Search Results

TENS (Modes 1, 2, 4, 5, 6, 8)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (also called EMS, Modes 1, 3, 7)

To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating Mode Temporary relief of minor aches and pains.

Electronic Pulse Stimulator delivers electric pulses generated to the user's body areas such as the back neck and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). It includes operating elements of ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and/or timer selection button, and could be attached to electrodes. In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 °C.

The device could be easily operated through its buttons to manually realize its functions, such as turning on/off, increasing/decreasing intensity, changing mode/timer, and providing heat/temperature if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.

The electrodes cleared include the electrode pads and electrode garments, which could be packaged separately and/or together with the subject device.

This document is a 510(k) summary for an Electronic Pulse Stimulator (device K162517). It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices (K153520 and K070299). Since this is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulation (PMS) device, the acceptance criteria and study information will focus on its electrical and heating parameters rather than clinical performance metrics typically associated with AI/ML devices (like sensitivity, specificity, AUC).

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a predetermined numerical threshold for a clinical outcome (e.g., "sensitivity must be >90%"). Instead, it demonstrates "substantial equivalence" based on various technical specifications and intended use. The "reported device performance" is essentially a comparison of these technical specifications between the subject device and the predicate devices.

The table below summarizes the comparison from Table 1 in the document for the subject device (PL-029K13, as it includes the heating mode) and its primary predicate (PL-029K6, K153520) for electrical stimulation, and the heating predicate (ezFit Digital Heating TENS, K070299) for the heating function. The ranges and specific values are presented as performance data.

For non-clinical tests, the "acceptance criteria" were compliance with specific voluntary standards:

• IEC 60601-1 (medical electrical equipment safety and essential performance)
• IEC 60601-1-2 (electromagnetic compatibility)
• IEC 60601-2-10 (particular requirements for nerve and muscle stimulators)
• FDA Guidance for Premarket Submissions for Software Contained in Medical Devices.

The reported device performance for these non-clinical tests is that the device "conformed" and "met the requirement of safety" for the standards and guidance, respectively.

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device..."

Therefore, there is no clinical test set, human subject data, or data provenance (country of origin, retrospective/prospective) described in this 510(k) summary for the purpose of demonstrating substantial equivalence. The evaluation relies on technical comparisons to predicate devices and adherence to engineering and safety standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

As no clinical test set was used, there was no ground truth established by experts in a clinical context for this submission. The "ground truth" for the non-clinical tests would be the specifications and requirements of the regulatory standards themselves, which are established by expert committees in their respective fields (e.g., electrical engineering, medical device safety).

4. Adjudication Method for the Test Set

Since no clinical test set with human subject outcomes was used for demonstrating substantial equivalence, no adjudication method (like 2+1 or 3+1 consensus) was applied.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI/ML device on human reader performance, which is not applicable to an Electronic Pulse Stimulator submission focused on electrical and heating parameters and substantial equivalence to existing devices.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

No, a standalone performance study in the context of an AI/ML algorithm was not done. The "performance" in this submission refers to the technical specifications of the device (e.g., output voltage, current, temperature) and its compliance with safety standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the technical specifications, the "ground truth" is established by engineering measurements against reference standards (e.g., voltmeters, ammeters, thermometers calibrated to international standards) to verify the device's output. For compliance with voluntary standards (IEC 60601-1, -1-2, -2-10), the "ground truth" is the requirements outlined in those international standards. For software, it's compliance with FDA guidance for software in medical devices.

8. The Sample Size for the Training Set

Since this is not an AI/ML device, there is no training set sample size described. The device's operation is based on fixed electrical circuits and heating elements, not learned models.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Ask a specific question about this device