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The Everyway EV-820 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The Everyway EV-820 OTC Pain Relief TENS is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.

The Everyway EV-820 OTC Pain Relief TENS consists mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.

The stimulation modes for Everyway EV-820 OTC Pain Relief TENS is pre-program modes with fixed pulse width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simple design change from the pre-program modes of comparison clear model, existing 510(k) cleared devices, Low Back Pain Relief System/ Model EV-820(K110716). Every operation mode of Everyway EV-820 OTC Pain Relief TENS Syste has its individual stimulation operation cycle.

I am unable to provide a description of acceptance criteria and a study that proves the device meets the acceptance criteria from the provided document. The document is a 510(k) premarket notification letter from the FDA to Everyway Medical Instruments Co., Ltd. regarding their Everyway EV-820 OTC Pain Relief TENS device.

Here's why I cannot fulfill your request based on the provided text:

• No specific acceptance criteria are stated: The document primarily focuses on establishing substantial equivalence to predicate devices based on regulatory classification, intended use, and technological characteristics. It does not define specific performance metrics or acceptance criteria for the device itself (e.g., pain reduction percentage, battery life benchmarks).
• No detailed study is presented to prove acceptance criteria: The document explicitly states: "No particular Clinical Test was conducted for Everyway EV-820 OTC Pain Relief TENS." It mentions compliance with voluntary standards (IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2) and software verification, which are non-clinical tests for safety and performance, but these are not presented as studies designed to prove specific acceptance criteria for the device's therapeutic effectiveness. The comparison tables provided highlight characteristics, not performance against acceptance criteria.
• The document is a regulatory submission, not a research paper: A 510(k) summary aims to demonstrate substantial equivalence to legally marketed predicate devices, not to present a detailed clinical study proving device effectiveness against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from this document.

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The LIFECARE Arm & Leg Pain Relief System, model EV-820 is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities

The LIFECARE Arm & Leg Pain Relief System, model EV-820 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. Basically the stimulation model EV-820 is completely identical to that of model as mentioned in our previous submission of Everyway Low Back Pain Relief System, model EV-820(K110716). To change the indication for use for the treatment location as the chosen predicate devices, Everyway changed the design of electrode.

For the device included in this submission, we use the following of our 510(K) legally marketed predicate garment electrodes and self adhesive electrode :

K103716, "Lifecare HC-88 Series Conductive Garments" together with our Lifecare TKF4080( 4x8 CM )/K083302 self adhesive electrode.

EV-820 is a selectable dual channel, 9V battery operated TENS device with the following features:

• The operation function is dual channels completely identical to the model being modified, EV-820 for low back pain relief(K110716).
• For the stimulation electrode, LIFECARE Arm & Leg Pain Relief System, model EV-820 uses our K103716 " Lifecare HC-88 Series Conductive Garment Electrodes" together with our Lifecare TKF4080( 4x8 CM )/K083302 self adhesive electrode as standard accessories.
• The output waveform is selectable pre-programming change among P1~P8.
• The output strength is adjustable at 0~80 mA, with maximum setting time 60 minutes counting from switching ON.
• The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low warning.

With the combination of the main device parts, the device can be worn on the Arm & Leg part of user so as to place the stimulation pads on the treatment location of Arm & Leg for over the counter use without prescription in temporary relief of pain associated with sore and aching muscles in the Arm & Leg.

This document describes the 510(k) summary for the LIFECARE Arm & Leg Pain Relief System, model EV-820.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly define acceptance criteria as pass/fail thresholds for clinical performance metrics (e.g., specific pain reduction percentages). Instead, the acceptance criteria are implicitly based on demonstrating substantial equivalence to predicate devices through device characteristics and electrical output comparisons.

The reported device performance primarily focuses on the electrical output characteristics of the device and direct comparison to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" in the traditional sense involving human subjects for performance evaluation. The "test set" for demonstrating electrical output equivalence consisted of various electrode types (Glove, Sleeve & Knee, Sock) used with a 1K ohm loading resistance.

• Sample Size for Electrical Comparison: Not explicitly stated as a number of devices or measurements, but it refers to the comparison across three electrode types.
• Data Provenance: The electrical output comparison was conducted by the manufacturer, EVERYWAY MEDICAL INSTRUMENTS CO.,LTD., based in Taiwan. This was a prospective measurement for the purpose of this 510(k) submission.

3. 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. There was no clinical ground truth established by experts for a test set. The device's performance was evaluated through non-clinical bench testing and comparison to predicate devices, not through a clinical study with human subjects requiring expert assessment of outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Since there was no clinical test set requiring expert interpretation or adjudication, no such method was employed.

5. 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. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-powered diagnostic or assistive technology that would involve human readers or cases in an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a TENS unit, which is a physical medical device delivering electrical stimulation, not an algorithm. Its "standalone" performance is assessed through its electrical output characteristics and safety testing.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the electrical output comparison, the "ground truth" was the measured electrical output (current and power density) of the predicate devices (Prizm 5000-Z System and Well-Life OTC TENS for Arm & Leg Pain Relief, model WL-2407) under controlled bench testing conditions, against which the EV-820's output was compared. There was no clinical ground truth (e.g., expert consensus on pain, pathology, or outcomes data) used for this 510(k) submission.

8. The sample size for the training set

Not applicable. There was no machine learning or AI component requiring a training set for this device.

9. How the ground truth for the training set was established

Not applicable, as there was no training set.

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