FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

HIVOX OTC Electrical Stimulator, EM49-2 -

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

HIVOX OTC Electrical Stimulator – EM49-1 and EM49-2, falls into the electro stimulation device category.

EM49-1 provides one basic function, TENS, whereas EM49-2 provides two basic functions, TENS/EMS:

Electrical stimulation of nerve tracts (TENS)
Electrical stimulation of muscle tissue (EMS)

The two models also feature two independent stimulation channels and four adhesive electrodes which FDA cleared k number is K132588. For TENS, EM49-1 and EM49-2 are designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities; for EMS, EM49-2 is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. For these purposes, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

The principle of electro stimulation units is based on the imitation of impulses in our bodies that are transferred to nerve and muscle fibers with electrodes via our skin. The electrodes can be applied to many parts of the body. In certain applications the user will merely notice a slight tingling or vibrating sensation. For EM49-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area: for EM49-2, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves, nerve centers and muscle groups in the application area.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HIVOX OTC Electrical Stimulator (EM49-1, EM49-2):

This device is cleared through a 510(k) Special submission, meaning it's substantially equivalent to a previously cleared device. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through non-clinical testing and comparison to the predicate device, rather than a standalone clinical study with specific performance metrics against a defined standard.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission showing substantial equivalence, specific numerical acceptance criteria (e.g., sensitivity, specificity) for clinical performance are not provided in the document. Instead, the acceptance criteria are about meeting various safety and performance standards for electrical stimulators. The device performance is demonstrated by successfully meeting these test requirements.

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Shelf Life	Meets requirements
Biocompatibility	Meets requirements
Software Validation	Meets requirements
Electromagnetic Compatibility (EMC) and Electrical Safety	Meets requirements
Function Test	Meets requirements
Usability	Meets requirements
Overall Substantial Equivalence	Demonstrated for intended use, design, technology/principles of operation, materials and performance compared to the predicate device (K171803).Differences (model, LCD type, button arrangement, cable plug, PCB layout, weight) do not raise new issues of substantial equivalence and do not affect intended use or fundamental scientific technology.

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

Sample Size: Not applicable. The "test set" here refers to the actual device being tested against engineering and bench standards, not a dataset of patients or images.
Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical (bench testing, engineering verification).

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

Number of Experts: Not applicable. Ground truth for non-clinical engineering tests is established by industry standards, specifications, and established scientific principles, not by human expert opinion.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers interpreting clinical data. This document describes non-clinical testing.

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

No MRMC study was done. This device is an electrical stimulator, not an AI-powered diagnostic tool. The submission states, "No clinical test data was used to support the decision of substantial equivalence."

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

Not applicable. This isn't an algorithm or AI device; it's an electrical stimulator. Its "performance" is measured by its electrical characteristics, safety, and functionality, not by diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests (Shelf Life, Biocompatibility, Software Validation, EMC/Electrical Safety, Function test, Usability), the ground truth is established by:
- Industry standards and regulatory requirements: e.g., electrical safety standards, biocompatibility standards, software development lifecycle standards.
- Device design specifications: The device is tested to ensure it performs according to its engineered design.
- Predicate device characteristics: For substantial equivalence, the device's technical characteristics are compared to those of the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant.

Summary

Regulation Number and Section

§ 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).