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Disposable neutral electrodes are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.

Solid Electrosurgical pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical pads are for use with generators that have a CQMS (i.e. REM,ARM,NESSY etc.).

Disposable neutral electrodes are part of a family of patient return electrodes. They are non-sterile, single-use devices used in electrosurgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrodes helps to prevent unintended HF burns. The solid electrosurgical pads are designed to be compatible with generators without Contact Quality Monitoring System (CQMS), and the split electrosurgical pads are designed to be compatible with the Contact Quality Monitoring System (CQMS) of compatible generators. The models share the same design elements (functional design, technology design, packaging, etc.) but have different sizes and shapes. The models are designed for adults, children, and neonates, separate catalog numbers are assigned for the intended patients, and pre-attached cord.

Disposable neutral electrodes consist of foam backing, cable connection area, conductive aluminum foil, conductive adhesive gel layer and release liner. The pads are applied on a release liner. The surface of the conductive aluminum foil is fully covered with a soft, conformable conductive adhesive gel.

The electrode backing is made of foam material. The electrodes are supplied with or without cable. For the non-corded pads, a reusable cable is not available as an accessory.

The provided text describes the 510(k) premarket notification for "Disposable Neutral Electrodes" (K242204). This device is classified as an accessory to electrosurgical cutting and coagulation devices. The document focuses on demonstrating substantial equivalence to a predicate device (K203494) through non-clinical performance testing and comparison of characteristics.

This document does not include information about a study that proves a device meets acceptance criteria related to AI/ML software performance. Specifically, it does not contain information on:

• Acceptance criteria for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
• Sample sizes for test sets used to evaluate AI/ML performance.
• Data provenance for AI/ML test sets.
• Number and qualifications of experts for ground truth establishment in an AI/ML context.
• Adjudication methods for AI/ML test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies involving AI assistance.
• Standalone algorithm performance.
• Types of ground truth for AI/ML (e.g., pathology, outcomes data).
• Training set details for AI/ML.

The "Performance Testing" section (page 7) and "Comparison with Predicate Device" section (pages 8-9) refer to engineering and biocompatibility testing for a hardware medical device (neutral electrodes), not AI/ML software.

Therefore,Based on the provided text, I cannot answer your request as it pertains to AI/ML software performance. The document describes the premarket notification for a physical medical device (Disposable Neutral Electrodes) and details the non-clinical testing performed to demonstrate its safety and effectiveness and substantial equivalence to a predicate device. It does not mention any AI/ML components or studies to evaluate AI/ML performance.

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