(203 days)
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.
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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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.
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The sample size for the training set: Not applicable. The device is not an AI/ML model that requires training data.
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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.
§ 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.