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Interferential Stimulation can be used 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
• Maintain or increase range of motion
• Increase local blood circulation

Neuromuscular Stimulation can be used in the following applications:

• · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
• · Prevention or retardation of disuse atrophy
• · Muscle-re-education

The Avid CT2, Model AV-CT20A is a combination therapy device. Like its predicate Avid IF2, it 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 primary difference between the two devices is the addition of user- adjustable parameters that allow the existing interferential waveform to turn on and off within a small, preselected range to provide necessary control for neuromuscular stimulation. This same method of gating the interferential on and off was used in VQ's previous Surgi Stim stimulator.

The provided text is a 510(k) summary for a medical device called the "Avid CT2 Neuromuscular and Interferential Stimulation System." It aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document does not contain the information requested in the prompt regarding acceptance criteria for device performance studies, sample sizes, expert involvement, or MRMC studies. This type of information is typically found in clinical study reports or validation documents, not in a 510(k) summary focused on demonstrating equivalence through comparison to predicate devices' specifications and functionalities.

The document primarily focuses on bench testing and electrical output comparisons to establish substantial equivalence, rather than human-in-the-loop performance studies or clinical effectiveness trials that would involve the detailed data collection and analysis described in the prompt.

Therefore, I cannot extract the requested information from this document. The prompt's requirements pertain to performance studies, especially those involving human interaction or clinical outcomes, which are not detailed in this 510(k) summary.

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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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