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MEDIPOINT is intended for relief of chronic or acute pain.
MEDIPOINT is an electronic pulse generator that has been designed to provide in MEDIPOINT IS an electionic pulse generator that has has has and post-traumatic acute pain (TENS).

MEDIPOINT is a portable hand held battery operated micro current pulse generator Pusing a very minute biphasic DC current.

The provided text is a 510(k) Premarket Notification for the MEDIPOINT Microcurrent Therapy device. It does not contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics.

Instead, the document focuses on:

• Device Identification: Trade name (MEDIPOINT), common name (Microcurrent Therapy), and classification name (Transcutaneous electrical nerve stimulator for pain relief).
• Predicate Device: Identifies SOLITENS™ (K913522) as the predicate device.
• Device Description: A portable hand-held, battery-operated micro current pulse generator using a very minute biphasic DC current.
• Intended Use: For relief of chronic or acute pain.
• FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
• Indications For Use: Specifically states "MEDIPOINT is an electronic pulse generator that has been designed to provide in MEDIPOINT IS an electronic pulse generator that has has has and post-traumatic acute pain (TENS)." (There appears to be a transcription error in the original document's "Indications For Use" statement, with repeated words).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating its performance against such criteria, as this information is not present in the provided text. The 510(k) pathway primarily demonstrates substantial equivalence to a predicate device, rather than requiring extensive performance studies against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might.

The other requested information (sample size, data provenance, expert details, adjudication, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are also not found in this document, as they would typically be part of detailed clinical or performance studies, which are not outlined here.

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