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To be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.

The provided document is a 510(k) submission summary for a Transcutaneous Nerve Stimulator (TENS) device. It describes the device, its intended use, and its claim of substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or device performance in the typical sense of a diagnostic or screening algorithm study (e.g., sensitivity, specificity, AUC). Instead, for a TENS device, "acceptance criteria" are related to safety and functionality, and "device performance" refers to demonstrated adherence to these safety and functional standards, and equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a device used for pain relief, not a diagnostic or screening algorithm that would typically have a "test set" of patient data. The evaluation primarily relies on bench testing for electrical safety and functional equivalence, rather than clinical data from a "test set" of patients.

• Sample Size for Test Set: Not applicable in the context of this submission. The tests performed are on the device itself and its accessories, not a dataset of patient cases.
• Data Provenance: The device manufacturer (EVERLIFE MEDICAL EQUIPMENT CO., LTD.) is based in HSIN-CHU CITY, CHINA (TAIWAN). The testing described is non-clinical bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The submission focuses on non-clinical testing and comparison to predicate devices, not on diagnostic accuracy against a "ground truth" established by experts.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication of test set results is mentioned, as the evaluation is based on objective engineering and safety standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document explicitly states: "Clinical Tests Submitted: None". Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or reported.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device (TENS unit), not an AI algorithm. Its performance is inherent in its electrical and mechanical functions, not a standalone algorithmic output.

7. Type of Ground Truth Used

The "ground truth" in this context is the fulfillment of established engineering and safety standards for TENS devices, and the demonstrated functional equivalence to legally marketed predicate devices. There is no "ground truth" derived from patient pathology, outcomes, or expert consensus in a clinical sense for this 510(k) submission.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned in this submission.

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Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy ●
• . Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• . Maintaining or increasing range of motion

A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin.
Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.

The provided document is a 510(k) summary for the EVERLIFE Powered Muscle Stimulator. It outlines the device's intended use and the non-clinical tests performed. However, it explicitly states that no clinical tests were submitted. Therefore, there is no information available to describe acceptance criteria based on clinical performance or a study proving the device meets such criteria.

The substantial equivalence decision for this device was based on comparison to legally marketed predicate devices and non-clinical testing, not on clinical performance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided. The document does not specify quantitative acceptance criteria for device performance based on clinical outcomes or a study proving it meets such criteria. The "Conclusion" section states that the device is "as safe and effective as, and the function in a manner equivalent to the predicate devices" based on product description and non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set or data provenance is mentioned as no clinical studies were submitted. Non-clinical testing was performed on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No clinical test set requiring expert ground truth was performed or submitted.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was performed or submitted.

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 Powered Muscle Stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a Powered Muscle Stimulator, not an algorithm. The non-clinical tests were performed on the device and its accessories, indicating device-alone performance in terms of safety and waveform output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical ground truth was established as no clinical studies were submitted. The "ground truth" for the non-clinical testing would be the defined safety standards and specified waveform outputs, confirmed through laboratory measurements.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm is mentioned as this is a physical medical device, not an AI/algorithm-based product.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is mentioned.

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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.

The IF-100507 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the IF-100507 can provide results from this electrical stimulation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EVERLIFE Interferential Current Therapy, IF-100507:

It is critical to note that the provided documentation is a 510(k) summary for a medical device cleared via the substantial equivalence pathway. This means there was no clinical study explicitly performed to prove the device meets specific performance acceptance criteria defined by the manufacturer for this submission. Instead, the clearance is based on demonstrating equivalence to a predicate device that was already legally marketed.

Therefore, many of the requested sections below will reflect the absence of a direct clinical study for this specific device model.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, there are no specific quantitative "acceptance criteria" for clinical performance established for this device within this document. The device's performance is implicitly accepted as equivalent to the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not applicable. No clinical test set data was provided or generated for this 510(k) submission.
• Data Provenance: Not applicable. No clinical data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No clinical test set requiring expert-established ground truth was performed for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done for this device as part of the 510(k) submission. The clearance is based on substantial equivalence to a predicate device, not a comparative clinical trial.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device itself is a standalone stimulator, no standalone performance study (in the context of an algorithm's output or diagnostic accuracy) was done. The non-clinical tests focused on electrical safety, EMC, and waveform generation.

7. The Type of Ground Truth Used

Not applicable for a clinical performance study. The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate device (APEX Interferential Current Therapy, IF-4000, K952683).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and no "training set" in that context was used or described. The device's design and functionality are based on established engineering principles for interferential current therapy.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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