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POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.

TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.

This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.

The provided text describes the acceptance criteria and the study conducted for the POCKET TENS (EP-300) device.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document states that the POCKET TENS (EP-300) device underwent a series of safety and performance tests. It doesn't explicitly list specific quantitative acceptance criteria values next to the device performance for most parameters, but generally states that "All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices."

However, a comparison table (Section 12) between the subject device and two predicate devices provides various specifications. This comparison indirectly implies the acceptance criteria are met if the subject device's specifications are comparable or within acceptable ranges of the predicate devices and comply with relevant standards.

Here's a summary of the stated performance and comparison points, implying acceptance criteria are met by equivalence or compliance:

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 explicitly mention a "test set" in the context of clinical data. It states, "No clinical test data was used to support the decision of substantial equivalence."

Instead, the evaluation appears to be based on non-clinical testing, compliance with recognized standards, and comparison with predicate devices. For these non-clinical tests (e.g., biocompatibility, software validation, EMC, electrical safety, performance verification, usability), the sample sizes are not specified, nor is the country of origin or whether they were retrospective or prospective.

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, as no clinical test data was used and therefore no need for experts to establish ground truth for a clinical test set. The substantial equivalence relies on technical comparison and compliance with standards.

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

Not applicable, as no clinical test data was used and therefore no adjudication was necessary.

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. The device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

Not applicable. The device is a physical TENS unit, not an algorithm.

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

Not applicable, as no clinical test data was used. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles outlined in the referenced national and international standards (e.g., ISO, IEC, ANSI/AAMI standards, FDA guidance documents).

8. The sample size for the training set

Not applicable, as the device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as the device is not an AI/ML algorithm.

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The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) 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 Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) 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 are fixed for every operation mode, only the intensity is adjustable within specified limit. The Balego™ TENS Digital Edition 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 Balego™ TENS Digital Edition are pre-program modes with fixed pulse width, pulse rate, frequency. The amplitude for each program are adjustable. The subject and predicate devices both use Everyway Electrode, Wire Series/ model no. KF5050, size 50x50mm, wire type as a standard accessory. The Electrode was cleared under K083302.

With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual 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.

This regulatory submission for the Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) (K181207) does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (EV-804 OTC Pain Relief TENS, K172919). This means that the acceptance criteria are implicitly met by virtue of being essentially the same as the predicate device, which presumably met its own acceptance criteria during its clearance.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria as performance thresholds for this specific device in comparison to a clinical outcome. Instead, the acceptance criteria are met by demonstrating the device's technical specifications and intended use are identical or very similar to the predicate device.

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

• Sample Size for Test Set: Not applicable in this context. The submission relies on technical comparison to a predicate device rather than a new clinical test set.
• Data Provenance: Not applicable for a traditional test set. The data presented focuses on the technical specifications and comparison to a predicate device. The manufacturing establishment is in Taiwan.

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 as no clinical test set requiring expert ground truth establishment was conducted.

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

• Not applicable as no clinical test set requiring adjudication was conducted.

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

• No MRMC comparative effectiveness study was done. This device is a TENS unit for pain relief, not an AI-powered diagnostic tool engaging human readers.

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

• No standalone algorithm performance study was done. This device is a physical TENS unit.

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

• Not applicable for a "ground truth" in the typical sense of a diagnostic or prognostic device. The "ground truth" for this submission is the established performance and safety profile of the predicate device based on its own prior clearance.

8. The sample size for the training set

• Not applicable. There is no training set for an AI algorithm mentioned.

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

• Not applicable. There is no training set for an AI algorithm mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves" the device meets acceptance criteria is a technical and regulatory comparison study against a legally marketed predicate device (EV-804 OTC Pain Relief TENS, K172919). The core argument is that, because the Balego™ TENS Digital Edition is identical in all material respects (intended use, technological characteristics, manufacturing, and general labeling) to its predicate device, it is therefore substantially equivalent and inherently meets the same safety and effectiveness standards that the predicate device met for its clearance.

The report states: "Non-clinical performance data is not required to determine the safety and performance of the device. The subject device is identical to the predicate device with regards to intended use, technological characteristics, manufacturing, and labeling (apart from the different tradename). Therefore, descriptive information alone is sufficient to address the substantial equivalence determination." This explicitly indicates that a new dedicated study to establish functional performance or clinical efficacy was not undertaken for K181207.

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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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To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin.

Single patient use - re-usable.

Self adhering and re-positionable.

Over the counter use.

Theratrode electrodes are constructed as a layered assembly comprised of four components:

• A patient contacting layer of hydrogel material which has been tested and . found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin.
• A carbon dispersion pad middle layer that evenly distributes the electrical . current across the surface of the electrode,
• A non-conductive top layer of various materials such as spun lace (fabric), . polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode.
• A wire or conductive carbon fiber lead wire which is glued to the assembly . of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today. The female connector complies with IEC60601-1 Sub clause 56 3(c).

Theratrode electrodes are non-sterile and are intended for multiple use by a single patient to apply electrical stimulation. Theratrode's construction is equivalent to the predicate device's construction.

The provided document, K112312, is a 510(k) summary for Phoenix Medical Devices' Theratrode Family of Cutaneous Electrodes. This document does not describe an AI/ML medical device, and therefore the requested information regarding AI model performance, multi-reader multi-case studies, expert adjudication, training/test sets, and ground truth establishment for AI applications is not applicable to this submission.

Instead, this document details the substantial equivalence of the Theratrode electrodes to a legally marketed predicate device (Lifecare Electrodes, K083302) based on traditional medical device assessment methods.

Here's a breakdown of the relevant information provided:

Acceptance Criteria and Device Performance (for a non-AI/ML device)

The basis for substantial equivalence for this type of device (cutaneous electrodes) primarily relies on:

• Construction: The Theratrode electrodes are constructed in the same manner as the predicate device (layered assembly of hydrogel, carbon dispersion pad, non-conductive top layer, lead wire).
• Materials: Constructed of the same or similar bio-compatible materials to the predicate device.
• Indications for Use: Identical indications for use as the predicate device: "To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin. Single patient use - re-usable. Self adhering and re-positionable. Over the counter use."
• Performance Characteristics: Very similar performance characteristics, specifically electrical conductivity (inverse of impedance).

Acceptance Criteria and Reported Device Performance Table (based on the provided document)

Since there are no established performance standards for cutaneous electrodes, the acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device. The key performance metric assessed was electrical conductivity.

Non-Applicable Information for this Traditional Device Submission

As this is a 510(k) for cutaneous electrodes, and not an AI/ML medical device, the following points from your request are not relevant or discussed in the document:

• Sample size used for the test set and the data provenance: Not an AI test set; bench testing was performed. The document doesn't specify a "sample size" in the context of a dataset for an algorithm. It implies multiple electrodes were tested.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not generated for this type of device.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating observer performance, typically with imaging or diagnostic devices where human interpretation is central.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable in the AI sense. The "ground truth" for this device lies in its physical and electrical properties being demonstrably equivalent to a safe and effective predicate.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

In summary, the K112312 submission demonstrates substantial equivalence for a traditional medical device (cutaneous electrodes) through a comparison of design, materials, intended use, and bench test performance to a predicate device, rather than through AI/ML model validation methods.

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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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