(270 days)
The relief of pain associated with sore or aching muscles due to strain from exercise or normal household work activities.
The EASYWELL TENS System is a Transcutaneous Electrical Nerve Stimulation (TENS) set consisting of a stimulator console, an electrode patch, gel pads and an AC/DC adaptor. used for pain relief. There are two models available over-the-counter- (1) TENS only, and (2) a combination of TENS and heat for a warming sensation up to 41.0℃ (105.8°F). The TENS session lasts 15 minutes with 3 stages of varying frequencies.
The stimulator console is wearable, weights 32g, with one micro-USB port and one LED light indicator. It has two buttons- "+" button to turn on the stimulator console and to increase the TENS intensity level by 1 (10 intensity levels); "." button to decrease the TENS intensity or turn off the stimulator console when it's pressed for 3 seconds. The green LED light is lit up when the stimulator console is activated. The AC/DC adaptor can be connected to the micro-USB port to recharge the Li-ion battery.
The electrode patch is covered by polyester and nylon blended textile and can be connected to the stimulator console via connectors. Patches with varying shapes and sizes are available to fit different and anatomical positions. Carbon fiber is embedded between the electrode and textile to provide heat conductance and far infrared radiation (model EETTA00 and EETTL00 to provide TENS and heat).
The gel pads are applied to the electrode surface. They are directly in contact with the skin and made from medical grade electrically conductive hydrogel. Thev comply with ISO 10993-5 biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 biological evaluation of medical devices- Part 10: tests for irritation and skin sensitization.
The AC/DC adapter is medical graded which complies with IEC 60601-1 and IEC 60601-1-2
The provided document is a 510(k) summary for the Easywell TENS System, a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document focuses on demonstrating substantial equivalence to a predicate device (Omron Heat Pain Pro K160115), rather than providing details of a study with specific acceptance criteria and performance metrics for an AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document, as it describes a different type of medical device submission (a TENS device, not an AI/ML diagnostic or assistive device that would typically involve such studies).
The document details safety and performance testing for the TENS device based on established electrical and medical device standards (e.g., AAMI NS4, IEC 60601 series, ISO 10993 series). The "Performance and Specifications" section in Table 1 shows measured electrical parameters of the device and compares them to the predicate, demonstrating that the device meets general performance characteristics relevant to its function, but not "acceptance criteria" in the context of an AI/ML study evaluating diagnostic accuracy.
In summary, this document is not a study report for an AI/ML device and thus does not contain the information requested in your prompt.
§ 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).