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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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aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Cysto HD System is a combination of an endoscope, Ambu® aScope™ 5 Cysto HD, and a compatible displaying unit, Ambu® aBox™ 2.

Ambu aScope 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract. The cystoscope is intended to be used with a compatible and reusable Ambu displaying unit to visualise the urethra and the bladder.

The cystoscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu ° a Scope 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 cystoscope are available: aScope 5 Cysto HD – Reverse Deflection and aScope 5 Cysto HD – Standard Deflection. Apart from the mode of deflection, the cystoscopes share the same design.

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 Cysto HD to a monitor
• Can record, store and transport image data from Ambu® aScope™ 5 Cysto HD
• Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

The provided text is a 510(k) Premarket Notification summary from the FDA for a medical device called the Ambu® aScope™ 5 Cysto HD System. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to legally marketed predicate devices.

However, the document does not contain the detailed acceptance criteria and the study results in the format requested (e.g., a table of acceptance criteria vs. device performance, sample sizes for test/training sets, expert qualifications, clear details on MRMC studies, or specific ground truth methodologies for image-based AI studies).

This 510(k) summary primarily lists the types of tests performed (e.g., bending performance, optical performance tests, biocompatibility, electrical safety) and states that the device "performed as expected and met the test specifications set" or "passed the predefined acceptance criteria." It does not provide the specific numerical acceptance criteria or the actual measured performance values for these tests. Also, there is no mention of AI/ML or image-based diagnostic assistance, so no specific information on AI model training, ground truth establishment through expert consensus, or MRMC studies is present in this document.

Therefore,Based on the provided text, I cannot provide the specific details regarding acceptance criteria and study results in the format requested. The document does not contain this level of detail.

The document states: "In all instances, the Ambu® aScope™ 5 Cysto HD System performed as expected and met the test specifications set. N/A 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." This is a general statement of compliance, not a detailed breakdown of criteria and performance.

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only lists types of tests (e.g., Bending performance, Irrigation performance, Optical performance tests like Field of view, Sharpness and Depth of field, Resolution, Color performance, Noise performance, Dynamic range) and states they "met the test specifications set" or "passed the predefined acceptance criteria" without giving the specifics.

2. Sample sizes used for the test set and the data provenance: Not provided. The tests mentioned are primarily bench tests, electrical safety, biocompatibility, and stability tests rather than clinical study data from patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable based on the provided document. This document describes the safety and performance validation of an endoscope and its display unit, not an AI-enabled diagnostic device that would require expert-established ground truth for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. The device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For the physical and optical performance tests, the "ground truth" would be established by validated measurement standards and engineering specifications rather than clinical ground truth as understood for diagnostic AI.

8. The sample size for the training set: Not applicable. The device is not an AI/ML model that requires training data.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) Premarket Notification summary confirms that various non-clinical performance and safety tests were conducted and successfully met predefined acceptance criteria. However, it does not offer the detailed breakdown of the acceptance criteria or reported performance values, nor does it describe AI-specific testing methodologies (like MRMC studies, training/test set details for AI, or expert ground truth). This is likely because the device cleared (endoscope and display unit) is a hardware device where the focus of the submission is on physical, optical, electrical, and biocompatibility performance, not on AI/ML diagnostic capabilities.

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