(142 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
The Electronic Pulse Stimulator is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (waist, back, neck, shoulders, legs, and arms). The proposed Electronic Pulse Stimulator, which is compact, portable, and microprocessorcontrolled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
This is a 510(k) premarket notification for a medical device called "Electronic Pulse Stimulator," which is a Transcutaneous Electrical Nerve Stimulator (TENS). The submission argues for substantial equivalence to a predicate device (Prospera OTC TENS Electronic Pulse Massager, K122744).
Here's the analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (TENS), the "acceptance criteria" are primarily related to meeting established electrical and safety standards, and demonstrating substantial equivalence to a legally marketed predicate device. There aren't "performance metrics" in the typical sense (e.g., accuracy, sensitivity, specificity) as one would find for diagnostic AI. Instead, the performance is assessed by meeting established technical specifications that are equivalent to the predicate.
| Acceptance Criteria Category | Specific Criterion / Standard | Reported Device Performance |
|---|---|---|
| Technical Equivalence | Intended Use | Substantially equivalent to predicate |
| Power Source | Battery (Matches predicate) | |
| Number of Output Channels | 2 (Matches predicate) | |
| Automatic Overload Trip | No (Matches predicate) | |
| Automatic No-Load Trip | No (Matches predicate) | |
| Automatic Shut Off | Yes (Matches predicate) | |
| User Override Control | Yes (Matches predicate) | |
| Indicator | Yes (Matches predicate) | |
| Waveform | Pulsed (Matches predicate) | |
| Shape | Rectangular (Matches predicate) | |
| Frequency (Hz) | 100 (Matches predicate) | |
| Maximum charge (µC) at 500Ω | 23 (Matches predicate) | |
| Maximum current density (mA/cm²) at 500Ω | 1.4 (Matches predicate) | |
| Safety and EMC Standards | IEC60601-1 (General requirements for basic safety and essential performance) | Compliance reported |
| IEC60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) | Compliance reported | |
| FDA Specific Regulations | 21 CFR 898 (Performance standards for TENS devices) | Compliance reported |
| Software Verification | FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | Verification carried out according to guidance |
| Accessory Safety | Electrodes meet safety requirements | Requirement met |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a "test set" or "data provenance" in the context of AI/ML performance evaluation. The device is a TENS unit, and its evaluation for substantial equivalence is based on:
- Comparison of technical characteristics with a predicate device.
- Non-clinical testing against recognized electrical safety and electromagnetic compatibility (EMC) standards.
- Software verification.
- Accessory safety.
There are no patient data sets (retrospective or prospective) used to "test" the device's diagnostic or predictive capabilities, as this is a therapeutic device, not a diagnostic AI.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As explained above, there is no "test set" for which ground truth is established by experts in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" and thus no adjudication method for it.
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. TENS devices are not typically evaluated using MRMC studies, as they are not diagnostic tools where human reader performance is a primary metric. The effectiveness of TENS devices is evaluated through clinical trials for specific indications (though for this 510(k), compliance with previous predicate device's intended use and safety standards is sufficient).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the "Electronic Pulse Stimulator" because it is not an AI/ML algorithm or a diagnostic device. It is a physical medical device (TENS unit) that delivers electrical pulses. Its performance is inherent to its physical and electrical specifications, not an algorithm's standalone performance.
7. The Type of Ground Truth Used
Not applicable. There is no "ground truth" as would be defined for AI/ML assessment (e.g., pathology, expert consensus, outcomes data) in this 510(k) submission. The "truth" here is compliance with established electrical and safety standards and equivalence to a predicate device's design and specifications.
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI/ML component; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for one.
§ 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).