Search Results

This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

The PM3030 is a small, battery operated, three (3) output mode TENS device for pain relief intended for OTC use. The output modes are intended for application to the following areas: Shoulder/Arm, Lower Back and Ley/Foot. The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. As above the device is battery powered there is no connection to AC mains supply.

The provided text describes a Premarket Notification 510(k) for the Omron OTC TENS device (Model PM3030). This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a standalone study with acceptance criteria for device performance in the way one might for a diagnostic or therapeutic medical AI device.

Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance against a ground truth) is not applicable to this 510(k) summary. The document is primarily concerned with comparing the technical specifications and intended use of the new device to a predicate device to establish that it is as safe and effective.

Here's an analysis based on the provided text, focusing on what is available:

Acceptance Criteria and Device Performance (based on Substantial Equivalence comparison)

The "acceptance criteria" here are implicitly that the Omron PM3030 device is "substantially equivalent" to its predicate device (Endurance Therapeutics, Model T1040, K060846) in terms of safety and effectiveness. The reported device performance is presented as a comparison of specifications between the new device and the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

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

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

The JQ-5C is a portable; battery powered (3.7VDC) multi function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.

Double channels that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operation.

This document is a 510(k) summary for the Hi-Dow JQ-5C, a powered muscle stimulator and TENS device. It focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and ground truth evaluations typically seen for novel diagnostic or AI-driven devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by substantial equivalence to predicate devices, particularly T1040, 5000Z, and Compex. The performance is reported in terms of electrical stimulation parameters. There are no explicit "acceptance criteria" or "pass/fail" thresholds stated in this document beyond meeting the general characteristics of the predicate devices.

Note: The "acceptance criteria" here are that the JQ-5C's values fall within a range considered "substantially equivalent" to existing cleared devices. The document explicitly states: "The JQ-5C has modes that offer substantially equivalent technical specifications, features and effective results as the predicate listed." The differences are deemed "insignificant in the terms of safety or effectiveness."

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

This document does not describe a clinical test set with a sample size for evaluating device performance in terms of its intended use (pain relief, muscle stimulation). The "test set" in this context refers to the electrical characteristics of the device being compared against predicate devices. No human subject data or specific "test set" in the sense of clinical cases is mentioned for performance evaluation.

The provenance of the data is from non-clinical tests measuring the electrical outputs of the device and comparing them to those of predicate devices. There is no mention of country of origin for such comparative electrical data, nor is it described as retrospective or prospective in a clinical sense.

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

Not applicable. This type of submission (510(k) for a TENS/PMS device) relies on engineering specifications and comparison to predicate devices, not on expert consensus for clinical ground truth or AI model validation.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context of this submission. The comparison is based purely on technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention any MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not for a powered muscle stimulator/TENS device seeking substantial equivalence based on technical specifications.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The Hi-Dow JQ-5C is a physical medical device, not an algorithm, and the submission is focused on its electrical characteristics and safety, not an AI or software algorithm's standalone performance.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the technical specifications and cleared status of the predicate devices. The Hi-Dow JQ-5C is deemed safe and effective because its electrical stimulation parameters and intended uses fall within the established and cleared parameters of similar devices already on the market.

Additionally, the document cites:

• "No adverse events have been reported since 2007 with over 300,000 units sold without a prescription in Europe and Asia." This serves as real-world evidence of safety.
• "A number of articles in peer-reviewed publications, which demonstrate that electrical stimulation does improve muscle performance as well as temporary pain reduction." This refers to general scientific literature, not specific to the Hi-Dow JQ-5C, to support the effectiveness of the technology (electrical stimulation) for the stated indications.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML algorithm, there is no training set or ground truth establishment for such a set.

Ask a specific question about this device