(63 days)
QuadraTENS is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
The QuadraTENS Model QT-42 is a 2 channel version of the BioTENS with the addition of a burst mode. Like the BioTENS, it is also intended to be used by or on the order of a licensed practitioner. The burst mode has been added specifically because a single stimulus is sometimes insufficient. By adding a second channel, the QuadraTENS Model QT-42 can be applied simultaneously to another separately enervated area on the same patient. The low frequency stimulation (1.0 Hz rate) of the QuadraTENS Model QT-42, the same as its predecessor BioTENS, is applied to a patient through surface electrodes. The Unit is powered by a single 9 volt battery. It produces a symmetrical bipolar pulse with a factory-set pulse-width of 600 microseconds and a rate of 1 pulse/second. The transformer-coupled outputs, which are equivalent to the both the BioTENS and the EMPI Model 989, apply 0.0 milliamps of net dc current to the patient. In the burst mode, a fixed train of 8 pulses with a repetition rate of 800 Hz is output once/second. The nominal pulse amplitude is controlled separately for each channel and ranges from 0.0 ma to a maximum of 40 milliamps peak. The 2 channels are isolated from each other and their output pulses are staggered in time to prevent any current from flowing between channels, which results in zero crosstalk. Each channel also includes a balance control that adjusts the amplitudes of the positive and negative half waves differentially. The balance is used to equalize the responses at each electrode site.
The provided text describes a 510(k) submission for the QuadraTENS Model QT-42, a transcutaneous electrical nerve stimulator (TENS) device. The information focuses on its design, comparison to predicate devices, and non-clinical performance assessment.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design Qualification: | Validation: |
| 1. Validation test of automatic stand-by mode for safety | Completed [x], results validate design meets specifications |
| 2. Validation of symmetric bipolar waveform with zero net DC | Completed [x], results validate design meets specifications |
| 3. Validation test of non-crossover between the separate channel outputs | Completed [x], results validate design meets specifications |
| 4. Validation test of constant current outputs | Completed [x], results validate design meets specifications |
| Equivalence to Legally Marketed Devices: | Results validate device is equivalent to current legally marketed devices |
| Acceptability for Intended Use: | Results validate device is acceptable for its intended use |
| Wave-shape and pulse-width (single pulse mode): | Symmetrical bipolar pulse, factory-set pulse-width of 600 microseconds, rate of 1 pulse/second. (Fig. 1 shows a square wave signal, 5.00V/div, 100 µs/div, peak current 15mA across 1,000 Ohm load) |
| Burst Mode Characteristics: | Fixed train of 8 pulses, repetition rate of 800 Hz, output once/second. Nominal pulse amplitude 0.0 mA to 40 mA peak. (Fig. 2 describes a peak current of 24 milliamps in burst mode) |
| Channel Isolation: | 2 channels isolated, output pulses staggered in time to prevent current flow between channels (zero crosstalk). |
| Net DC current: | 0.0 milliamps of net dc current to the patient. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance testing and design validation. It does not mention a "test set" in the context of patient data or clinical trials. The tests performed are engineering-level validation tests. Therefore, information on sample size and data provenance for a clinical test set is not applicable based on the provided text.
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)
This information is not applicable as the document describes non-clinical engineering validation tests, not a study involving experts to establish clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as above.
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
This information is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS), which is a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm. The "standalone" performance would refer to the device's electrical characteristics, which are implicitly covered by the design qualification tests.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical performance assessment, the "ground truth" implicitly refers to the engineering specifications and design requirements for the device's electrical output, safety features, and functional characteristics. The validation tests (e.g., for waveform, DC current, channel isolation) were performed against these predefined specifications.
8. The sample size for the training set
This information is not applicable. The QuadraTENS Model QT-42 is a hardware device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 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).