(132 days)
aScope 5 Cysto HD is a sterile, single-use, flexible cysto-nephroscope intended to be used for endoscopic access to and examination of the lower urinary tract and kidney.
The cysto-nephroscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.
The Ambu® aScope™ 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract and kidney via antegrade (percutaneous) access. The cysto-nephroscope is intended to be used with a compatible and reusable Ambu displaying unit (the Ambu® aBox™ 2 or the Ambu® aView™ 2 Advance) to visualise the urethra and the bladder as well as the kidney.
The cysto-nephroscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, for instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu® aScope 5 Cysto HD shall be disposed of as infected medical device with electronic components.
Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cysto-nephroscope are available: aScope 5 Cysto HD - Reverse Deflection and aScope 5 Cysto HD - Standard Deflection. Apart from the mode of deflection, the cysto-nephroscopes share the same design.
The provided FDA 510(k) Clearance Letter for the Ambu® aScope™ 5 Cysto HD (K250269) does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.
This device is a physical endoscope, and the provided document focuses on its mechanical, optical, and safety characteristics following standard medical device testing procedures. There is no mention of an AI/ML component or associated performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for AI/ML performance. The document only lists verification and optical performance tests for the physical device, and states that these tests were met.
Here's an analysis based on the information that is present in the document, acknowledging that it's not related to AI/ML performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that the device "met the test specifications set" and "passed the predefined acceptance criteria" for various tests. However, it does not provide specific numerical acceptance criteria or detailed reported performance values for most of these tests. For instance, for "Resolution," it doesn't state "Resolution shall be X lines per mm, and was Y lines per mm."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Verification Tests | Performed as expected and met test specifications. (e.g., Bending, Irrigation, Working Channel, Laser Fiber Activation Compatibility, High Frequency Tool Activation Compatibility, Functionality) |
| Optical Performance Tests | Performed as expected and met test specifications. (e.g., Field of view (ISO 8600-3), Direction of view (ISO 8600-3), Sharpness and Depth of field, Image intensity uniformity, Geometric distortion, Resolution, Color performance, Noise performance, Dynamic range) |
| Photobiological Safety | Met according to IEC 62471. |
| Transportation Study | Met according to ASTM D4169. |
| Sterilization Validation | Met according to ISO 11135. |
| Stability Study | Documented shelf life according to ASTM F1980. |
| Sterile Packaging Integrity | Met. |
| Biocompatibility | Met according to ISO 10993-1 (including Cytotoxicity, Irritation, Sensitization, Material-mediated pyrogenicity, Acute Systemic Toxicity). |
| Electrical Safety & Performance | Met according to IEC 60601-1 and IEC 60601-2-18. |
| Electromagnetic Compatibility | Met according to IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
Since this is not an AI/ML clinical study, but rather engineering and bench testing of a physical device:
- Sample Size: Not specified for most tests. For physical device verification and optical performance tests, the "sample size" would typically refer to the number of physical devices or components tested. The document does not provide these numbers.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data comes from internal testing and validation activities by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. For physical device performance, "ground truth" is defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM, IEC). It does not involve expert readers establishing a medical diagnosis "ground truth."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for AI/ML, to resolve discrepancies among human readers or validate AI outputs against human consensus. This device's testing involves objective measurements against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document pertains to the clearance of a medical device (endoscope), not an AI/ML diagnostic software. There is no mention of human readers, AI assistance, or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. The device is a physical endoscope. There is no AI/ML algorithm described that would have standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Engineering Specifications: Internal design requirements for the device.
- International Standards: e.g., ISO 8600-3 (for field of view, direction of view), IEC 62471 (photobiological safety), ASTM D4169 (transportation), ISO 11135 (sterilization), ASTM F1980 (stability/shelf life), ISO 10993-1 (biocompatibility), IEC 60601-1/60601-2-18 (electrical safety), IEC 60601-1-2 (EMC).
- Validated Test Methods: Procedures designed to objectively measure specific performance characteristics.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component mentioned that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI/ML component or training set.
In summary: The provided FDA 510(k) clearance letter details the regulatory approval of a physical endoscope (Ambu® aScope™ 5 Cysto HD). It successfully underwent a series of non-clinical (bench) tests to demonstrate its safety and performance in line with established engineering specifications and international standards, thereby proving substantial equivalence to a predicate device. However, it does not involve any AI/ML components or studies that would address acceptance criteria related to AI/ML performance, such as diagnostic accuracy, human reader improvement, or training/validation data characteristics.
§ 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.