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The Painmaster MCT Patch is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.

The provided 510(k) summary for the Painmaster MCT Patch (K130114) states that no additional performance testing or clinical data was required for this submission. The device is considered substantially equivalent to a previously cleared device (K090042) because it has the same technological characteristics and intended use.

Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for the current submission is not available in the provided text, as these studies were not conducted for K130114.

The summary does mention a usability study conducted in support of the previous submission (K090442), which demonstrated that users could correctly identify themselves as candidates for treatment and properly assemble and apply the device. However, details of its acceptance criteria or specific performance metrics are not provided.

Based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for K130114. No new performance testing or clinical trials were conducted for this submission. The device was deemed substantially equivalent to a predicate device (K090042) without requiring new data.

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

Not applicable for K130114. No new test set was used for performance evaluation in this submission.

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

Not applicable for K130114.

4. Adjudication Method

Not applicable for K130114.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not conducted for K130114.

6. Standalone Performance Study

No. A standalone performance study was not conducted for K130114.

7. Type of Ground Truth Used

Not applicable for K130114.

8. Sample Size for the Training Set

Not applicable for K130114. No new training set was used for this submission.

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

Not applicable for K130114.

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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.

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