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The CystoSure® Plus catheter provides access and visualization for the female urinary bladder.

The single-use CystoSure® Plus catheter provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of an endoscope. It is suitable for medium- to long-term use with a maximum patient indwelling time < 30 days.

The CystoSure® and CystoSure® Plus catheters are intended for use in the diagnostic visualization of the female bladder with a port to allow for the insertion of an endoscope. They are made from silicone and they are used in both surgical and diagnostic procedures for draining the bladder and enabling the visualization of internal bladder surfaces.

The provided text is a 510(k) summary for the CystoSure® Plus Catheter. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-based medical device performance study.

The document states: "The CystoSure Plus catheter meets all performance criteria of the predicate CystoSure catheter." However, it does not elaborate on what these performance criteria are, nor does it present data from a specific study demonstrating compliance with these criteria for the CystoSure Plus device itself. Instead, the submission relies on the concept of "substantial equivalence" to a legally marketed predicate device (K142194 CystoSure Urinary Access System) and modifications for improved patient comfort and ease of insertion.

Therefore, I cannot provide the requested information. The text does not describe an AI/ML device, nor does it include a study with acceptance criteria specific to the performance of such a device.

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The CystoSure™ Urinary Access System provides catheterization and visualization for the female urinary bladder.

The CystoSure™ rigid metal scope is used to visualize the urinary bladder for diagnostic procedures. The CystoSure™ access catheter accessory provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of the CystoSure™ scope.

The Emmy Medical CystoSure Urinary Access System is intended for use in the diagnostic visualization of the female bladder. The CystoSure cystoscope is a reusable, rod lens optic that can be used with standard O.R. camera couplers and light guides. The length and field of view of the Emmy Medical cystoscope are optimized for inspection of the female bladder. The Emmy Medical cystoscope does not include the traditional outer sheath as those functions are provided by the access catheter accessory.

The CystoSure Access Catheter accessory provides a single use access catheter with four ports: One for bladder drainage, one for bladder irrigation, one for balloon inflation and one for the CystoSure cystoscope. The access catheter encompasses only one balloon size (5 cc) and length (female only) and it does not include any hydrophilic or antimicrobial coatings or features to make it radiopaque.

This document is a 510(k) Premarket Notification for the CystoSure™ Urinary Access System. It does not contain information about an AI-powered device or a study comparing AI with human readers. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as these are not relevant to the content provided.

The document focuses on demonstrating substantial equivalence of the CystoSure™ Urinary Access System to legally marketed predicate devices based on design, materials, construction, intended use, and technological characteristics, supported by nonclinical testing, biocompatibility, and sterilization validation.

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