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Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain.

VT-300 device is portable and battery operated. VT-300 Device is comprised of a PCBA and a lithium-ion battery enclosed in a polycarbonate housing. The device's dimensions are 2.1 inches wide, 3.3 inches long, and 0.75 inch in height.

Vecttor VT-300 provides Interferential Current Therapy. Eight electrodes attached to a pair of lead wires are intended to be positioned on the patient's body to deliver four channels of current from VT-300 dual output jacks. Temperature sensors continually monitor finger surface temperatures with the intention of identifying and then applying an Interferential Current Therapy level that results in specified temperature increases.

The user controls the VT-300 device using Vecttor Mobile App which is a mobile application downloadable on Bluetooth enabled mobile devices using Android or iOS operating systems from the Google Play or Apple App store. Vecttor Mobile App provides the necessary user interface to establish connection to the VT-300 device via Bluetooth, and operate VT-300 device to provide interferential current therapy.

The provided text is a 510(k) premarket notification for the Vecttor VT-300 device, which is a transcutaneous electrical nerve stimulator for pain relief. The document mainly focuses on demonstrating substantial equivalence to a predicate device (Vecttor VT-200) based on technological characteristics and non-clinical performance testing.

Crucially, this document states: "No clinical tests are being submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence."

This means that the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically related to clinical performance (e.g., human reader performance, ground truth establishment, sample sizes for medical imaging AI/ML models), is not present in this document.

The "acceptance criteria" presented are related to the device's technical specifications and compliance with recognized standards, not its clinical efficacy or AI/ML performance.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided text, as it pertains to a different type of device clearance (hardware-based equivalence) and explicitly states the absence of clinical test data.

If the prompt were for an AI/ML medical device, the information requested would be highly relevant. However, for this specific device (a TENS unit), the clearance pathway does not require such studies to demonstrate substantial equivalence if predicate devices exist and technical specifications can be shown to be equivalent or safer.

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