ground truth" is established by:

• Engineering Specifications: Designed performance parameters (e.g., length, diameter, bending angles, optical characteristics).
• Validated Test Methods: Standardized procedures to objectively measure these parameters.
• Recognized Standards: Compliance with international and national standards for safety, biocompatibility, sterilization, electrical safety, and electromagnetic compatibility (e.g., IEC 62471, ISO 10993-1, ISO 11135, IEC 60601 series).

8. The sample size for the training set
This is not applicable. The device is not an AI/ML algorithm; therefore, there is no "training set" in the machine learning sense. Design and development are based on engineering principles and preclinical testing.

9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.

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