(224 days)
The 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.
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.
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.
The aBox™ 2 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® aBox™ 2.
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 guidance 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 instruments, instillation/ suction of fluids. The aScope 5 Uretero is intended to be used with a compatible Ambu displaying unit - Ambu® aBox™ 2.
The Ambu® aBox™ 2, 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 base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.
The Ambu® aBox™ 2 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
The provided text pertains to a 510(k) premarket notification for the Ambu® aScope™ 5 Uretero and Ambu® aBox™ 2. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial to prove a new device meets specific performance criteria.
Therefore, the document describes verification and validation testing against predefined specifications and established standards, not a comparative clinical study with acceptance criteria in the manner requested for an AI/device performance study.
Based on the provided text, the device's performance was evaluated through a series of non-clinical (bench) tests to demonstrate that it performs as expected and meets its predefined specifications. There is no mention of an AI component requiring a study to prove improved human reader performance with AI assistance, nor is there information about ground truth established by experts, sample sizes for training or test sets in the context of an AI model.
The document explicitly states: "All included bench tests, which have been designed to evaluate substantial equivalence as well as the product's conformity to established quality and performance measures, have been successfully conducted, and have passed the predefined acceptance criteria."
Here's an attempt to answer your questions based only on the provided text, highlighting what is and is not present:
Acceptance Criteria and Study for Ambu® aScope™ 5 Uretero and Ambu® aBox™ 2
The acceptance criteria and "study" described in this 510(k) are primarily focused on non-clinical verification and validation testing to demonstrate substantial equivalence to predicate devices, rather than a clinical trial for an AI-powered device. The device in question is a flexible digital video ureteroscope and its display unit. There is no indication of an AI component in this submission.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists categories of tests performed and states that the device "met the test specifications set" and "passed the predefined acceptance criteria." However, it does not provide a specific table with quantitative acceptance criteria values or detailed reported performance values for each test. Instead, it offers a high-level summary of the types of tests conducted.
| Category of Test | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Verification Tests | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Insertion portion dimensions and performance | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Working channel performance | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Bending performance | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Irrigation performance | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Suction performance | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Functionality | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Optical Performance Tests | "Test specifications set" (e.g., ISO 8600-3) | "Performed as expected and met the test specifications set." |
| Field of view (ISO 8600-3) | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Direction of view (ISO 8600-3) | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Sharpness and Depth of field | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Image intensity uniformity | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Geometric distortion | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Resolution | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Color performance | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Noise performance | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Dynamic range | "Test specifications set" | "Performed as expected and met the test specifications set." |
| Safety & Other Tests | Relevant ISO/IEC/ASTM standards | "Performed as expected and met the test specifications set." |
| Photobiological safety (IEC 62471) | "IEC 62471" | "Performed as expected and met the test specifications set." |
| Transportation study (ASTM D4169) | "ASTM D4169" | "Performed as expected and met the test specifications set." |
| Sterilization validation (ISO 11135) | "ISO 11135" | "Performed as expected and met the test specifications set." |
| Stability study (ASTM F1980) | "ASTM F1980" | "Performed as expected and met the test specifications set." |
| Sterile packaging integrity | N/A (implied by sterile packaging) | "Performed as expected and met the test specifications set." |
| Biocompatibility (ISO 10993) | "ISO 10993-1, 5, 23, 10, 11" | "Assessed according to relevant standards." |
| Electrical Safety (IEC 60601-1, 60601-2-18) | "IEC 60601-1 and IEC 60601-2-18" | "Performed as expected and met the test specifications set." |
| EMC (IEC 60601-1-2) | "IEC 60601-1-2" | "Performed as expected and met the test specifications set." |
2. Sample Size for Test Set and Data Provenance:
The document describes bench testing, not clinical studies with patient data. Therefore, the concept of "sample size for the test set" in the context of patient data is not applicable here. The "test set" would refer to the number of devices or components tested during verification and validation. The document does not specify the number of units tested for each category. Data provenance (country of origin, retrospective/prospective) is not applicable to these bench tests.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The ground truth for this device's performance is based on engineering specifications and recognized industry standards (e.g., ISO, IEC, ASTM), not expert consensus from medical image review.
4. Adjudication Method for the Test Set:
Not applicable. This was not a study involving human interpretation of medical images or data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not performed. The device is a ureteroscope and a display unit, not an AI diagnostic tool designed to assist human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device does not have an AI algorithm with standalone performance.
7. Type of Ground Truth Used:
The "ground truth" for this submission is based on engineering specifications, design requirements, and adherence to international performance and safety standards (e.g., ISO 8600-3 for optical performance, IEC 60601 for electrical safety, ISO 11135 for sterilization, ISO 10993 for biocompatibility). There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. Sample Size for the Training Set:
Not applicable. This device does not involve training an AI model, so there is no training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable. As above, there is no AI training set.
§ 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.