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PZ-2622 is TENS and EMS Stimulator
Mode 1-12: TENS: This mode is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Mode 13-24: EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

PZ-2622E (Mode 1-24) is EMS Stimulator
This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

PZ-2622T (Mode 1-24) is TENS Stimulator
This device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

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I am sorry, but the provided FDA 510(k) Clearance Letter for "Smart Pulse Relief" (K250033) is for a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS). This document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI or algorithm-driven component.

The letter primarily focuses on:

• Confirmation of 510(k) clearance and substantial equivalence to legally marketed predicate devices.
• Regulatory requirements and general controls for medical devices.
• Indications for Use for the various models (PZ-2622, PZ-2622T, PZ-2622E).

TENS and EMS devices typically operate based on electrical stimulation parameters (e.g., intensity, frequency, pulse width) and are cleared based on electrical safety, biocompatibility, and performance testing related to these physical parameters, rather than AI model performance or diagnostic accuracy.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone algorithm performance, ground truth types, training set details) from this document, as it pertains to AI/algorithm performance studies which are not described here for this specific device.

To fulfill your request, I would need a 510(k) summary or a scientific publication that details the clinical validation or performance study for a medical device that incorporates an AI or algorithmic component, and explicitly outlines its acceptance criteria and the results of a study designed to prove those criteria are met.

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