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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."

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.

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