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The Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrode is intended for use in defibrillation procedures, cardioversion, pacing, and ECG monitoring.

The Ludlow Gradient Edge Adult Multifunctional Electrode is for use on adults (an adult is defined as a patient weighing over 10 Kg). The Ludlow Gradient Edge Adult Multifunctional Electrode is not intended for use on children or infants. The device is non-sterile and single-use only.

The Ludlow Gradient Edge Pediatric Multifunctional Electrode is for use on pediatrics (a pediatric is defined as a patient weighing less than 10 Kg). The device is non-sterile and single-use only.

Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes

This document (K012218) is an FDA 510(k) clearance letter for the Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about specific acceptance criteria or details of a study (clinical or otherwise) that proves the device meets such criteria.

The letter focuses on the regulatory determination of substantial equivalence based on the device's indications for use and classification. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information about multi-reader multi-case comparative effectiveness studies, standalone algorithm performance, or ground truth types.
• Details on training sets or how their ground truth was established.

Therefore, I cannot fulfill your request for these specifics based solely on the provided document. The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, which may involve referencing performance data or design specifications of the predicate, but the details of such assessments are typically found in the full 510(k) submission, not in the clearance letter itself.

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