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The acupressure bracelets are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

The TumEase Acupressure bracelet is a wrist bracelet that has a small round bump on the inside face of the bracelet. This small bump is manually aligned with the P6 (Neiguan or Pericardium) acupressure point. The bracelet is affixed using a Velcro strap and the desire amount of pressure is applied. One key design feature is the ability to adjust the pressure level using the "tightness" of the Velcro strap. More pressure generally increases the desired anti-nausea affect. The functionality of the Veloro strap allows each patient the ability to find the right amount of pressure for themselves based on their condition and needs. In addition, the TumEase bracelets are designed to be cosmetically attractive. It is supplied to the counter (non-sterile). The acupressure bracelets are intended to be worn over a thin fabric. It can be used as frequently as needed by the patient.

The provided document is a 510(k) summary for the TumEase Acupressure Bracelets, which is a regulatory submission to the FDA. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical performance metrics for clinical outcomes. Instead, it focuses on establishing substantial equivalence to predicate devices based on various specifications, and the "performance testing" section describes bench testing related to force applied.

Here's a breakdown of the comparison to predicate devices, which serves as the basis for demonstrating equivalence:

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

• Test Set Sample Size: The document only describes bench testing for "Performance Testing." It does not provide a specific sample size for this bench test, nor does it detail the number of units tested.
• Data Provenance: The bench testing involved comparing the TumEase product to the "Acu-Strap product." The origin of the Acu-Strap product or the environment of the test is not specified, but it's understood to be a controlled laboratory or engineering environment for mechanical testing. No patient data or clinical data provenance is mentioned as no clinical studies were conducted for this 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. The "test set" described is for mechanical/bench testing of physical properties (force applied), not clinical performance requiring expert ground truth establishment.

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

Not applicable. This concept is relevant for clinical studies where multiple experts independently evaluate data and consensus is needed. The testing performed was bench testing of physical attributes.

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

No. The device is a physical acupressure bracelet, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

Not applicable. The device is a physical product, not an algorithm.

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

For the bench testing, the "ground truth" was based on measured physical properties (force applied) of the TumEase device and a predicate device (Acu-Strap). The fixed pressure of the Acu-Strap served as a reference point.

8. The sample size for the training set

Not applicable. The device is a physical product and does not involve machine learning or a "training set" in the context of AI.

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

Not applicable, as there is no training set for this device.

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