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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

Since this document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator, it does not describe an AI/ML device or a clinical performance study with human subjects, therefore, the following requested information is not applicable and not present in the provided text:

• Sample sized used for the test set and the data provenance: Not a clinical study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for device specification comparison.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, no AI component.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no AI component.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the established and accepted specifications of legally marketed predicate devices, and the new device's ability to meet those or be within acceptable variance. It's a technical comparison, not a clinical "ground truth" derived from patient outcomes or expert reads.
• The sample size for the training set: Not applicable, no AI component.
• How the ground truth for the training set was established: Not applicable, no AI component.

Summary of the Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" conducted to demonstrate that the Avid IF2 Interferential Stimulator meets its "acceptance criteria" (i.e., is substantially equivalent to predicate devices) primarily involved:

1. Technical Specification Comparison: Detailed tables comparing key electrical output parameters (e.g., max current/voltage, waveform shape, frequency range, phase charge, current/power density) between the Avid IF2 and two previously cleared T.E.A.R. Tech3 predicate devices (K030507 and K090532).
2. Functionality Comparison: Qualitative descriptions of shared functional aspects, such as user interface, power source, software control, and safety features.
3. Waveform Analysis: Presentation of oscilloscope traces (waveform drawings) under various resistive loads (500 Ohm, 2000 Ohm, and 10,000 Ohm) for the Avid IF2, along with claims that these show "cleaner waveforms and less voltage variation over load" compared to the predicates, further supporting equivalence or improvement.
4. Compliance with Standards: Demonstration of compliance with relevant electrical safety (EN60601-1), EMC (IEC60601-1-2), and FDA regulations (21 CFR 898).

The "data provenance" is essentially the manufacturer's internal testing and characterization of their device and comparison to published specifications or their own predicate devices. It is a retrospective analysis based on the design and testing of the new device against existing predicate information.

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