(83 days)
The Epix® VT is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
The Epix® VT is a dual channel TENS device with twelve pre-programmed output modes. It is powered by a standard 9V rechargeable battery with a maximum output of 60mA. The Epix® VT has the ability to monitor the pain level of the user before and after a treatment session, number of treatment sessions, the intensity range of each treatment session and the length of each treatment session. Using this information, the Epix® VT calculates and displays the percentage of sessions with pain relief, the number of sessions used, the average session length, the most frequent change in pain relief and the most frequent intensity range used. The Epix VT System requires the use of a set of lead wires and one or two pair of electrodes. The lead wires used with the Epix® VT have a protected safety connector which attaches to the device and either a snap or pin style connector which attaches to the electrode.
The provided text describes a medical device, the Epix® VT TENS System, and its comparison to a predicate device for 510(k) submission. However, it does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on sample sizes, ground truth establishment, or expert involvement as requested.
The document primarily focuses on:
- Device Description: What the Epix® VT is and its features.
- Intended Use: The medical conditions it's designed to treat, which are identical to its predicate device.
- Technological Differences: How it differs from the predicate device (Epix® XL TENS System), primarily in user interface (buttons vs. knobs, LCD display), safety connectors, and a slight reduction in frequency options for some modes, along with added data recording/display features.
- Non-Clinical Test Results (Summary): A general statement that design qualification testing was performed based on hazard analysis and voluntary standards, including firmware, functional, simulated misuse/safety, and electromagnetic compatibility testing. It concludes that "the results showed that the product meets specifications and functions as expected."
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance study as this information is not present in the provided text.
The document states: "The results of all testing done show that this design meets all specifications, is equivalent to currently marketed products and is acceptable for its intended use." This is a general conclusion, not a detailed breakdown of acceptance criteria and performance data.
Here's a breakdown of what is not available in the provided text, corresponding to your request:
- A table of acceptance criteria and the reported device performance: Not provided. The text only vaguely states "meets specifications."
- Sample size used for the test set and the data provenance: Not mentioned. The document only lists types of non-clinical tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with "ground truth" is described. The device is a TENS unit, and its assessment is primarily functional and safety-related rather than diagnostic.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a TENS device, not an AI diagnostic algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).