(46 days)
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
TENS Series Electro-Stimulator, which includes models TENS 2800 and TENS 3000, are Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients. These TENS electro-stimulator have the same housing in a molded portable plastic case, an accessible, switch, and accessible battery storage compartment. The case shape is rectangular, The process to set the parameter and attach lead wires to the two models is also the same except the Housing printing artwork, Mode No. TENS 3000 stimulator has three treatment mode: normal mode, burst mode and modulation mode. The treatment mode can by selected by switch. TENS 2800 only one treatment mode: normal mode. The difference on the two device can be identified by panel, Mode No.
The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS device) seeking substantial equivalence to a predicate device. This type of submission does not typically involve clinical trials with acceptance criteria, human readers, or ground truth as would be seen in studies for AI/ML-based diagnostic or prognostic devices. Instead, it focuses on non-clinical engineering and safety performance.
Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information and indicate where information is not applicable.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (TENS 2800/3000) |
|---|---|
| Power Source: 9V Battery | 9V Battery |
| Method of Line Current Isolation: Battery Supply N/A | Battery Supply N/A |
| Patient Leakage Current - Normal Condition: 1.1uA | 1.2uA |
| Patient Leakage Current - Single Fault Condition: 1.3uA | 1.3uA |
| Number of Output Channels: 2 | 2 |
| Method of Channel Isolation: By enclosure | By enclosure |
| Regulated Current or Voltage: Voltage control | Voltage control |
| Software/Firmware/Microprocessor Control: Yes | Yes |
| Automatic Overload Trip: No | No |
| Automatic Over Current Trip: No | No |
| Automatic No Load Trip: No | No |
| Automatic Shut off: No | No |
| Patient Override Control: No | No |
| Indicator Display - On/Off Status: Yes | Yes |
| Indicator Display - Voltage/Current Level: Yes | Yes |
| Indicator Display - Low Battery: Yes | Yes |
| Waveform: Biphasic Rectangular pulse | Biphasic or Monophasic Rectangular pulse |
| Compliance with Voluntary Standards: IEC60601-1, IEC60601-1-2, IEC60601-2-10 | IEC60601-1, IEC60601-1-2, IEC60601-2-10 |
| Compliance with 21 CFR 898: Yes | Yes |
| Housing Materials & Construction: Enclosure: ABS,94, V-1,80°C,UL Approved | Enclosure: ABS,94, V-1,80°C,UL Approved |
Note: Some criteria from the predicate device differ slightly or are not explicitly stated as "acceptance criteria" but serve as a basis for substantial equivalence comparison. For example, timer range, pulse width range, frequency range, weight, and dimensions are compared but aren't presented as strict acceptance criteria in the same way as safety metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a TENS device, which relies on non-clinical testing (bench testing, safety reports, risk analysis) rather than clinical studies with test sets in the context of diagnostic performance. The document focuses on performance specifications and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of expert review, is not relevant for this type of device submission. The "truth" is established by adherence to engineering specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method was used, as this was not a clinical evaluation of diagnostic performance.
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 is a TENS device, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware-based TENS stimulator, not an algorithm or AI model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is based on established electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and performance specifications that are expected for TENS devices, as demonstrated through bench testing and risk analysis. The comparison to the predicate device's characteristics also serves as a benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. This is an electrical medical device submission, not a machine learning model, so there is no concept of a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply.
§ 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).