Search Results

ReliefBand(R) is indicated for use in the treatment of nausea, vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. ReliefBand is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For over the counter use.

ReliefBand® models 1.5 and 2.0 are battery-powered non-invasive digital therapeutic devices that are worn on the wrist like a watch. They are indicated for the counter use in the relief of mild to moderate nausea and retching associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness associated with pregnancy as an adjunct to antiemetics in reducing mild to moderate postoperative nausea.

ReliefBand 1.5 and 2.0 include two electrical contacts on the back of the device (ReliefBand 1.5) or on the clasp (ReliefBand 2.0), which must be placed firmly against the underside of the wrist at 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 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 includes a five-level (ReliefBand 1.5) or 10-level (ReliefBand 2.0) LED that indicates the signal intensity. 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 face of the devices. A low battery indicator LED is also included on the face of the devices. ReliefBand 1.5 uses disposable batteries while ReliefBand 2.0 has a lithium-ion rechargeable battery. A fully charged battery will last for up to 18 hours of continuous use at the mid-power level or below.

This FDA 510(k) summary for ReliefBand 1.5 and ReliefBand 2.0 indicates that the devices are substantially equivalent to their predicate devices (ReliefBand 1.5 K173233 and ReliefBand 2.0 K182960). The submission does not include a study proving that the device meets specific acceptance criteria based on performance because the claim for substantial equivalence is based on the lack of changes to the device's technical characteristics and performance specifications.

Therefore, the requested information regarding acceptance criteria and the study proving the device meets them, including sample sizes, ground truth establishment, expert adjudication, or MRMC studies, is not available in the provided text.

The document explicitly states:

• "The subject and the predicate ReliefBand devices are identical. Only the wording in the indications for use has changed."
• "The are no changes in technical characteristic between the predicate and the subject devices."
• "The performance specifications for the applicant ReliefBand devices are identical, and thus substantially equivalent, to the predicate devices."
• "Substantial equivalence was determined on the basis that there have been no changes in the physical device, technology, mechanism of action or intended use. Device modifications include only the clarified intended use, which includes an additional anticipated source of nausea (physician-diagnosed migraine) that Reliefband is intended to treat. These changes do not impact the safety of efficacy of the ReliefBand 1.5 or ReliefBand 2.0 devices."

This means ReliefBand Technologies LLC is asserting that because the device itself (hardware, technology, mechanism of action, performance specifications) is unchanged from previously cleared devices, no new performance study is required to demonstrate its effectiveness against specific acceptance criteria for this 510(k) submission. The FDA concurred with this assessment for substantial equivalence.

In summary, based on the provided text, the device's substantial equivalence is established by its identity to predicate devices, not by a new clinical or performance study with defined acceptance criteria.

If such a study existed, it would likely have been part of the original 510(k) submissions for the predicate devices (K173233 and K182960).

Ask a specific question about this device

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

Reliefband® is a digital therapeutic device indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, morning sickness associated with pregnancy, and chemotherapy. Reliefband® is also indicated as an adjunct to antiemetic therapy in reducing postoperative nausea.

The ReliefBand® 1.5 is a non-invasive device that is indicated for the counter use in the relief of mild to moderate nausea, retching 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. This device was originally marketed under its predicate name of Reliefband RB-EL (K020180) when owned by Woodside Biomedical, Inc. The devices are technologically identical. The same contract manufacturer has made this device for decades.

Exactly like its predicate, the Reliefband 1.5 is contained within a wristband, and provides relief of nausea, retching and vomiting through electrical stimulation of the nerves on the ventral side of the patient's wrist. The device can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, 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 ReliefBand® 1.5 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 provided document, a 510(k) Summary for the ReliefBand® 1.5 device (K173233), primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific performance acceptance criteria through clinical studies.

The core argument for the ReliefBand® 1.5's acceptance is that it is technologically identical to its predicate device, the Reliefband® RB-EL (K020180). Therefore, the performance and acceptance of the predicate device are directly applied to the new device.

Because the submission relies on substantial equivalence based on technological identity, a new study proving the device meets acceptance criteria similar to what would be done for a novel or significantly modified device is not described.

Here's an analysis of the provided information in the context of your questions:

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

• Acceptance Criteria: The document does not explicitly state numerical "acceptance criteria" for performance that the new device had to meet through a new study. Instead, the acceptance criterion is substantial equivalence to the predicate devices. This means the device must perform as safely and effectively as the predicates.
• Reported Device Performance: The "Performance Data" section (Section 3) states: "The performance data indicate that the Relief is substantially equivalent to the predicate devices cleared to market via 510(k) #s: K994387 and K020180." This is a declarative statement of equivalence, not a presentation of new performance data from a study of the ReliefBand® 1.5.
• The "Technical Characteristics - Substantial Equivalency Table" provides a comparison of specifications between the subject device and the predicate devices (Section 2). This table effectively serves as the "performance data" demonstrating equivalence by showing identical or highly similar technical specifications. For example, Output Range, Waveform Characteristics, Maximum Charge Delivered, Voltage, and Channels are all essentially carried over from the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• No new test set or clinical study for performance is described for the ReliefBand® 1.5. The basis for clearance is technological identity and substantial equivalence to existing devices. Therefore, these questions are not applicable to this 510(k) submission.

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 performance study was conducted or described in this 510(k) summary, there's no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No new performance study 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. This device is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a hardware device, not an algorithm.

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

• Not applicable for new data. The "ground truth" for the ReliefBand® 1.5's effectiveness and safety is implicitly based on the historical performance and regulatory clearance of its technologically identical predicate devices.

8. The sample size for the training set

• Not applicable. This isn't an AI/machine learning device. No training set is involved.

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

• Not applicable.

In summary, the key takeaway from this 510(k) summary regarding "acceptance criteria" and "proof" is that:

• Acceptance Criteria: Substantial equivalence based on technological identity to a legally marketed predicate device (Reliefband® RB-EL, K020180).
• Proof: The "study" proving this device meets the acceptance criteria is a comparison of engineering specifications and design features that demonstrates the ReliefBand® 1.5 is the same device as the predicate, merely being re-marketed under new ownership/branding. No new clinical or performance studies were necessary or conducted for this specific submission because the device itself had not changed. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." based on this argument.

Ask a specific question about this device

The ReliefBand® device is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.

The ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are non-invasive devices which are indicated for over the counter use in the relief of nausea and vomiting (NV) due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy. The devices are contained within a wristband, and provide relief 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® device Model RB-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® device Model RB-xL family is powered by two 3V lithium batteries. The batteries are not user replaceable in the disposable device model RB-DL, but are user replaceable in the reusable device models RB-EL and RB-RL. The battery life for all models is specified to be 150 hours when used at setting 3.

Here's an analysis of the provided text regarding the ReliefBand® Device, specifically addressing the requested information:

The provided document (KO20180) is a 510(k) submission for the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL. It aims to demonstrate substantial equivalence to previously cleared predicate devices. Crucially, this submission does not contain specific acceptance criteria, performance data, or detailed study results for the new devices. Instead, it relies on the previously cleared predicate devices for performance validation.

Therefore, many of the requested categories cannot be directly answered from the provided text.

Acceptance Criteria and Device Performance

Since the entire submission is based on demonstrating substantial equivalence to predicate devices, there are no specific acceptance criteria defined or reported for the new devices (RB-DL, RB-EL, RB-RL) in this document.

The document states:

• "The performance data indicate that the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are substantially equivalent to the predicate ReliefBand® Devices distributed under K982967 and K994387."
• "Woodside Biomedical, Inc. has demonstrated through its evaluation of the ReliefBand® Device Models RB-DL, RB-EL, and RB-RL that the devices are equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness."

This means the acceptance criteria and performance were implicitly met by demonstrating "substantial equivalence" to the predicate devices, which had previously undergone their own testing and established performance. The document doesn't provide what those criteria were for the predicate, nor how the new device's performance directly compared against them.

Detailed Breakdown of Study Information:

Due to the nature of this 510(k) submission (substantial equivalence to a predicate device rather than de novo clinical trials for the new models), much of the requested information regarding study details is not available in the provided text. The performance data section explicitly states that the performance data indicate substantial equivalence, but it does not provide the performance data itself for the new devices, nor the specifics of the studies that generated it. Instead, it refers back to the predicate devices' clearance numbers.

Here's what can be inferred or explicitly stated based on the document:

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

   • Acceptance Criteria: Not explicitly stated in this document for the new device models. The implied criterion is "substantial equivalence" to the predicate devices.
   • Reported Device Performance: Not explicitly stated in this document for the new device models. The document only claims "substantial equivalence" to the predicate devices regarding performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided in the document. The document does not describe direct testing on the new models (RB-DL, RB-EL, RB-RL) that would involve a "test set" in the context of clinical performance. The focus is on demonstrating technological equivalence to previously cleared devices.

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/Not provided. As no new test set/clinical study is described for the performance of the new models, there's no mention of experts establishing ground truth within this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. No new test set or adjudication process is described in this submission.

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 ReliefBand® is a transcutaneous nerve stimulator for nausea relief, not an AI-assisted diagnostic device. This type of study is irrelevant to this device.

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

   • Not applicable. The ReliefBand® is a physical medical device, not an algorithm.

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

   • Not explicitly stated for the new models. For the predicate devices, the "ground truth" for efficacy would likely have been patient-reported symptom relief (outcomes data) or a reduction in objectively measured nausea/vomiting episodes in clinical trials. However, this document does not detail those studies.

8. The sample size for the training set:

   • Not applicable/Not provided. As this is not an AI/algorithm-based device, there is no "training set."

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

   • Not applicable/Not provided. No training set is involved.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The ReliefBand® Device is indicated for the relief of nausea and vomiting (NV) due to motion sickness

ReliefBand® Device Models RB-2, RB-6, and RB-R

This document is a marketing clearance letter for the ReliefBand device, not a study describing acceptance criteria and device performance. Therefore, I cannot provide the requested information. The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indicated use of relieving nausea and vomiting due to motion sickness.

To answer your request, I would need a different type of document, such as a clinical study report or a summary of safety and effectiveness data.

Ask a specific question about this device

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.

Ask a specific question about this device

The ReliefBand is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.

The ReliefBand® Model SW-111 is a non-invasive nerve stimulation therapy device, and is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The device is contained within a wristband, and provides relief of NV through electrical stimulation of the P6 acupuncture area on the patient's wrist.

This acustimulation wrist band can be worn on either hand on the ventral or palmar (i.e., inside) surface of the wrist, approximately 2-3 fingers breadth above the distal skin crease of the wrist joint between the tendons of the palmaris longus and flexor carpi radialis muscles.

There are three operating modes based on pulse amplitude modulation scheme:

• Mode A: 2 second burst, 6 seconds off. This is the first setting in the 3 mode sequence.
• Mode B: 4 second burst. continuous. This is the second setting in the 3 mode sequence.
• Mode C: 2 second burst, continuous. This is the third setting in the 3 mode sequence.

There are six intensity levels present for each of the three operating modes, and the intensity setting determines the strength of the stimulation. The user display on the wristband identifies both the operating mode and intensity level, so the patient can select the desired stimulation. The wristband is powered by either three silver oxide batteries (type 392/IEC SR41, 1.5 V), or three zinc-air batteries (type 312/IEC PR41, 1.4V), and should not be immersed in water.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria in a quantitative manner. The submission largely focuses on establishing substantial equivalence to a predicate device.

However, based on the available information, we can infer some aspects and construct a table to reflect what is reported:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Table:

It's crucial to understand that the given document is a Summary of Safety and Effectiveness Section for a 510(k) submission from 1998. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to conduct new, extensive clinical trials proving novel performance against predefined numerical criteria. Therefore, the "acceptance criteria" here are largely inferred from the criteria for substantial equivalence itself. The "reported device performance" directly quotes or paraphrases the statements made in the document regarding the device's capabilities and how it compares to the predicate.

Missing Information:

The document lacks specifics on:

• Quantitative numerical acceptance criteria (e.g., "device must reduce nausea by X%").
• The exact methodology of the "performance data" study (e.g., number of participants, study design).
• Detailed statistical results demonstrating meeting any specific performance targets.

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

• Sample Size for Test Set: Not specified. The document states "The performance data indicate that the ReliefBand meets the functional requirements and specifications of devices used for acustimulation of the P6 point," but does not provide any details about a test set, sample size, or the specific study that generated this "performance data."
• Data Provenance: Not specified. It is unclear if the "performance data" refers to internal testing, a clinical study, or other forms of evaluation. The country of origin and whether the data is retrospective or prospective are not mentioned.

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

• This information is not provided. As no specific test set or clinical study supporting novel performance is detailed, there's no mention of experts establishing ground truth. The submission relies on demonstrating equivalence to an already cleared device.

4. Adjudication Method for the Test Set

• This information is not provided.

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

• No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on device characteristics and equivalence, not human-in-the-loop performance or comparison of human readers with/without AI.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

• Yes, implicitly. The "device performance" mentioned refers to the ReliefBand operating as a standalone medical device. As it's a physical nerve stimulation device and not an AI/software product, its "standalone performance" is its primary mode of operation without a human interpreting its output in the same way an AI algorithm's standalone performance might be assessed. However, no specific study solely focused on this "algorithm-only" performance with detailed metrics is described. The performance data generally refers to the device's functional characteristics.

7. Type of Ground Truth Used

• The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, outcomes data) is not directly applicable or mentioned in this context. The "performance data" statement is very general. The closest thing to "ground truth" for this type of device in a 510(k) context would be the established efficacy and safety profile of the predicate device, against which the new device seeks equivalence in its functional and technological characteristics.

8. Sample Size for the Training Set

• This information is not applicable and not provided. The ReliefBand is a hardware device for nerve stimulation, not a machine learning model that requires a training set.

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

• This information is not applicable and not provided, as there is no machine learning model or training set involved.

Ask a specific question about this device

To reduce the frequency of nausea and vomiting due to chemotherapy, motion sickness, and pregnancy.

Not Found

The provided document does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

The document is a 510(k) clearance letter from the FDA for a device named "ReliefBand." This letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for information about acceptance criteria, study details, or performance metrics from this document. This kind of information would typically be found in the 510(k) submission itself or in published clinical studies related to the device, not in the FDA clearance letter.

Ask a specific question about this device