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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 is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).

The ReliefBand® NST™ Device Models WB-2L, WB-6L, and WB-RL 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, and pregnancy. The ReliefBand ® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON). The devices are contained within a wristband, and provide relief of NV and PON 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 Model WB-xL family has a user display that incorporates five blinking LEDs which are used to identify the intensity level (5 discrete LEDs, one for each intensity level), so that the patient can easily select the desired stimulation. Selection of the intensity level is performed via a pushbutton located on the user display, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. A sixth blinking LED is used to display the low battery indicator.

The ReliefBand™ NST™ device Model WB-xL family is powered by two commercially available 3V lithium batteries. These batteries are not user replaceable in the disposable 2 day (WB-2L) and 6 day (WB-6L) devices, but are user replaceable in the Reusable device (WB-RL). The battery life for the 2 day device is specified to be 50 hours when used at setting 3. The battery life for the 6 day and Reusable devices is specified to be 150 hours when used at setting 3.

The acceptance criteria and study that proves the device meets the acceptance criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not describe a new clinical study with a "test set" in the traditional sense for evaluating the ReliefBand™ NST™ Model WB-xL family. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K982436 and K983907). This means the "provenance" of the data for this submission is historical, relying on the data that supported the clearance of the predicate devices.

• Sample Size for Test Set: Not applicable, as no new clinical test set with human subjects is described for the WB-xL family. The submission refers to "performance data" but does not specify a distinct new study or sample size for this specific family of devices.
• Data Provenance: The data provenance for demonstrating equivalence would stem from the studies and data submitted for the predicate devices (K982436 and K983907), which are not detailed in this document. The current submission is a retrospective comparison to existing cleared devices.

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

Not applicable. As this submission relies on substantial equivalence to predicate devices, there's no mention of a new test set requiring expert ground truth establishment for this specific submission. The expertise would have been part of the original predicate device clearances.

4. Adjudication Method for the Test Set

Not applicable. No new test set or clinical study with human observations requiring adjudication is described for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technological characteristics and existing performance data from predicate devices, not on comparing human reader performance with or without AI assistance. The device in question is a nerve stimulation device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The ReliefBand™ NST™ is a physical medical device for nerve stimulation, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant to this submission.

7. The Type of Ground Truth Used

The "ground truth" for this submission is effectively the established safety and effectiveness profile of the predicate devices (ReliefBand® NST™ Models WB-2, WB-6, and WB-R, cleared under K982436 and K983907). The argument is that the new devices are so similar in design and function that they inherently share the same "truth" of efficacy and safety as the predicates.

8. The Sample Size for the Training Set

Not applicable. The ReliefBand™ NST™ is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI model.

Summary of the Study Proving Acceptance Criteria:

The document describes a 510(k) premarket notification for the ReliefBand™ NST™ Device Models WB-2L, WB-6L, and WB-RL. The acceptance criterion for these devices is substantial equivalence to legally marketed predicate devices: ReliefBand® NST™ Models WB-2, WB-6, and WB-R (cleared under K982436 and K983907).

The study proving this acceptance criterion is a comparison of technological characteristics and performance data between the new devices and the predicate devices. The submission asserts that the new models are "of comparable type" and have equivalent technological characteristics to the predicates. While the detailed performance data itself is not provided in this excerpt, the submission explicitly states that "The performance data indicate that the ReliefBand® NST™ Device Models WB-2L, WB-6L, and WB-RL are substantially equivalent to the ReliefBand® Devices distributed under K982436 and K983907." This statement, along with the detailed device description, forms the basis of their claim for substantial equivalence, which the FDA concurred with. The battery life specifications for the new models indicate that they meet pre-defined performance metrics, but these are part of the overall demonstration of equivalence, not a standalone clinical trial.

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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 is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).

ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R

The provided text is a 510(k) clearance letter from the FDA for the Relief Band® NST™ Device. This document does not contain information regarding acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or expert qualifications. It only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its indications for use.

Therefore, I cannot provide the requested information based on the given text. A 510(k) summary or the full 510(k) submission would be needed to extract these details.

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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:

1. 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.

2. 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.

3. 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.

4. 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.

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. The device is a nerve stimulation therapy device, not an AI-based diagnostic tool requiring human reader comparison.

6. 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.

7. 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."

8. The sample size for the training set
   Not applicable, as this is not an AI algorithm requiring a training set.

9. 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):

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.

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