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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).

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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.

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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.

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