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510(k) Data Aggregation
(185 days)
The aScope Gastro is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.
The aScope Gastro is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
The aBox 2 is intended to display live imaging data from compatible Ambu visualization devices.
The Ambu® Gastrointestinal (GI) 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™ Gastro, and a displaying unit, the Ambu® aBox™ 2.
The provided text describes the 510(k) premarket notification for the Ambu® aScope™ Gastro and Ambu® aBox™ 2, an endoscopic system. However, it does not contain information about a study that proves a device meets acceptance criteria related to an AI/ML algorithm or its performance in detection/diagnosis as is typically associated with the requested criteria (e.g., sensitivity, specificity, expert ground truth, MRMC studies).
The "Acceptance Criteria" listed in the document refer to general performance tests for the endoscopic system (e.g., geometrical characteristics, functional performance, optical performance, safety, etc.) rather than the performance of an AI/ML algorithm in a clinical setting for a specific diagnostic task.
Therefore, I cannot fulfill the request to provide details about a study that proves an AI/ML-enabled device meets acceptance criteria based on the provided text, as the text describes a conventional medical device submission without mention of an AI/ML component.
The following table and subsequent sections would be populated if the document contained information about an AI/ML component and its performance study.
Based on the provided text, the device is a standard endoscope system, not one that utilizes AI/ML for diagnostic or detection purposes. Therefore, the requested information regarding AI/ML-specific acceptance criteria and performance studies (like sensitivity, specificity, MRMC studies, ground truth establishment for AI training/testing) is not present in the document.
The "Performance Data - Bench" section in the document lists the following types of tests, which are typical for an endoscope:
| Acceptance Criteria (as gathered from "Performance Data - Bench") | Reported Device Performance |
|---|---|
| Geometrical Characteristics: | Performed as expected and met the set test specifications. |
| - Length of insertion tube, umbilical cord, tip | |
| - Outer diameter of bending section, insertion tube and overlap | |
| - Tip reach | |
| - Bending angles | |
| Functional Performance: | Performed as expected and met the set test specifications. |
| - Insufflation | |
| - Suction | |
| - Rinsing | |
| - Water Jet | |
| Optical Performance: | Performed as expected and met the set test specifications. |
| - Field of view | |
| - Direction of view | |
| - Sharpness and Depth of field | |
| - Geometric distortion | |
| - Image intensity uniformity | |
| - Color performance | |
| - Noise characterization | |
| - Dynamic range | |
| - Camera view orientation | |
| Safety and Other Performance: | Performed as expected and met the set test specifications. |
| - Photobiological safety | |
| - Biocompatibility (cytotoxicity, irritation, sensitization) | |
| - Sterilization validation | |
| - Transport validation (packaging integrity) | |
| - Stability study (shelf life) | |
| - Electrical Safety and performance (IEC 60601-1, IEC 60601-2-18) | |
| - Electromagnetic Compatibility (IEC 60601-1-2) | |
| - Procedural performance |
The document states: "In all instances, the Ambu® GI Endoscopy System performed as expected and met the set test specifications."
Given the content, I cannot provide the following requested information, as it pertains to AI/ML algorithm validation, which is not described in this submission:
- Sample sizes for test set and data provenance: Not applicable, as this is for a traditional medical device, not an AI/ML algorithm detection study.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study: Not mentioned or applicable for this device.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable for AI/ML validation. Ground truth for an endoscope's performance would be physical measurements and established engineering standards.
- Sample size for training set: Not applicable (no AI/ML training dataset).
- How ground truth for training set was established: Not applicable.
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