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The Sea-Band Limited "Sea-Band" is indicated for the relief of nausea.

(Nausea is a symptom that may be experienced due to a variety of causes, for example:

• . Travel/Motion
• Pregnancy (Morning Sickness) .
• . Chemotherapy
• Post Operative) .

The "Sea-Band" consists of elasticated wrist band with a plastic button. The button is designed to apply pressure to the P6 or "nei-kuan", acupuncture point.

"Sea-Bands" are designed to be worn on each wrist and are supplied in pairs in a plastic case. The case is contained in an outer cardboard box with instructions for use.

The Sea-Band Ltd , Sea-Band will be available in a variety of different colors and pack types.

I am sorry, but based on the provided text, there is no information about explicit acceptance criteria or a study designed to prove the device meets such criteria in the way you've described for a medical device with performance metrics.

The document is a 510(k) summary for the Sea-Band, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against predefined acceptance criteria. This is a common approach for 510(k) submissions, where the safety and effectiveness of a new device are established by showing it is as safe and effective as a legally marketed device.

Here's why I cannot complete the table and answer your questions directly:

• No Explicit Acceptance Criteria: The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy) or thresholds for those metrics that the Sea-Band needed to achieve.
• No Dedicated Performance Study: Instead of a study to prove performance against criteria, the submission relies on:
  • "Published clinical evaluations": This refers to existing literature supporting the general principle of acupressure for nausea relief, and likely for the predicate devices. It does not describe a specific study conducted for this Sea-Band device with a predefined study design, sample size, or ground truth establishment.
  • "Biocompatibility data": This relates to material safety, not clinical performance for nausea relief.
  • "Bench testing of physical properties of realtime age data": This also relates to product integrity/durability, not clinical efficacy.
  • Substantial Equivalence Argument: The core of the submission is that the Sea-Band is "substantially equivalent" to other legally marketed products (like the Acu-Band and ReliefBand® products) based on technological characteristics (applying pressure to the P6 point) and general indications for use.

Therefore, I cannot extract the following information:

• Table of Acceptance Criteria and Reported Device Performance: This information is not present.
• Sample size used for the test set and the data provenance: There is no described test set or clinical study for this specific device.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• The type of ground truth used: Not applicable, as there's no described clinical study for this specific device.
• The sample size for the training set: Not applicable (no algorithm).
• How the ground truth for the training set was established: Not applicable.

The submission focuses entirely on substantial equivalence to existing devices cleared by the FDA, implying that since the predicate devices are considered safe and effective, and this device is similar, it too should be considered safe and effective.

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