(190 days)
Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities.
PAT is an OTC medical device. This device is used for temporary relief of pain of sore and aching muscles and joints, due to strain from exercise or normal household and work activities. The device consists of a small battery operated enclosure with an LCD screen and user buttons to control the device. A monophasic micro-current waveform is transmitted to the affected body part through a cable connected via snaps to skin surface electrodes. There are 8 non-programmable modes representing 8 different body areas to treat.
The provided document is a 510(k) Premarket Notification from the FDA for the device "PAT (Pain Alleviation Technologies)", which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The document focuses on establishing substantial equivalence to a predicate device, the Painmaster MCT Patch (K130114).
1. Table of Acceptance Criteria and Reported Device Performance
This document primarily describes the equivalence to a predicate device rather than setting specific acceptance criteria for performance metrics in a clinical study. The "acceptance criteria" here are understood as the comparison between the proposed device (PAT) and the predicate device (Painmaster MCT Patch) across various technical specifications to demonstrate substantial equivalence.
| Parameter | Predicate Device (Painmaster MCT Patch) Performance | Proposed Device (PAT) Performance | Acceptance Criteria/Remarks (Based on Substantial Equivalence Logic) |
|---|---|---|---|
| Waveform | Monophasic square wave with 50% duty cycle | Monophasic square wave with 50% duty cycle | Waveform should be similar. |
| Amplitude | 42 μA | 40 μA | Amplitude should be similar or within safe limits. |
| Frequency | 0.5 Hz | 3 Hz | Frequency is different but within historical TENS ranges for safety and effectiveness. This difference is not deemed to raise new questions of safety or effectiveness. |
| Maximum Output Voltage (500 Ω) | 22 mV | 20.8 mV | Output voltage should be similar. |
| Maximum Output Current (500 Ω) | 42 μA | 41.6 μA | Output current should be similar. |
| Max. Phase Charge @500 Ω | 44 microcoulombs | 6.9 microcoulombs | Phase charge should be similar or within safe and effective limits. The proposed device has a significantly lower phase charge, indicating potential safety benefits (lower risk of tissue damage). |
| Max. Average Current @500 Ω | 42 μA | 41.6 μA | Average current should be similar. |
| Max. Current Density @500 Ω | 0.002 mA/cm² | 0.0016 mA/cm² | Current density should be similar or lower for safety. |
| Maximum Power Density (500 Ω) | 0.00005 mW/cm² | 0.000035 mW/cm² | Power density should be similar or lower for safety. |
| Indications for Use | Temporary relief of pain associated with sore and aching muscles in upper and lower extremities due to strain from exercise or normal household and work activities. | Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities. | Indications for Use should be similar or the expanded use should be supported by similar technology characteristics that do not raise new questions of safety or effectiveness. "Joints" added. |
| OTC Use | Yes | Yes | Same use environment. |
| Safety Standards Compliance | EN 60601-1, HA60601-1-11, IEC 60601-1-2, IEC 60601-2-10 | AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10 | Compliance with recognized electrical safety standards. |
The study described primarily relies on nonclinical tests and a comparison of technical specifications to demonstrate substantial equivalence, rather than a clinical study with specific performance acceptance criteria for diagnosing or treating a condition. The conclusion is that "The waveform used in both devices is similar with a square waveform with a 50% duty cycle as discovered with oscilloscope readings. The indications for use are very similar, both devices met the same test standards, and both use very low frequency pulses." This establishes that the differences in output parameters and indications for use "do not raise new questions of safety or effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set with human subjects for performance evaluation. The "test set" in this context refers to the device specifications and nonclinical test results (e.g., electrical safety and performance testing) of the PAT device, which are then compared to the predicate device.
- Sample size: Not applicable, as no human subject test set is described.
- Data provenance: The data regarding the device specifications and nonclinical tests would originate from the manufacturer's internal testing and reports (Shenzhen Bless Electronic Technology Co., Ltd. and Marchan Medical, LLC). It is retrospective in the sense that these are design specifications and test results conducted prior to the submission, not a prospective clinical trial. The country of origin for manufacturing and base specifications development is likely China (Shenzhen Bless Electronic Technology Co., Ltd.) and the USA (Marchan Medical, LLC for specifications developer).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a technical and regulatory comparison for substantial equivalence, not a study requiring expert readers to establish ground truth for diagnostic or therapeutic efficacy in a human population. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the technical/performance specifications of both devices.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as there is no human subject test set or review of images/data by multiple experts for adjudication. The "adjudication" is performed by the FDA reviewers based on the engineering, electrical safety, and performance testing data provided by the manufacturer.
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 Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, it is a physical medical device (TENS unit). The "performance" is its ability to generate electrical impulses as specified, which was assessed through nonclinical engineering and electrical safety tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the purpose of substantial equivalence, the "ground truth" relies on:
- Established safety and effectiveness of the predicate device: The predicate device (Painmaster MCT Patch) is a legally marketed device with a known safety and efficacy profile under its 510(k) clearance (K130114).
- Engineering and electrical testing data: The PAT device underwent nonclinical tests to ensure it meets electrical safety standards (e.g., AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10) and performs according to its specifications (waveform, amplitude, frequency, current, voltage, etc.). This data serves as the "ground truth" for its technical performance and safety.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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).