(443 days)
The Painmaster MCT Patch is indicated for:
-temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
-temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
-symptomatic relief of chronic, intractable pain.
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
The provided text is a 510(k) summary for the Painmaster MCT Patch, which is a transcutaneous electrical nerve stimulator. It states that "Additional performance testing was not required to determine the substantial equivalence of this device because the device is the same as the device previously cleared via 510(k) K090442, K130114 and MCT F5 model K013167."
Therefore, this document does not contain information about acceptance criteria or specific studies proving the device meets those criteria for the current submission (K151995). Instead, it relies on prior clearances.
However, a usability study was conducted for one of the predicate devices (K090042). While not explicitly acceptance criteria in terms of performance metrics, the "usability study" section can be interpreted as demonstrating the device meets criteria related to user comprehension and proper application.
Here's the information extracted, specifically focusing on the usability study as it's the only performance-related study mentioned for a predicate device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Usability Study) | Reported Device Performance |
|---|---|
| Users could correctly identify themselves as candidates for treatment. | Achieved |
| Users could properly assemble the device. | Achieved |
| Users could properly apply the device according to the instructions for use. | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (presumably prospective, as it was a study conducted for a prior submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable for a usability study. The "ground truth" would be the successful completion of tasks by the users themselves.
4. Adjudication Method for the Test Set
- Not applicable as this was a usability study, not a diagnostic or comparative effectiveness study requiring adjudication. The assessment would likely be based on observers' evaluation of user behavior.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done. This device is a transcutaneous electrical nerve stimulator, not an algorithm-based diagnostic tool.
7. Type of Ground Truth Used
- For the usability study, the ground truth was based on observed user behavior and comprehension of the instructions for use and device application.
8. Sample Size for the Training Set
- Not applicable, as this was a usability study (for a predicate device) and clinical performance was not re-evaluated for the current submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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).