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Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, Removal of Ureteral Calculus, and Treatment of Vesical Neck Constriction.

The Vista CTR Bipolar Loop Electrode is a double loop bipolar electrosurgical device, designed to work with currently marketed Electrosurgery Systems. These systems consist of an electrosurgical generator (the Controller), a reusable or disposable Cable (Bipolar Active Cord) and a Bipolar Resectoscope System.

The provided document is a 510(k) premarket notification for a medical device called the "ACMI Vista CTR Bipolar Loop Electrode." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics commonly seen in software or AI/ML device submissions.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or specific study designs (MRMC or standalone).

Here's why the requested information isn't present in this document:

• Device Type: This is a physical electrosurgical device, not a software or AI/ML-based device that would typically involve performance metrics like sensitivity, specificity, or the impact of AI on human reader performance.
• Regulatory Pathway: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This is often achieved through comparative testing (e.g., bench testing, material compatibility) and a review of intended use and technological characteristics, not necessarily through clinical studies with quantifiable performance metrics against a defined standard.
• Focus of this specific 510(k): This particular submission is a "Special 510(k)" which proposes modifications (materials, packaging, sterilization, labeling) to an existing device. It explicitly states that "The indications for use, principles of operation, of the Vista CTR Bipolar Loop Electrode remain the same as in the predicate devices. The proposed modifications... are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This means the focus is on showing the modifications don't negatively impact the established performance, rather than proving new performance criteria.

In summary, the provided text does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way a performance study for a diagnostic or AI-driven device would.

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