(181 days)
The Rainbow® GT-4A machine is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
The Rainbow® GT-4A is a tetrad channel traditional TENS device. It is powered by an AC adaptor. All operation modes produce the GT Bi-phasic waveform. The GT-4A requires the use of a set of lead wires and a pair of electrodes for each channel.
The provided text describes a 510(k) premarket notification for the Rainbow GT-4A Pain Relief Machine (TENS Unit). This submission claims substantial equivalence to a predicate device, the Empi Epix XL Model 989, and therefore does not include a study proving the device meets specific acceptance criteria based on clinical performance metrics.
Instead, the acceptance criteria and "proof" are based on the device's technical specifications and a comparison to the predicate, arguing that the technical differences do not raise new questions of safety or effectiveness.
Here’s a breakdown based on the provided information, addressing your points where possible, and noting when information is not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device must be electrically safe. | Meets UL2601 Standards for electrical safety. |
| Effectiveness: Must be as effective as the predicate device. | Technical characteristics are considered "not really differences" from the predicate. Differences in modes and channels do not require testing to establish equivalence. Functional testing confirms it meets product specifications. |
| Intended Use: Comparable to predicate device. | Indicated for symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain (identical to predicate's presumed intended use). |
| Technical Specifications: (e.g., waveform, output settings) | Produces GT Bi-phasic waveform. Outputs 2 and 100 Hz rates (predicate had more options). Has 4 independent channels (predicate had 2). Powered by AC adaptor (predicate used battery). No Low Battery Indicator. |
2. Sample size used for the test set and the data provenance
- No clinical test set was used. The submission states: "No clinical testing is needed."
- Data provenance: Not applicable as no clinical data was generated for this submission. The comparison is against the predicate device's established performance and general TENS technology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set and thus no ground truth established by experts for performance evaluation.
4. Adjudication method for the test set
- Not applicable. No test set or clinical study requiring adjudication.
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
- No. This is a TENS unit, not an AI-powered diagnostic device. An MRMC study is not relevant to this type of device and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This section is relevant for AI/ML devices. The Rainbow GT-4A is a hardware medical device (TENS unit).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical performance. The "ground truth" for the submission is the predicate device's established safety and effectiveness. The GT-4A's performance is deemed acceptable if its technical specifications are sufficiently similar to (or justified as not raising new questions compared to) the predicate device. Functional testing was performed against product specifications to ensure the device operates as designed (which is distinct from clinical performance).
8. The sample size for the training set
- Not applicable. This is a hardware medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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).