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The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications:

• -Symptomatic relief of post-surgical and/or post traumatic acute pain
• -Symptomatic relief of chronic intractable pain
  -Relaxation of muscle spasms
  -Maintaining and increasing range of motion
  -Increases local blood circulation

The Avid IF2, Model AV-IF19A is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad.

The provided document is a 510(k) Premarket Notification for the Avid IF2 Interferential Stimulator, Model AV-IF19A. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (including sample size, expert involvement, adjudication methods, MRMC studies, standalone performance), and ground truth establishment cannot be extracted from this document.

This document describes a device based on well-established technology (transcutaneous electrical nerve stimulation for pain relief) and demonstrates its similarity to previously cleared devices. It relies on device specification comparison and waveform analysis to prove substantial equivalence, not clinical performance data derived from patient studies or AI algorithm validation.

However, I can extract the information that is present, which primarily revolves around the comparative specifications used to demonstrate "equivalency" rather than "acceptance criteria" for a novel performance claim.

Here's an attempt to frame the available information in the context of your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicates)

The "acceptance criteria" in this context are not typically quantitative metrics for clinical performance for a novel claim but rather a demonstration that the new device's technical specifications and operational characteristics are substantially equivalent to predicates. The study proving this involves comparing the new device's outputs and functionalities to those of the predicate devices.

Table 1: "Acceptance Criteria" (Substantial Equivalence Parameters) and Reported Device Performance

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