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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.

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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® 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.

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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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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.

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