(86 days)
The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.
The ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are non-invasive nerve stimulation therapy devices, and are indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS). The devices are contained within a wristband, and provide relief of nausea and vomiting through electrical stimulation of the nerves in the patient's wrist.
The devices can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists. approximately 2 fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles.
The ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R have a single dial for setting the stimulation , and incorporate an LED which is used to display a normal operating condition (green color at a slow flash rate) and a low battery condition (red color at a faster flash rate).
All three models have a single operating mode, controlled by a single dial, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. The three models vary by (1) the number of intensity settings available to the user, (2) whether or not the device is reusable, and (3) the length of time that the batteries will last.
The provided text describes a 510(k) submission for the ReliefBand® NST™ Device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new, independent clinical studies to establish acceptance criteria and prove device performance against those criteria in the same way a PMA (Pre-Market Approval) would.
Based on the provided document:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., a specific percentage reduction in nausea, or a specific statistical significance level). Instead, it states that the performance data "indicate that the ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are substantially equivalent to the ReliefBand® Devices distributed under K980333." This indicates that the acceptance criterion for this 510(k) was substantial equivalence to the predicate device (ReliefBand, Model SW-111, K980333). The reported device performance is that it meets this criterion of substantial equivalence. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide details on a specific test set, its sample size, or data provenance. The 510(k) submission relies on demonstrating equivalence through technological characteristics and existing performance data (likely from the predicate device or a combination of bench testing and prior clinical understanding of similar devices), rather than new human clinical trials with defined test sets. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no new clinical study with a defined "test set" requiring expert ground truth establishment for a diagnostic or AI algorithm is described. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study with a defined "test set" requiring adjudication for a diagnostic or AI algorithm is described. -
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. The device is a nerve stimulation therapy device, not an AI-based diagnostic tool requiring human reader comparison. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device for nerve stimulation, not an AI algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of a new clinical study. The "ground truth" for this 510(k) submission is the performance and safety profile of the predicate device, against which the new devices are deemed "substantially equivalent." -
The sample size for the training set
Not applicable, as this is not an AI algorithm requiring a training set. -
How the ground truth for the training set was established
Not applicable, as this is not an AI algorithm requiring a training set.
Summary of Acceptance Criteria and Device Performance (Based on 510(k) Framework):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (ReliefBand, Model SW-111, K980333) in: | The performance data indicate that the ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are substantially equivalent to the predicate ReliefBand® Devices distributed under K980333. This equivalence is based on: |
| - Technological Characteristics | "A comparison of the technological characteristics of the ReliefBand® NST™ Device and the predicate device has been performed. The results of this comparison demonstrate that the ReliefBand® NST™ Device is equivalent to the marketed predicate device." |
| - Intended Use | The Indications for Use are identical: "treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS)." (Note: The final clearance letter from FDA omits "therapy related to acquired immune deficiency syndrome (AIDS)" in the Indications for Use, which is not reflected in the applicant's submission but is typically the cleared indication.) |
| - Safety and Effectiveness | Implied through the substantial equivalence determination, meaning the new devices present no new questions of safety or effectiveness compared to the predicate. |
Study Details:
The document describes a 510(k) premarket notification rather than a clinical study designed to establish acceptance criteria and prove device performance through new data. The primary "study" is a comparison to a predicate device (ReliefBand, Model SW-111, K980333) to demonstrate substantial equivalence.
- Sample Size and Data Provenance: Not explicitly detailed for a new clinical test set. The submission relies on existing data and comparisons to the predicate device's established performance.
- Experts and Ground Truth: Not applicable for establishing new ground truth for a diagnostic test set in this context.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable (device is a treatment, not an AI diagnostic).
- Standalone Performance: The devices are standalone nerve stimulation devices; their performance is assessed in comparison to the predicate's known performance.
- Type of Ground Truth: The "ground truth" in 510(k) is the established safety and effectiveness of the predicate device.
- Training Set Sample Size and Ground Truth: Not applicable, as this is not an AI algorithm.
§ 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).