(29 days)
Ambu® aScope™ 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract. Ambu® aScope™ 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. Ambu® aScope™ 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi.
Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.
The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aView™ 2 Advance.
The Ambu® aScope™ 5 Uretero is a sterile, digital video ureteroscope. The Ambu® aScope™ 5 Uretero can be used in retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for providing endoscopic access and visual quidance to and in the upper urinary tract.
The Ambu® aScope™ 5 Uretero is available in one size and can be operated by either left or right hand. The Ambu® aScope™ 5 Uretero can be used with endoscopic accessories. The working channel system allows the passage of endoscopic instillation/ suction of fluids. The Ambu° aScope™ 5 Uretero is intended to be used with a compatible Ambu displaying unit, Ambu° aView™ 2 Advance.
The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8″ LCD screen. The displaying unit is powered by a rechargeable lithium-ion battery and includes a power supply with region-specific power cable.
The Ambu® aView™ 2 Advance has the following physical and performance characteristics:
- · Can process and display live imaging data from Ambu® aScope™ 5 Uretero to a monitor
- · Can record, store and transport image data from Ambu® aScope™ 5 Uretero
- Is a portable device with an integrated monitor, and the possibility to connect to an external monitor
This FDA 510(k) summary (K242108) is a clearance for an updated version of the Ambu® aScope™ 5 Uretero and Ambu® aView™ 2 Advance, primarily focusing on additional compatibility between these two devices. It does not provide a study to prove the device meets acceptance criteria in the traditional sense of a clinical or comparative effectiveness study against a human baseline. Instead, it describes non-clinical performance testing to demonstrate that the updated device combination remains safe and effective and substantially equivalent to its predicate devices.
Therefore, many of the requested categories (like MRMC study, expert ground truth, sample size for test sets/training sets in a clinical context) are not applicable or cannot be extracted from this specific document, as the summary focuses on technical performance and equivalence,
not a study of diagnostic accuracy or human performance improvement.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document lists various performance characteristics that were tested. The overall reported performance is that the device "performed as expected and met the test specifications set." Specific numerical acceptance criteria or performance metrics are not
provided in this summary.
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Optical performance | Performed as expected and met test specifications |
| - Field of view and Direction of view | Performed as expected and met test specifications |
| - Sharpness and Depth of field | Performed as expected and met test specifications |
| - Image intensity uniformity | Performed as expected and met test specifications |
| - Geometric distortion | Performed as expected and met test specifications |
| - Resolution | Performed as expected and met test specifications |
| - Color performance | Performed as expected and met test specifications |
| - Noise performance | Performed as expected and met test specifications |
| - Dynamic range | Performed as expected and met test specifications |
| Software verification testing | Performed as expected and met test specifications |
| Electrical Safety (IEC 60601-1:2005+A1:2012+A2:2020 Ed. 3.2 and IEC 60601-2-18:2009 Ed. 3.0) | Performed as expected and met test specifications |
| Electromagnetic Compatibility (IEC 60601-1-2:2014+A1:2020 Ed. 4.1) | Performed as expected and met test specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document describes non-clinical performance testing of the device itself (hardware and software), not a study with patient data. Therefore, the concepts of "sample size" for a test set (in a clinical context) or "data provenance" (country/retrospective/prospective) are not applicable. The testing was likely conducted in a controlled lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. As this involved technical performance testing of the device, not a diagnostic or clinical evaluation, the concept of "experts" establishing ground truth in a clinical sense is not relevant here. Engineering and testing personnel would have verified performance against technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. Adjudication methods like 2+1 or 3+1 are used for clinical studies with expert reviewers. This was technical performance testing.
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. This document does not mention or describe an MRMC comparative effectiveness study. The device is a ureteroscope system, not an AI-assisted diagnostic tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
N/A. This is a medical device for direct visualization, not an algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical tests would be the established engineering and optical specifications/standards (e.g., specific measurable values for resolution, field of view, electrical safety limits set by IEC standards, etc.) that the device was designed to meet.
8. The sample size for the training set:
N/A. This document pertains to the clearance of a physical medical device and its compatibility, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
N/A. Not applicable for the reasons stated above.
§ 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.