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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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Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

EVERLIFE, Various Models of Self Adhesive Electrodes, AP series

The provided text is a 510(k) summary for the EVERLIFE Self Adhesive Electrodes. This document primarily focuses on establishing substantial equivalence to a predicate device based on intended use and existing safety/effectiveness data for similar products. It does not contain information about a study proving specific performance acceptance criteria for the EVERLIFE electrodes.

Therefore, many of the requested elements for describing an acceptance criteria study cannot be found in the provided text.

Here is an analysis of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for the electrical performance (e.g., impedance levels, signal-to-noise ratio) of the EVERLIFE Self Adhesive Electrodes, nor does it report specific device performance data against such criteria.

The closest to "acceptance criteria" are the biocompatibility tests performed, which are inherently "pass/fail" or "meet standard X" criteria.

The summary states, "the effect of impedance levels for the intended situations is assured for both of the devices, and the safety and effectiveness hazards are not present." This is a qualitative statement about performance relative to the predicate, but it does not specify quantitative acceptance criteria or report measured impedance levels.

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

Not applicable. No performance study data is presented for the EVERLIFE electrodes related to signal recording or electrical stimulation. The biocompatibility tests, while involving samples, do not align with a "test set" in the context of diagnostic or AI device performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This information is relevant for studies establishing ground truth, typically in AI/diagnostic imaging, which is not the subject of this 510(k) submission.

4. Adjudication Method

Not applicable. No expert-based adjudication process is described in the context of device performance testing.

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

No. This document does not pertain to an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant or mentioned.

6. Standalone (Algorithm Only) Performance

No. This device is a medical accessory (electrodes), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" here is implied by the successful completion of the biocompatibility tests according to ISO standards, and the claim of substantial equivalence based on the predicate device's established safety and effectiveness. For the biocompatibility, the "ground truth" would be the standard biological reactions or lack thereof as defined by the ISO guidelines.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI or machine learning product.

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

Not applicable. As there is no training set, this information is irrelevant.

In summary, the provided 510(k) document is for a medical accessory (self-adhesive electrodes) and primarily relies on substantial equivalence to a legally marketed predicate device, along with successful biocompatibility testing. It does not describe a performance study with quantitative acceptance criteria, test sets, or expert-adjudicated ground truth as would be seen for a diagnostic or AI-driven device.

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