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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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