Search Results

ReliefBand 2.0 is indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, chemotherapy and morning sickness associated with pregnancy. ReliefBand 2.0 is also indicated as an adjunct to antiemetics in reducing postoperative nausea.

ReliefBand® 2.0 is a rechargeable, non-invasive digital therapeutic device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over the counter use in the relief of mild to moderate nausea and vomiting associated with chemotherapy, motion sickness, mild to moderate nausea and vomiting associated with pregnancy, and as an adjunct to antiemetics in reducing mild to moderate postoperative nausea.

ReliefBand 2.0® includes a hypoallergenic band with two electrical contacts on the clasp end of the band. The two contacts must be placed firmly against the underside of the P6 location, approximately two fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles. The electrodes in the wristband provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.

The ReliefBand® Device has a user display that incorporates a ten-segment linear LED that is used to display the intensity level. The patient can easily select the pulse amplitude of the electrical impulse and control the intensity of the stimulation via a pushbutton located on the edge of the device. Battery charge level is indicated by a separate four-segment circular LED. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.

The provided document describes the FDA 510(k) clearance for the ReliefBand 2.0 device, a transcutaneous electrical nerve stimulator for pain relief, specifically for nausea, retching, and vomiting due to various conditions.

However, the document is a 510(k) summary (K182960), which primarily focuses on demonstrating substantial equivalence to a predicate device (ReliefBand 1.5) rather than providing detailed results from a clinical study proving its performance against pre-defined acceptance criteria.

Therefore, many of the requested details about acceptance criteria and a study proving device performance (especially those related to diagnostic performance, such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details) are not present in this document.

The document states:

• "Substantial equivalence was determined on the basis that there have been no changes in the technology, mechanism of action or intended use."
• "Device modifications include relocation of the electrodes from the back of the device face to the clasp end of the wrist band, changes in the size, shape and aesthetic appearance of the casing, a simpler and more streamlined user interface and a power source change from disposable to rechargeable batteries."
• "These changes do not impact the safety of efficacy of the ReliefBand® 2.0 device."
• "ReliefBand 2.0 was tested to the following standard: ISO 14971: Medical Devices Application of Risk Management to Medical Devices."

This indicates that the clearance was based on comparative analysis with the predicate device and engineering/safety testing (like risk management and adherence to ISO standards), not on a clinical trial with specific performance acceptance criteria for diagnostic accuracy or efficacy. The device is a direct treatment device, not an AI/diagnostic device, so many of the questions related to AI performance are not applicable.

Below is an attempt to address the questions based on the available information, noting where information is explicitly NOT provided.

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative clinical acceptance criteria or a reported performance based on those criteria for the ReliefBand 2.0's therapeutic effect in a clinical study. Instead, its "performance" is demonstrated by its substantial equivalence to the predicate device (ReliefBand 1.5) and compliance with relevant standards.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical study with a "test set" of patients for measuring efficacy of the ReliefBand 2.0. The device's approval is based on substantial equivalence to a predicate, not new clinical performance data from a specific test set.
• Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. This device is a therapeutic device, not a diagnostic one that requires expert ground truth for image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study.

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

• Not applicable. This device is a direct therapeutic device, not a standalone algorithm.

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

• Not applicable. As a therapeutic device cleared via substantial equivalence, new clinical efficacy data with defined ground truth is not the primary basis for this 510(k) clearance.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a "training set."

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

• Not applicable.

Summary of findings from the document:

The FDA 510(k) clearance for ReliefBand 2.0 (K182960) is based on demonstrating substantial equivalence to a previously cleared predicate device (ReliefBand 1.5). The document highlights that there have been no changes in technology, mechanism of action, or intended use that would raise new questions about safety or effectiveness. The modifications are primarily cosmetic, user interface improvements, and a change from disposable to rechargeable batteries. Compliance with ISO 14971 (Risk Management) and IEC 62133 (Battery safety), as well as the use of ISO 10993 compliant materials for the wristband, are mentioned as part of the safety assessment. There is no indication of a new clinical study involving a test set of patients or experts that would generate the type of performance data typically associated with diagnostic AI devices.

Ask a specific question about this device