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Intended Use / Indications for Use

The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.

Product codes

GXY

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.

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The provided text is a 510(k) clearance letter from the FDA for the "Everlast Neurostimulation Electrodes." This document primarily addresses the substantial equivalence of the device to a previously marketed predicate device and grants permission to market the product.

Crucially, the document does not contain information regarding acceptance criteria, a study proving the device meets those criteria, or any details about a clinical study's methodology (sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance).

Therefore, I cannot provide the requested information. The 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, which may involve non-clinical testing and comparison of device characteristics rather than a full-scale clinical trial with acceptance criteria specific to its performance.

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