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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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