(53 days)
TENS (Mode 16)6)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 1
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
1)Stylish appearance, compact size, humanized design for easy portability.
2)TENS and EMS modes with 6 different modes each, catering to various treatment needs and a wider range of users.
3)Dual-channel output, allowing control of intensity for each channel.
4)Unique combination of electric pulses for a different sensory experience.
5)LCD display for clear and easy use.
6)Powered by three AAA batteries (size 7), providing long-lasting usage and convenient for home and travel use.
7) The electrode patches used with the device are previously cleared under K221589 for safety use. The main unit delivers the electrical
The document describes the acceptance criteria and study proving the device meets the criteria.
Note: The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. As such, the "acceptance criteria" discussed are primarily related to general device safety and performance according to established standards and the "study" is a non-clinical testing report to demonstrate substantial equivalence to predicate devices, rather than a clinical efficacy trial. The information available in a 510(k) summary for a TENS device typically does not include the detailed breakdown of acceptance criteria and multi-reader studies as might be found for more complex AI/ML-driven diagnostic devices.
Here's the breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (Transcutaneous Electrical Nerve Stimulator), "acceptance criteria" are predominantly demonstrated through compliance with recognized electrical safety and performance standards, and comparison to predicate devices. There aren't explicit numerical targets for accuracy, sensitivity, or specificity as might be found for a diagnostic AI model.
| Acceptance Criterion (Demonstrated by) | Reported Device Performance (Compliance/Similarity) |
|---|---|
| Electrical Safety Standards | |
| IEC 60601-1 (Basic safety & essential performance) | Test passed |
| IEC 60601-1-2 (Electromagnetic disturbances) | Test passed |
| IEC 60601-1-11 (Home healthcare environment) | Test passed |
| IEC 60601-2-10 (Nerve & muscle stimulators) | Test passed; output parameters found similar to predicates |
| Biocompatibility Standards (for electrode patches) | |
| ISO 10993-5 (In Vitro Cytotoxicity) | Electrode patches comply (cleared under K221589) |
| ISO 10993-10 (Irritation & Skin Sensitization) | Electrode patches comply (cleared under K221589) |
| Software Verification & Validation | |
| FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices | Tests conducted and passed |
| Output Waveform Specifications | |
| FDA Guidance Document for Powered Muscle Stimulator 510(k)s | Waveform test report conducted and passed |
| Technological Equivalence to Predicates | |
| Same intended use | Yes |
| Same mode of action | Yes |
| Same design (dual-channel, display) | Yes |
| Similar output parameters (Max Output Current, Pulse frequency, etc.) | Yes (tested according to IEC 60601-2-10) |
| Same waveform and shape (biphasic symmetric square wave, rectangular) | Yes |
| Same safety features (Type BF applied part) | Yes |
| Same housing materials | Yes (ABS plastic) |
| Similar energy source | Yes (three AAA batteries, 4.5V DC) |
| Differences (modes, intensity levels, size, weight) | Determined not to lead to safety/effectiveness problems; output parameters similar, passed IEC 60601-2-10 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a dataset for an AI model. For this TENS device, the "testing" refers to non-clinical verification and validation activities conducted on the physical device itself.
- Sample Size: Not applicable in the context of an AI/ML test dataset. The testing was performed on the device prototypes/production samples.
- Data Provenance: Not applicable. The "data" are results from engineering and electrical tests on the device, not patient data. The electrode patches relied on previous FDA clearance (K221589), implying their safety and biocompatibility data would originate from the studies for that specific clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI/ML diagnostic device that requires expert-established ground truth from medical images/data. The ground truth for this device's performance is compliance with engineering standards and direct measurement of its electrical outputs.
4. Adjudication Method for the Test Set
Not applicable. There is no expert review or adjudication process described for the device's functional performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a TENS unit, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the device's electrical outputs and safety features were evaluated independently for compliance with standards. This is not an AI algorithm, so the term "standalone" performance isn't directly analogous, but the device's intrinsic characteristics were tested.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Engineering Specifications and Industry Standards: The device's output parameters (e.g., current, frequency, waveform) are measured and compared against design specifications and the requirements of standards like IEC 60601-2-10.
- Safety Standards Compliance: The device's electrical safety and electromagnetic compatibility are tested against established performance criteria outlined in IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.
- Biocompatibility Data: For the electrode patches, the "ground truth" for safety (e.g., non-cytotoxicity, non-irritation) was established through previous testing for clearance K221589, likely following ISO 10993 standards.
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML component or training set, this question is not relevant.
§ 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).