Search Results

TENS- Transcutaneous Nerve Stimulation

• . Symptomatic relief of chronic intractable pain
• Post traumatic and post surgical pain relief .

EMS- Electrical Muscle Stimulation

• . Relaxation of muscle spasm
• . Increasing local blood circulation
• . Muscle re-education
• . Prevention or retardation of disuse atrophy
• . Prevention of venous thrombosis of the calf muscles immediately after surgery
• . Maintaining or increase range of motion

The TENS-EMS-14 is a combination TENS and EMS device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 4 AA batteries. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.

This document is a 510(k) premarket notification for the EMSI TENS-EMS-14, a combination Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS) device. The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a de novo study with acceptance criteria and performance data in the typical sense of a medical diagnostic or AI-powered device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for devices that require extensive performance validation (e.g., diagnostic accuracy for AI algorithms).

Here's a breakdown of why the requested information is absent and what the document does discuss:

1. A table of acceptance criteria and the reported device performance: This is not present. The document focuses on demonstrating substantial equivalence to predicate devices, which means showing that its technological characteristics, intended use, and safety/effectiveness are similar to devices already cleared by the FDA. The "Discussion of performance testing" section mentions general safety testing (electrical leakage current, electrodes, leads, output current, power density) in accordance with IEC 60601-1-2, but does not provide specific acceptance criteria or quantitative performance results for each.

2. Sample size used for the test set and the data provenance: Not applicable/not provided. This type of information is relevant for studies involving data analysis (e.g., image analysis, diagnostic algorithms), which is not the nature of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.

4. Adjudication method for the test set: Not applicable/not provided.

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 TENS/EMS stimulator, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided in the context of device performance. The "ground truth" here would relate to the physical and electrical safety standards it passed.

8. The sample size for the training set: Not applicable/not provided.

9. How the ground truth for the training set was established: Not applicable/not provided.

Summary of what the document does provide:

• Intended Use: Details the specific medical conditions for which the TENS and EMS functions are intended.
• Safety Testing: Mentions that safety testing was performed in accordance with IEC 60601-1-2 (Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility- Requirements and Test), and the device "passed all of the applicable test." However, no specific pass/fail criteria or quantitative results are elaborated.
• Substantial Equivalence: States that the device's output specifications, design, waveforms, and programmability demonstrated it to be substantially equivalent to a predicate device. This is the primary "proof" in a 510(k) submission for this type of device.

In conclusion, the 510(k) summary for the EMSI TENS-EMS-14 does not include the detailed performance study information with explicit acceptance criteria, sample sizes, and ground truth establishment methods that would be pertinent to a device requiring such validation, especially one involving AI or diagnostic interpretation. Instead, it relies on demonstrating adherence to general safety standards and substantial equivalence to a predicate device already on the market.

Ask a specific question about this device