(120 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.
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.
This device (Painmaster MCT Patch) is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for over-the-counter (OTC) use for temporary pain relief. The submission for this device, K090042, relies on substantial equivalence to previously cleared devices rather than new performance studies demonstrating its effectiveness.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No performance acceptance criteria were explicitly stated or required for this 510(k) submission. The submission is based on substantial equivalence to a predicate device that was previously cleared for prescription use (K013167, Model 7500 Microcurrent TENS Device, Version F5), and other OTC TENS devices (K033122, K060222). | Substantial Equivalence: The Painmaster MCT Patch is deemed substantially equivalent to the predicate devices because its technological characteristics are identical to the F-5 version cleared under K013167, and its intended use for OTC pain relief is a subset of the previous prescription clearance and identical to other OTC TENS devices. |
| Usability (for OTC use) | A usability study was conducted and demonstrated that "users could correctly identify themselves as candidates for treatment, and could properly assemble and apply the device according to the instructions for use." However, specific quantitative acceptance criteria for this study (e.g., success rates, error rates) are not provided in this summary document. |
2. Sample Size Used for the Test Set and Data Provenance:
- Performance Testing: "Additional performance testing was not required to determine the substantial equivalence of this device for OTC use because the device is the same as the device previously cleared for prescription use via 510(k) #K013167." Therefore, there was no new test set for performance evaluation. The data provenance for the previous clearance (K013167) is not detailed in this document.
- Usability Study: The document states "A usability study was conducted," but does not specify the sample size for this study. The data provenance (country of origin, retrospective/prospective) for the usability study is also not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable for performance testing. As stated above, no new performance testing was conducted that would require a test set with expert-established ground truth.
- Not applicable for the usability study in the way typically thought of for clinical image-based or diagnostic device studies. The "ground truth" for a usability study would be the ability of users to correctly perform tasks, which is typically observed and recorded by trained researchers, not established by clinical experts.
4. Adjudication Method for the Test Set:
- Not applicable. No new performance test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence and a usability study for OTC use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is not applicable. The device is a physical TENS patch, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- For the original prescription clearance (K013167), this document does not specify the ground truth used (e.g., pain scales, patient outcomes, etc.).
- For the current OTC clearance, the "ground truth" for the usability study was the observation of users successfully understanding instructions and applying the device. This is a form of empirical observation of user behavior.
8. The Sample Size for the Training Set:
- Not applicable. This device is hardware for electrical stimulation; it does not involve machine learning or AI that would require a "training set" of data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no AI/ML training set.
§ 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).