(166 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety | Tested in accordance with applicable standards for medical device electrical safety. |
| Electromagnetic Compatibility (EMC) | Tested in accordance with applicable standards for electromagnetic compatibility. |
| Safety of Nerve and Muscle Stimulators (Specific Requirements) | Tested in accordance with particular requirements for safety of nerve and muscle stimulators. |
| Accessory Safety (Electrodes) | Specified 510(k) electrodes are used and meet safety requirements. |
| Accessory Safety (Patient Cable) | Patient cable utilizes shrouded connectors to meet lead wire safety requirements. |
| System Level Functionality (Waveform Testing) | System level testing, including waveform testing, was performed. |
| Substantial Equivalence (to Predicate Devices) | New devices (EVERLIFE Transcutaneous Nerve Stimulators) are found to be as safe and effective as, and function in a manner equivalent to, the predicate devices based on product description and tests. Specifically, several models are either "Identical" or demonstrate "Substantial Equivalence" to predicate devices (K902102, K931570, K012643, K021755, K970429). |
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.
§ 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).