(64 days)
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
We do not feel pain until a coded message travels to the brain where it is decoded, analyzed and responded to. The pain message travels from the affected area along small nerve fibers leading into the spinal cord. Here the message is relayed to different nerves that travel up the spinal cord to the brain.
The kind provided to you by your personal Transcutaneous Electrical Nerve Stimulator, TN-28C T.E.N.S. Unit consists of sending small electrical pulses through the skin to the body's nervous system. According to the " gate " theory for pain control, the stimulation of large nerve fibers may result in the blocking of pain transmission.
This 510(k) summary for the EasyMed TN-28C T.E.N.S. Unit does not describe a study involving acceptance criteria and device performance in the way a clinical study for an AI/ML device would. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (FDTENS 2010), primarily through a comparison of design principles, power sources, and electrical output parameters.
Therefore, many of the requested fields cannot be filled as they pertain to a type of study not conducted or reported in this document.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable (N/A). The document does not describe specific quantitative acceptance criteria and corresponding measured device performance data. The basis for equivalence is a qualitative and parametric comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
N/A. No test set or associated data provenance is described for performance evaluation in the context of efficacy for pain relief in a human population. The comparison is based on device specifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications
N/A. This document does not describe a study that required expert consensus for ground truth.
4. Adjudication Method
N/A. No adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. An MRMC study was not conducted or reported for this Transcutaneous Electrical Nerve Stimulator (TENS) unit. These studies are typically relevant for diagnostic imaging or AI-assisted interpretation, which is not the function of a TENS device.
6. Standalone Performance Study
N/A. While the document describes the technical specifications and operational principles of the device, it does not present a standalone performance study in terms of its clinical effectiveness or diagnostic accuracy. The equivalence is established on technical similarity, not a standalone clinical outcome study for the new device.
7. Type of Ground Truth Used
N/A. No ground truth is described, as the submission focuses on substantial equivalence based on technical specifications and intended use matching a predicate device.
8. Sample Size for the Training Set
N/A. This TENS device is not an AI/ML device, and thus, there is no "training set."
9. How Ground Truth for the Training Set Was Established
N/A. Not applicable as there is no training set mentioned.
Summary of the K040253 Submission:
The EasyMed TN-28C T.E.N.S. Unit obtained 510(k) clearance by demonstrating substantial equivalence to a previously legally marketed device, the FDTENS 2010 (K994266). The submission emphasizes that:
- Their circuits design are based on the same principle.
- Both devices use two 1.5V AA batteries and have two output channels.
- Their output electrical parameters (frequency, pulse width, intensity, etc.) are very similar substantially.
- The intended use of providing symptomatic pain relief for chronic, acute, or post-operative pain is the same as the predicate device.
This type of 510(k) submission, especially for a well-established device type like a TENS unit, typically relies on comparing technical specifications and intended use to a predicate device rather than conducting extensive new clinical performance studies with acceptance criteria as one might see for novel AI software or high-risk devices. The FDA's letter explicitly states that the determination of substantial equivalence allows the device to be marketed, subject to general controls.
§ 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).