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Disposable neutral electrodes are self-adhesive, ready-to-use and single-use products and are an accessory for HF surgery in monopolar applications. The electrical circuit between the patient and the HF generator on the passive side.

BOWA Neutral Electrodes for adults, children and neonates provide a safe return path for electrosurgical current. The electrode consists of a conductive adhesive area surrounded by a non-conductive border adhesive. The conductive area is split in longitudinal or circumferential direction which enables a quicker detection of disconnection. The electrode backing is fluid resistant. The neutral electrode is single-use only, disposable, and non-sterile. The electrodes are supplied with or without a pre-attached cable. For the non-pre-corded electrodes, a reusable cable is available as accessory.

The provided document describes the FDA 510(k) premarket notification for BOWA Neutral Electrodes, which are accessories for electrosurgical cutting and coagulation devices. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria for AI-related functions.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using an AI/ML context (e.g., accuracy, sensitivity, specificity) is not present in this document.

This document is for an electrosurgical accessory and its 510(k) submission primarily relies on:

• Comparison to predicate devices: Highlighting similarities in intended use, indications for use, principles of operation, and technological characteristics.
• Non-clinical performance data: This includes compliance with established electrical safety and biocompatibility standards (e.g., IEC 60601-2-2, ISO 10993-1, ISO 10993-5, ISO 10993-10), shelf-life testing, and reprocessing testing for consumable accessories.

There is no mention of AI/ML components, diagnostic performance metrics (accuracy, sensitivity, specificity), test sets, training sets, ground truth establishment by experts, or MRMC studies.

In summary, this document does not contain the information needed to address the prompt's specific requirements concerning acceptance criteria and study details for an AI-powered device.

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