(220 days)
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
| Acceptance Criteria Category | Specific Tests/Evaluations Performed | Reported Device Performance |
|---|---|---|
| Geometrical Characteristics | - Length of insertion tube, umbilical cord, tip | Performed as expected and met set test specifications. |
| - Outer diameter of bending section, insertion tube, and overlap | ||
| - Tip reach | ||
| - Bending angles | ||
| - Working channel width | ||
| Functional Performance | - Insufflation | Performed as expected and met set test specifications. |
| - Suction | ||
| - Rinsing | ||
| - Water Jet | ||
| Optical Performance | - Field of view | Performed as expected and met set test specifications. |
| - Direction of view | ||
| - Sharpness and Depth of field | ||
| - Geometric distortion | ||
| - Image intensity uniformity | ||
| - Color performance | ||
| - Noise characterization | ||
| - Dynamic range | ||
| - Camera view orientation | ||
| Safety & Biocompatibility | - Photobiological safety (according to IEC 62471) | Performed as expected and met set test specifications. |
| - Biocompatibility (according to ISO 10993-1, including cytotoxicity, irritation, and sensitization) | ||
| - Sterilization validation (according to ISO 11135) | ||
| - Transport validation (including packaging integrity) | ||
| - Stability study (to document shelf life) | ||
| - Electrical Safety and performance (according to IEC 60601-1 and IEC 60601-2-18) | ||
| - Electromagnetic Compatibility (according to IEC 60601-1-2) | ||
| Procedural Performance | - Tests to confirm procedural performance | Performed as expected and met set test specifications. |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.