(90 days)
The Painmaster MCT Patch is indicated for 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.
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 510(k) summary for the Painmaster MCT Patch (K130114) states that no additional performance testing or clinical data was required for this submission. The device is considered substantially equivalent to a previously cleared device (K090042) because it has the same technological characteristics and intended use.
Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for the current submission is not available in the provided text, as these studies were not conducted for K130114.
The summary does mention a usability study conducted in support of the previous submission (K090442), which demonstrated that users could correctly identify themselves as candidates for treatment and properly assemble and apply the device. However, details of its acceptance criteria or specific performance metrics are not provided.
Based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable for K130114. No new performance testing or clinical trials were conducted for this submission. The device was deemed substantially equivalent to a predicate device (K090042) without requiring new data.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for K130114. No new test set was used for performance evaluation in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for K130114.
4. Adjudication Method
Not applicable for K130114.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not conducted for K130114.
6. Standalone Performance Study
No. A standalone performance study was not conducted for K130114.
7. Type of Ground Truth Used
Not applicable for K130114.
8. Sample Size for the Training Set
Not applicable for K130114. No new training set was used for this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable for K130114.
§ 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).