(42 days)
The Ultima Five™ external, non-invasive, non-narcotic, electrotherapy device is indicated for use as an adjunctive therapy in providing symptomatic pain relief for chronic, acute, or post-operative pain.
The Ultima Five consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
The provided text is a 510(k) summary for the Ultima Five™ Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study as would be done for a novel device or a device with new intended uses.
Therefore, many of the requested elements for a detailed study description, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, are not present in this 510(k) summary.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (Ultima Five™) |
|---|---|
| Electrical Output Equivalence | Produces the exact same electrical output as the Easy Med TN-28C. |
| - Frequency | Same frequency as the Easy Med TN-28C. |
| - Waveform | Same waveform as the Easy Med TN-28C. |
| - Modes | Similar modes to the Easy Med TN-28C. |
| - Voltage Output Range | Same voltage output range as the Easy Med TN-28C. |
| - Dual Channel Output Performance | Same dual channel output performance as the Easy Med TN-28C. |
| - Pulse Widths | Identical pulse widths to the Easy Med TN-28C. |
| - Max Output Values | Identical max output values to the Easy Med TN-28C. |
| Intended Use Equivalence | Indicated for use as an adjunctive therapy in reducing the level of chronic, acute, and post-surgical pain, similar to the predicate. |
| Safety and Effectiveness | Substantially equivalent to the legally marketed predicate device (Easy Med TN-28C). |
| Display Functionality | Utilizes an LCD screen to display the settings. (This is a feature improvement, not a direct equivalence to the predicate's stated performance, but is noted as part of the summary). |
Explanation: The acceptance criteria for a 510(k) submission are largely implicit in the concept of "substantial equivalence." The device must be as safe and effective as a legally marketed predicate device. For TENS devices, this primarily constitutes demonstrating equivalent electrical performance and similar intended use. The "study" here is a comparative analysis of technical specifications between the proposed device and the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. There was no "test set" in the traditional sense of a clinical or retrospective data study aimed at evaluating diagnostic accuracy or treatment efficacy against a specific outcome. The submission relies on a technical comparison to a predicate device.
- Data Provenance: Not applicable in the context of a dataset. The data provenance is from the technical specifications of the Ultima Five™ and the predicate device, the Easy Med TN-28C.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth as typically understood (e.g., expert consensus on medical images or pathology results) is not relevant for this type of submission focused on technical equivalence for a TENS device.
4. Adjudication Method for the Test Set:
- Not applicable. There was no test set requiring expert adjudication.
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, which are common for diagnostic imaging AI. The aim here is to show equivalent electrical output and intended use to a predicate, not to assess a human reader's improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in a way. The "performance" being assessed is the inherent electrical output characteristics of the device itself, independent of a human operator's actions beyond setting the parameters. This is a "standalone" technical performance evaluation. However, it's not an algorithm-only performance in the context of AI, but rather the device's physical output.
7. The Type of Ground Truth Used:
- Technical Specifications and Intended Use: The "ground truth" for this submission is the established technical specifications of the predicate device (Easy Med TN-28C) and its legally marketed intended use. The Ultima Five™ is compared directly against these documented characteristics.
8. The Sample Size for the Training Set:
- Not applicable. There was no "training set" in the context of machine learning or AI algorithm development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set was used, no ground truth needed to be established 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).