(250 days)
The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
The Staodyn® Max Preset is a Transcutaneous Electrical Nerve Stimulator (TENS) that transmits small electrical pulses through the skin to the underlying peripheral nerves. It is battery operated using 3-AAA batteries and includes two controllable output channels. It generates and delivers electrical impulses whose duration, rate and modulation can be altered by selection of 24 preset programs. The amplitude of the impulses can be increased or decreased with the use of two intensity toggle buttons, one for each output channel. The device has an on/off button that enables the device to be turned on off. In addition, the on/off button can be used to pause a treatment program during use. The stimulator is housed in a molded portable plastic case with a viewable LCD display, accessible keypad, and accessible battery storage compartment.
Here's an analysis of the provided text regarding the Staodyn® Max Preset TENS Device, focusing on acceptance criteria and study information:
Key Takeaway: The provided document explicitly states that clinical testing was not required to demonstrate substantial equivalence for the Staodyn® Max Preset TENS Device. Therefore, many of the requested elements related to clinical study design and outcomes are not present.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (510(k) for a TENS device) and the explicit statement that clinical testing was not required, there isn't a table of specific clinical acceptance criteria with corresponding device performance metrics in the document. Instead, the "acceptance criteria" are implied by the non-clinical testing and the comparison to an already marketed predicate device.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|
| Non-clinical Electrical Performance: | |
| - Symmetric biphasic pulse | Virtually identical to predicate: Symmetric biphasic pulse |
| - Peak voltage up to 50 Volts on 500 ohms load | Up to 50 Volts on 500 ohms load (matches predicate) |
| - User-selectable preset programs | 24 preset programs available |
| - Adjustable intensity (1-20) | Intensity adjustable from 1 to 20 |
| - Two controllable output channels | Two controllable output channels |
| - Lead open detection | Has lead open detection |
| - Auto shut-off feature | Has Auto shut-off feature |
| Non-clinical Mechanical Performance: | |
| - Meets product specifications over operating and storage conditions | Verification and validation testing conducted to show device meets product specifications and user needs. |
| Intended Use Equivalence: | |
| - Symptomatic relief and management of chronic intractable pain | States "used for symptomatic relief and management of chronic intractable pain" |
| - Relief of pain associated with arthritis | States "relief of pain associated with arthritis" |
| - Adjunctive treatment in post-surgical and post-traumatic pain | States "adjunctive treatment in the management of post-surgical and post-traumatic pain" |
| Safety and Effectiveness: | |
| - Safe and effective | Non-clinical testing demonstrates device is "safe, effective, and performs as well as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set data is reported. The non-clinical testing would have involved engineering samples and lab tests, not a patient test set in the clinical sense.
- Data Provenance: Not applicable for clinical data. The non-clinical testing was performed by the manufacturer/OEMs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical ground truth was established, as no clinical study was performed or required. The "ground truth" for the device's performance was its ability to meet engineering specifications and demonstrate equivalence to a predicate device through non-clinical means.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set, thus no adjudication method needed.
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 device is a TENS stimulator, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting data. No MRMC study was conducted or relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical device for pain relief, not an algorithm. Its performance is inherent to its physical and electrical characteristics.
7. The Type of Ground Truth Used
- Engineering Specifications and Equivalence to Predicate: The "ground truth" for this submission is that the device's electrical and mechanical characteristics meet its design specifications and are substantially equivalent to a legally marketed predicate TENS device. The intended use, function, and performance were compared to the American Imex Premier Plus - K032003.
8. The Sample Size for the Training Set
- Not applicable. As this is not an AI/ML device, there is no "training set" in the computational sense. The device's design is based on established TENS technology and the predicate device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used. The device's functionality is based on its hardware design and the established principles of transcutaneous electrical nerve stimulation, which have been validated through decades of use in this product category.
§ 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).