(88 days)
The Acu-Strap™ Travel and Motion Sickness Band is intended for the relief of nausea. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy.
The Acu-Strap™ Travel and Motion Sickness Band product comprises a pair of wristbands, each with a round button added to the interior face of the band. Because the Acu-Strap™ Travel and Motion Sickness Band is stretchable, it will be sold in only one size. The Acu-Strap™ Travel and Motion Sickness Band operates by placing a constant pressure on an acupressure point (the P6 or "Nei-Kuan" point) near the wrist.
This document is a 510(k) summary for the Acu-Strap™ Travel and Motion Sickness Band. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not describe any clinical study with acceptance criteria for device performance.
Here's an analysis of why the requested information cannot be provided from the given document:
1. A table of acceptance criteria and the reported device performance:
- The document states: "Acu-Strap™ Travel and Motion Sickness Band has been subjected to testing for dimensions, elasticity, and relative pressure."
- It does not provide any specific acceptance criteria for these tests (e.g., "dimension must be X +/- Y mm", "elasticity must be within Z range") nor does it report the results or performance data of these tests.
- More importantly, it does not describe any clinical performance study (e.g., efficacy in reducing nausea) with associated acceptance criteria. The 510(k) relies on substantial equivalence to a predicate device, not on demonstrating clinical efficacy through a new study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No test set for clinical performance is mentioned. The only "tests" referred to are for physical characteristics: "dimensions, elasticity, and relative pressure." No sample sizes for these physical tests are provided.
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. There is no clinical test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 not an AI-assisted diagnostic tool and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable, as no clinical performance study is described.
8. The sample size for the training set:
- Not applicable, as no algorithm or machine learning model is being trained.
9. How the ground truth for the training set was established:
- Not applicable.
Conclusion:
The provided 510(k) summary for the Acu-Strap™ Travel and Motion Sickness Band focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics (dimensions, materials, mechanical characteristics) and intended use. It does not include details of a clinical study aimed at proving the device meets specific performance acceptance criteria for its intended clinical effect (nausea relief). Therefore, none of the requested information regarding acceptance criteria or a study proving clinical performance can be extracted from this document. The "performance testing" mentioned refers only to physical properties of the band, not its efficacy in treating nausea.
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